Impact of a Communication Toolkit on Antibiotic Prescribed by General Practitioners: a Randomised Trial

Study Overview
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Brief Summary
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This study is a pragmatic, randomised, controlled, before-after interventional study conducted in one region in France in primary care. The GPs in the intervention group will receive a public commitment charter, a non prescription pad and a patient information leaflet to be used when antibiotics are prescribed, while the control group will be not aware of the intervention.

Detailed Description
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Antimicrobial resistance is a major public health threat and the overuse of antibiotics contributes to its development. In France, outpatient antibiotic use remains above the European average. Ninety percent of antibiotics are prescribed to outpatients and 70% of these are prescribed by general practitioners.

Official Title
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Impact of a Public Commitment Charter Associated With Patient Information Leaflets on Antibiotics Prescribed by General Practitioners

Conditions
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Antibiotic Prescription

Intervention / Treatment
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* Other: Charter & patient information leaflets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: working in the Lorraine region in France prescribing more than 25 antibiotic items per 100 patients without a chronic illness, aged 16 to 65 years proportion of patients treated with critical antibiotics exceeding 27% (among patients treated with antibiotics) Exclusion Criteria: practicing exclusively alternative medicine, such as homeopathy or acupuncture GPs reaching the retirement age in the two years following the beginning of the intervention or who were not working two years before GPs who had already displayed a commitment charter promoting antibiotic stewardship in their practice
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Charter & patient information leaflets<br>A public commitment charter promoting antibiotic stewardship, signed by the general practitioner (GP) and displayed in the practice waiting room; a non-prescription pad, to be distributed to patients when an antibiotic is not needed; and a patient information leaflet to be used when antibiotics were prescribed | Other: Charter & patient information leaflets<br>* Public commitment charter, non-prescription pad, information leaflet in case of antibiotic prescription<br>|
| No Intervention: Control<br>No intervention, eligible general practitioners randomised in the control group not informed of the intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription | prescription rate by all included GPs of all systemic antibiotics (J01 code according to the Anatomical Therapeutic Chemical - ATC - 2017 classification) between the before (2017-2018) and after (2018-2019) period using an auto regressive integrated moving average (ARIMA) model | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the public commitment charter associated with patient information leaflets on broad-spectrum antibiotics' prescriptions | prescription rates by included GPs of amoxicillin-clavulanate (J01CR02), cephalosporins (J01DD) and fluoroquinolones (J01MA) for each eligible GP between the before and after period using an auto regressive integrated moving average (ARIMA) model | 2 years | 
| Impact of the intervention on the seasonal variation of both total antibiotic use and quinolones' use | ratio of the [number of prescriptions of all antibiotics / quinolones during the cold-weather season (January-March and October-December)] / [number of prescriptions of all antibiotics / quinolones during the hot-weather season (April-September)] - 1 x 100 Title: Broad-spectrum antibiotics' prescriptions between the before and after period using ANOVA models | 2 years | 
| Adherence of GPs regarding the intervention: display of the public commitment charter | checking visually, without the GP being informed, during the opening hours of the practice, that the charter is effectively displayed in the waiting room at month 12 | 1 years | 
| Adherence of GPs regarding the intervention: use patient information leaflets | Estimating the number of patient information leaflets distributed to patients by GPs, from the number of pads ordered from the Regional Health Insurance | 1 years | 
| Acceptability of the intervention by GPs | semi-structured individual interviews with a randomised sample of GPs from the intervention group and focus groups or individual interviews with patients of the included GPs, in order to assess their perceptions regarding the intervention | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotic, antibiotic stewardship