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Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH): a Cluster Randomized Trial of the Bedside Paediatric Early Warning System

NCT01260831•The Hospital for Sick Children

View on ClinicalTrials.gov

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.

Detailed Description

The Bedside Paediatric Early Warning System (Bedside PEWS) is a scientifically developed documentation-based system of care designed to identify children who are clinically deteriorating while admitted to hospital inpatient wards. It was developed and validated by the applicants. The investigators have preliminary data demonstrating that the Bedside PEWS addresses multiple factors (communication, hierarchy, secondary review) contributing to delayed treatment of children at risk. In our pilot study of implementation at a single site the investigators showed statistically significant reductions in late transfers, 'stat' calls, decreased apprehension when nurses called physicians to review patients, and improved communication. Our preliminary data show that the Bedside PEWS score is superior to other methods being used to identify children at risk for impending cardiopulmonary arrest. A 2-year cluster-randomized trial will evaluate the impact of Bedside PEWS on clinical outcomes, processes of care and resource utilization in 22 paediatric hospitals.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For Hospitals:
•provide care for more than 200 inpatient admissions aged \<18 years and \>37 weeks gestational age in eligible inpatient wards each year
•have specialised paediatric physicians (including paediatricians, paediatric surgeons, other paediatric sub-specialists) and, one or more intensive care unit (PICU) that provides care for children. A PICU is a designated, staffed area for prolonged mechanical ventilation, invasive monitoring and circulatory support for children- including but not limited to neonates. Other areas designated for patients of increased acuity, such as 'constant observation' or 'high dependency' or 'step-down' units will be regarded as part of the PICU where the PICU staff physicians are wholly or jointly responsible for the care of children in these areas (can write orders in the chart).
•may or may not have a MET-RRT for children. A MET-RRT is defined as an identified team of one or more trained healthcare professionals who report to an on service PICU physician, and perform urgent consultations on hospital inpatients.
•For inpatient wards:
•areas where care is provided to patients who are admitted to the hospital, other than PICU, operating rooms, and other designated areas where anaesthetist-supervised procedures are performed. All eligible inpatient wards will participate in the study.
•For patients:
•Within eligible hospitals we will study patients older than 37 weeks gestational age and less than 18 years who are admitted to eligible inpatient wards, who receive care in an eligible inpatient area during the study.

Exclusion Criteria

•For hospitals:
•have plans to introduce a new 'medical emergency team' during the study, and where a severity of illness score (Brighton, Cardiff, PEWS, Bedside PEWS or other unpublished score) is used in ward areas
•For patients:
•those who are less than 37 weeks gestational age throughout their hospitalization
•are cared for exclusively in an NICU
•children who are admitted directly to a PICU and die before PICU discharge and thus have not received care in an eligible inpatient ward

Locations (22)

HUDERF: Queen Fabiola Children's University Hospital

Brussels, Belgium

Alberta Children's Hospital

Calgary, Alberta, Canada

Stollery Children's Hospital

Edmonton, Alberta, Canada

Victoria General Hospital

Victoria, British Columbia, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

McMaster Children's Hospital

Hamilton, Ontario, Canada

London Health Sciences Center University Hospital

London, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Centre hospitalier universitaire Sainte-Justine

Montreal, Quebec, Canada

Key Dates

Start Date

January 1, 2011

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

June 21, 2017

Enrollment

144,539

ACTUAL participants

Conditions

Critically Ill Children

Interventions

Implementation of Bedside Paediatric Early Warning System

OTHER

Hospital Standard of Care

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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