Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 7, 2025
Date Accepted: Feb 24, 2026
Enhancing Continuous Medication Safety Through ePrescription and Clinical Decision Support Systems in Outpatient Practices and Pharmacies: Protocol for a Multi-Perspective Study (The eRIKA Study)
ABSTRACT
Background:
The increase in life expectancy is associated with increasing multimorbidity and polypharmacy, leading to a heightened risk of drug-drug interactions and adverse events, especially when multiple healthcare providers are involved. To address the urgent need for safer medication management in this population, tools such as medication plans, electronic prescriptions (ePrescriptions), and clinical decision support systems (CDSS) offer valuable support. These instruments offer the potential of enhancing medication safety by providing physicians and pharmacists with a comprehensive overview of a patient’s overall medication regimen and by assisting healthcare professionals in making informed prescribing decisions.
Objective:
This study aims to improve medication therapy safety through combining ePrescriptions, use of claims data, medication plans, CDSS and interprofessional communication. To evaluate the various effects of this complex intervention, a holistic multi-phase study is conduced examining a) the effectiveness as well as b) health-economic and c) implementation-related aspects.
Methods:
A multi-phase study design will be employed. In the first phase, the intervention will be implemented in selected outpatient practices (n=10) and pharmacies (n=10) in two regions in Germany as part of a cluster-randomized controlled trial to assess process-related outcomes. The primary outcome is the congruence between the medication plan and claims data. In phase 2, the intervention will be scaled up in three regions and evaluated in a quasi-experimental study. The required sample size for the intervention group is n = 3,528 patients, with a synthetic control group matched from existing claims data. The primary outcome is a combined endpoint of all-cause mortality or hospitalization within three months of an index prescription. Quantitative methods (descriptive, regression-based methods using claims data, calculation of the incremental cost-effectiveness ratio, survey-based analyses of implementation-related aspects) and qualitative methods (interviews and focus groups to capture experiences of healthcare professionals and patients) will be used.
Results:
In Phase 1, 187 patients were recruited (74 IG, 113 CG) by June 2025. Phase 2 is currently ongoing and data collection continuing through 31.12.2025. Final analyses are planned by March 2027.
Conclusions:
Medication safety in polypharmacy remains a critical challenge in Germany. This study provides multi-perspective evidence supporting the nationwide implementation of the eRIKA intervention. Clinical Trial: Phase 1: DRKS00032777 (https://www.drks.de/search/de/trial/DRKS00032777/details); Phase 2: DRKS00035030 (https://www.drks.de/search/de/trial/DRKS00035030/details)
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