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临床试验/NCT06553534
NCT06553534进行中(未招募)不适用

Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU in the Pediatric Resuscitation Quality Collaborative

Children's Hospital Medical Center, Cincinnati10 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
5
试验地点
10
主要终点
Effectiveness - CPR Event Rate

研究概览

简要总结

The goal of this pragmatic prospective Type 1 Hybrid Implementation-Effectiveness Trial study is to learn if The Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In (SAMURAI) the PICU Bundle can reduce PICU CPR events. The SAMURAI PICU Bundle includes an automated PICU warning tool, twice daily huddles and mitigation plans. The main questions it aims to answer are:

Is the adapted bundle will be acceptable, feasible, and appropriate to stakeholders prior to implementation?

Will there be at least a 30% relative reduction in PICU CPR events following successful implementation of the bundle?

Each site will:

Adapt and implement SAMURAI PICU Bundle which includes an automated PICU warning tool, twice daily huddles and mitigation plans

详细描述

As nearly 95% of pediatric IHCAs occur in PICUs, we developed an interventional cardiac arrest prevention bundle targeted to PICU healthcare providers. In a previous single center trial, the use of the SAMURAI PICU bundle improved early identification of high-risk patients, increased shared situation awareness, and supported risk mitigation plans, leading to a >50% decrease in IHCA events requiring cardiopulmonary resuscitation (CPR). Early identification occurs via the PICU Warning Tool, an automated, electronic medical record clinical decision support tool that provides a non-interruptive notification to care providers of high-risk patients. This prediction tool prompts a bedside huddle to ensure shared situation awareness and development of a mitigation plan. This novel approach of emphasizing shared situation awareness through automated clinical decision support and mitigation of risk has demonstrated reduction in CPR events and mortality within the PICU clinical environment.

This study employs a user-centered design model to adapt, implement, and assess the feasibility and effectiveness of SAMURAI PICU at other pediatric institutions. The hypothesis is that identification of PICU patients at high risk for IHCA through the use of the PICU Warning Tool and integration of this high-risk status in daily safety huddles will lead to improved shared situation awareness and subsequent reduction in CPR events at participating institutions. This approach will utilize a five-center pragmatic prospective Hybrid Type 1 effectiveness-implementation study leveraging the existing infrastructure of Pediatric Resuscitation Quality Collaborative (pediRES-Q).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients admitted to the five PICUs in pediRES-Q during the study period

排除标准

  • 未提供

结局指标

主要结局

Effectiveness - CPR Event Rate

时间窗: 2 years and 4 years

The primary outcome is CPR Event Rate per 1000 Patient Days. CPR Events will be defined per Utstein Criteria.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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