Evaluating the Impact of a Digital Prescription Support System on Antibiotic Use in Belgian Primary Care
A Stepped-Wedge Cluster Randomized Trial
Led by KU Leuven · Updated on 2026-07-17
48
Participants Needed
1
Research Sites
14 weeks
Total Duration
AI-Summary
What this Trial Is About
Inappropriate antibiotic prescribing in primary care contributes significantly to antimicrobial resistance. This trial evaluates a digital Prescription Support System PSS designed to help Belgian general practitioners follow national antimicrobial guidelines more closely during patient consultations. The study uses a stepped-wedge cluster randomized design where general practices gradually transition from usual care to using the PSS, allowing comparison of prescribing patterns over time.
The PSS integrates guideline-based recommendations from the Belgian BAPCOC guidelines into existing electronic health records. It presents advice through a decision tree for common infections and guides antibiotic choice, dosage, duration, and situations where antibiotics are not recommended. Practices start without access to the PSS and switch to using it in four sequential steps lasting three months each, after which they retain access for the study duration.
Participants are general practices whose prescribing data are collected quarterly via the Belgian Antibiotic Barometer, ensuring anonymity and data security. Researchers will measure antibiotic prescribing rates and monitor PSS usage, usability, acceptability by clinicians, and any unintended effects on workflow. The study lasts up to 12 months per practice, aiming to inform broader implementation and optimization of the PSS in Belgian primary care.
CONDITIONS
Brief Title
Prescription Support System for Antimicrobial Use in Belgian Primary Care
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National Institute for Health and Disability Insurance, Belgium
Collaborating Sponsor
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
General practices in Belgium using compatible electronic health record systems
Willingness to use and activate the Prescription Support System by giving consent
Agreement to participate with signed informed consent
You will not qualify if you...
Practices using an electronic health record system that only allows single sign-on to a standalone Prescription Support System
Practices already using a similar Prescription Support System or involved in overlapping projects
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Control Period
Duration - Up to 3 months
Participants provide usual care without access to the Prescription Support System. General practitioners follow standard antimicrobial prescribing guidelines at their discretion.
Routine clinical practice visits
Intervention Period
Duration - At least 9 months
Participants receive access to the Prescription Support System integrated into their electronic health records to assist antibiotic prescribing decisions during eligible consultations.
Routine clinical practice visits with system use as needed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
A computerized decision support system (CDSS) for antibiotic prescription in primary care-Antibioclic: implementation, adoption and sustainable use in the era of extended antimicrobial resistance.
Impact evaluation of a Prescription Search Support (PSS) for antimicrobials: protocol for a stepped-wedge cluster randomised trial in Belgian primary care.
Jan Yvan Verbakel, Hannelore Dillen, Annelien Dankaerts...