Improvement of Adherence to Treatment Among COPD Patients in Primary Care by Physician-directed Intervention
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adherence to COPD-related inhalers
研究概览
简要总结
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.
详细描述
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:
- To evaluate the effect of specific COPD patient centric educational program for primary care physicians on adherence to recommended therapy.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patients that will have their outcomes annalyzed will be unaware of group allocation or of the study considering data will be annalyzed retrospectively.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary care physicians
- •Have at least 18 COPD patients in his unit as documented in medical records
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: COPD-care seminar (Behavioral)
Control
Primary care physicians that will be included without any intervention.
结局指标
主要结局
Adherence to COPD-related inhalers
时间窗: 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
次要结局
- Change in adherence to inhaler therapy pre-post study(From first patient visit after study initiation to 12 months after.)
- Guideline-based treatment(From first patient visit after study initiation to 12 months after.)
- Non-inhaler medications adherence pre-post study(From first patient visit after study initiation to 12 months after.)
- Non-inhaler medication adherence(From first patient visit after study initiation to 12 months after.)
- Annualized rate of moderate or severe COPD exacerbations(From first patient visit after study initiation to 12 months after.)
- All-cause mortality(From first patient visit after study initiation to 12 months after.)
- Cardiovascular events(From first patient visit after study initiation to 12 months after.)
- Physician knowledge on COPD(From first patient visit after study initiation to 12 months after.)