Prescription Support System for Antimicrobial Use in Belgian Primary Care

NCT07347015 | Recruiting

• 1 other identifier: MP037810
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infectious Diseases

Keywords

Antimicrobial Stewardship; Primary Care; Clinical Decision Support; Stepped-Wedge Cluster Randomized Trial; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Antibiotic Prescribing Rate in General Practice

  To evaluate whether the PSS reduces antibiotic prescribing rates in Belgian general practice. The project will assess whether implementation of the PSS tool leads to improvements in specific prescribing indicators as monitored by the Belgian Antibiotic Barometer (AB Barometer). These include total antibiotic prescribing rate and use of broad- versus narrow-spectrum antibiotics.

  Measured quarterly from baseline until study completion (up to 12 months per practice).

Secondary Outcomes (5)

• Intensity of PSS use

  Measured during the intervention period from each practice's transition to the PSS arm until study completion (up to 12 months).

• Usability and acceptability of the PSS - clinician reported

  Assessed after transition to the intervention group, during the final 6 months of the study period.

• Usability and acceptability of the PSS - system usage

  Assessed during the intervention period from each practice's transition to the PSS arm until study completion (up to 12 months).

• Potential Unintended Consequences of PSS Implementation - clinician reported

  Assessed after transition to the intervention group, during the final 6 months of the study period.

• Potential Unintended Consequences of PSS Implementation - system usage

  Measured quarterly from baseline until study completion (up to 12 months)

Study Arms (2)

Control: Usual Care

NO INTERVENTION

In the control arm, general practices will provide usual care, left at the discretion of the treating general practitioner. Apart from the general information or training session attended by all participating physicians prior to recruitment and randomization, practices in the control arm will not receive access to the Prescription Support System (PSS) or any additional decision support tools. General practitioners in the control arm are expected (but not forced) to follow the Belgian guidelines for antimicrobial prescribing, as described in the BAPCOC national guidelines.

Intervention: access to PSS

ACTIVE COMPARATOR

Prescription Support System (PSS) Providing guideline-based recommendations for antimicrobial prescribing in ambulatory care.

Other: Prescription Support System (PSS)

Interventions

Prescription Support System (PSS) OTHER

General practices in this arm have access to the Prescription Support System (PSS), a digital clinical decision support tool integrated into the electronic health record that provides guideline-based recommendations for antimicrobial prescribing in ambulatory care. The PSS presents recommendations derived from the Belgian BAPCOC guidelines using a structured decision-tree format. During eligible consultations, the PSS can be consulted by the general practitioner to support clinical decision-making regarding antibiotic prescribing. The tool provides information on recommended antibiotic choice, dosage, and duration, as well as guidance on situations in which antibiotic treatment is not indicated. Practices transition to this arm according to the stepped-wedge design and retain access to the PSS for the duration of the study.

Also known as: Clinical decision support system (CDSS)

Intervention: access to PSS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General practices in Belgium using compatible EHR systems.
• Willingness to use and activate the PSS by giving consent.
• Agreement to participate in the study, provided signed informed consent form is in place.

You may not qualify if:

• Practices using an EHR system that solely allows a single sign-on to the standalone PSS.
• Practices already using a similar PSS or participating in overlapping projects.

Sponsors & Collaborators

• KU Leuven: lead
• National Institute for Health and Disability Insurance (RIZIV-INAMI): collaborator
• INTEGO - Flemish General Practice Morbidity Registry (KU Leuven): collaborator
• SMALS: collaborator

Study Sites (1)

GPs associated with KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (6)

• Madar R, Ugon A, Ivankovic D, Tsopra R. A Web Interface for Antibiotic Prescription Recommendations in Primary Care: User-Centered Design Approach. J Med Internet Res. 2021 Jun 11;23(6):e25741. doi: 10.2196/25741.

  PMID: 34114958 BACKGROUND

• Delory T, Jeanmougin P, Lariven S, Aubert JP, Peiffer-Smadja N, Boelle PY, Bouvet E, Lescure FX, Le Bel J. 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. J Antimicrob Chemother. 2020 Aug 1;75(8):2353-2362. doi: 10.1093/jac/dkaa167.

  PMID: 32357226 BACKGROUND

• Helou RI, Foudraine DE, Catho G, Peyravi Latif A, Verkaik NJ, Verbon A. Use of stewardship smartphone applications by physicians and prescribing of antimicrobials in hospitals: A systematic review. PLoS One. 2020 Sep 29;15(9):e0239751. doi: 10.1371/journal.pone.0239751. eCollection 2020.

  PMID: 32991591 BACKGROUND

• Fralick M, Haj R, Hirpara D, Wong K, Muller M, Matukas L, Bartlett J, Leung E, Taggart L. Can a smartphone app improve medical trainees' knowledge of antibiotics? Int J Med Educ. 2017 Nov 30;8:416-420. doi: 10.5116/ijme.5a11.8422.

  PMID: 29200402 BACKGROUND

• Kyaw BM, Tudor Car L, van Galen LS, van Agtmael MA, Costelloe CE, Ajuebor O, Campbell J, Car J. Health Professions Digital Education on Antibiotic Management: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration. J Med Internet Res. 2019 Sep 12;21(9):e14984. doi: 10.2196/14984.

  PMID: 31516125 BACKGROUND

• 1. BAPCOC - Belgische Gids voor Anti-Infectieuze Behandeling in de Ambulante Praktijk 2022. Available from: https://www.bcfi.be/nl/chapters/12?frag=8000010. Accessed 11 July 2024.

  BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Jan Y. Verbakel

Model Details: This study uses a stepped-wedge cluster randomized design to evaluate the implementation of a Prescription Support System (PSS) in Belgian primary care. All participating general practices start in a control condition and transition once to the intervention condition in four predefined steps over a nine-month period. Each step lasts three months. Practices contribute data during both control and intervention periods, allowing within- and between-cluster comparisons while accounting for time effects. Primary and secondary outcomes are based on routinely collected indicators from the Belgian Antibiotic Barometer. Analyses assess changes in antibiotic prescribing over time and compare practices by intensity of PSS use, derived from application log files. A process evaluation will be embedded, consisting of semi-structured interviews using a topic guide and log file analysis to assess implementation fidelity, reach and mechanisms of impact.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 16, 2026
• Study Start: December 21, 2025
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study protocol is published and accessible. SAP, CSR, ICF and analytical code will be available after publishing the results in a medical journal. Individual patient data from this trial will not be published in the public domain.
• Access Criteria: Individual patient data from this trial will not be published in the public domain. Deidentified participant data is available for further analyses. Requests for data, with justification, should be sent to Jan Verbakel (jan.verbakel@kuleuven.be). The trial protocol is available online for an indefinite period.

Locations

BE (1)