跳至主要内容
临床试验/NCT04987840
NCT04987840Enrolling By Invitation不适用

A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children

Johns Hopkins University8 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
15
试验地点
8
主要终点
Respiratory Culture Rate

研究概览

简要总结

The objective of this study is to evaluate implementation of diagnostic stewardship programs as a strategy to safely reduce antibiotic use, and to generate evidence and tools to support dissemination of diagnostic stewardship programs to a large and diverse group of hospitals.

详细描述

The Bright STAR Collaborative, or Testing STewardship to reduce Antibiotic Resistance Collaborative, is a prospective multicenter quality improvement (QI) program with the goal of implementing diagnostic stewardship interventions to reduce bacterial culture use as a strategy to reduce antibiotic overuse. Investigators will use data collected by participating sites to determine whether reliable implementation of clinical practice guidelines for evaluation of patients can decrease antibiotic use in pediatric intensive care units. Investigators will perform a quasi-experimental study to compare outcome data in pre- and post- periods.

Greater than or equal to 10 institutions will participate in this collaborative. Participating institutions will develop and implement an evidenced-based clinical decision-making tool as part of their quality improvement (QI) program in their pediatric intensive care unit (PICU).

Specific Aim 1: Evaluate whether locally devised quality improvement programs focused on diagnostic stewardship of respiratory cultures lead to a reduction in respiratory cultures and antibiotic use.

Specific Aim 2: To determine whether these quality improvement initiatives are associated with unintended consequence of patient harm such as mortality, length of stay, readmissions, ventilator associated infections, sepsis and septic shock.

Variables: total respiratory culture rates, culture results, ICU length of stay, mortality rates, hospital and ICU readmission, cause of death, ventilator-associated infection/ventilator-associated condition rate, sepsis, septic shock.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

排除标准

  • •Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

结局指标

主要结局

Respiratory Culture Rate

时间窗: up to 42 months

Rate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month

次要结局

  • Length of ICU stay(up to 42 months)
  • Hospital readmission(up to 42 months)
  • ventilator associated infections(up to 42 months)
  • Septic shock(up to 42 months)
  • Broad spectrum antibiotic use for ICU days >2 days(up to 42 months)
  • Sepsis(up to 42 months)
  • ICU readmission(up to 42 months)
  • New initiations - Broad spectrum antibiotic use for ICU days >2 days(up to 42 months)
  • Mortality(up to 42 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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