Actively Recruiting

Phase Not Applicable
All Genders
ID07347015

Impact Evaluation of a Prescription Search Support (PSS) for Antimicrobials Using a Stepped-Wedge Cluster Randomized Design in Belgian Primary Care

Led by KU Leuven · Updated on 2026-03-06

48

Participants Needed

1

Research Sites

14 weeks

Total Duration

On this page

Sponsors

K

KU Leuven

Lead Sponsor

N

National Institute for Health and Disability Insurance, Belgium

Collaborating Sponsor

AI-Summary

What this Trial Is About

Inappropriate antibiotic prescribing in primary care contributes to antimicrobial resistance, especially when antibiotics are used for infections that usually resolve on their own. This research aims to evaluate a digital Prescription Support System (PSS) designed to help general practitioners in Belgium follow national guidelines for antimicrobial use during patient visits. The study uses a stepped-wedge cluster randomized design where general practices transition from usual care to using the PSS over four steps. The PSS integrates the Belgian BAPCOC guidelines into a user-friendly decision tree within electronic health records. It provides recommendations on antibiotic choice, dosage, duration, and when antibiotics are not needed for common infections seen in ambulatory care. Practices start with usual care and then sequentially gain access to the PSS, maintaining use for the remainder of the study. This digital tool aims to support prescribing decisions during routine consultations. Participants include general practices that use compatible electronic health records and consent to participate. The study monitors antibiotic prescribing rates quarterly using data from the Belgian Antibiotic Barometer for up to 12 months per practice. Researchers also assess the PSS's usability, acceptability, intensity of use, and any unintended effects reported by clinicians or observed in system data. Data privacy is ensured through pseudonymization and secure handling. Results will guide future improvements and broader implementation of the PSS in Belgian primary care.

CONDITIONS

Brief Title

Prescription Support System for Antimicrobial Use in Belgian Primary Care

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • General practices in Belgium using compatible EHR systems
  • Willingness to use and activate the PSS by giving consent
  • Agreement to participate in the study with signed informed consent form
Not Eligible

You will not qualify if you...

  • Practices using an EHR system that only allows single sign-on to the standalone PSS
  • Practices already using a similar Prescription Support System or involved in overlapping projects

AI-Screening

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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 (Usual Care)

Duration - Variable up to 3 months depending on randomization step

Participants receive usual care without access to the Prescription Support System (PSS). General practitioners provide care based on existing guidelines at their discretion.

Routine visits as part of usual care

Intervention Period (Access to Prescription Support System)

Duration - Up to 12 months following transition to intervention

Participants’ general practices receive access to the Prescription Support System (PSS), a digital tool integrated into their electronic health record to support antimicrobial prescribing decisions.

Routine visits as part of usual care with use of the PSS during eligible consultations

Follow-up and Evaluation

Duration - Up to 12 months from baseline

Participants are monitored for antibiotic prescribing rates, system usability, and potential unintended consequences through routine data collection and feedback during and after the intervention period.

No additional visits beyond usual care; data collected via routine health records and quarterly feedback

Trial Site Locations

Total: 1 location

1

GPs associated with KU Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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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.

Tristan Delory, Pauline Jeanmougin, Sylvie Lariven...

https://pubmed.ncbi.nlm.nih.gov/32357226

Use of stewardship smartphone applications by physicians and prescribing of antimicrobials in hospitals: A systematic review.

R I Helou, D E Foudraine, G Catho...

https://pubmed.ncbi.nlm.nih.gov/32991591

Health Professions Digital Education on Antibiotic Management: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration.

Bhone Myint Kyaw, Lorainne Tudor Car, Louise Sandra van Galen...

https://pubmed.ncbi.nlm.nih.gov/31516125