Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care: the ImpProGUIDE Hybrid Type II Effectiveness-implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Defined daily doses of antibiotics commonly used for acute respiratory infections per 1000 consultations
研究概览
简要总结
The ImpProGUIDE study aims to find out whether implementing new Swiss national guidelines for acute respiratory infections (ARI) can help to reduce antibiotic prescribing in primary care. In Switzerland, most antibiotics are prescribed in outpatient care, and many of these prescriptions may not be needed - especially when infections are caused by viruses, which antibiotics do not treat. Reducing overuse of antibiotics is important to slow the spread of antibiotic resistance.
The new guidelines were developed by the Swiss Society for Infectious Diseases (SSI) to support family doctors in managing ARIs, based on a syndromic approach. They recommend the targeted use of point-of-care C-reactive protein (CRP) testing when bacterial infection is suspected, as well as shared decision-making with patients.
This study will be carried out in quality circles (QCs) - small groups of family doctors who meet regularly to discuss and improve clinical practice - and in walk-in clinics in French- and Italian-speaking regions of Switzerland. Each will be randomly assigned to either an "intervention" group or a "control" group.
In the intervention group, QC moderators and medical center directors will receive implementation resources to lead a session and distribute materials to their group in autumn 2025 on the new guidelines. Doctors can then decide whether or not to use the recommendations in their consultations.
In the control group, QCs and centers will continue their regular activities. They will receive access to the same educational materials later, in summer 2026.
Throughout the study, the researchers will collect de-identified data from health insurance billing records to track antibiotic prescribing and the use of diagnostic tests. Doctors and QC moderators will also be invited to complete short online surveys twice a year (10-15 minutes) and may be asked to join optional interviews or group discussions after the winter season.
The study will also explore the effectiveness of the implementation strategies on the adoption of the SSI guidelines, as well as the barriers and facilitators to adoption. This study type is known as a hybrid effectiveness implementation study, simultaneously evaluating an intervention's impact on antibiotic prescribing and the strategies used to implement the new national guidelines in a real-world setting.
Participation in the study is voluntary. Doctors can withdraw at any time. All data will be handled confidentially and in line with Swiss data protection laws.
The study is funded by the Swiss National Science Foundation. No support is received from pharmaceutical companies or manufacturers of diagnostic tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for quality circles (QCs)
- •Willing to participate in a study mainly conducted in French
- •Agreeing to participate in evaluation surveys
排除标准
- •- Not having any physician included in the study
- •Inclusion criteria for walk-in clinics
- •The clinic offers general practice/primary care medicine consultations, including emergencies
- •The clinic includes at least five physicians
- •The clinic has an "Admission to practice charged to Swiss compulsory health insurance"
- •The clinic plans to still be active in April 2026
- •Located in one of the following cantons: Vaud, Geneva, Valais, Fribourg, Jura, Neuchatel, Bern, Ticino.
- •Serving mainly adult patients
- •Willing to participate in the study
- •Physicians in QCs fulfilling all of the following inclusion criteria are eligible for the study:
- •Registered primary care physicians
- •Specialist title in general internal medicine or practicing physician.
- •Practicing in one of the following cantons: Vaud, Geneva, Valais, Fribourg, Jura, Neuchatel, Bern, Ticino.
- •Participating in a QC or working in an outpatient clinic participating in the study*.
- •Willing to participate in a study mainly conducted in French.
- •Agreeing to participate in evaluation surveys and agreeing to be invited to interviews
- •Eligibility criteria for physicians in clinics :
- •- Having a clinical activity as primary care physician or supervising clinical activity of physicians in post-graduate training within a clinic included in the study
- •The only exclusion criterion for physicians is planning to retire before April
- •*Note: not all physicians from a QC or a clinic are expected or required to participate individually in the study, but at least one should participate.
研究组 & 干预措施
Acute respiratory infection guideline implementation
Quality circles (QC) and walk-in clinics randomized to the intervention arm will receive an overarching multifaceted implementation strategy for the new acute respiratory infection (ARI) guidelines. This includes educational materials to help the QC moderators or the person responsible for education in the clinic to lead a thematic session in autumn 2025, focusing on the use of a syndromic approach, targeted C-reactive protein (CRP) testing when bacterial infection is suspected, and shared decision-making with patients. Other facets include an information sheet and pocket card for physicians, and patient leaflets on acute cough.
干预措施: Training Session on acute respiratory infection guideline within a multifaceted implementation strategy (Behavioral)
Usual care
QCs and walk-in clinics randomized to the control arm will continue their routine activities without receiving the educational materials on the new guidelines during the initial phase. In the summer 2026, these groups will be offered the same training materials provided to the intervention arm, with the option to use them in their QC sessions or internal training.
结局指标
主要结局
Defined daily doses of antibiotics commonly used for acute respiratory infections per 1000 consultations
时间窗: Over the influenza-like illness (ILI) season (6 months).
Defined daily doses (DDD) of selected antibiotics (amoxicillin, co-amoxicillin, clarithromycin, azithromycin) per 1000 consultations, based on de-identified health insurance billing data. These antibiotics represent those most commonly prescribed for pneumonia, acute bronchitis, and upper respiratory tract infections (excluding pharyngitis, sinusitis, and otitis media).
Penetration of acute respiratory infection guidelines
时间窗: Baseline and after 6 months.
Percentage of physicians who self-declare adoption of the new acute respiratory infection (ARI) guidelines (i.e., treating patients according to the guidelines).
次要结局
- Contextual and individual determinants of adoption(Within 6 months after the ILI season.)
- Monthly antibiotic prescribing rate(Monthly for 12 months.)
- Model-estimated differences in antibiotic use(Over the ILI season (6 months).)
- Model-estimated differences in antibiotic use(Over 12 months.)
- Use of diagnostic tests(Over the ILI season (6 months).)
- Perceived acceptability of the CRP flowchart(Baseline and after 6 months.)
- Perceived acceptability of the CRP flowchart assessed by custom questions(Baseline and after 6 months.)
- Perceived acceptability of shared decision-making(Baseline and after 6 months.)
- Perceived acceptability of shared decision-making assessed by custom questions(Baseline and after 6 months.)
- Perceived appropriateness of the CRP flowchart(Baseline and after 6 months.)
- Perceived appropriateness of the CRP flowchart assessed by custom questions(Baseline and after 6 months.)
- Perceived appropriateness of shared decision-making(Baseline and after 6 months.)
- Perceived appropriateness of shared decision-making assessed by custom questions(Baseline and after 6 months.)
- Perceived feasibility of the CRP flowchart(Baseline and after 6 months.)
- Perceived feasibility of the CRP flowchart assessed by custom questions(Baseline and after 6 months.)
- Perceived feasibility of shared decision-making(Baseline and after 6 months.)
- Perceived feasibility of shared decision-making assessed by custom questions(Baseline and after 6 months.)
- Intended adoption of acute respiratory infection guidelines(Baseline and after 6 months.)
- Fidelity to C-reactive protein(Baseline and after 6 months.)
- Fidelity to shared decision-making(Baseline and after 6 months.)
- Anticipated sustainment of acute repiratory infection guidelines(Baseline and after 6 months.)
- Intended adoption of implementation strategies(Baseline and after 6 months.)
- Adoption of implementation strategies(Baseline and after 6 months.)
- Fidelity in delivering the implementation strategies(During the ILI season (6 months).)
- Acceptability of moderator implementation materials(During the ILI season (6 months).)
- Acceptability of physician implementation materials(During the ILI season (6 months).)