Efectiveness of the MultiPAP Plus Intervention in Young-old Patients With Multimorbidity and Polypharmacy Aimed at Improving Prescription in Primary Care: Cluster RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,162
- 试验地点
- 3
- 主要终点
- Hospitalizations and/or mortality
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 hospitalization-mortality at six 6 (T1), 12 (T2) and 18 (T3) months from baseline compared to usual care.
详细描述
Design: Pragmatic cluster randomized clinical trial with 18 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=1234 patients (617 in each arm, 8 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 (Participant, Investigator)
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
Hospitalizations and/or mortality
时间窗: From Baseline to Month 18
Difference in percentages in the final combined variable
次要结局
- Hospitalizations and/or mortality (T2)(From Baseline to Month 12)
- Therapeutic adherence questionnaire(Baseline, 6, 12 and 18 months)
- Use of health services(at 12 and at 18 months)
- Disability(Baseline, 12 and 18 months)
- Medication Safety: Potentially Drug-Drug interactions (DDI), Potentially Innappropiate Medication (PIM), Adverse Drug Reactions(Baseline, 6, 12 and 18 months)
- Perceived Quality of Life: Euroqol 5D-5L questionnaire(Baseline, 12 and 18 months)
- System Usability Scale of the CDSS(at 6 and 18 months.)
研究者
Alexandra Prados Torres
Principal Investigator, MD, PhD
Instituto Aragones de Ciencias de la Salud