Antibiotic Prescription Clinical Trial
Official title:
Impact of a Public Commitment Charter Associated With Patient Information Leaflets on Antibiotics Prescribed by General Practitioners
Verified date | September 2019 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 349 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Université de Lorraine | Nancy | Grand Est |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France | University of Lorraine |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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