Unisanté
Lausanne, Canton of Vaud, 1011, Switzerland
Location status: Recruiting
Location contact
Jelena Dunaiceva, MPH
CONTACT
Yolanda Mueller, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07396428
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.
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Lausanne, Canton of Vaud, 1011, Switzerland
Location status: Recruiting
Jelena Dunaiceva, MPH
CONTACT
Yolanda Mueller, MD, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for quality circles (QCs)
Exclusion criteria
for QCs*
Inclusion criteria
for walk-in clinics
Physicians in QCs fulfilling all of the following inclusion criteria are eligible for the study:
Eligibility criteria for physicians in clinics :
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.
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Over 12 months.
Multilevel regression coefficients estimating differences in antibiotic use (DDD per 1000 consultations) according to physician, practice, QC, walk-in clinic and patient characteristics.
Time frame: Over the ILI season (6 months).
Number of C-reactive protein (CRP) measurements, blood counts, and chest radiographs per 1000 consultations.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline and after 6 months.
Fidelity to the CRP flowchart of the new ARI guidelines, using custom questions.
Time frame: Baseline and after 6 months.
Fidelity to shared decision-making of the new ARI guidelines, using custom questions.
Time frame: Baseline and after 6 months.
Anticipated sustainment of the new ARI guidelines, using custom questions.
Time frame: 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).
Time frame: Baseline and after 6 months.
Adoption of implementation strategies, measured with custom questions (single answer, yes/no).
Time frame: During the ILI season (6 months).
Fidelity of delivering the implementation strategies as intended, using custom questions.
Time frame: 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).
Time frame: 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).
Time frame: Within 6 months after the ILI season.
Determinants of adoption of the ARI guidelines identified through quantitative and potentially qualitative data collection.
Time frame: Baseline and after 6 months.
Knowledge about ARI management according to the new guidelines, measured with a custom questionnaire: "Knowledge questionnaire on the diagnosis and treatment of acute respiratory infections and influenza-like syndromes", (6 questions, of which 3 multiple choice, 3 single choice).
Time frame: Over the ILI season (6 months).
Incremental cost-effectiveness ratio (ICER), expressed in CHF per percentage point reduction in antibiotic prescribing, comparing the ARI guideline implementation strategy to routine practice.
Contact information is provided by the study sponsor or research team.
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Other
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
Acronym: ImpProGUIDE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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