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Completed

NCT Number: NCT04562571

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

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.

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Key information

Conditions

Antibiotic Prescription

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Lorraine

Nancy, Grand Est, 54000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Charter & patient information leaflets

Other

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

Primary outcomes

  1. Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription

    Time frame: 2 years

    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

Secondary outcomes

  1. Impact of the public commitment charter associated with patient information leaflets on broad-spectrum antibiotics' prescriptions

    Time frame: 2 years

    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. Impact of the intervention on the seasonal variation of both total antibiotic use and quinolones' use

    Time frame: 2 years

    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

  3. Adherence of GPs regarding the intervention: display of the public commitment charter

    Time frame: 1 years

    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

  4. Adherence of GPs regarding the intervention: use patient information leaflets

    Time frame: 1 years

    Estimating the number of patient information leaflets distributed to patients by GPs, from the number of pads ordered from the Regional Health Insurance

  5. Acceptability of the intervention by GPs

    Time frame: 1 years

    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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • University of Lorraine

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 24, 2020
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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