Improving Adherence to COPD Treatments in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COPD-care seminar.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease), Adherence to Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improvement of Adherence to Treatment Among COPD Patients in Primary Care by Physician-directed Intervention
Overview
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.
Interventions
- Behavioral 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,
Primary outcome measures
- Adherence to COPD-related inhalers [Time frame: From first patient visit after study initiation to 12 months after.]
Secondary outcome measures (8)
- Change in adherence to inhaler therapy pre-post study [Time frame: From first patient visit after study initiation to 12 months after.]
- Non-inhaler medications adherence pre-post study [Time frame: From first patient visit after study initiation to 12 months after.]
- Non-inhaler medication adherence [Time frame: From first patient visit after study initiation to 12 months after.]
- Annualized rate of moderate or severe COPD exacerbations [Time frame: From first patient visit after study initiation to 12 months after.]
- All-cause mortality [Time frame: From first patient visit after study initiation to 12 months after.]
- Cardiovascular events [Time frame: From first patient visit after study initiation to 12 months after.]
- Guideline-based treatment [Time frame: From first patient visit after study initiation to 12 months after.]
- Physician knowledge on COPD [Time frame: From first patient visit after study initiation to 12 months after.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Clalit health services — Tel Aviv
Publications
- 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. PMID 33610138
Identifiers
NCT: NCT07104136 · 0195-24-COM1