Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
A prospective, multicenter study including a cross-section validation to define sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant Chronic Obstructive Pulmonary Disease (COPD), and its impact on clinical care across a broad range of primary care settings in a cluster randomized controlled clinical trial.
Detailed description
This is a large prospective, multi-center study explore the impact of the CAPTURE tool on clinical care and patient outcomes across a broad range of primary care settings in a cluster randomized controlled clinical trial. The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD. The CAPTURE study will enroll approximately 5,000 patients across 100 participating primary care clinics associated with practice-based research networks (PBRNs). Participants will be assessed with the CAPTURE Tool and have research spirometry testing. Participating primary care practices will be randomized in a 1:1 fashion to one of the following interventions: * Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education (CAPTURE+ COPD education). * Arm 2: Practice clinicians will receive basic COPD education only (COPD education) and will be blinded to patient-level CAPTURE information. A predefined subgroup of participants will undergo longitudinal follow-up at 12 months to determine the impact of the CAPTURE Tool on clinical care and patient outcomes. Participant reported data will be collected through in-person visits, telephone and mail-based methodologies, depending upon practice site preferences and feasibility. Clinic site data will also be collected from the medical record to assess for changes in practice-level care. Primary outcome measure changes have been made in this ClinicalTrials.gov record because a planned part of the primary outcome measure was inadvertently missing from the initial draft of the protocol. It has been added to this ClinicalTrials.gov record to align with the most recent IRB-approved protocol. Secondary outcome measure changes were initiated as driven by the literature and advances in accepted methods of management and categorization of patients with COPD. An additional secondary outcome measure was added due to the COVID-19 pandemic. The changes have been made in ClinicalTrials.gov to align with the most recent IRB-approved protocol.
Interventions
OTHERCOPD plus CAPTURE education and patient-level information
Basic COPD Education plus CAPTURE education and patient-level CAPTURE information will be provided to all practice personnel randomized to the 'CAPTURE + COPD Education' arm.
OTHERCOPD Education Only
Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
National Jewish Health
Wake Forest University Health Sciences
Duke University
High Plains Research Network
L.A. Net Community Health Resource Network
Oregon Health and Science University
University of Kentucky
University of Minnesota
COPD Foundation
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Masking description
Practitioners at sites randomized to the COPD education only intervention will be blinded to CAPTURE scores. Practitioners in both intervention arms will be blinded to research spirometry results. Participants will be blinded to spirometry results.
Intervention model description
Participating primary practices will be randomized to one of 2 arms. * Arm 1: Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education (CAPTURE+ COPD education). * Arm 2: Practice clinicians will receive basic COPD education only (COPD education).
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Provision of signed and dated informed consent form * 2\. Stated willingness to comply with all study procedures and availability for the duration of the study * 3\. Male or female, aged 45 - 80 years * 4\. Able to read and speak English or Spanish
Exclusion criteria
* 1\. Previous clinician provided diagnosis of COPD * 2\. Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days * 3\. Participants unable to perform spirometry due to any of the following conditions within the past 30 days 1. Chest surgery 2. Abdominal surgery 3. Eye surgery 4. Heart attack 5. Stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD | Baseline to 12 months | Proportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey. |
| Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination. | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below. | Baseline to 12 months | Proportion of CAPTURE+ participants currently smoking at the baseline visit who have any of the components of the Aim 3 primary endpoint: 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. OR 1\) clinical counseling or recommendation for smoking cessation, 2) referral to a smoking cessation program, 3) referral to a smoking quit line, 4) newly prescribed medication for smoking cessation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation. | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation. | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants | Baseline to 12 months | The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact. CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (\<350 L/min for males,\<250 L/min for females). Higher values = higher likelihood of COPD. The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months. Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change. The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC. |
| Proportion of CAPTURE+ Participants Who Experience Exacerbations. | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up. |
| Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of participants with clinically significant COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. (composite endpoint) Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey. |
| Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation. | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of participants with spirometric COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination. | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD. | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey. |
| Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation. | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint | Baseline to 12 months | Proportion of participants with Mild COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD With a New Diagnosis of COPD | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey. |
| Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation. | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With a Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination. | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of participants with preserved ratio, impaired spirometry (PRISm) who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Clinical Spirometry Testing. | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With New Diagnosis of COPD. | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Pulmonary Rehabilitation. | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Receive a Recommendation for or Administration of Influenza Vaccination. | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of participants with symptomatic non-obstructed (SNO) meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC\<0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Clinical Spirometry Testing. | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) With a New Diagnosis of COPD | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Pulmonary Rehabilitation. | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Who Receive a Recommendation or Administration of Influenza Vaccination. | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of CAPTURE+ participants enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of CAPTURE+ participants enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Newly Diagnosed With COPD | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Newly Diagnosed With COPD | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Have Received a Recommendation for, or Administration of Influenza Vaccination | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled Before March 20, 2019 | Baseline to 12 months | The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact. CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (\<350 L/min for males,\<250 L/min for females). Higher values = higher likelihood of COPD. The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months. Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change. The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC. |
| 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled on or After March 20, 2019 | Baseline to 12 months | The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact. CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (\<350 L/min for males,\<250 L/min for females). Higher values = higher likelihood of COPD. The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months. Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change. The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC. |
| Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Exacerbations. | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up. |
| Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Exacerbations. | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Meet Any of Components of the Primary Endpoints. | Baseline to 12 months | Proportion of participants with clinically significant COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 Who Meet Any of Components of the Primary Endpoints. | Baseline to 12 months | Proportion of participants with clinically significant COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 a New Diagnosis of COPD | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description) | Baseline to 12 months | Clinically significant COPD = post-bronchodilator FEV1/FVC \<0.7, plus: 1) FEV1 \< 60% predicted or 2) \> 1 exacerbation like event in the last year. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice. |
| Proportion of Participants With Clinically Significant COPD Enrolled After August 13, 2020 Who Receive a Recommendation for or Administration of Influenza Vaccination | Baseline to 12 months | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. |
| Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint | Baseline to 12 months | Proportion of participants with spirometric COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint | Baseline to 12 months | Proportion of participants with spirometric COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description) | Baseline to 12 months | Spirometric COPD: post-bronch FEV1/FVC \<0.7. If only pre-bronch spirometry is available and FEV1/FVC \< 0.65, subject will be considered to have COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice. |
| Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment (Abbreviated as Proportion in the Description) | Baseline to 12 months | Spirometric COPD: post-bronch FEV1/FVC \<0.7. If only pre-bronch spirometry is available and FEV1/FVC \< 0.65, participant will be considered to have COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice. |
| Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination | Baseline to 12 months | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. |
| Proportion of Mild COPD Participants Enrolled Before 3/20/2019 With Any of :1) Clinical Spirometry Referral, 2) New COPD Diagnosis, 3) Newly Prescribed Respiratory Medication, 4) Respiratory Specialist Referral, 5) Referral/Completion of Pulmonary Rehab | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory Mild COPD = post-bronch FEV1/FVC\<0.7 plus 1) FEV1 ≥ 60% and 2) No prior COPD exacerbation The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) aren't based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope Intervention - EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcome between subjects in same practice |
| Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint | Baseline to 12 months | Proportion of participants with mild COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description) | Baseline to 12 months | Mild COPD = post-bronch FEV1/FVC\<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference). When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice. |
| Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description) | Baseline to 12 months | Mild COPD = post-bronchodilator FEV1/FVC\<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice. |
| Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication (Abbreviated as Proportion in the Description) | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD = post-bronchodilator FEV1/FVC\<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and c |
| Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination | Baseline to 12 months | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. |
| Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With New Diagnosis of COPD | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With New Diagnosis of COPD | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description) | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) = participants without spirometrically defined COPD who have post-bronch FEV1 \< 80% predicted. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference). When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice. |
| Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination | Baseline to 12 months | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | Baseline to 12 months | Proportion of participants with symptomatic non-obstructed (SNO) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description) | Baseline to 12 months | SNO = post-bronch FEV1/FVC ≥ 0.7 and post-bronch FEV1 ≥ 80% predicted and a COPD Assessment Test (CAT) score ≥ 10. The CAT is scored 0-40. Higher score = more severe COPD The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits not based on raw data proportions. Reported units are on the scale from 0% - 100%. Ie. 50 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope Intervention - EUC proportion = slope. Ie 10 = Intervention met outcome 10% \> EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 With a New Diagnosis of COPD | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Newly Prescribed Respiratory Medication | Baseline to 12 months | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination. | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination. | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Received Over-the-counter Patches/Gum for Smoking Cessation | Baseline to 12 months | — |
| Proportion of CAPTURE+ Participants Who Experience Hospitalizations | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Number of Enrolled CAPTURE+ Participants Who Experience Mortality | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Hospitalizations | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Hospitalizations | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Number of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Mortality. | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Number of CAPTURE+ Participants Enrolled After March 20, 2019 Who Experience Mortality. | Baseline to 12 months | CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. |
| Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | Baseline to 12 months | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results Intervention Arm: Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results. | 1,118 |
| Intervention Arm: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results Intervention Arm: Practice clinicians received basic COPD education, CAPTURE education, and clinician receipt of patient-level CAPTURE screening results. | 51 |
| Enhanced Usual Care Arm: COPD Education Enhanced Usual Care Arm: Practice clinicians received basic COPD education only. | 886 |
| Enhanced Usual Care Arm: COPD Education Enhanced Usual Care Arm: Practice clinicians received basic COPD education only. | 48 |
| Total | 2,103 |
Baseline characteristics
| Characteristic | Intervention Arm: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Total | Enhanced Usual Care Arm: COPD Education |
|---|---|---|---|
| Acute respiratory illness in the past 12 months before baseline False | 966 Participants | 1729 Participants | 763 Participants |
| Acute respiratory illness in the past 12 months before baseline Missing | 1 Participants | 3 Participants | 2 Participants |
| Acute respiratory illness in the past 12 months before baseline True | 151 Participants | 272 Participants | 121 Participants |
| Age, Continuous | 62 Years STANDARD_DEVIATION 9 | 62 Years STANDARD_DEVIATION 9 | 63 Years STANDARD_DEVIATION 9 |
| Asthma and respiratory medication Asthma with maintenance respiratory medication | 77 Participants | 139 Participants | 62 Participants |
| Asthma and respiratory medication Asthma with SABD only | 59 Participants | 113 Participants | 54 Participants |
| Asthma and respiratory medication Missing Data | 3 Participants | 5 Participants | 2 Participants |
| Asthma and respiratory medication No asthma, and no respiratory medication | 825 Participants | 1486 Participants | 661 Participants |
| Asthma and respiratory medication No asthma, but short-acting bronchodilator (SABD) or maintenance respiratory medication | 87 Participants | 149 Participants | 62 Participants |
| Asthma and respiratory medication No asthma with no respiratory medication | 67 Participants | 112 Participants | 45 Participants |
| Body Max Index (BMI) | 33 kg/m2 STANDARD_DEVIATION 8 | 33 kg/m2 STANDARD_DEVIATION 8 | 33 kg/m2 STANDARD_DEVIATION 8 |
| CAPTURE question 5 response None | 810 Participants | 1482 Participants | 672 Participants |
| CAPTURE question 5 response Once | 154 Participants | 263 Participants | 109 Participants |
| CAPTURE question 5 response Two or more | 154 Participants | 259 Participants | 105 Participants |
| Cigarette smoking Current | 223 Participants | 369 Participants | 146 Participants |
| Cigarette smoking Former | 373 Participants | 656 Participants | 283 Participants |
| Cigarette smoking Missing | 4 Participants | 5 Participants | 1 Participants |
| Cigarette smoking Never | 518 Participants | 974 Participants | 456 Participants |
| Education College degree | 250 Participants | 468 Participants | 218 Participants |
| Education High school or GED | 298 Participants | 529 Participants | 231 Participants |
| Education Less than high school | 128 Participants | 246 Participants | 118 Participants |
| Education Missing Data | 5 Participants | 9 Participants | 4 Participants |
| Education Professional or graduate degree | 127 Participants | 245 Participants | 118 Participants |
| Education Vocational school or some college | 310 Participants | 507 Participants | 197 Participants |
| Employment Missing | 5 Participants | 6 Participants | 1 Participants |
| Employment Not working due to disability | 427 Participants | 803 Participants | 376 Participants |
| Employment Not working for reason other than disability | 488 Participants | 856 Participants | 368 Participants |
| Employment Working part-time or full-time | 198 Participants | 339 Participants | 141 Participants |
| Enrollment Date Before March 20, 2019 | 284 Participants | 364 Participants | 80 Participants |
| Enrollment Date Mar 20, 2020 or later | 293 Participants | 491 Participants | 198 Participants |
| Enrollment Date March 20, 2019 - November 19, 2019 | 277 Participants | 578 Participants | 301 Participants |
| Enrollment Date Sep 20, 2019 - Mar 19, 2020 | 264 Participants | 571 Participants | 307 Participants |
| Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) mean | 77 percent STANDARD_DEVIATION 8 | 76 percent STANDARD_DEVIATION 8 | 76 percent STANDARD_DEVIATION 8 |
| Forced Expiratory Volume in 1 second (FEV1), percent of predicted value | 81 percent predicted STANDARD_DEVIATION 16 | 81 percent predicted STANDARD_DEVIATION 17 | 82 percent predicted STANDARD_DEVIATION 19 |
| Forced Vital Capacity (FVC) percent of predicted value | 82 percent predicted STANDARD_DEVIATION 16 | 83 percent predicted STANDARD_DEVIATION 17 | 84 percent predicted STANDARD_DEVIATION 18 |
| Health insurance Other/Don't know | 24 Participants | 36 Participants | 12 Participants |
| Health insurance Private or both private and public insurance | 562 Participants | 1029 Participants | 467 Participants |
| Health insurance Public insurance or no insurance | 532 Participants | 939 Participants | 407 Participants |
| Maintenance respiratory medication Inhaled Corticosteroids (ICS) alone | 31 Participants | 53 Participants | 22 Participants |
| Maintenance respiratory medication Long-acting brochodilator (LABA) and ICS | 63 Participants | 118 Participants | 55 Participants |
| Maintenance respiratory medication Missing Data | 1 Participants | 2 Participants | 1 Participants |
| Maintenance respiratory medication None | 1014 Participants | 1812 Participants | 798 Participants |
| Maintenance respiratory medication Other combination of LABA, Long-acting beta2-agonist (LAMA), and ICS | 9 Participants | 19 Participants | 10 Participants |
| Number of participants with a COPD Assessment Test (CAT) Score ≥ 10 CAT score < 10 | 517 Participants | 968 Participants | 451 Participants |
| Number of participants with a COPD Assessment Test (CAT) Score ≥ 10 CAT score ≥ 10 | 600 Participants | 1035 Participants | 435 Participants |
| Number of participants with a COPD Assessment Test (CAT) Score ≥ 10 Missing Data | 1 Participants | 1 Participants | 0 Participants |
| Number of participants with Modified Medical Research Council dyspnea score ≥ 2 False | 285 Participants | 487 Participants | 202 Participants |
| Number of participants with Modified Medical Research Council dyspnea score ≥ 2 Missing | 2 Participants | 4 Participants | 2 Participants |
| Number of participants with Modified Medical Research Council dyspnea score ≥ 2 True | 831 Participants | 1513 Participants | 682 Participants |
| Participants with a history of asthma False | 203 Participants | 365 Participants | 162 Participants |
| Participants with a history of asthma Missing | 2 Participants | 3 Participants | 1 Participants |
| Participants with a history of asthma True | 913 Participants | 1636 Participants | 723 Participants |
| Practice Baseline Characteristic: Number of primary care clinicians 0 - 4 | 17 practices | 34 practices | 17 practices |
| Practice Baseline Characteristic: Number of primary care clinicians 10 or more | 11 practices | 25 practices | 14 practices |
| Practice Baseline Characteristic: Number of primary care clinicians 5 -0 | 21 practices | 36 practices | 15 practices |
| Practice Baseline Characteristic: Number of primary care clinicians Missing | 2 practices | 4 practices | 2 practices |
| Practice Baseline Characteristic: Practice is a residency site Missing | 1 practices | 2 practices | 1 practices |
| Practice Baseline Characteristic: Practice is a residency site No | 37 practices | 77 practices | 40 practices |
| Practice Baseline Characteristic: Practice is a residency site Yes | 13 practices | 20 practices | 7 practices |
| Practice Baseline Characteristic: Practice Type Federally Qualified Health Center | 10 practices | 18 practices | 8 practices |
| Practice Baseline Characteristic: Practice Type Independent practice | 6 practices | 9 practices | 3 practices |
| Practice Baseline Characteristic: Practice Type Missing | 1 practices | 2 practices | 1 practices |
| Practice Baseline Characteristic: Practice Type Other | 2 practices | 7 practices | 5 practices |
| Practice Baseline Characteristic: Practice Type Part of academic medical center/health system | 15 practices | 28 practices | 13 practices |
| Practice Baseline Characteristic: Practice Type Part of large health system, Accountable Care Organization (ACO), or similar | 17 practices | 35 practices | 18 practices |
| Practice Baseline Characteristic: Rural location No | 41 practices | 81 practices | 40 practices |
| Practice Baseline Characteristic: Rural location Yes | 10 practices | 18 practices | 8 practices |
| Practice Baseline Characteristic: Spirometry is performed in-house Missing | 1 practices | 2 practices | 1 practices |
| Practice Baseline Characteristic: Spirometry is performed in-house No | 22 practices | 39 practices | 17 practices |
| Practice Baseline Characteristic: Spirometry is performed in-house Yes | 28 practices | 58 practices | 30 practices |
| Race/Ethnicity, Customized Black or African American | 362 Participants | 598 Participants | 236 Participants |
| Race/Ethnicity, Customized Don't know/Prefer not to answer | 52 Participants | 142 Participants | 90 Participants |
| Race/Ethnicity, Customized Don't Know/Prefer not to answer | 45 Participants | 67 Participants | 22 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 89 Participants | 238 Participants | 149 Participants |
| Race/Ethnicity, Customized Missing Data | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Non-Hispanic/Non-Latino | 984 Participants | 1695 Participants | 711 Participants |
| Race/Ethnicity, Customized Other than White or Black/African American | 62 Participants | 106 Participants | 44 Participants |
| Race/Ethnicity, Customized White | 642 Participants | 1156 Participants | 514 Participants |
| Sex: Female, Male Female | 677 Participants | 1207 Participants | 530 Participants |
| Sex: Female, Male Male | 441 Participants | 797 Participants | 356 Participants |
| Short-acting bronchodilator Use False | 920 Participants | 1651 Participants | 731 Participants |
| Short-acting bronchodilator Use Missing Data | 1 Participants | 2 Participants | 1 Participants |
| Short-acting bronchodilator Use True | 197 Participants | 351 Participants | 154 Participants |
| Spirometry classification Normal spirometry | 478 Participants | 860 Participants | 382 Participants |
| Spirometry classification Preserved ratio, impaired spirometry | 372 Participants | 650 Participants | 278 Participants |
| Spirometry classification Spirometry-defined COPD | 180 Participants | 344 Participants | 164 Participants |
| Spirometry classification Undetermined | 88 Participants | 150 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 331 | 2 / 225 |
| other Total, other adverse events | 0 / 1,118 | 0 / 886 |
| serious Total, serious adverse events | 0 / 1,118 | 0 / 886 |
Outcome results
Primary
Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD
Proportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD | 45.9 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD | 41.9 percent |
p-value: 0.4795% CI: [-6.9, 15]generalized estimating equation contrast
Secondary
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants
The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact. CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (\<350 L/min for males,\<250 L/min for females). Higher values = higher likelihood of COPD. The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months. Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change. The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Time frame: Baseline to 12 months
Population: There was missing data from 2 participants in the Enhanced Usual Care arm and missing data from 4 participants in the Intervention arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants | -1.25 CAT score point scale |
| Enhanced Usual Care: COPD Education | 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants | -0.93 CAT score point scale |
p-value: 0.5595% CI: [-2.01, 1.36]Mixed Models Analysis
Secondary
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled Before March 20, 2019
The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact. CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (\<350 L/min for males,\<250 L/min for females). Higher values = higher likelihood of COPD. The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months. Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change. The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled Before March 20, 2019 | -2.44 CAT score point scale |
| Enhanced Usual Care: COPD Education | 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled Before March 20, 2019 | -1.30 CAT score point scale |
p-value: 0.9795% CI: [-6.42, 4.13]Generalized estimating equation contrast
Secondary
12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled on or After March 20, 2019
The COPD Assessment Test (CAT) is scored 0-40. Higher score = more severe COPD impact. CAPTURE+ is defined as a CAPTURE score ≥ 5, or CAPTURE score 2, 3, or 4 with low PEF (\<350 L/min for males,\<250 L/min for females). Higher values = higher likelihood of COPD. The mixed model for 12 month CAT change was: 12 month CAT change = intercept (Enhanced Usual Care (EUC) parameter) + slope (difference between Intervention and EUC) + practice random intercept. 12 month change units are CAT score differences; ie. if 12 month CAT change = 1, CAT score increased by 1 point in 12 months. Intercept term estimates mean EUC 12 month CAT change. The intercept + slope terms estimate mean intervention group 12 month CAT change. The slope estimates mean 12 month CAT change differences between Intervention versus EUC where difference direction is: Intervention results minus the EUC results; ie. if the slope = 1, the intervention group had 1 point higher 12 month CAT change compared to EUC.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled on or After March 20, 2019 | -0.92 CAT score point scale |
| Enhanced Usual Care: COPD Education | 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled on or After March 20, 2019 | -0.92 CAT score point scale |
p-value: 0.4795% CI: [-1.86, 1.85]Generalized estimating equation contrast
Secondary
Number of CAPTURE+ Participants Enrolled After March 20, 2019 Who Experience Mortality.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Analysis population is CAPTURE positive participants selected for follow-up and enrolled after March 20, 2019. This analysis population does not require a follow-up survey to be completed, hence the size of this analysis population differs from analyses requiring a follow-up survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Number of CAPTURE+ Participants Enrolled After March 20, 2019 Who Experience Mortality. | 2 Participants |
| Enhanced Usual Care: COPD Education | Number of CAPTURE+ Participants Enrolled After March 20, 2019 Who Experience Mortality. | 2 Participants |
Secondary
Number of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Mortality.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Analysis population is CAPTURE positive participants selected for follow-up and enrolled prior to March 20, 2019. This analysis population does not require a follow-up survey to be completed, hence the size of this analysis population differs from analyses requiring a follow-up survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Number of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Mortality. | 0 Participants |
| Enhanced Usual Care: COPD Education | Number of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Mortality. | 0 Participants |
Secondary
Number of Enrolled CAPTURE+ Participants Who Experience Mortality
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Analysis population is CAPTURE positive participants selected for follow-up. This analysis population does not require a follow-up survey to be completed, hence the size of this analysis population differs from analyses requiring a follow-up survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Number of Enrolled CAPTURE+ Participants Who Experience Mortality | 2 Participants |
| Enhanced Usual Care: COPD Education | Number of Enrolled CAPTURE+ Participants Who Experience Mortality | 2 Participants |
Secondary
Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline who had follow-up data available for referral information for a smoking quit line were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line | 55.60 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line | 59.54 percent |
p-value: 0.7695% CI: [-31.03, 23.16]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication | 37.05 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication | 30.22 percent |
p-value: 0.4595% CI: [-10.84, 24.5]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing | 37.52 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing | 24.19 percent |
p-value: 0.1995% CI: [-6.72, 33.38]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Have Received a Recommendation for, or Administration of Influenza Vaccination
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Have Received a Recommendation for, or Administration of Influenza Vaccination | 71.66 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Have Received a Recommendation for, or Administration of Influenza Vaccination | 82.70 percent |
p-value: 0.2395% CI: [-29.06, 7]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD | 24.62 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD | 23.77 percent |
p-value: 0.9395% CI: [-17.82, 19.52]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants currently smoking at baseline who had follow-up data for newly prescribed medication for smoking cessation were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation. | 55.14 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation. | 55.90 percent |
p-value: 0.9595% CI: [-25.36, 23.83]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation. | 12.01 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation. | 10.16 percent |
p-value: 0.8195% CI: [-13.17, 16.88]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline who had follow-up data available for referral information for smoking cessation programs were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program | 30.36 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program | 40.70 percent |
p-value: 0.4195% CI: [-34.78, 14.09]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment | 21.58 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment | 13.98 percent |
p-value: 0.4195% CI: [-10.58, 25.78]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation | 71.98 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation | 63.96 percent |
p-value: 0.5195% CI: [-15.38, 31.4]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Received Over-the-counter Patches/Gum for Smoking Cessation
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline who had follow-up data available for over-the-counter patches/gum cessation programs were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Received Over-the-counter Patches/Gum for Smoking Cessation | 41.52 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Received Over-the-counter Patches/Gum for Smoking Cessation | 56.18 percent |
p-value: 0.2195% CI: [-37.54, 8.22]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 19.78 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 7.30 percent |
p-value: 0.1695% CI: [-5, 29.96]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Newly Diagnosed With COPD
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Newly Diagnosed With COPD | 13.11 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Newly Diagnosed With COPD | 12.70 percent |
p-value: 0.9495% CI: [-10.97, 11.79]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing | 28.86 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing | 18.45 percent |
p-value: 0.4995% CI: [-19.39, 40.2]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | 11.34 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | 6.06 percent |
p-value: 0.4495% CI: [-8.07, 18.62]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Exacerbations.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Exacerbations. | 26.62 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Exacerbations. | 8.78 percent |
p-value: 0.0295% CI: [2.34, 33.34]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Hospitalizations
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Hospitalizations | 0.0 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Hospitalizations | 0.0 percent |
Secondary
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination | 88.30 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination | 95.39 percent |
p-value: 0.3995% CI: [-23.18, 9]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of CAPTURE+ participants enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 52.81 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 36.04 percent |
p-value: 0.0995% CI: [-2.89, 36.42]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication | 24.15 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication | 22.79 percent |
p-value: 0.8995% CI: [-18.01, 20.73]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 16.9 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 12.7 percent |
p-value: 0.2995% CI: [-3.6, 12.2]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Newly Diagnosed With COPD
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Newly Diagnosed With COPD | 14.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Newly Diagnosed With COPD | 12.1 percent |
p-value: 0.5795% CI: [-6.5, 11.8]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing | 30.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing | 19.6 percent |
p-value: 0.0695% CI: [-0.5, 22.1]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | 5.2 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | 6.8 percent |
p-value: 0.6295% CI: [-7.6, 4.5]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Exacerbations.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low peak expiratory flow (PEF), defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Exacerbations. | 23.7 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Exacerbations. | 15.9 percent |
p-value: 0.1295% CI: [-2, 17.6]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Hospitalizations
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Hospitalizations | 2.1 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Hospitalizations | 1.5 percent |
p-value: 0.6695% CI: [-2.1, 3.4]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination | 83.3 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination | 89.9 percent |
p-value: 0.0895% CI: [-13.9, 0.8]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of CAPTURE+ participants enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 45.7 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 42.0 percent |
p-value: 0.5695% CI: [-8.6, 15.9]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication | 26.1 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication | 28.4 percent |
p-value: 0.6595% CI: [-12.1, 7.6]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment | 17.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment | 12.3 percent |
p-value: 0.1695% CI: [-2.1, 12.3]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below.
Proportion of CAPTURE+ participants currently smoking at the baseline visit who have any of the components of the Aim 3 primary endpoint: 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. OR 1\) clinical counseling or recommendation for smoking cessation, 2) referral to a smoking cessation program, 3) referral to a smoking quit line, 4) newly prescribed medication for smoking cessation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Only Capture positive participants currently smoking at baseline who had complete follow-up data for all elements of the composite endpoints available were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below. | 83.37 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below. | 85.90 percent |
p-value: 0.6895% CI: [-14.5, 9.5]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Time frame: Baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD | 13.7 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD | 12.4 percent |
p-value: 0.7595% CI: [-6.7, 9.2]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
Population: Participants who completed the 12-month follow-up survey, which required them to survive, were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing | 30.0 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing | 19.6 percent |
p-value: 0.0595% CI: [0.1, 20.7]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation | 6.40 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation | 7.00 percent |
p-value: 0.8295% CI: [-6.4, 5.1]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Who Experience Exacerbations.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. Exacerbation is defined as acute respiratory illness requiring antibiotic/steroid during follow-up.
Time frame: Baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Who Experience Exacerbations. | 23.9 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Who Experience Exacerbations. | 15.3 percent |
p-value: 0.0595% CI: [-0.1, 17.4]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Who Experience Hospitalizations
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Who Experience Hospitalizations | Hospitalized for respiratory illness during follow-up | 4 Participants |
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Who Experience Hospitalizations | No hospitalized for respiratory illness during follow-up | 221 Participants |
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Who Experience Hospitalizations | Missing | 1 Participants |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Who Experience Hospitalizations | Hospitalized for respiratory illness during follow-up | 2 Participants |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Who Experience Hospitalizations | No hospitalized for respiratory illness during follow-up | 158 Participants |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Who Experience Hospitalizations | Missing | 1 Participants |
p-value: 0.7695% CI: [-2, 2.7]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination.
CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination. | 84.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination. | 90.8 percent |
p-value: 0.0695% CI: [-13, 0.4]Generalized estimating equation contrast
Secondary
Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.
Time frame: Baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication | 25.2 percent |
| Enhanced Usual Care: COPD Education | Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication | 27.9 percent |
p-value: 0.5495% CI: [-11.5, 6.1]Generalized estimating equation contrast
Secondary
Proportion of Mild COPD Participants Enrolled Before 3/20/2019 With Any of :1) Clinical Spirometry Referral, 2) New COPD Diagnosis, 3) Newly Prescribed Respiratory Medication, 4) Respiratory Specialist Referral, 5) Referral/Completion of Pulmonary Rehab
Respiratory medication = long acting bronchodilator or anti-inflammatory Mild COPD = post-bronch FEV1/FVC\<0.7 plus 1) FEV1 ≥ 60% and 2) No prior COPD exacerbation The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) aren't based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope Intervention - EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcome between subjects in same practice
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Mild COPD Participants Enrolled Before 3/20/2019 With Any of :1) Clinical Spirometry Referral, 2) New COPD Diagnosis, 3) Newly Prescribed Respiratory Medication, 4) Respiratory Specialist Referral, 5) Referral/Completion of Pulmonary Rehab | 0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Mild COPD Participants Enrolled Before 3/20/2019 With Any of :1) Clinical Spirometry Referral, 2) New COPD Diagnosis, 3) Newly Prescribed Respiratory Medication, 4) Respiratory Specialist Referral, 5) Referral/Completion of Pulmonary Rehab | NA percent |
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled After August 13, 2020 Who Receive a Recommendation for or Administration of Influenza Vaccination
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled After August 13, 2020 Who Receive a Recommendation for or Administration of Influenza Vaccination | 91.13 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled After August 13, 2020 Who Receive a Recommendation for or Administration of Influenza Vaccination | 94.00 percent |
p-value: 0.6995% CI: [-17.14, 11.39]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Meet Any of Components of the Primary Endpoints.
Proportion of participants with clinically significant COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Meet Any of Components of the Primary Endpoints. | 42.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Meet Any of Components of the Primary Endpoints. | 0 percent |
p-value: 1Fisher Exact
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)
Clinically significant COPD = post-bronchodilator FEV1/FVC \<0.7, plus: 1) FEV1 \< 60% predicted or 2) \> 1 exacerbation like event in the last year. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description) | 100 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description) | 100 percent |
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD | 14.3 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD | 0 percent |
p-value: 1Fisher Exact
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication | 42.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication | 0 percent |
p-value: 1Fisher Exact
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing | 14.3 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing | 0 percent |
p-value: 1Fisher Exact
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation | 0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation | 0 percent |
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment | 14.3 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment | 0 percent |
p-value: 1Fisher Exact
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 a New Diagnosis of COPD
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 a New Diagnosis of COPD | 26.62 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 a New Diagnosis of COPD | 13.96 percent |
p-value: 0.2195% CI: [-7.05, 32.37]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 Who Meet Any of Components of the Primary Endpoints.
Proportion of participants with clinically significant COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 Who Meet Any of Components of the Primary Endpoints. | 51.76 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 Who Meet Any of Components of the Primary Endpoints. | 49.69 percent |
p-value: 0.8795% CI: [-22.67, 26.79]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication | 21.04 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication | 39.33 percent |
p-value: 0.0895% CI: [-38.66, 2.08]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing | 18.14 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing | 23.66 percent |
p-value: 0.5695% CI: [-24.33, 13.28]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation | 6.54 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation | 12.02 percent |
p-value: 0.2995% CI: [-15.72, 4.77]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for clinically significant COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment | 9.31 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment | 9.98 percent |
p-value: 0.9295% CI: [-14.06, 12.71]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with clinically significant COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. (composite endpoint) Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint. | 50.05 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint. | 48.25 percent |
p-value: 0.8895% CI: [-21.47, 25.08]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination | 93.22 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination | 94.28 percent |
p-value: 0.8795% CI: [-13.39, 11.27]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD | 24.26 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD | 13.58 percent |
p-value: 0.2495% CI: [-7.27, 28.63]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication | 24.87 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication | 38.42 percent |
p-value: 0.1995% CI: [-33.65, 6.55]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing | 17.42 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing | 23.04 percent |
p-value: 0.5395% CI: [-23.21, 11.97]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation.
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation. | 5.63 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation. | 12.61 percent |
p-value: 0.1495% CI: [-16.12, 2.17]Generalized estimating equation contrast
Secondary
Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment
Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7, plus one of the following: 1) FEV1 \< 60% predicted or \> 1 exacerbation like event within the past 12 months.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for clinically significant COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment | 10.14 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment | 9.76 percent |
p-value: 0.9595% CI: [-12.5, 13.27]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)
Mild COPD = post-bronch FEV1/FVC\<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference). When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description) | 0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description) | 0 percent |
Secondary
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 0 percent |
Secondary
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 0 percent |
Secondary
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only CAPTURE+ participants enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination | 77.75 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination | 82.7 percent |
p-value: 0.8295% CI: [-47.92, 38.04]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)
Mild COPD = post-bronchodilator FEV1/FVC\<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description) | 0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description) | NA percent |
Secondary
Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication (Abbreviated as Proportion in the Description)
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD = post-bronchodilator FEV1/FVC\<0.7 plus: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and c
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication (Abbreviated as Proportion in the Description) | 0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication (Abbreviated as Proportion in the Description) | NA percent |
Secondary
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 20.1 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 12.5 percent |
p-value: 0.295% CI: [-4.1, 19.3]Wilcoxon (Mann-Whitney)
Secondary
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 4.0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 8.2 percent |
p-value: 0.2795% CI: [-12, 3.4]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 6.7 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 6.1 percent |
p-value: 0.8895% CI: [-7.8, 9]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
Proportion of participants with mild COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint | 30.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint | 28.9 percent |
p-value: 0.8295% CI: [-14.5, 18.4]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination | 86.3 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination | 87.4 percent |
p-value: 0.8795% CI: [-14.5, 12.2]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD | 12.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD | 7.9 percent |
p-value: 0.3695% CI: [-5.5, 15.3]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for mild COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication | 19.6 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication | 15.0 percent |
p-value: 0.4795% CI: [-7.9, 17.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing | 17.25 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing | 11.16 percent |
p-value: 0.2795% CI: [-4.63, 16.8]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation. | 3.49 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation. | 7.50 percent |
p-value: 0.2695% CI: [-10.97, 2.95]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment | 5.89 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment | 5.53 percent |
p-value: 0.9395% CI: [-8.13, 8.85]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint
Proportion of participants with Mild COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint | 27.02 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint | 28.66 percent |
p-value: 0.8495% CI: [-17.27, 13.99]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination.
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination. | 85.04 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination. | 87.07 percent |
p-value: 0.7495% CI: [-14.28, 10.21]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD With a New Diagnosis of COPD
Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD With a New Diagnosis of COPD | 11.36 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD With a New Diagnosis of COPD | 8.45 percent |
p-value: 0.5595% CI: [-6.59, 12.41]Generalized estimating equation contrast
Secondary
Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for mild COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication | 17.29 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication | 14.92 percent |
p-value: 0.6995% CI: [-9.09, 13.83]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 18.21 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 41.27 percent |
p-value: 0.0695% CI: [-47.4, 1.27]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | NA percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 0 percent |
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 17.60 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 29.87 percent |
p-value: 0.3495% CI: [-37.72, 13.18]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)
Preserved ratio, impaired spirometry (PRISm) = participants without spirometrically defined COPD who have post-bronch FEV1 \< 80% predicted. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits are not based on raw data proportions. Reported units are on the scale from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference). When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description) | NA percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description) | 100 percent |
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication | 13.17 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication | 55.27 percent |
p-value: 0.0195% CI: [-74.27, -9.92]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With New Diagnosis of COPD
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With New Diagnosis of COPD | 7.33 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With New Diagnosis of COPD | 9.05 percent |
p-value: 0.8495% CI: [-18.24, 14.8]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 17.6 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 14.4 percent |
p-value: 0.3995% CI: [-4, 10.4]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 3.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 4.7 percent |
p-value: 0.5995% CI: [-5.5, 3.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 12.6 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 10.2 percent |
p-value: 0.3995% CI: [-3.1, 7.9]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination | 84.7 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination | 84.3 percent |
p-value: 0.9495% CI: [-8.2, 8.8]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication | 18.3 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication | 15.8 percent |
p-value: 0.4795% CI: [-4.2, 9.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With New Diagnosis of COPD
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With New Diagnosis of COPD | 7.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With New Diagnosis of COPD | 5.5 percent |
p-value: 0.4295% CI: [-2.9, 6.9]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Clinical Spirometry Testing.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Clinical Spirometry Testing. | 18.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Clinical Spirometry Testing. | 15.9 percent |
p-value: 0.4695% CI: [-4.3, 9.6]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Pulmonary Rehabilitation.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Pulmonary Rehabilitation. | 4.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Pulmonary Rehabilitation. | 4.6 percent |
p-value: 0.9695% CI: [-4.3, 4]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred to a Specialist for Respiratory Evaluation/Treatment
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred to a Specialist for Respiratory Evaluation/Treatment | 13.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred to a Specialist for Respiratory Evaluation/Treatment | 11.2 percent |
p-value: 0.495% CI: [-3, 7.5]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with preserved ratio, impaired spirometry (PRISm) who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint. | 30.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint. | 30.4 percent |
p-value: 0.9895% CI: [-7.9, 8.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Receive a Recommendation for or Administration of Influenza Vaccination.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Receive a Recommendation for or Administration of Influenza Vaccination. | 85.2 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Receive a Recommendation for or Administration of Influenza Vaccination. | 85.1 percent |
p-value: 0.9895% CI: [-7.9, 8.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With a Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With a Newly Prescribed Respiratory Medication | 17.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With a Newly Prescribed Respiratory Medication | 17.5 percent |
p-value: 0.9695% CI: [-6.8, 6.5]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With New Diagnosis of COPD.
Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for preserved ratio, impaired spirometry (PRISm) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With New Diagnosis of COPD. | 7.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With New Diagnosis of COPD. | 5.8 percent |
p-value: 0.595% CI: [-3, 6.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled before March 18, 2020 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISM enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 29.03 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 66.7 percent |
p-value: 0.0395% CI: [-71.8, -3.5]Generalized estimating equation contrast
Secondary
Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 \< 80% predicted.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for PRISm enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 31.2 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 28.8 percent |
p-value: 0.5695% CI: [-5.6, 10.3]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)
Spirometric COPD: post-bronch FEV1/FVC \<0.7. If only pre-bronch spirometry is available and FEV1/FVC \< 0.65, subject will be considered to have COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description) | NA percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description) | 0 percent |
Secondary
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment (Abbreviated as Proportion in the Description)
Spirometric COPD: post-bronch FEV1/FVC \<0.7. If only pre-bronch spirometry is available and FEV1/FVC \< 0.65, participant will be considered to have COPD. The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits (CL) are not based on raw data proportions. Reported units are from 0% to 100%. Ie. 50.0 = 50% met outcome. EUC proportion = intercept. Intervention proportion = intercept + slope. Intervention minus EUC proportion = slope. Ie. 10.0 = Intervention met outcome 10% more than EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for different numbers of subjects in practices and correlation of outcomes between subjects in the same practice.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment (Abbreviated as Proportion in the Description) | NA percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment (Abbreviated as Proportion in the Description) | 0 percent |
Secondary
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | 0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | 0 percent |
Secondary
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
Proportion of participants with spirometric COPD enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint | 16.03 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint | 29.18 percent |
p-value: 0.3295% CI: [-39.06, 12.76]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination | 88.25 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination | 88.42 percent |
p-value: 0.9995% CI: [-26.06, 25.72]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD | 5.10 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD | 13.71 percent |
p-value: 0.4395% CI: [-30.19, 12.97]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication | 15.75 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication | 14.93 percent |
p-value: 0.9495% CI: [-20.92, 21.92]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 19.3 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 16.2 percent |
p-value: 0.5595% CI: [-7, 13.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 7.6 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 8.7 percent |
p-value: 0.895% CI: [-9.3, 7.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | 4.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation | 8.4 percent |
p-value: 0.1895% CI: [-9.7, 1.8]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
Proportion of participants with spirometric COPD enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint | 37.0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint | 37.2 percent |
p-value: 0.9895% CI: [-15.5, 15]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination | 87.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination | 90.1 percent |
p-value: 0.5995% CI: [-12, 6.8]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD | 17.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD | 9.9 percent |
p-value: 0.195% CI: [-1.4, 16.5]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants that met the criteria for spirometric COPD enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication | 20.1 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication | 23.5 percent |
p-value: 0.5595% CI: [-14.4, 7.6]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing | 17.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing | 15.1 percent |
p-value: 0.6395% CI: [-7.2, 11.8]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment | 7.6 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment | 8.1 percent |
p-value: 0.8995% CI: [-8.3, 7.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation. | 4.0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation. | 7.8 percent |
p-value: 0.1695% CI: [-9.2, 1.5]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with spirometric COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint. | 34.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint. | 36.2 percent |
p-value: 0.8195% CI: [-15.9, 12.4]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC \<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination. | 87.6 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination. | 89.8 percent |
p-value: 0.6295% CI: [-10.9, 6.5]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD.
Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD. | 15.9 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD. | 10.1 percent |
p-value: 0.1795% CI: [-2.5, 14.2]Generalized estimating equation contrast
Secondary
Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC\<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for spirometric COPD were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication | 19.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication | 22.7 percent |
p-value: 0.5895% CI: [-13, 7.3]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Newly Prescribed Respiratory Medication | 14.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Newly Prescribed Respiratory Medication | 15.2 percent |
p-value: 0.9795% CI: [-20.4, 19.5]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 21.7 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 25.1 percent |
p-value: 0.4895% CI: [-12.7, 6]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 4.1 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 5.0 percent |
p-value: 0.8295% CI: [-8.8, 7]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 8.1 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 9.9 percent |
p-value: 0.3995% CI: [-5.8, 2.3]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure. Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 35.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 35.2 percent |
p-value: 0.9395% CI: [-12.2, 13.4]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination. | 87.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination. | 94.8 percent |
p-value: 0.1495% CI: [-17.3, 2.5]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)
SNO = post-bronch FEV1/FVC ≥ 0.7 and post-bronch FEV1 ≥ 80% predicted and a COPD Assessment Test (CAT) score ≥ 10. The CAT is scored 0-40. Higher score = more severe COPD The generalized estimating equation (GEE) model for the Proportion: Proportion = intercept (Enhanced Usual Care (EUC) parameter) + slope (Intervention vs. EUC difference). Exchangeable correlation within practice assumed. GEE proportion estimates and confidence limits not based on raw data proportions. Reported units are on the scale from 0% - 100%. Ie. 50 = 50% met outcome EUC proportion = intercept. Intervention proportion = intercept + slope Intervention - EUC proportion = slope. Ie 10 = Intervention met outcome 10% \> EUC (absolute difference) When the GEE model does not converge, raw numbers other than 0% or 100% are inappropriate to report, CL are unavailable. Raw proportions do not account for the different numbers of subjects in practices and correlation of outcomes in the same practice
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled before March 20, 2019 were analyzed for this measure.~Participants enrolled before March 20, 2019 completed their 1 year follow-up prior to the COVID-19 pandemic onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description) | NA percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description) | 0 percent |
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for symptomatic non-obstructed (SNO) enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Newly Prescribed Respiratory Medication | 10.6 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Newly Prescribed Respiratory Medication | 22.7 percent |
p-value: 0.0495% CI: [-23.5, -0.6]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 17.1 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing | 13.1 percent |
p-value: 0.4595% CI: [-6.3, 14.2]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 6.2 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation | 5.6 percent |
p-value: 0.8695% CI: [-6.6, 7.9]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for symptomatic non-obstructed (SNO) enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 4.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment | 11.7 percent |
p-value: 0.0695% CI: [-14.9, 0.4]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
Proportion of participants with symptomatic non-obstructed (SNO) enrolled on or after March 20, 2019 who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 25.5 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint. | 33.7 percent |
p-value: 0.2595% CI: [-22, 5.7]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination. | 77.0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination. | 88.2 percent |
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for SNO enrolled on or after March 20, 2019 were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 With a New Diagnosis of COPD | 4.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 With a New Diagnosis of COPD | 6.7 percent |
p-value: 0.4895% CI: [-8.4, 3.9]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Meet Any of the Components of the Primary Endpoint.
Proportion of participants with symptomatic non-obstructed (SNO) meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC\<0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Meet Any of the Components of the Primary Endpoint. | 28.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Meet Any of the Components of the Primary Endpoint. | 32.6 percent |
p-value: 0.4695% CI: [-15.2, 6.8]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Newly Prescribed Respiratory Medication
Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Newly Prescribed Respiratory Medication | 12.3 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Newly Prescribed Respiratory Medication | 21.0 percent |
p-value: 0.0895% CI: [-18.3, 0.9]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Clinical Spirometry Testing.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Clinical Spirometry Testing. | 18.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Clinical Spirometry Testing. | 14.9 percent |
p-value: 0.3795% CI: [-4.7, 12.4]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Pulmonary Rehabilitation.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Pulmonary Rehabilitation. | 5.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Pulmonary Rehabilitation. | 5.0 percent |
p-value: 0.8995% CI: [-5.1, 5.9]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred to a Specialist for Respiratory Evaluation/Treatment
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred to a Specialist for Respiratory Evaluation/Treatment | 6.0 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred to a Specialist for Respiratory Evaluation/Treatment | 10.8 percent |
p-value: 0.1195% CI: [-10.6, 1.1]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) Who Receive a Recommendation or Administration of Influenza Vaccination.
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) Who Receive a Recommendation or Administration of Influenza Vaccination. | 80.4 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) Who Receive a Recommendation or Administration of Influenza Vaccination. | 89.1 percent |
p-value: 0.0595% CI: [-17.5, 0]Generalized estimating equation contrast
Secondary
Proportion of Participants With Symptomatic Non-obstructed (SNO) With a New Diagnosis of COPD
Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD (post-bronchodilator FEV1/FVC \< 0.7) and without PRISm (post-bronchodilator FEV1 ≥ 80% predicted) who have a COPD Assessment Test score ≥ 10. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.
Time frame: Baseline to 12 months
Population: Only participants who met the criteria for symptomatic non-obstructed (SNO) were analyzed for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results | Proportion of Participants With Symptomatic Non-obstructed (SNO) With a New Diagnosis of COPD | 4.8 percent |
| Enhanced Usual Care: COPD Education | Proportion of Participants With Symptomatic Non-obstructed (SNO) With a New Diagnosis of COPD | 5.7 percent |
p-value: 0.7595% CI: [-6, 4.4]Generalized estimating equation contrast