Effectiveness and Cost-effectiveness of the Application of an Electronic Medication Management Support System in Patients With Polypharmacy in General Practice (AdAM).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BARMER
- 入组人数
- 12,000
- 试验地点
- 2
- 主要终点
- Combined endpoint of all-cause mortality and all-cause hospital admissions
研究概览
简要总结
This study assesses whether an electronic medication management support system improves quality, safety, and cost-effectiveness of the drug therapy in adult patients with polypharmacy compared to usual care during the observation period of 15 months from baseline per practice (from 2017 4th quarter to 2020 3rd quarter).
详细描述
Title:
Application of an electronic medication management support system.
Objectives:
The aim of the study is to assess the effectiveness of an electronic medication management support system on hospitalization and death, its cost-effectiveness and its effects on the quality and safety of prescribing in patients with polypharmacy.
Methods:
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
- None
盲法说明
Due to the character of the intervention, blinding is not possible.
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
- •Patients ≥ 18 years of age with polypharmacy (5 or more drugs taken for at least two quarters).
- •Informed consent.
排除标准
- •Incapacitated patients without legal representative
研究组 & 干预措施
Computer-assisted medication management
Family physician adds, modifies and optimizes medication in patient's with polypharmacy assisted by an user-initiated computerized decision support system (CDSS) which provides drug-therapy relevant information about patients (e.g. diagnoses and treatments) and alerts in case of drug-drug, drug-disease, drug-age interactions to systematically assess the appropriateness of medication:
- CDSS provides drug-therapy relevant information
- modification of medication
- assessment of medication appropriateness
- medication plan
- Guidance in medication process
干预措施: CDSS provides drug-therapy relevant information (Other)
Computer-assisted medication management
Family physician adds, modifies and optimizes medication in patient's with polypharmacy assisted by an user-initiated computerized decision support system (CDSS) which provides drug-therapy relevant information about patients (e.g. diagnoses and treatments) and alerts in case of drug-drug, drug-disease, drug-age interactions to systematically assess the appropriateness of medication:
- CDSS provides drug-therapy relevant information
- modification of medication
- assessment of medication appropriateness
- medication plan
- Guidance in medication process
干预措施: Modification of medication (Other)
Computer-assisted medication management
Family physician adds, modifies and optimizes medication in patient's with polypharmacy assisted by an user-initiated computerized decision support system (CDSS) which provides drug-therapy relevant information about patients (e.g. diagnoses and treatments) and alerts in case of drug-drug, drug-disease, drug-age interactions to systematically assess the appropriateness of medication:
- CDSS provides drug-therapy relevant information
- modification of medication
- assessment of medication appropriateness
- medication plan
- Guidance in medication process
干预措施: Assessment of medication appropriateness (Other)
Computer-assisted medication management
Family physician adds, modifies and optimizes medication in patient's with polypharmacy assisted by an user-initiated computerized decision support system (CDSS) which provides drug-therapy relevant information about patients (e.g. diagnoses and treatments) and alerts in case of drug-drug, drug-disease, drug-age interactions to systematically assess the appropriateness of medication:
- CDSS provides drug-therapy relevant information
- modification of medication
- assessment of medication appropriateness
- medication plan
- Guidance in medication process
干预措施: Medication plan (Other)
Computer-assisted medication management
Family physician adds, modifies and optimizes medication in patient's with polypharmacy assisted by an user-initiated computerized decision support system (CDSS) which provides drug-therapy relevant information about patients (e.g. diagnoses and treatments) and alerts in case of drug-drug, drug-disease, drug-age interactions to systematically assess the appropriateness of medication:
- CDSS provides drug-therapy relevant information
- modification of medication
- assessment of medication appropriateness
- medication plan
- Guidance in medication process
干预措施: Guidance in medication process (Other)
Control arm
Patients will receive the usual clinical care based on current clinical practice guidelines during intervention period. After completion of trial, the patients in the control group will be invited to participate after written informed consent to receive the intervention.
结局指标
主要结局
Combined endpoint of all-cause mortality and all-cause hospital admissions
时间窗: Observation period of 15 months per practice
The primary outcome is the combined endpoint of all-cause mortality and all-cause hospital admissions (including night- and day-only admissions) in patients with polypharmacy.
次要结局
- Number of potential inappropriate prescriptions(Observation period of 15 months per practice)
- All-cause hospital admissions(Observation period of 15 months per practice (quarterly))
- All-cause mortality(Observation period of 15 months per practice (quarterly))