Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH)

NCT01260831 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144539

Last updated 2017-06-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the impact of Bedside Paediatric Early Warning System (Bedside-PEWS) on early identification of children at risk for near and actual cardiopulmonary arrest, hospital mortality, processes of care and PICU resource utilization.

Conditions

  • Critically Ill Children

Interventions

OTHER

Implementation of Bedside Paediatric Early Warning System

The Bedside Paediatric Early Warning System (Bedside PEWS) is a documentation-based system of care that will replace existing documentation systems for vital signs in inpatient ward areas in hospitals randomized to implement Bedside-PEWS. Frontline staff education within each hospital will occur over a period of three months preceding a 5 week run-in implementation phase, which will be followed by hospital-wide implementation. The Bedside-PEWS documentation record will become the primary method of documentation for vital signs and related data.

OTHER

Hospital Standard of Care

Hospitals randomized to standard care will continue with established methods of care. This will include the use of calling criteria and/or the expert model to identify children at risk. As in intervention hospitals, existing MET-RRT practices, established staffing and documentation practices will continue.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Christopher Parshuram, MD · The Hospital for Sick Children

  • Patricia Parkin · The Hospital for Sick Children

  • James Hutchison · The Hospital for Sick Children

  • Catherine Farrell · Sainte Justine's Hospital

  • Martin Gray · St. George's Health Care NHS Trust

  • Ronald Gottesman · Montreal Children's Hospital of the MUHC

  • Mark Helfaer · Children's Hospital of Philadelphia

  • Elizabeth Hunt · Johns Hopkins University

  • Ari Joffe · Stollery Children's Hospital

  • Jacques LaCroix · Sainte Justine's Hospital

  • Vinay Nadkarni · Children's Hospital of Philadelphia

  • David Wensley · Provincial Health Services Authority

  • Andrew Willan · The Hospital for Sick Children, Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Belgium
  • Canada
  • Ireland
  • Italy
  • Netherlands
  • New Zealand
  • United Kingdom

Study Locations

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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 NCT01260831 on ClinicalTrials.gov