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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04562571
Enrollment
349
Registered
2020-09-24
Start date
2018-10-01
Completion date
2019-09-30
Last updated
2020-09-24

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

Conditions

Antibiotic Prescription

Keywords

antibiotic, antibiotic stewardship

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.

Interventions

OTHERCharter & patient information leaflets

Public commitment charter, non-prescription pad, information leaflet in case of antibiotic prescription

Sponsors

University of Lorraine
CollaboratorOTHER
Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription2 yearsprescription 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

MeasureTime frameDescription
Impact of the public commitment charter associated with patient information leaflets on broad-spectrum antibiotics' prescriptions2 yearsprescription 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
Impact of the intervention on the seasonal variation of both total antibiotic use and quinolones' use2 yearsratio 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
Adherence of GPs regarding the intervention: display of the public commitment charter1 yearschecking 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 leaflets1 yearsEstimating the number of patient information leaflets distributed to patients by GPs, from the number of pads ordered from the Regional Health Insurance
Acceptability of the intervention by GPs1 yearssemi-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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026