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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Christopher Parshuram, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01260831
First received: December 14, 2010
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Intensive Care
Other: Implementation of Bedside Paediatric Early Warning System
Other: Hospital Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH): a Cluster Randomized Trial of the Bedside Paediatric Early Warning System

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • All Cause Hospital Mortality (Baseline) [ Time Frame: for 26 weeks starting at Week 0 ] [ Designated as safety issue: No ]
    All cause hospital mortality will include all deaths of eligible inpatients who were cared for in an eligible inpatient ward during their hospital stay will be prospectively assessed for 6 months (26 weeks) to provide baseline data.

  • All Cause Hospital Mortality (Intervention) [ Time Frame: for 52 weeks starting at Week 31 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Number of Significant Clinical Deterioration Events [ Time Frame: for 26 weeks starting at Week 0 (baseline) and for 52 weeks starting at week 31 (intervention) ] [ Designated as safety issue: No ]

    This will be defined as the provision of significant respiratory or circulatory therapies or cardiopulmonary resuscitation in the 12 hours before transfer from inpatient ward, or death without DNR order in an inpatient ward.

    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.



Estimated Enrollment: 100000
Study Start Date: January 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Hospitals 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.
Active Comparator: Control Hospitals 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.

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • hospitals where randomization is not deemed acceptable. These exclusion criteria ensure that major system changes including introduction of MET-RRT, new documentation systems, physician staffing, and hospital capacity will not bias results.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260831

Contacts
Contact: Christopher Parshuram, MD 416-813-7654 ext 6504 christopher.parshuram@sickkids.ca

Locations
Belgium
HUDERF: Queen Fabiola Children's University Hospital Recruiting
Brussels, Belgium
Principal Investigator: Ariane Willems         
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada
Principal Investigator: Kathy Tobler         
Stollery Children's Hospital Completed
Edmonton, Alberta, Canada
Canada, British Columbia
Victoria General Hospital Recruiting
Victoria, British Columbia, Canada, L6X0R1
Principal Investigator: Amanda Barclay         
Canada, New Brunswick
Saint John Regional Hospital Completed
Saint John, New Brunswick, Canada
Canada, Nova Scotia
IWK Health Centre Completed
Halifax, Nova Scotia, Canada
Canada, Ontario
McMaster Children's Hospital Suspended
Hamilton, Ontario, Canada
London Health Sciences Center University Hospital Recruiting
London, Ontario, Canada
Principal Investigator: Douglas Fraser         
The Hospital for Sick Children Completed
Toronto, Ontario, Canada
Canada, Quebec
Centre hospitalier universitaire Sainte-Justine Active, not recruiting
Montreal, Quebec, Canada, L6X0R1
Montreal Children's Hospital Active, not recruiting
Montreal, Quebec, Canada, L6X0R1
Canada
Centre hospitalier universitaire de Québec (CHUQ) Completed
Quebec, Canada
Ireland
Our Lady's Children's Hospital Recruiting
Dublin, Ireland
Principal Investigator: Cormac Breathnach         
Children's University Hospital Recruiting
Dublin, Ireland
Principal Investigator: Dermot Doherty         
Italy
Bambino Gesù Children's Hospital Recruiting
Rome, Italy
Principal Investigator: Corrado Cecchetti         
Netherlands
Erasmus MC-Sophia Recruiting
Rotterdam, Netherlands
Principal Investigator: Cynthia van der Starre         
New Zealand
Starship Children's Health Completed
Auckland, New Zealand
United Kingdom
Kings College Hospital Recruiting
London, United Kingdom
Principal Investigator: Simon Broughton         
Royal Brompton Hospital Recruiting
London, United Kingdom
Principal Investigator: Margarita Burmester         
St. Mary's Hospital - Imperial College Healthcare Recruiting
London, United Kingdom
Principal Investigator: David Inwald         
Barts Health - The London NHS Trust Recruiting
London, United Kingdom
Principal Investigator: Mamta Vaidya         
St. George's Hospital Active, not recruiting
London, United Kingdom
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Christopher Parshuram, MD The Hospital for Sick Children
Study Chair: 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
Study Chair: Andrew Willan The Hospital for Sick Children, Research Institute
  More Information

No publications provided

Responsible Party: Christopher Parshuram, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01260831     History of Changes
Other Study ID Numbers: 1000018562
Study First Received: December 14, 2010
Last Updated: December 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Bedside PEWS
Intensive Care

ClinicalTrials.gov processed this record on October 20, 2014