Application for an Electronic Medication Management Support System
Last updated on July 2021Recruitment
- Recruitment Status
- Unknown status
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Polypharmacy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Masking Description: Due to the character of the intervention, a blinding is not possible.Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 prescribin...
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: A parallel, cluster-randomised controlled trial will be conducted in about 1,080 general practices located in the Westphalia-Region (Germany), which care for adult patients covered by BARMER health insurance. Per group, 17,200 clustered-randomized patients (about 32 patients per practice) will be included, if they take ? 5 long-term prescriptions (at least 2 consecutive quarters). In the intervention group, family physicians will use an user-initiated clinical decision support system (CDSS) which provides drug-therapy relevant information (e.g. on diagnoses and treatments) and alerts in case of drug-drug, drug-disease and drug-age interactions. Based on that information, the family physician systematically assesses the appropriateness of patient's medication and optimizes it. Patients receive an updated medication plan in their mother's language, if needed. In the control group, patients continue to receive usual care where there is no access to the CDSS. The primary outcome is the combined endpoint of all-cause mortality and all-cause hospital admissions after 15 months. The outcome measures will be based on secondary data (i.e. claims data). Primary and secondary outcomes will be measured at patient level. The primary analysis will be performed adhering to the intention-to-treat (ITT) principle.
Tracking Information
- NCT #
- NCT03430336
- Collaborators
- Association of Statutory Health Insurance Physicians Westphalia/Lippe
- Goethe University
- University of Cologne
- Ruhr University of Bochum
- Bielefeld University
- Investigators
- Study Director: Petra Kellermann-Mühlhoff BARMER Health Insurance
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