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

NCT01260831 | Completed Phase 2 DMC

• 1 other identifier: 1000018562
• Study Type: interventional
• Target: 144,539
• Locations: 7 countries
• Sites: 22

Brief 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

Keywords

BedsidePEWS; Intensive Care

Outcome Measures

Primary Outcomes (1)

• All Cause Hospital Mortality (Intervention Phase)

  All cause hospital mortality includes all deaths of eligible inpatients who were cared for in an eligible inpatient ward and will be prospectively assessed for 52 weeks following the 5-week run in period at intervention hospitals. The following sub-group analyses will be performed: \[1\] Hospital size. Hospitals with \>200 eligible inpatient ward beds will be one group and those with \<200 eligible inpatient ward beds the other. \[2\] Hospitals with and without medical emergency teams. \[3\] Hospitals with ECMO for children. \[4\] patients with urgent PICU admission initiated in an inpatient ward.

  for 52 weeks starting at Week 31

Secondary Outcomes (1)

• Number of Significant Clinical Deterioration Events

  for 26 weeks starting at Week 0 (baseline) and for 52 weeks starting at week 31 (intervention)

Study Arms (2)

Intervention Hospitals

EXPERIMENTAL

hospitals randomized to implement bedsidePEWS documentation system (vital sign assessment record)

Other: Implementation of Bedside Paediatric Early Warning System

Control Hospitals

ACTIVE COMPARATOR

hospitals randomized to continue with their pre existing documentation system (vital sign assessment record)

Other: Hospital Standard of Care

Interventions

Implementation of Bedside Paediatric Early Warning System OTHER

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.

Intervention Hospitals

Hospital Standard of Care OTHER

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.

Control Hospitals

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (22)

HUDERF: Queen Fabiola Children's University Hospital

Brussels, Belgium

Location

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

Victoria General Hospital

Victoria, British Columbia, L6X0R1, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

McMaster Children's Hospital

Hamilton, Ontario, Canada

Location

London Health Sciences Center University Hospital

London, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Centre hospitalier universitaire Sainte-Justine

Montreal, Quebec, L6X0R1, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, L6X0R1, Canada

Location

Centre hospitalier universitaire de Québec (CHUQ)

Québec, Canada

Location

Children's University Hospital

Dublin, Ireland

Location

Our Lady's Children's Hospital

Dublin, Ireland

Location

Bambino Gesù Children's Hospital

Rome, Italy

Location

Erasmus MC-Sophia

Rotterdam, Netherlands

Location

Starship Children's Health

Auckland, New Zealand

Location

Barts Health - The London NHS Trust

London, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

St. George's Hospital

London, United Kingdom

Location

St. Mary's Hospital - Imperial College Healthcare

London, United Kingdom

Location

Related Publications (3)

• Gawronski O, Parshuram CS, Cecchetti C, Tiozzo E, Szadkowski L, Ciofi Degli Atti ML, Dryden-Palmer K, Dall'Oglio I, Raponi M, Joffe AR, Tomlinson G. Evaluating associations between patient-to-nurse ratios and mortality, process of care events and vital sign documentation on paediatric wards: a secondary analysis of data from the EPOCH cluster-randomised trial. BMJ Open. 2024 Jul 4;14(7):e081645. doi: 10.1136/bmjopen-2023-081645.

  PMID: 38964797 DERIVED

• Parshuram CS, Dryden-Palmer K, Farrell C, Gottesman R, Gray M, Hutchison JS, Helfaer M, Hunt EA, Joffe AR, Lacroix J, Moga MA, Nadkarni V, Ninis N, Parkin PC, Wensley D, Willan AR, Tomlinson GA; Canadian Critical Care Trials Group and the EPOCH Investigators. Effect of a Pediatric Early Warning System on All-Cause Mortality in Hospitalized Pediatric Patients: The EPOCH Randomized Clinical Trial. JAMA. 2018 Mar 13;319(10):1002-1012. doi: 10.1001/jama.2018.0948.

  PMID: 29486493 DERIVED

• Parshuram CS, Dryden-Palmer K, Farrell C, Gottesman R, Gray M, Hutchison JS, Helfaer M, Hunt E, Joffe A, Lacroix J, Nadkarni V, Parkin P, Wensley D, Willan AR; Canadian Critical Care Trials Group. Evaluating processes of care and outcomes of children in hospital (EPOCH): study protocol for a randomized controlled trial. Trials. 2015 Jun 2;16:245. doi: 10.1186/s13063-015-0712-3.

  PMID: 26033094 DERIVED

Study Officials

• Christopher Parshuram, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Patricia Parkin

  The Hospital for Sick Children

  STUDY CHAIR

• James Hutchison

  The Hospital for Sick Children

  STUDY CHAIR

• Catherine Farrell

  Sainte Justine's Hospital

  STUDY CHAIR

• Martin Gray

  St. George's Health Care NHS Trust

  STUDY CHAIR

• Ronald Gottesman

  Montreal Children's Hospital of the MUHC

  STUDY CHAIR

• Mark Helfaer

  Children's Hospital of Philadelphia

  STUDY CHAIR

• Elizabeth Hunt

  Johns Hopkins University

  STUDY CHAIR

• Ari Joffe

  Stollery Children's Hospital

  STUDY CHAIR

• Jacques LaCroix

  Sainte Justine's Hospital

  STUDY CHAIR

• Vinay Nadkarni

  Children's Hospital of Philadelphia

  STUDY CHAIR

• David Wensley

  Provincial Health Services Authority British Columbia

  STUDY CHAIR

• Andrew Willan

  The Hospital for Sick Children, Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 15, 2010
• Study Start: January 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); BE (1); IE (2); CA (11); IT (1); NZ (1); NL (1)