Clinical trial NCT04562571: Impact of a Communication Toolkit on Antibiotic Prescribed by General Practitioners: a Randomised Trial
Official title: Impact of a Public Commitment Charter Associated With Patient Information Leaflets on Antibiotics Prescribed by General Practitioners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic Prescription
Keywords: antibiotic
antibiotic stewardship
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2020-09-24
Enrollment: 349
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription
timeFrame: 2 years
Secondary outcomes:
measure: Impact of the public commitment charter associated with patient information leaflets on broad-spectrum antibiotics' prescriptions
timeFrame: 2 years
measure: Impact of the intervention on the seasonal variation of both total antibiotic use and quinolones' use
timeFrame: 2 years
measure: Adherence of GPs regarding the intervention: display of the public commitment charter
timeFrame: 1 years
measure: Adherence of GPs regarding the intervention: use patient information leaflets
timeFrame: 1 years
measure: Acceptability of the intervention by GPs
timeFrame: 1 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: Université de Lorraine
state: Grand Est
Study officials:
affiliation: CHRU Nancy
name: Céline Pulcini
role: PRINCIPAL_INVESTIGATOR
References:
citation: Essilini A, Le Dref G, Bocquier A, Kivits J, Welter A, Pulcini C, Thilly N; AntibioCharte scientific committee. French general practitioners' and patients' acceptability of a public commitment charter and patient information leaflets targeting unnecessary antibiotic use: a qualitative study. Antimicrob Resist Infect Control. 2022 Feb 8;11(1):32. doi: 10.1186/s13756-022-01065-3.