Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07396428

Acronym

ImpProGUIDE

Enrollment

200

Registered

2026-02-09

Start date

2025-05-19

Completion date

2026-11-01

Last updated

2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Infection, Influenza-like Illness

Keywords

family medicine, primary care, implementation, hybrid design, effectiveness-implementation study, general medicine, outpatient, antibiotics, antibiotic prescribing, antimicrobial resistance, antimicrobial stewardship, guidelines, shared decision making, CRP, c-reactive protein

Brief summary

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.

Interventions

BEHAVIORALTraining Session on acute respiratory infection guideline within a multifaceted implementation strategy

Implementation strategies are deployed within quality circles, consisting of a structured educational session including a PowerPoint presentation, a facilitation guide, clinical vignettes, and printed materials for physicians and patients. The session is designed to support clinical decision-making about antibiotic use for ARI, based on targeted use of CRP and shared decision-making.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

for quality circles (QCs) * Willing to participate in a study mainly conducted in French * Agreeing to participate in evaluation surveys

Exclusion criteria

for QCs\* \- 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 2026. \*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.

Design outcomes

Primary

Measure	Time frame	Description
Defined daily doses of antibiotics commonly used for acute respiratory infections per 1000 consultations	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	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).

Secondary

Countries

Switzerland

Contacts

CONTACTJelena Dunaiceva, MPH

jelena.dunaiceva@unisante.ch; imppro@unisante.ch+41 78 654 23 74

PRINCIPAL_INVESTIGATORYolanda Mueller, MD, PhD

Unisanté, Centre for Primary care and Public Health & University of Lausanne, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026

Measure	Time frame	Description
Monthly antibiotic prescribing rate	Monthly for 12 months.	Monthly prescribing rates expressed as: (1) DDD of antibiotics commonly used for ARI per 1000 consultations, and (2) DDD of total antibiotics per 1000 consultations.
Model-estimated differences in antibiotic use	Over the ILI season (6 months).	Multilevel regression coefficients estimating differences in antibiotic use (DDD per 1000 consultations) according to physician, practice, quality circle (QC), walk-in clinic, and patient characteristics.
Use of diagnostic tests	Over the ILI season (6 months).	Number of C-reactive protein (CRP) measurements, blood counts, and chest radiographs per 1000 consultations.
Perceived acceptability of the CRP flowchart	Baseline and after 6 months.	Perceived acceptability of the CRP flowchart, measured using a French translation of the "Acceptability of Intervention Measure" (5-point Likert scale, higher score means better outcome).
Perceived acceptability of the CRP flowchart assessed by custom questions	Baseline and after 6 months.	Perceived acceptability of the CRP flowchart, assessed using study-specific custom questions (e.g. "I generally agree with prescribing antibiotics in patients with an acute respiratory infection and a CRP level ≥ 100 mg/L." (question originally asked in French), with answer options according to a 5-point Likert scale, higher scores indicate better outcomes).
Perceived acceptability of shared decision-making	Baseline and after 6 months.	Perceived acceptability of shared decision-making, measured using a French translation of the "Acceptability of Intervention Measure" (5-point Likert scale, higher score means better outcome).
Perceived acceptability of shared decision-making assessed by custom questions	Baseline and after 6 months.	Perceived acceptability of shared decision-making, assessed using study-specific custom questions (e.g. "I appreciate the Consultation Support Tool for shared decision-making." (question originally asked in French), with answer options according to a 5-point Likert scale; higher scores indicate better outcomes).
Perceived appropriateness of the CRP flowchart	Baseline and after 6 months.	Perceived appropriateness of the CRP flowchart, measured using a French translation of "Intervention Appropriateness Measure" (5-point Likert scale, higher score means better outcome).
Perceived appropriateness of the CRP flowchart assessed by custom questions	Baseline and after 6 months.	Perceived appropriateness of the CRP flowchart, assessed using study-specific custom questions (e.g. "The CRP decision tree corresponds to the patient population in my practice/medical center." (question originally asked in French), with answer options according to a 5-point Likert scale, higher scores indicate better outcomes).
Perceived appropriateness of shared decision-making	Baseline and after 6 months.	Perceived appropriateness of shared decision-making, measured using a French translation of "Intervention Appropriateness Measure" (5-point Likert scale, higher score means better outcome).
Perceived appropriateness of shared decision-making assessed by custom questions	Baseline and after 6 months.	Perceived appropriateness of shared decision-making, assessed using study-specific custom questions (e.g. "Shared decision-making in patients with an acute respiratory infection and a CRP level ≥ 50 mg/L and \< 100 mg/L corresponds to the patient population in my practice/medical center." (question originally asked in French), with answer options according to a 5-point Likert scale, higher scores indicate better outcomes).
Perceived feasibility of the CRP flowchart	Baseline and after 6 months.	Perceived feasibility of the CRP flowchart, measured using a French translation of "Feasibility of Intervention Measure" (5-point Likert scale, higher score means better outcome).
Perceived feasibility of the CRP flowchart assessed by custom questions	Baseline and after 6 months.	Perceived feasibility of the CRP flowchart, assessed using study-specific custom questions (e.g. "CRP testing in patients with an acute respiratory infection can be performed within a reasonable timeframe." (question originally asked in French), with answer options according to a 5-point Likert scale, higher scores indicate better outcomes).
Perceived feasibility of shared decision-making	Baseline and after 6 months.	Perceived feasibility of shared decision-making, measured using a French translation of "Feasibility of Intervention Measure" (5-point Likert scale).
Perceived feasibility of shared decision-making assessed by custom questions	Baseline and after 6 months.	Perceived feasibility of shared decision-making, assessed using study-specific custom questions (e.g. "Shared decision-making in patients with an acute respiratory infection and a CRP level ≥ 50 mg/L and \< 100 mg/L takes too much time." (question originally asked in French), with answer options according to a 5-point Likert scale, higher scores indicate better outcomes).
Intended adoption of acute respiratory infection guidelines	Baseline and after 6 months.	Intended adoption of the new ARI guideline using custom questions. Intended adoption of the CRP flowchart using custom questions. Intended adoption of shared decision-making using custom questions.
Fidelity to C-reactive protein	Baseline and after 6 months.	Fidelity to the CRP flowchart of the new ARI guidelines, using custom questions.
Fidelity to shared decision-making	Baseline and after 6 months.	Fidelity to shared decision-making of the new ARI guidelines, using custom questions.
Anticipated sustainment of acute repiratory infection guidelines	Baseline and after 6 months.	Anticipated sustainment of the new ARI guidelines, using custom questions.
Intended adoption of implementation strategies	Baseline and after 6 months.	Intended adoption of implementation strategies, measured with custom questions (5-point Likert scale, higher score is higher intention to adopt).
Adoption of implementation strategies	Baseline and after 6 months.	Adoption of implementation strategies, measured with custom questions (single answer, yes/no).
Fidelity in delivering the implementation strategies	During the ILI season (6 months).	Fidelity of delivering the implementation strategies as intended, using custom questions.
Acceptability of moderator implementation materials	During the ILI season (6 months).	Acceptability of implementation materials for moderators, measured with the instrument "Acceptability of Intervention Measure" (5-point Likert scale, higher score means better outcome) and additional custom question(s).
Acceptability of physician implementation materials	During the ILI season (6 months).	Acceptability of implementation materials for physicians, measured with the instrument "Acceptability of Intervention Measure" (5-point Likert scale, higher score means better outcome) and additional custom question(s).
Contextual and individual determinants of adoption	Within 6 months after the ILI season.	Determinants of adoption of the ARI guidelines identified through quantitative and potentially qualitative data collection.