Effectiveness of an Intervention for Improving Drug Prescription in Primary Care Patients With Multimorbidity and Polypharmacy: Study Protocol of a Cluster Randomized Clinical Trial (Multi-PAP Project)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 593
- 试验地点
- 3
- 主要终点
- Medication Appropriateness Index (MAI) score
研究概览
简要总结
This study assesses the effectiveness of a complex intervention in young-old patients with multimorbidity and polypharmacy aimed at improving physician drug prescription in primary care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.
详细描述
Design: Pragmatic cluster randomized clinical trial with 12 months follow-up.
Unit of randomization: general practitioner.
Unit of analysis: patient.
Setting: Primary Health Care Centres in three different Spanish Autonomous Communities (Aragón, Madrid and Andalucía).
Population: Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months). N=400 patients (200 in each arm, 5 patients per physician) will be recruited by general practitioners before randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 74 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months).
- •Informed consent.
排除标准
- •Institutionalized patient at nursing homes or similar
- •Life expectancy < 12 months
结局指标
主要结局
Medication Appropriateness Index (MAI) score
时间窗: Change from baseline MAI score at 6 months
次要结局
- Morisky-Green questionnaire(Baseline, at six 6 months and at 12 months)
- Patient perception of shared decision-making(Baseline and at six 6 months and at 12 months)
- Medication Appropriateness Index (MAI) score(Change from baseline MAI score at 12 months)
- Euroqol 5D-5L questionnaire(Baseline, at six 6 months and at 12 months)
- Use of health services(at six 6 months and at 12 months)
- Haynes-Sackett test(Baseline, at six 6 months and at 12 months)
- Medication safety(at six 6 months and at 12 months)
研究者
Alexandra Prados Torres
Medical Doctor, PhD
Instituto Aragones de Ciencias de la Salud