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

Antibiotic Prescription Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562571
• Other study ID #: 201701939
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2019
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Antibiotic Prescription

Intervention

Other:
• Charter & patient information leaflets
Public commitment charter, non-prescription pad, information leaflet in case of antibiotic prescription

Locations

Country	Name	City	State
France	Université de Lorraine	Nancy	Grand Est

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

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