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临床试验/NCT04051281
NCT04051281已完成不适用

A Letter From the CMO in England to Reduce Antibiotic Prescribing in General Practice: A Randomized Controlled Trial Comparing Monitoring and Feedback (With and Without Graphs), and Social Norms Feedback (Without and Without a Specific Case Study of Patient Harm)

Public Health England2 个研究点 分布在 1 个国家目标入组 2,963 人开始时间: 2019年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,963
试验地点
2
主要终点
Total antibiotic prescribing in from September-February

研究概览

简要总结

This trial aims to reduce inappropriate prescription of antibiotics and broad spectrum antibiotics by general practitioners (GPs) in England. Unnecessary prescriptions are defined as those that do not improve patient health outcomes. The intervention is to send GPs a letter from the Chief Medical Officer (CMO) that gives feedback on their practice's prescribing levels.

There will be three intervention samples:

  1. practices whose prescribing in the past year was under the new target of 0.965 items per STAR-PU but who would exceed the target if they had a 5% increase in prescribing; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing is just under the new target to that of practices that are not sent a letter
  2. Practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing exceeds the new target to practices who get a letter that includes a graph showing their prescribing relative to the target and to practices that are not sent a letter
  3. Practices that are currently in the top 20% of prescribers; trial compares effect on prescribing of a feedback letter with a social norms message (current standard practice for this group) to a letter informing GPs that their practice's prescribing exceeds the new target and to a letter with a social norms message, that includes a specific example of a case of patient harm caused by antimicrobial resistance.

详细描述

The study will involve three trials, each conducted as non-blinded randomised controlled trial, with GP practices as the unit of randomisation.

Trial 1 Targeting practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing

  • Control: No letter
  • Intervention: Letter informing them that their practice's prescribing is just under the new target (Letter A) Trial hypothesis: Sending a letter to GPs whose practices are just under the new prescribing target will reduce antibiotic prescribing

Trial 2 Targeting practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers

  • Control: No letter
  • Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter B1)
  • Intervention 2: Letter informing them that their practice's prescribing exceeds the new target with a graph representing prescribing relative to the target (Letter B2) Hypotheses: (i) Sending a letter to GPs whose practices missed the new prescribing target will reduce their prescribing; (ii) A letter with a graph will be more effective than a letter without a graph.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • GP practices that prescribed more than 0.919 Antibacterial Items/STAR- PU (5% under the target of 0.965) for the twelve months April 2018 - March 2019

排除标准

  • Practices in the 99th percentile of prescribers

结局指标

主要结局

Total antibiotic prescribing in from September-February

时间窗: 6 months

antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

Total antibiotic prescribing in September

时间窗: 1 month

antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

Total antibiotic prescribing in October

时间窗: 2 months

antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

Total antibiotic prescribing in December

时间窗: 4 months

antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

Total antibiotic prescribing in February

时间窗: 6 months

antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

Proportion of practices in each group whose prescribing was under the target

时间窗: 8 months

Whether antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) for April 2019-March 2020 is under the NHS target of 0.965 items per STAR-PU

Total antibiotic prescribing in November

时间窗: 3 months

antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

Total antibiotic prescribing in January

时间窗: 5 months

antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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