Impact of a Communication Toolkit on Antibiotic Prescribed by General Practitioners: a Randomised Trial
- Conditions
- Antibiotic Prescription
- Interventions
- Other: Charter & patient information leaflets
- Registration Number
- NCT04562571
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 349
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Charter & patient information leaflets Charter & patient information leaflets 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
- Primary Outcome Measures
Name Time Method Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription 2 years 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
- Secondary Outcome Measures
Name Time Method Adherence of GPs regarding the intervention: display of the public commitment charter 1 years 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
Adherence of GPs regarding the intervention: use patient information leaflets 1 years Estimating the number of patient information leaflets distributed to patients by GPs, from the number of pads ordered from the Regional Health Insurance
Impact of the intervention on the seasonal variation of both total antibiotic use and quinolones' use 2 years 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
Impact of the public commitment charter associated with patient information leaflets on broad-spectrum antibiotics' prescriptions 2 years 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
Acceptability of the intervention by GPs 1 years 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
Trial Locations
- Locations (1)
Université de Lorraine
🇫🇷Nancy, Grand Est, France