Reduction of Polypharmacy in Elderly People With Multiple Diseases - a Stepped Wedge Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,146
- 试验地点
- 2
- 主要终点
- Rate of adverse drug reactions
研究概览
简要总结
Elderly GP patients are often treated with five or more medications and therefore prone to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. The primary aim of this study to reduce the frequency of ADRs in multimorbid patients aged 70 years and older by reducing polypharmacy.
详细描述
Introduction
Many elderly people are multimorbid and are treated with five or more medications (polypharmacy) at the same time. Due to age related physiological changes they are especially vulnerable to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. Up to 16% of unplanned hospitalizations of elderly people with polypharmacy are caused by ADRs. The primary aim of this study is the evaluation of the effectivity of a multi-component-intervention to reduce the frequency of ADRs in multimorbid patients aged 70 years and older.
Methods: We are planning a multi-center stepped wedge cluster randomized controlled trial at 40 primary care practices affiliated to the RaPHaeL-network (Research Practices Halle-Leipzig) in Saxony-Anhalt and Saxony, Germany. The planned intervention follows the recommendations of the New Medical Research Council and comprises a pharmacological medication plan review according to the STOPP/START-criteria and an adherence support measure employing motivational interviewing. Control group will receive usual care. Eligible patients are ≥ 70 years old, are diagnosed with three or more chronic medical conditions and are prescribed five or more medications. The primary outcome is the rate of ADRs six months post intervention. The secondary outcomes are number of ADRs, hospitalization rate due to ADRs, medication adherence (Morisky Adherence Score MMAS-8), the health-related quality of life (Euro-QOL EQ-5D-5L), the number of PIPs (according to STOPP/START), number of primary care physician per quarter, the medication appropriateness index and the mean number of de-prescriptions per patient. The planned sample size is 1,146 patients.
Discussion: Multimorbid patients with polypharmacy show an increased risk for PIPs, since prescriptions can be based on evidence for pharmacological therapy of a single condition without taking into account the complex drug interactions. Based on the existing evidence we are aiming to reduce ADRs in this patient population.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 5 longterm medications (> 6 months) (polypharmacy)
- •≥ 3 chronic diseases (multimorbidity)
- •≥ 1 family doctor consultation within the last 6 months
排除标准
- •Patients with a critically reduced life expectancy
- •Patients who cannot autonomously visit the family practice
- •Patients who cannot participate in the informed consent process
- •Patients who are residing in a nursing home
- •Patients with dementia or a mental of behavioral disorder ICD-10 F00-F99
- •Patients who are participating in another medical study with a focus on polypharmacy or multimorbidity
结局指标
主要结局
Rate of adverse drug reactions
时间窗: 6 months
Rate of self-reported adverse drug reactions per patient based on a list of commonly reported drug-related symptoms in primary care.
次要结局
- Potentially inappropriate prescriptions(6 months)
- Family doctor consultations(6 months)
- Deprescription(6 months)
- Hospitalizations(6 months)
- Adherence(6 months)
- Health-related quality of life(6 months)
- Types of adverse drug reactions(6 months)
- Medication appropriateness(6 months)
研究者
Alexander Bauer
Reserach Coordinator
Martin-Luther-Universität Halle-Wittenberg