Prescription Support System for Antimicrobial Use in Belgian Primary Care

Inappropriate antibiotic prescribing in primary care remains an important contributor to antimicrobial resistance. Despite the availability of evidence-based clinical guidelines, antibiotics are still frequently prescribed for self-limiting infections. Digital clinical decision support tools may help general practitioners (GPs) align prescribing decisions with guideline recommendations during patient consultations. This study evaluates the impact of a digital Prescription Support System (PSS) designed to support antimicrobial prescribing in Belgian primary care. The PSS provides guideline-based recommendations derived from the Belgian BAPCOC guidelines for common infections in ambulatory care. Recommendations are presented through a user-friendly decision tree that is integrated into existing electronic health record systems and can be consulted during routine care. The study is embedded within the national implementation strategy of the PSS coordinated by the National Institute for Health and Disability Insurance (RIZIV-INAMI). A stepped-wedge cluster randomized design is used, in which participating general practices transition sequentially from usual care to access to the PSS over four predefined implementation steps. This approach ensures that all participating practices eventually receive access to the system while allowing comparisons over time. The primary objective is to assess whether implementation of the PSS is associated with changes in antibiotic prescribing in Belgian general practice. Prescribing outcomes are measured using routinely collected indicators from the Belgian Antibiotic Barometer, including overall antibiotic prescribing rates and the use of broad- versus narrow-spectrum antibiotics. Secondary objectives include assessing the usability and acceptability of the PSS among clinicians and identifying factors that influence its adoption in daily practice. The study will also monitor potential unintended consequences, such as changes in workflow or concerns about underprescribing. Findings from this study will inform future decisions regarding further optimization and wider implementation of the PSS in Belgian primary care.

NCT Number	NCT07347015
Lead Sponsor	KU Leuven Collaborators: National Institute for Health and Disability Insurance, Belgium, INTEGO - Flemish General Practice Morbidity Registry (KU Leuven), SMALS
Conditions	Infectious Diseases
Enrollment	48 participants
Start Date	2025-12-24
Primary Completion	2026-12-21 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-17