Infectious DiseasesPaSSoNCT07347015
Prescription Support System for Antimicrobial Use in Belgian Primary Care
A study testing Prescription Support System (PSS) in people with Infectious Diseases, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- Prescription Support System (PSS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Dec 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
GPs associated with KU Leuven
Leuven, Vlaams-Brabant, 3000
Hannelore Dillen, PhD, +32498828605, hannelore.dillen@kuleuven.be
Annelien Dankaerts, MD, annelien.dankaerts@kuleuven.be
About this study
Official title: Impact Evaluation of a Prescription Search Support (PSS) for Antimicrobials Using a Stepped-Wedge Cluster Randomized Design 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.
Read more
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.
Read the detailed description
Inappropriate antibiotic prescribing in primary care contributes to the development of antimicrobial resistance. Despite guidelines and public health efforts, overprescribing remains prevalent, especially for self-limiting infections which often resolve without antibiotic treatment. Digital tools such as a Prescription Search Support (PSS) may aid general practitioners (GPs) in making more informed prescribing decisions.
This implementation project builds upon a previously conducted mixed-methods implementation study evaluating the usability of a PSS, which was approved by the Ethical Review Board UZ KU Leuven (Onderwijs-Begeleidingscommissie) on 27 September 2024 (MP031770).
The PSS under study contains the current recommendations for the proper use of antimicrobial agents for common infections in ambulatory care in Belgium. In other words, it represents the BAPCOC guidelines in a digital and user-friendly environment, by using a decision tree. Advice for the following diagnoses (ICPC-2 codes) is included in the PSS: sore throat (R21, R74), pertussis (R71), common cold (R74), acute rhinosinusitis (R75), acute bronchitis / bronchiolitis (R78), influenza (R80), pneumonia (R81), ear pain (H01), otorrhea (H04), acute otitis media (H71), acute epiglottitis (R77), acute exacerbations of chronic obstructive pulmonary disease, aspiration pneumonia (R81), laryngitis stridulosa (R77), acute cystitis (U71), acute prostatitis (Y73), acute pyelonephritis (U70), acute vulvovaginitis (X84), asymptomatic bacteriuria, epididymo-orchitis (Y74), genital herpes (Y72, X90), partner treatment and treatment of asymptomatic sexually transmitted infections, pelvic inflammatory disease (X74), syphilis (X70, Y70), and urethritis (U72).
This PSS was developed as part of the Belgian National Action Plan on AMR by the Federal Public Service Health, Food Chain Safety and Environment and the National Institute for Health and Disability Insurance (NIHDI; RIZIV-INAMI), in collaboration with various experts and stakeholders, including physicians, infectiologists, hygienists, policymakers, guideline developers, and software developers. The company Smals, under instruction of RIZIV-INAMI, developed the software for this application in close collaboration with the RIZIV-INAMI working group. Guideline recommendations regarding appropriate prescribing of antimicrobials in ambulatory care were converted into decision rules, which serve as the knowledge source for the PSS.
Digital education offers several advantages, such as easy access without time or location constraints, varying possible forms and levels, and the ability to disseminate evidence on a large scale. Previous research has shown that standalone web- or smartphone-based applications in this context have the potential to increase physicians' knowledge of antimicrobials and guideline recommendations, potentially improving guideline adherence.
In Belgium, antibiotic use in ambulatory care is closely monitored through the Antibiotic Barometer, a national surveillance system coordinated by the Academic Centre of General Practice of KU Leuven and financed by the National Institute for Health and Disability Insurance (RIZIV-INAMI). The Antibiotic Barometer was approved by the Sociaal-maatschappelijke Ethische Commissie (SMEC; G-2023-6352) and provides quarterly feedback to general practices based on routine health insurance claims data.
This study evaluates the implementation and impact of the PSS in routine Belgian primary care using a stepped-wedge cluster randomized trial design. Participating general practices are recruited to ensure broad representation across Belgian primary care. General practices constitute the unit of randomization and are randomly allocated to one of four predefined implementation steps. All practices start in a control condition without access to the PSS and transition once to the intervention condition according to their assigned step. Each implementation step lasts three months, after which practices retain access to the PSS for the remainder of the study period. By the end of the study, all participating practices will have received access to the intervention.
Data for this study are derived from routine sources and handled within the secure data infrastructure of KU Leuven. Prescribing data obtained via the Antibiotic Barometer are aggregated and pseudonymized at practice level prior to analysis, ensuring that individual patients cannot be identified. Data linkage, storage, and analysis are conducted in accordance with applicable data protection regulations. Quantitative and qualitative analyses are used to evaluate both the effectiveness and implementation of the PSS in real-world primary care. Findings from this study will inform future policy decisions regarding national rollout, optimization, and long-term integration of the PSS within Belgian antimicrobial stewardship strategies.
- Conditions
- Infectious Diseases
- Being tested
- Prescription Support System (PSS)
- Keywords
- Antimicrobial Stewardship, Primary Care, Clinical Decision Support, Stepped-Wedge Cluster Randomized Trial, Antibiotics
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription Support System (PSS)Other
Also called Clinical decision support system (CDSS)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prescription Support System (PSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured quarterly from baseline until study completion (up to 12 months per practice).
Secondary outcomes (5)
Intensity of PSS use
PSS usage intensity at practice level derived from application log files (e.g., frequency of access/consultations and categorization into high, medium, or no use during the intervention period), reflecting the overall level of exposure to the PSS.
Measured: 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
To assess the usability of the Prescription Support System (PSS) among general practitioners in routine clinical practice. Usability will be explored through semi-structured interviews with clinicians. The evaluation will examine clinicians' experiences with the PSS, perceived usefulness, ease of use, and integration into workflow, and factors influencing adoption, sustained use, and perceived impact on prescribing decisions.
Measured: Assessed after transition to the intervention group, during the final 6 months of the study period.
Usability and acceptability of the PSS - system usage
Usability of the Prescription Support System (PSS) will also be assessed using system usage data derived from application log files, including patterns of use and interaction with the PSS during routine clinical practice, focusing on how the system is used rather than how often it is accessed.
Measured: 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
To monitor potential unintended consequences associated with implementation of the Prescription Support System (PSS), including perceived workflow disruption. These outcomes will be explored using qualitative information obtained through semi-structured interviews with clinicians.
Measured: Assessed after transition to the intervention group, during the final 6 months of the study period.
Potential Unintended Consequences of PSS Implementation - system usage
To monitor potential unintended consequences associated with implementation of the Prescription Support System (PSS), including signals of underprescribing and changes in prescribing patterns. These outcomes will be explored using routinely collected prescribing indicators from the Belgian Antibiotic Barometer.
Measured: Measured quarterly from baseline until study completion (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start24 Dec 2025
- Primary completion21 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health and Disability Insurance, Belgium, INTEGO - Flemish General Practice Morbidity Registry (KU Leuven), SMALS
- Responsible party
- Principal investigator, Jan Verbakel, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347015
- Sponsor's protocol ID
- MP037810
- Other IDs
- MP037810
- Acronym
- PaSSo
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34114958Delory 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.
PubMed 32357226Helou 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.
PubMed 32991591Fralick 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.
PubMed 29200402Kyaw 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.
PubMed 315161251. 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.
Verbakel JY, Dillen H, Dankaerts A, Michiels N, Vaes B, De Burghgraeve T. Impact evaluation of a Prescription Search Support (PSS) for antimicrobials: protocol for a stepped-wedge cluster randomised trial in Belgian primary care. BMJ Open. 2026 Jul 24;16(7):e120670. doi: 10.1136/bmjopen-2026-120670.
PubMed 42498468
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of a Prescription Search Support (PSS) for Antimicrobials Using a Stepped-Wedge Cluster Randomized Design in Belgian Primary Care
- ClinicalTrials.gov ID
- NCT07347015
- Acronym / sponsor ID
- PaSSo / MP037810
- Conditions
- Infectious Diseases
- Keywords
- Antimicrobial Stewardship, Primary Care, Clinical Decision Support, Stepped-Wedge Cluster Randomized Trial, Antibiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- National Institute for Health and Disability Insurance, Belgium, INTEGO - Flemish General Practice Morbidity Registry (KU Leuven), SMALS
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inappropriate antibiotic prescribing in primary care contributes to the development of antimicrobial resistance. Despite guidelines and public health efforts, overprescribing remains prevalent, especially for self-limiting infections which often resolve without antibiotic treatment. Digital tools such as a Prescription Search Support (PSS) may aid general practitioners (GPs) in making more informed prescribing decisions.
This implementation project builds upon a previously conducted mixed-methods implementation study evaluating the usability of a PSS, which was approved by the Ethical Review Board UZ KU Leuven (Onderwijs-Begeleidingscommissie) on 27 September 2024 (MP031770).
The PSS under study contains the current recommendations for the proper use of antimicrobial agents for common infections in ambulatory care in Belgium. In other words, it represents the BAPCOC guidelines in a digital and user-friendly environment, by using a decision tree. Advice for the following diagnoses (ICPC-2 codes) is included in the PSS: sore throat (R21, R74), pertussis (R71), common cold (R74), acute rhinosinusitis (R75), acute bronchitis / bronchiolitis (R78), influenza (R80), pneumonia (R81), ear pain (H01), otorrhea (H04), acute otitis media (H71), acute epiglottitis (R77), acute exacerbations of chronic obstructive pulmonary disease, aspiration pneumonia (R81), laryngitis stridulosa (R77), acute cystitis (U71), acute prostatitis (Y73), acute pyelonephritis (U70), acute vulvovaginitis (X84), asymptomatic bacteriuria, epididymo-orchitis (Y74), genital herpes (Y72, X90), partner treatment and treatment of asymptomatic sexually transmitted infections, pelvic inflammatory disease (X74), syphilis (X70, Y70), and urethritis (U72).
This PSS was developed as part of the Belgian National Action Plan on AMR by the Federal Public Service Health, Food Chain Safety and Environment and the National Institute for Health and Disability Insurance (NIHDI; RIZIV-INAMI), in collaboration with various experts and stakeholders, including physicians, infectiologists, hygienists, policymakers, guideline developers, and software developers. The company Smals, under instruction of RIZIV-INAMI, developed the software for this application in close collaboration with the RIZIV-INAMI working group. Guideline recommendations regarding appropriate prescribing of antimicrobials in ambulatory care were converted into decision rules, which serve as the knowledge source for the PSS.
Digital education offers several advantages, such as easy access without time or location constraints, varying possible forms and levels, and the ability to disseminate evidence on a large scale. Previous research has shown that standalone web- or smartphone-based applications in this context have the potential to increase physicians' knowledge of antimicrobials and guideline recommendations, potentially improving guideline adherence.
In Belgium, antibiotic use in ambulatory care is closely monitored through the Antibiotic Barometer, a national surveillance system coordinated by the Academic Centre of General Practice of KU Leuven and financed by the National Institute for Health and Disability Insurance (RIZIV-INAMI). The Antibiotic Barometer was approved by the Sociaal-maatschappelijke Ethische Commissie (SMEC; G-2023-6352) and provides quarterly feedback to general practices based on routine health insurance claims data.
This study evaluates the implementation and impact of the PSS in routine Belgian primary care using a stepped-wedge cluster randomized trial design. Participating general practices are recruited to ensure broad representation across Belgian primary care. General practices constitute the unit of randomization and are randomly allocated to one of four predefined implementation steps. All practices start in a control condition without access to the PSS and transition once to the intervention condition according to their assigned step. Each implementation step lasts three months, after which practices retain access to the PSS for the remainder of the study period. By the end of the study, all participating practices will have received access to the intervention.
Data for this study are derived from routine sources and handled within the secure data infrastructure of KU Leuven. Prescribing data obtained via the Antibiotic Barometer are aggregated and pseudonymized at practice level prior to analysis, ensuring that individual patients cannot be identified. Data linkage, storage, and analysis are conducted in accordance with applicable data protection regulations. Quantitative and qualitative analyses are used to evaluate both the effectiveness and implementation of the PSS in real-world primary care. Findings from this study will inform future policy decisions regarding national rollout, optimization, and long-term integration of the PSS within Belgian antimicrobial stewardship strategies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Prescription Support System (PSS)Prescription Support System (PSS) Providing guideline-based recommendations for antimicrobial prescribing in ambulatory care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescription Support System (PSS)Also: Clinical decision support system (CDSS)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. | Other | Intervention: access to PSS |
Primary outcome
Antibiotic Prescribing Rate in General Practice
Time frame: Measured quarterly from baseline until study completion (up to 12 months per 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.
5 secondary outcomes
Intensity of PSS use
Time frame: 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
Time frame: Assessed after transition to the intervention group, during the final 6 months of the study period.
Usability and acceptability of the PSS - system usage
Time frame: 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
Time frame: Assessed after transition to the intervention group, during the final 6 months of the study period.
Potential Unintended Consequences of PSS Implementation - system usage
Time frame: Measured quarterly from baseline until study completion (up to 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 34114958Madar 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.
- Background: PubMed 32357226Delory 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.
- Background: PubMed 32991591Helou 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.
- Background: PubMed 29200402Fralick 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.
- Background: PubMed 31516125Kyaw 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.
- Background1. 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.
- Derived from this study: PubMed 42498468Verbakel JY, Dillen H, Dankaerts A, Michiels N, Vaes B, De Burghgraeve T. Impact evaluation of a Prescription Search Support (PSS) for antimicrobials: protocol for a stepped-wedge cluster randomised trial in Belgian primary care. BMJ Open. 2026 Jul 24;16(7):e120670. doi: 10.1136/bmjopen-2026-120670.
- Individual participant dataSharing planned: Yes. 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.
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Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription Support System (PSS) in people with Infectious Diseases, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic Prescribing Rate in General Practice (time frame: Measured quarterly from baseline until study completion (up to 12 months per practice).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07347015, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.