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

• ClinicalTrials.gov Identifier: NCT01260831
• Recruitment Status: Completed
• First Posted: December 15, 2010
• Last Update Posted: June 21, 2017
• Sponsor: The Hospital for Sick Children
• Information provided by (Responsible Party): Christopher Parshuram, The Hospital for Sick Children

Tracking Information

• First Submitted Date: December 14, 2010
• First Posted Date: December 15, 2010
• Last Update Posted Date: June 21, 2017
• Study Start Date: January 2011
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 20, 2017)

All Cause Hospital Mortality (Intervention Phase) [ Time Frame: for 52 weeks starting at Week 31 ]

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.

Original Primary Outcome Measures (submitted: December 14, 2010)

• All Cause Hospital Mortality (Baseline) [ Time Frame: for 26 weeks starting at Week 0 ]
  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 ]
  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 12 months (52 weeks) following the 5-week period during which the run in will occur in intervention hospitals.

Current Secondary Outcome Measures (submitted: March 17, 2011)

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) ]

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.

Original Secondary Outcome Measures (submitted: December 14, 2010)

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) ]

This is a composite outcome comprised of the treatment(s) provided or death prior to transfer from an inpatient ward. A significant clinical deterioration event 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH)
• Official Title: Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH): a Cluster Randomized Trial of the Bedside Paediatric Early Warning System
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Critically Ill Children

Intervention

• 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.

Study Arms

• Experimental: Intervention Hospitals
  hospitals randomized to implement bedsidePEWS documentation system (vital sign assessment record)
  Intervention: Other: Implementation of Bedside Paediatric Early Warning System
• Active Comparator: Control Hospitals
  hospitals randomized to continue with their pre existing documentation system (vital sign assessment record)
  Intervention: Other: Hospital Standard of Care

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 20, 2017): 144539
• Original Estimated Enrollment (submitted: December 14, 2010): 100000
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Day to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Canada, Ireland, Italy, Netherlands, New Zealand, United Kingdom

Administrative Information

• NCT Number: NCT01260831
• Other Study ID Numbers: 1000018562
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Christopher Parshuram, The Hospital for Sick Children
• Original Responsible Party: Dr. Christopher Parshuram / Principal Investigator, The Hospital for Sick Children
• Current Study Sponsor: The Hospital for Sick Children
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: The Hospital for Sick Children
• Verification Date: June 2017