Improving Adherence to COPD Treatments in Primary Care

NCT ID: NCT07104136

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2027-05-20

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Adherence to Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

COPD-care seminar

Intervention Type: 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.

Control

Primary care physicians that will be included without any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

COPD-care seminar

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Primary care physicians
• Have at least 18 COPD patients in his unit as documented in medical records

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clalit Health Services

OTHER

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clalit health services

Tel Aviv, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 33610138 (View on PubMed)

Other Identifiers

0195-24-COM1

Identifier Type: -

Identifier Source: org_study_id