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临床试验/NCT04562571
NCT04562571已完成不适用

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

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 349 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
349
试验地点
2
主要终点
Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

次要结局

  • Adherence of GPs regarding the intervention: display of the public commitment charter(1 years)
  • Adherence of GPs regarding the intervention: use patient information leaflets(1 years)
  • Impact of the intervention on the seasonal variation of both total antibiotic use and quinolones' use(2 years)
  • Impact of the public commitment charter associated with patient information leaflets on broad-spectrum antibiotics' prescriptions(2 years)
  • Acceptability of the intervention by GPs(1 years)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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