Impact Evaluation of a Prescription Search Support (PSS) for Antimicrobials Using a Stepped-Wedge Cluster Randomized Design in Belgian Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Antibiotic Prescribing Rate in General Practice
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control: Usual Care
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
Prescription Support System (PSS) Providing guideline-based recommendations for antimicrobial prescribing in ambulatory care.
干预措施: Prescription Support System (PSS) (Other)
结局指标
主要结局
Antibiotic Prescribing Rate in General Practice
时间窗: 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.
次要结局
- 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))