跳至主要内容
临床试验/NCT03697096
NCT03697096已完成不适用

INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI)

Harvard Pilgrim Health Care118 个研究点 分布在 1 个国家目标入组 55,412 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
入组人数
55,412
试验地点
118
主要终点
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day

研究概览

简要总结

The INSPIRE-ASP UTI trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with UTI is infected with a resistant pathogen.

Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.

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

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

入选标准

  • HCA hospitals admitting adults for UTI
  • Facility use of MEDITECH as their electronic health record system

排除标准

  • Note: unit of randomization is the hospital, however the CPOE alert intervention will calculate risk estimates for adults age >=18 admitted to non-ICU wards and who are ordered to receive extended-spectrum antibiotics for UTI. Prisoners were excluded from prompts and analysis.

结局指标

主要结局

Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day

时间窗: First 3 days of hospitalization for each patient during 15-month intervention period

The number of different extended-spectrum antibacterials received by the patient each empiric day-of-therapy (outcome measure unit), averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.

次要结局

  • Vancomycin Days of Antibacterial Therapy Per Empiric Day(First 3 days of hospitalization for each patient during 15-month intervention period)
  • Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day(First 3 days of hospitalization for each patient during 15-month intervention period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Platt

Professor and Chair, Department of Population Medicine

Harvard Pilgrim Health Care

研究点 (118)

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