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| Name | Class |
|---|---|
| Clalit Health Services | OTHER |
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The goal of this clinical trial is to learn whether a special training program for primary care doctors can help improve treatment adherence and overall outcomes for people with chronic obstructive pulmonary disease (COPD).
The main questions it aims to answer are:
In this study:
The investigators hypothesize that a primary care physician-directed intervention, consisting of a seminar with up-to-date professional guidance and motivational interviewing course, would result in patients' higher adherence to treatment, improved care, and fewer COPD exacerbations.
The study aims:
This is a two-arm, parallel, randomized controlled trial conducted in a primary care setting, involving primary care physicians. All physicians will sign an informed consent form to participate.
The study will include two groups:
The effect of the intervention will be assessed based on the outcomes of all COPD patients that visited one of the physicians in the intervention/control groups during the first 6 months after study initiation. These patients will be identified retrospectively from medical charts. Assessment of patient care and outcomes will be analyzed retrospectively, 18 months after study initiation (end of study), addressing each patient's first 12 months from first relevant clinic visit.
Randomization of primary care physicians to each group will be performed with stratification to the number of registered individual COPD patients for each physician. In addition, randomization will be performed with blocks of clinics from areas of similar sociodemographic characteristics.
COPD medication adherence rates vary by geographic location but are usually around 25-30%. Based on previous research, the investigators conservatively assume that our intervention will lead to an absolute 17% increase in adherence during the 12 months from first follow-up. Considering the above, to achieve an alpha of 0.05 and a power of 80%, there is a need for 127 patients in each group. Given that participating primary care physicians must have seen at least 18 individual COPD patients in the past year, and assuming a similar rate of visits during the follow-up period, along with a 15-20% loss-to-follow-up due to changes in the treating physician, the investigators estimate that 20 primary care physicians will be needed in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | In the study, primary care physicians assigned to the intervention group will participate in a two-day seminar led by senior pulmonology specialists and family medicine specialists. The seminar will cover the following topic: Understanding COPD and current guidelines, inhaler technique and device selection, cardiovascular diseases in patients with COPD and possible interventions, motivational interview seminar, and two workshops for simulation and practice. The physicians will undergo a refresher workshop 3 months after entering the study, and visual and informative newsletter will be sent to them every 3 months. |
|
| Control | No Intervention | Primary care physicians that will be included without any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPD-care seminar | Behavioral | A two day seminar which will include: Lectures: Understanding COPD and Current Guidelines COPD pathophysiology. Review of the latest GOLD guidelines and treatment strategies Hands-on Session: Inhaler Technique and Device Selection Practical demonstration of different inhaler devices. Evaluating patient inspiratory effort and selecting suitable devices. Understanding advantages of each device and molecule. Cardiovascular diseases in COPD - real-world evidence, how to identify at-risk patients, and intervention. Motivational interview seminar- On line pre-course lectures about the theory behind motivational interview. Two workshops for simulation and practice of the technic through clinical cases with relevance to COPD patients including smoking cessation counseling techniques. Panel Discussion: Multidisciplinary Approach to COPD Management Involving respiratory specialists, physiotherapists, and primary care physicians. Discussion on referral practices and collaborative care. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to COPD-related inhalers | Change in inhaler adherence from first clinic visit after trial initiation. Measured by the purchase of prescribed COPD inhalers and compared with the control group. The primary outcome will be assessed using the Proportion of Days Covered (PDC) method, calculated as the percentage of days a patient has medication available over the observation period. This outcome will be comapred between the intervention and control groups | From first patient visit after study initiation to 12 months after. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in adherence to inhaler therapy pre-post study | Change in inhaler adherence among COPD patients of primary care physicians in the 12 months prior and after inclusion, measured by the purchase of prescribed COPD medications and compared with the control group. | From first patient visit after study initiation to 12 months after. |
| Measure | Description | Time Frame |
|---|---|---|
| New diagnoses of cardiovascular diseases - post hoc analysis | Rate of new diagnoses of cardiovascular diseases during the study period between the study groups, including diabetes, hypertension, hyperlipidemia, heart failure, coronary artery disease, peripheral vascular disease. Will be assessed by ICD codes. | From first patient visit after study initiation to 12 months after. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clalit health services | Tel Aviv | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33610138 | Background | Martinez FJ, Thomashow B, Sapir T, Simone L, Carter J, Han M. Does Evaluation and Management of COPD Follow Therapeutic Strategy Recommendations? Chronic Obstr Pulm Dis. 2021 Apr 27;8(2):230-242. doi: 10.15326/jcopdf.2020.0175. |
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IPD might not be share due to limitations from the IRB committee
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Randomization of primary care physicians to each group will be performed with stratification to the number of registered individual COPD patients for each physician. In addition, randomization will be performed with blocks of clinics from areas of similar sociodemographic characteristics.
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Patients that will have their outcomes annalyzed will be unaware of group allocation or of the study considering data will be annalyzed retrospectively.
|
| Non-inhaler medications adherence pre-post study |
Non-inhaler medication adherence in the 12 months prior and after inclusion, measured by the purchase of prescribed COPD medications and compared with the control group. |
| From first patient visit after study initiation to 12 months after. |
| Non-inhaler medication adherence | Non-inahler medication adherence from first clinic visit after study initiation, measured by the purchase of prescribed COPD medications and compared with the control group. | From first patient visit after study initiation to 12 months after. |
| Annualized rate of moderate or severe COPD exacerbations | The difference in the annualized rate of moderate or severe COPD exacerbations between the intervention and control groups from first clinic visit after trial initiation. Moderate exacerbations are defined as those requiring treatment with systemic glucocorticoids, antibiotics, or both. Severe exacerbations are defined as those resulting in hospitalization or emergency medical care. | From first patient visit after study initiation to 12 months after. |
| All-cause mortality | Incidence of all-cause mortality between the intervention and control | From first patient visit after study initiation to 12 months after. |
| Cardiovascular events | The rate of patients with new cardiovascular events, including myocardial infarction, ischemic stroke, heart failure exacerbation leading to hospital, and cardiovascular-related mortality. | From first patient visit after study initiation to 12 months after. |
| Guideline-based treatment | The percentage of patients at study end with inhaler therapy which meet the standard of care, as defined by the GOLD guidelines between the intervention and control groups | From first patient visit after study initiation to 12 months after. |
| Physician knowledge on COPD | Evaluation of physicians knowledge about COPD and a questionnaire assessing whether, in the physician's opinion, the intervention has increased their knowledge and ability to treat patients with chronic obstructive pulmonary disease. | From first patient visit after study initiation to 12 months after. |
| Rate of guidelines-based cardiovascular treatment - post-hoc analysis | Rate of guidelines-based treatment for hypertension, diabetes, hyperlipidemia, and heart failure between the study groups. This outcome will be based on the ESC treatment guidelines. | From first patient visit after study initiation to 12 months after. |
| Cardiovascular events - post-hoc analysis | Rate of cardiovascular events between the study groups, including heart failure exacerbation, myocardial infraction, and stroke. | From first patient visit after study initiation to 12 months after. |
| Rate of cardio-pulmonary events - post-hoc analysis | The rate of cardio-pulmonary events, including COPD exacerbations, stroke, myocardial infraction, and heart failure exacerbations, between the study groups. | From first patient visit after study initiation to 12 months after. |
| Time to first cardiovascular event - post-hoc analysis | Time to first cardiovascular event, including heart failure exacerbation, stroke, and myocardial infraction, between the study groups. | From first patient visit after study initiation to 12 months after. |
| Control of cardiovascular risk - Post-hoc analysis | Rate of control of hypertension, diabetes, and hyperlipidemia, as assessed accoridng to the ESC guidelines between the groups. | From first patient visit after study initiation to 12 months after. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |