Motivational Interviewing and Medication Review in the Secondary Prevention of Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 417
- 试验地点
- 1
- 主要终点
- Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
Low medication adherence in patients with coronary heart disease increases mortality.
This study investigates if an intervention of medication review and counselling can improve patients' medication adherence and treatment results.
详细描述
The study will investigate the effects of medication review and Motivational Interviewing (MI) on patients with Coronary Heart Disease (CHD). Clinical pharmacists competent in MI and cardiology will conduct medication interviews and medication reviews at the outpatient clinic. The intervention will continue during 9 months, with interviews and reviews as needed.
Follow-up of results will take place 16 months after inclusion (corresponding to 4 months after the end of intervention).
The MI-Component will be quality assured by MITI 4.2-coding (Motivational Interviewing Treatment Integrity). The study will investigate effects on clinical outcomes, medication adherence, patients´ beliefs about medicines and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Admitted for angiography
- •Verified Coronary Artery Disease (ICD-10 I20-I21)
- •Planned for follow up at the out-patient clinic (standard treatment)
- •Swedish speaking
排除标准
- •Cognitive impairment or any othe condition making interview or phone calls impossible.
- •Non-participation in the standard follow-up
- •Prior participation in this study
研究组 & 干预措施
MI and Medication review
The intervention starts three months post-discharge after the standard treatment at the out-patients clinic. A medication review focused on cardiovascular drugs, and a counselling session with a clinical pharmacist using Motivational Interviewing (MI)-approach, and a follow-up phone call two weeks later. For patients with negative beliefs about medicines, three additional MI-sessions in clinic or by phone are planned together with the patient. Irrespective of beliefs the intervention ends with a second medication review and counselling session, which is coordinated with the 12-months post-discharge follow-up in primary care.
干预措施: Standard Treatment (Behavioral)
MI and Medication review
The intervention starts three months post-discharge after the standard treatment at the out-patients clinic. A medication review focused on cardiovascular drugs, and a counselling session with a clinical pharmacist using Motivational Interviewing (MI)-approach, and a follow-up phone call two weeks later. For patients with negative beliefs about medicines, three additional MI-sessions in clinic or by phone are planned together with the patient. Irrespective of beliefs the intervention ends with a second medication review and counselling session, which is coordinated with the 12-months post-discharge follow-up in primary care.
干预措施: MI and Medication review (Behavioral)
Standard treatment
Standard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months.
干预措施: Standard Treatment (Behavioral)
结局指标
主要结局
Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C)
时间窗: 16 months
According to Swedish guidelines the goal is \< 1,8mmol/L or at least 50% reduction from baseline.
次要结局
- Percentage of patients adherent to cholesterol lowering treatment(16 months)
- Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)(16 months)
- Percentage of patients adherent to preventive medication: P2Y12-antagonist(16 months)
- Percentage of patients with Systolic Blood Pressure <140(16 months)
- Changes in Quality of Life(16 months)
- Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)(16 months)
- Percentage of patients adherent to preventive medication: Beta-blocker(16 months)
- Number of Cardiovascular Re-admissions and Emergency Department visits(16 months)
研究者
Göran Petersson
Professor of Health Informatics with focus on Pharmaceutical Science
Linnaeus University