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

Central Hospital, Nancy, France349 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

349

Conditions

Antibiotic Prescription

Interventions

Charter & patient information leafletsOTHER

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Université de Lorraine

Nancy, Grand Est, France

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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