Enhancing Continuous Medication Safety Through e-Prescription and Clinical Decision Support Systems in Outpatient Practices and Pharmacies: Protocol for a Multiperspective Study (eRIKA Study)

Background: Increased life expectancy is associated with increasing multimorbidity and polypharmacy, leading to a heightened risk of drug-drug interactions and adverse events, especially when multiple health care providers are involved. To address the urgent need for safer medication management in this population, tools such as medication plans (MP), electronic prescriptions (e-prescriptions), and clinical decision support systems (CDSS) offer valuable support. These instruments have the potential to enhance medication safety by providing physicians and pharmacists with a comprehensive overview of a patient's overall medication regimen and by assisting health care professionals in making informed prescribing decisions. Objective: This study aims to improve medication therapy safety by combining e-prescriptions, the use of claims data, MPs, CDSS, and interprofessional communication. To comprehensively evaluate this complex intervention, a holistic multiphase study will be conducted, examining (1) the effectiveness of the intervention and (2) health-economic and (3) implementation-related aspects. Methods: A multiphase study design is used. In the first phase, the intervention is implemented in selected outpatient practices (n=10) and pharmacies (n=10) in 2 regions in Germany as part of a cluster-randomized controlled trial to assess process-related outcomes. The primary outcome is the congruence between the MP and claims data. In phase 2, the intervention is scaled up in 3 regions and evaluated in a quasi-experimental study. The required sample size for the intervention group is 3528 patients, with a synthetic control group matched from existing claims data. The primary outcome is a combined end point of all-cause mortality and hospitalization within 3 months of an index prescription. Quantitative methods (descriptive, regression-based methods using claims data, calculation of the incremental cost-effectiveness ratio, and survey-based analyses of implementation-related aspects) and qualitative methods (interviews and focus groups to capture experiences of health care professionals and patients) are used. Results: In phase 1, a total of 187 patients were recruited (74 in the intervention group and 113 in the control group) by June 2025. Phase 2 is currently ongoing, with data collection continuing through December 31, 2025. Final analyses are planned by March 2027. Conclusions: Medication safety in polypharmacy remains a critical challenge in Germany. This study provides multiperspective evidence supporting the nationwide implementation of the eRIKA (e-prescription as an element of interprofessional care pathways for continuous medication therapy management [eRezept als Element interprofessioneller Versorgungspfade für kontinuierliche AMTS]) intervention.