Improving Adherence to COPD Treatments in Primary Care
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease)Adherence to Care
- Registration Number
- NCT07104136
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief Summary
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:
* Does the training program help patients with COPD take their medications more regularly?
* Does it reduce the number of COPD flare-ups (exacerbations)?
* Does it improve how well doctors follow current treatment guidelines for COPD?
In this study:
* Primary care doctors will be randomly assigned to either receive the training or continue their usual care without intervention.
* The training includes updated information about COPD, a workshop on inhaler use, and a course on motivational interviewing (a method to support behavior change)
* The care of their patients with COPD will be reviewed over 12 months to see if the program made a difference in medication use, flare-ups, and other outcomes.
- Detailed Description
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:
1. To evaluate the effect of specific COPD patient centric educational program for primary care physicians on adherence to recommended therapy.
2. To evaluate the effect of specific COPD patient centric educational program for primary care physicians on the number of moderate and severe COPD exacerbations.
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:
1. Intervention Group - Twenty primary care physicians will be recruited. After inclusion and signing an informed consent, all physicians will participate in a two-day seminar. The seminar will include: up-to-date professional guidance on COPD management, an inhalers workshop and a course of motivational interview. 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.
2. Control Group - Twenty primary care physicians, matched to the intervention group by sociodemographic area and number of COPD patients in past year.
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Primary care physicians
- Have at least 18 COPD patients in his unit as documented in medical records
- Refusal to sign informed consent to participate in the study.
- Less than 1-year projection of employment in current clinic.
- Prior completion of a course in motivational interviewing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adherence to COPD-related inhalers From first patient visit after study initiation to 12 months after. 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
- Secondary Outcome Measures
Name Time Method Change in adherence to inhaler therapy pre-post study From first patient visit after study initiation to 12 months after. 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.
Guideline-based treatment From first patient visit after study initiation to 12 months after. 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
Non-inhaler medications adherence pre-post study From first patient visit after study initiation to 12 months after. 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.
Non-inhaler medication adherence From first patient visit after study initiation to 12 months after. 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.
Annualized rate of moderate or severe COPD exacerbations From first patient visit after study initiation to 12 months after. 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.
All-cause mortality From first patient visit after study initiation to 12 months after. Incidence of all-cause mortality between the intervention and control
Cardiovascular events From first patient visit after study initiation to 12 months after. The rate of patients with new cardiovascular events, including myocardial infarction, ischemic stroke, heart failure exacerbation leading to hospital, and cardiovascular-related mortality.
Physician knowledge on COPD From first patient visit after study initiation to 12 months after. 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.
Trial Locations
- Locations (1)
Clalit health services
🇮🇱Tel Aviv, Israel
Clalit health services🇮🇱Tel Aviv, IsraelHanny Yeshua, MDContact972-50-8326824HannyYe@clalit.org.ilYael GillermanContact972-502861343YaelLiv@clalit.org.il