Treatment of Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Quality Improvement, Quality Enhancement Research Initiatives, QuERI, Interventional, Multicenter, Inhaled corticosteroids, Pneumonia, Safety, De-implementation, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive, Pulmonary Diseases, Chronic Obstructive COPD
Brief summary
This Quality Enhancement Research Initiative (QuERI) project is designed to determine efficacy and acceptance of an intervention method to provide primary care providers with patient-tailored electronic consults and corresponding unsigned orders for de-implementation of inhaled corticosteroids (ICS) for patients with COPD when ICS are not indicated by guidelines.
Detailed description
Chronic obstructive pulmonary disease (COPD) is among the most common medical diagnoses among Veterans. Approximately half of those who carry a diagnosis of COPD are prescribed inhaled corticosteroids (ICS), despite ICS having no role among those patients without fixed airflow obstruction (AFO) and a limited role among those who do. Guidelines explicitly state that ICS for COPD patients should be limited to those with severe AFO and those with frequent exacerbations. Even this benefit comes at a cost, as ICS use has been shown in multiple randomized controlled trials to increase rates of pneumonia. After prolonged exposure, ICS is also associated with higher bone fracture risk, incidence of cataracts and poor diabetes control. Among patients without disease or with mild-moderate AFO and low risk of exacerbation, ICS have no demonstrated efficacy, but retain the risk of harm. For this reason, evidence-based guidelines specifically recommend against their use in mild-moderate AFO. The goal of this project is to improve the delivery and safety of care by de-implementing the ineffective use of ICS among Veterans with a diagnosis of COPD who otherwise lack a clinical indication for the medication. The primary aim is to reduce ICS use among Veterans with limited clinical indication for the medication. Investigators will test an intervention to de-implement unnecessary use of inhaled corticosteroids in Veterans with chronic obstructive pulmonary disease (COPD) by having pulmonologists assume more responsibility for supporting COPD patients. The investigators will compare a substitution approach using proactive patient-tailored electronic consult (E-consult) compared to usual care with a single-session education outreach, which represents a non-intensive unlearning approach. The investigators are targeting the intervention to Patient Aligned Care Team (PACT) providers who are randomized to either receive the intervention or not receive the intervention. For patients within intervention PACTs, the project clinicians will leverage the VA's integrated healthcare informatics system using specialist support through proactive patient-tailored electronic consults (E-consult) and inputting unsigned orders on behalf of Primary Care Providers (PCPs) to recommend and facilitate de-implementation of ICS. Primary care providers will have final say in accepting (signing), modifying, or declining the recommendations.
Interventions
Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Provider: Primary care provider (medical doctor/osteopathic physician, nurse practitioner, physician assistant \[MD/DO, NP, PA\]) assigned to a PACT from VA Puget Sound Health Care System or Edith Nourse Rogers Memorial Veterans Hospital (Bedford VA). Patient: * Patient is a Veteran who is assigned a VA PCP and has received Rx for an inhaled corticosteroid within the past 180 days. * Patient has an inpatient or outpatient diagnosis of COPD in the prior two years. * Patient has undergone spirometry in the past 5 years that indicates either no airflow obstruction or mild to moderate airflow obstruction indicated by a forced expiratory volume 1 (FEV1)/\[greater of forced vital capacity (FVC) or vital capacity (VC)\] =\< 0.7 & FEV1% predicted \>= 30%.
Exclusion criteria
Patients: * Very severe airflow obstruction (\<30% FEV1 % predicted) * Severe disease as indicated by 1 inpatient COPD exacerbation in the year prior * Severe disease as indicated by 2 outpatient COPD exacerbations in the year prior * International Classification of Diseases (ICD) 9 and/or 10 diagnosed or clinically indicated asthmatics * Significant bronchodilator response on spirometry (\>12% increase in FEV1 post bronchodilator; \>375 mL post-bronchodilator improvement)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months. | Assessed at 6 months post primary care visit defined as (index date + 180 days) | Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Pneumonia | Within 6 months defined as (index date +1 day) to (index date + 180 days) | Rate of pneumonia within 6 months starting the day after index date. |
| Mortality | Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days) | Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days) |
| Number of Patients Recommended to Stop Inhaled Corticosteroids | Collected at time of recommendation/order entry | Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids |
| Rate of COPD Exacerbation | Within 6 months defined as (index date +1 day) to (index date + 180 days) | Rate of COPD exacerbation within 6 months starting the day after index date. |
| Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date | Assessed at 6 months post index date | Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date |
| Number of Patients for Whom Recommendations Are Made | Collected at time or recommendation order entry | Among patients assigned to intervention providers, number of patients for whom recommendations are made. |
| Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers | Assessed during 6 months following index date | Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers |
Countries
United States
Participant flow
Recruitment details
Prior to study start, we stratified all primary care teams based on site, provider type, and median number of eligible patients. Primary care teams were the unit of randomization, and providers were randomized along with their primary care team in a 1:1 ratio. For new providers, the unit of randomization was at the level of the PCP (stratified by site, provider type and median number of eligible patients).Only PCPs were considered enrolled. Patients were not considered enrolled in this study.
Pre-assignment details
Prior to study start, we identified 139 primary care teams eligible for randomization; 2 primary care teams lost their associated provider prior to study start, leaving 137 primary care teams for initial randomization. Periodically, the Corporate Data Warehouse was queried to determine active primary care providers(PCPs) and their care teams. New PCPs and new care teams were added, resulting in a total of 220 distinct PCP-primary care team combinations.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Patients Standard practice (usual care). Primary care providers treat their patients as usual. | 281 |
| Intervention Patients Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care. | 269 |
| Usual Care Providers Standard practice (usual care). Primary care providers treat their patients as usual. | 88 |
| Intervention Providers Primary care clinicians receive patient-tailored guideline concordant treatment recommendations, including orders and rationale to discontinue inhaled corticosteroids.
Guideline treatment recommendations: Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care. | 93 |
| Total | 731 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Patients | Appointment rescheduled/cancelled | 5 | 7 |
| Patients | Deceased between review and index date | 0 | 1 |
| Patients | Hospice care | 0 | 1 |
| Patients | No capacity to review | 8 | 11 |
| Patients | No history of COPD | 0 | 1 |
| Patients | No ICS Rx upon review | 1 | 1 |
| Patients | PCP not assigned a clinic | 4 | 0 |
| Patients | PFT entry criteria not met | 43 | 50 |
| Patients | Protocol Violation | 2 | 1 |
| Providers | Without eligible patients | 21 | 28 |
Baseline characteristics
| Characteristic | Usual Care Patients | Intervention Patients | Total | Usual Care Providers | Intervention Providers |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | — | — |
| Age, Categorical >=65 years | 206 Participants | 211 Participants | 417 Participants | — | — |
| Age, Categorical Between 18 and 65 years | 75 Participants | 58 Participants | 133 Participants | — | — |
| Age, Continuous | 69.1 years STANDARD_DEVIATION 8.8 | 70.7 years STANDARD_DEVIATION 9 | 69.9 years STANDARD_DEVIATION 8.9 | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants | — | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 271 Participants | 257 Participants | 528 Participants | — | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 7 Participants | 13 Participants | — | — |
| Mean number of eligible patients | — | — | 4.1 number of patients STANDARD_DEVIATION 3.5 | 4.0 number of patients STANDARD_DEVIATION 3.5 | 4.1 number of patients STANDARD_DEVIATION 3.6 |
| Provider type Advanced Practice Providers | — | — | 64 Participants | 31 Participants | 33 Participants |
| Provider type Physicians | — | — | 117 Participants | 57 Participants | 60 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 5 Participants | 7 Participants | — | — |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants | — | — |
| Race (NIH/OMB) Black or African American | 15 Participants | 12 Participants | 27 Participants | — | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 1 Participants | 5 Participants | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 23 Participants | 38 Participants | — | — |
| Race (NIH/OMB) White | 244 Participants | 227 Participants | 471 Participants | — | — |
| Region of Enrollment United States | 281 Participants | 269 Participants | 550 Participants | — | — |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants | — | — |
| Sex: Female, Male Male | 274 Participants | 264 Participants | 538 Participants | — | — |
| Site Site 1 | 67 Participants | 57 Participants | 148 Participants | 12 Participants | 12 Participants |
| Site Site 2 | 214 Participants | 212 Participants | 583 Participants | 76 Participants | 81 Participants |
| Smoking Current Smoker | 115 Participants | 93 Participants | 208 Participants | — | — |
| Smoking Former or Never Smoker | 155 Participants | 162 Participants | 317 Participants | — | — |
| Smoking Missing | 11 Participants | 14 Participants | 25 Participants | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 281 | 10 / 269 |
| other Total, other adverse events | 0 / 281 | 0 / 269 |
| serious Total, serious adverse events | 41 / 281 | 30 / 269 |
Outcome results
Primary
Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months.
Percentage of patients with discontinued or expired and not renewed inhaled corticosteroids that remain off at 6 months from index date.
Time frame: Assessed at 6 months post primary care visit defined as (index date + 180 days)
Population: Patient participants that are assigned to usual care or intervention primary care providers.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months. | 94 Participants |
| Intervention | Percentage of Patients With Discontinued or Expired and Not Renewed Inhaled Corticosteroids That Remain Off at 6 Months. | 174 Participants |
p-value: <0.00195% CI: [2.5, 5.38]Regression, Logistic
Secondary
Mortality
Mortality determined by the presence of date of death occurring between (index date + 1 day) to (index date + 180 days)
Time frame: Assessed during 6 months following primary care visit defined as (index date + 1 day) to (index date + 180 days)
Population: Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Mortality | 9 Participants |
| Intervention | Mortality | 10 Participants |
Secondary
Number of Patients for Whom Recommendations Are Made
Among patients assigned to intervention providers, number of patients for whom recommendations are made.
Time frame: Collected at time or recommendation order entry
Population: We identified 269 patients meeting entry and exclusion criteria cared for by a primary care provider assigned to the intervention group. Of these, 262 received an electronic consult with recommendations for guideline concordant COPD care.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Patients for Whom Recommendations Are Made | 262 Participants |
Secondary
Number of Patients Recommended to Stop Inhaled Corticosteroids
Among patients of intervention PCPs, number of patients recommended to stop inhaled corticosteroids
Time frame: Collected at time of recommendation/order entry
Population: Patient participants assigned to intervention PCPs.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Patients Recommended to Stop Inhaled Corticosteroids | 181 Participants |
Secondary
Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date
Percentage of patients where ICS discontinuation recommendations are accepted but restarted by 6 months following index date
Time frame: Assessed at 6 months post index date
Population: Patients where ICS discontinuation recommendation was accepted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Patients Where ICS Discontinuation Recommendations Are Accepted But Restarted by 6 Months Following Index Date | 24 Participants |
Secondary
Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers
Among patients assigned to intervention PCPs, percentage of recommendations to discontinue inhaled corticosteroids accepted by primary care providers
Time frame: Assessed during 6 months following index date
Population: Recommendations to discontinue inhaled corticosteroids. A recommendation to discontinue inhaled corticosteroids was made only once per patient.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of Recommendations to Discontinue Inhaled Corticosteroids Accepted by Primary Care Providers | 92.3 Percentage of recommendations |
Secondary
Rate of COPD Exacerbation
Rate of COPD exacerbation within 6 months starting the day after index date.
Time frame: Within 6 months defined as (index date +1 day) to (index date + 180 days)
Population: Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Rate of COPD Exacerbation | 0.11 Events per 6 months of person-time |
| Intervention | Rate of COPD Exacerbation | 0.09 Events per 6 months of person-time |
p-value: 0.4795% CI: [0.44, 1.47]Regression, Logistic
Secondary
Rate of Pneumonia
Rate of pneumonia within 6 months starting the day after index date.
Time frame: Within 6 months defined as (index date +1 day) to (index date + 180 days)
Population: Patient participants that are assigned to usual care or intervention primary care providers. One patient in the intervention group died between clinical review and the index date and was excluded from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Rate of Pneumonia | 0.03 Events per 6 months of person-time |
| Intervention | Rate of Pneumonia | 0.02 Events per 6 months of person-time |
p-value: 0.4295% CI: [0.2, 1.96]Regression, Logistic