Clalit health services
Tel Aviv, Israel
NCT Number: NCT07104136
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Tel Aviv, Israel
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From first patient visit after study initiation to 12 months after.
Incidence of all-cause mortality between the intervention and control
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From first patient visit after study initiation to 12 months after.
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.
Time frame: From first patient visit after study initiation to 12 months after.
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.
Time frame: From first patient visit after study initiation to 12 months after.
Rate of cardiovascular events between the study groups, including heart failure exacerbation, myocardial infraction, and stroke.
Time frame: From first patient visit after study initiation to 12 months after.
The rate of cardio-pulmonary events, including COPD exacerbations, stroke, myocardial infraction, and heart failure exacerbations, between the study groups.
Time frame: From first patient visit after study initiation to 12 months after.
Time to first cardiovascular event, including heart failure exacerbation, stroke, and myocardial infraction, between the study groups.
Time frame: From first patient visit after study initiation to 12 months after.
Rate of control of hypertension, diabetes, and hyperlipidemia, as assessed accoridng to the ESC guidelines between the groups.
Tel-Aviv Sourasky Medical Center
Other Gov
Improvement of Adherence to Treatment Among COPD Patients in Primary Care by Physician-directed Intervention
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07339280
COPD, COPD (Chronic Obstructive Pulmonary Disease)
Karlovac, Croatia
View Trial DetailsNCT07343375
COPD (Chronic Obstructive Pulmonary Disease), Chronic Disease
Copenhagen, Denmark
View Trial DetailsNCT07363980
Anxiety Disorders, Arthritis
Aarhus, Denmark
View Trial DetailsNCT07123922
COPD (Chronic Obstructive Pulmonary Disease), Chronic Disease
Dhaka, Bangladesh
View Trial Details