Prioritising and Optimising Multiple Medications in Elderly Multimorbid Patients in General Practice. - A Pragmatic Cluster-randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 505
- 试验地点
- 2
- 主要终点
- Medication Appropriateness Index (MAI)-Score
研究概览
简要总结
Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices.
Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.
详细描述
Key elements (1 to 4) of the complex intervention:
- Basic assessment of medicines that were actually taken (brown bag review) by a general practice based health care assistant (HCA) and
- Checklist-based (MediMoL - Medication-Monitoring-List) pre-consultation interview on problems relating to medicines (technical handling, potential adverse drug reactions) and patient's therapeutic aims by HCA provides structured information in the Medication-Monitoring-List (MediMoL) for the general practitioner (GP) and enables patients to discuss their problems with the GP.
- GP uses a computerized decision support system (pharmaceutical information system, AiD+) to optimize medication (reducing number of inappropriate prescriptions, e.g. pharmaceutical interactions, renal dose adjustments, duplicate prescriptions) and
- prioritizes medication in the physician-patient consultation taking into consideration patient's preferences.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 60 years old of both sexes
- •at least three chronic diseases affecting two or more organ systems, which require pharmaceutical treatment
- •at least five long-term prescriptions with systemic effects
- •health care provided by GP (at least one contact in most recent quarter)
- •patient is legally competent to sign any documents
- •ability to understand and participate in trial of own free will, to fill out questionnaires and participate in telephone interviews
- •written informed consent to participate in trial
排除标准
- •diseases cause life expectancy of less than 12 months
- •abuse of alcohol or illegal drugs and visible clinical signs or symptoms thereof
- •cognitive impairment that prevents trial participation (MMSE < 26)
- •emotional stress that prevents trial participation
- •participation in a clinical trial within the last 30 days
研究组 & 干预措施
Control
Usual care in accordance with recommended standard#
#Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Intervention arm
Intervention: Healthcare assistant (HCA) and computer assisted optimization of multi-medication (complex intervention) in accordance with recommended standard#
#Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
干预措施: Optimization strategy (complex intervention) (Other)
结局指标
主要结局
Medication Appropriateness Index (MAI)-Score
时间窗: 6 months from baseline
Difference in Medication Appropriateness Index (MAI)-Score 6 months from baseline minus baseline (MAI T1-T0)
次要结局
- medication complexity(6 and 9 months from baseline)
- Change in all cause hospitalisation(6 months and 9 months)
- Cognitive dysfunction in verbal fluency(6 and 9 months from baseline)
- Depressive symptoms(6 and 9 months from baseline)
- Functional disability: Vulnerable Elderly Survey (VES-13)(9 months)
- Self-reported adherence (Morisky)(6 and 9 months from baseline)
- Beliefs about Medicines Questionaire (BMQ)(6 and 9 months from baseline)
- Satisfaction with shared decision making (Man Son Hing scale, MSH)(6 and 9 months from baseline)
- Future life expectancy / years of desired life(6 and 9 months from baseline)
- MAI-Score(9 months from baseline)
- "Observed" adherence(6 months from baseline and 9 months from baseline)
- Severity of chronic pain(6 and 9 months from baseline)
- Generic health related quality of life: EQ-5D(9 months)
研究者
Christiane Muth
Dr. Chrstiane Muth, MD, MPH
Goethe University