Chronic Obstructive Pulmonary Disease
Conditions
Keywords
pulmonary disease, chronic obstructive airflow, spirometry, primary healthcare, guideline-based therapy
Brief summary
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory (lung) disease that makes it harder to breathe over time. To date, there is no cure for COPD, but it can be managed when diagnosed and proper medical care is provided. The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient outcomes (the condition of a patient's health) compared to usual care which may or may not include the use of spirometry. Spirometry is a standardized test used in medical practice that measures how much air your lungs can hold and how forcefully you can breathe out. For this study, the investigators will compare two groups: 1) intervention (treatment) group and 2) usual care group (control). The intervention group will have a spirometry test and the results will be provided to the primary care physician. The usual care group will not initially have a spirometry test. Both groups will be followed for outcomes.
Detailed description
The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient associated outcomes compared to usual care which may or may not include the use of spirometry. To do this, we propose a comparative effectiveness trial of introducing a COPD assessment and management bundle targeted to primary care providers for patients suspected of having COPD versus usual care.
Interventions
DEVICESpirometry test
For the initial visit for the intervention group, an initial demographics form and a health questionnaire will given to the subject to complete. To evaluate the breathing and quality of living, a spirometry test will be performed that will evaluate how well and how fast the subject can breath and blow out air.
DRUGLevalbuterol
The spirometry test will be performed with a breathing medication called Levalbuterol (Xopenex®). Levalbuterol is used in standard practice for COPD and is commonly used during spirometry.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients, male and female, who are at least 40 years of age, receive primary treatment at the University of Illinois , and with any one of the following: New Diagnosis Inpatient or emergency department setting 1. New physician-diagnosis of COPD and/or new physician-diagnosis of asthma with a ≥10 pack year smoking without a spirometry 4 weeks or more after discharge from diagnosis setting. Outpatient setting 2. A new physician diagnosis of COPD within the past 6 months prior to their visit, without a spirometry or with a normal spirometry within the past 5 years prior to the diagnosis to the time of their visit. 3. A new physician diagnosis of asthma within past 6 months and a ≥10 pack year smoking history prior to their visit, without a diagnosis of COPD, without a spirometry or with a pre-bronchodilator spirometry with evidence of obstruction within the past 5 years prior to the diagnosis to the time of their visit. 4. Any patient with an existing physician-diagnosis of asthma within the past 2 years but \> 6 months prior to the time of their visit and a ≥10 pack year smoking history, without a diagnosis of COPD, using a respiratory medication in the past year, and no spirometry on record or had a pre-bronchodilator spirometry with evidence of obstruction on record for at least the past 5 years. Existing Diagnosis 5. Any patient with an existing physician-diagnosis of COPD within the past 2 years but \> 6 months prior to the time of their visit, and using a respiratory medication in the past year but no spirometry on record or had a spirometry without evidence of chronic obstruction in the past 5 years.
Exclusion criteria
1. Unable to perform adequate spirometry (e.g. muscle weakness, tracheostomy, cognitive dysfunction, mental retardation or other psychiatric disorders) 2. Non-English speaking 3. Pregnancy 4. Any patient planning to move away from the city within the next year. 5. Seen by a pulmonary specialist in the past 3 years. 6. Any terminal illness with a life expectancy of \<6 months (e.g. hospice care, malignancies) 7. Any patient with a physician diagnosis of COPD and had a pre or post-bronchodilator spirometry with evidence of chronic obstruction on record.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Accurate Classification of Irreversible Airflow Obstruction | spirometry was performed at the first visit for intervention group and at 1 year from recruitment for the usual care group, one time assessment for both groups | accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was \<0.7. |
Countries
United States
Participant flow
Pre-assignment details
None to report
Participants by arm
| Arm | Count |
|---|---|
| COPD Assessment and Management Recommendations Patients with a physician-diagnosed COPD or asthma suspicious for COPD being managed by the physician randomized to the intervention group will perform a spirometry test and provide information regarding their medical history on their initial visit, which is 90 minutes before their doctor's appointment. A letter containing the interpretation of spirometry test results, and recommendations for guideline based therapy based on GOLD guidelines will be available to the primary care doctor at the time of the patient's clinic visit. The doctor may review the results and use his or her own judgment in moving forward with the subject's diagnosis and management. A copy of the spirometry results and assessment based on the GOLD criteria at the time of the test of your subject will be uploaded to his or her electronic health record for future reference.
Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. | 34 |
| Usual Care Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care.
Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference. | 22 |
| Total | 56 |
Baseline characteristics
| Characteristic | Usual Care | COPD Assessment and Management Recommendations | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 13 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 21 Participants | 40 Participants |
| Age, Continuous | 57.0 years STANDARD_DEVIATION 6.9 | 60.3 years STANDARD_DEVIATION 10.1 | 58.9 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 22 participants | 34 participants | 56 participants |
| Sex: Female, Male Female | 17 Participants | 22 Participants | 39 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 22 |
| serious Total, serious adverse events | 0 / 34 | 0 / 22 |
Outcome results
Primary
Number of Participants With Accurate Classification of Irreversible Airflow Obstruction
accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was \<0.7.
Time frame: spirometry was performed at the first visit for intervention group and at 1 year from recruitment for the usual care group, one time assessment for both groups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COPD Assessment and Management Recommendations | Number of Participants With Accurate Classification of Irreversible Airflow Obstruction | 10 Participants |
| Usual Care | Number of Participants With Accurate Classification of Irreversible Airflow Obstruction | 5 Participants |