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Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU

NCT06553534 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-08-16

No results posted yet for this study

Summary

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

Conditions

  • In-hospital Cardiac Arrest
  • Cardiopulmonary Resuscitation

Interventions

OTHER

SAMURAI PICU Bundle

The proposed multifaceted SAMURAI PICU Bundle is an intervention with the following core elements: 1) PICU Warning Tool: an automated clinical decision support (CDS) tool to provide a non-interruptive interprofessional predictive alert, 2) twice daily safety huddles with unit leadership, and 3) bedside assessment including the care team and patient's family to complete and display a bedside mitigation plan to prevent deterioration. This intervention combines the automated accurate prediction of the PICU Warning Tool with the use of provider intuition or a "gut feeling" from huddles to improve decision making at the bedside. Peripheral elements and possible adaptations will be suggested during Aim 1 and additional peripheral elements may be added by local sites after discussion with the PI through a user-centered design approach.

Sponsors & Collaborators

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Maya L Dewan, MD, MPH · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06553534 on ClinicalTrials.gov