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临床试验/NCT03970356
NCT03970356已完成不适用

The Improving Rational Prescribing for Urinary Tract Infections in Frail Elderly (ImpresU) Project - Work Package 2 (WP2): a Cluster Randomised Multifaceted Antibiotic Stewardship Intervention Study

Cees Hertogh8 个研究点 分布在 4 个国家目标入组 1,146 人开始时间: 2019年9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
1,146
试验地点
8
主要终点
UTI prescriptions

研究概览

简要总结

The purpose of this study is to determine whether a tailored multifaceted antibiotic stewardship intervention reduces antibiotic use for urinary tract infections in residential care homes and nursing homes attended by general practitioners. This will be evaluated in a pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach.

详细描述

Rationale:

Almost 60% of antibiotics in frail elderly is prescribed for alleged UTI. About half of the antibiotics for UTI in this population are prescribed for non-specific signs and symptoms; a substantial part of these prescriptions might not be necessary.

Research question:

Does a tailored multifaceted antibiotic stewardship intervention reduce antibiotic use for UTI in residential care homes and nursing homes attended by general practitioners (GPs)?

Study design, setting and population:

研究设计

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

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • physical and/or mental disabilities and ADL dependency requiring residential care or nursing home care
  • attended by general practitioners
  • not on continuous prophylactic antibiotic use

排除标准

  • in hospice-care
  • very limited life expectancy (≤1 month)
  • no longer wish to participate
  • start continuous antibiotic (prophylaxis)
  • die or move away from the residential care home / nursing home
  • If patients are excluded within 2 months after inclusion, they will be taken out of the study. In other words: patients need to be included for at least 2 months to contribute data to the study.

结局指标

主要结局

UTI prescriptions

时间窗: Assessed during the 7-month follow-up period

Number of prescriptions of antibiotics for suspected urinary tract infections expressed per patient-year

次要结局

  • Complications(Assessed during the 7-month follow-up period)
  • Hospital referral(Assessed during the 7-month follow-up period)
  • UTI suspicions(Assessed during the 7-month follow-up period)
  • Mortality after UTI suspicion(Assessed during the 7-month follow-up period)
  • UTI prescriptions in office hours(Assessed during the 7-month follow-up period)
  • Incorrect UTI prescriptions(Assessed during the 7-month follow-up period)
  • Hospital admission(Assessed during the 7-month follow-up period)
  • Mortality(Assessed during the 7-month follow-up period)

研究者

发起方
Cees Hertogh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cees Hertogh

Prof. dr.

Amsterdam UMC, location VUmc

研究点 (8)

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