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

NCT ID: NCT01260831

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 144539 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Critically Ill Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Hospitals

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

Group Type: EXPERIMENTAL

Implementation of Bedside Paediatric Early Warning System

Intervention Type: 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.

Control Hospitals

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

Group Type: ACTIVE_COMPARATOR

Hospital Standard of Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Christopher Parshuram

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Parshuram, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Patricia Parkin

Role: STUDY_CHAIR

The Hospital for Sick Children

James Hutchison

Role: STUDY_CHAIR

The Hospital for Sick Children

Catherine Farrell

Role: STUDY_CHAIR

Sainte Justine's Hospital

Martin Gray

Role: STUDY_CHAIR

St. George's Health Care NHS Trust

Ronald Gottesman

Role: STUDY_CHAIR

Montreal Children's Hospital of the MUHC

Mark Helfaer

Role: STUDY_CHAIR

Children's Hospital of Philadelphia

Elizabeth Hunt

Role: STUDY_CHAIR

Johns Hopkins University

Ari Joffe

Role: STUDY_CHAIR

Stollery Children's Hospital

Jacques LaCroix

Role: STUDY_CHAIR

Sainte Justine's Hospital

Vinay Nadkarni

Role: STUDY_CHAIR

Children's Hospital of Philadelphia

David Wensley

Role: STUDY_CHAIR

Provincial Health Services Authority

Andrew Willan

Role: STUDY_CHAIR

The Hospital for Sick Children, Research Institute

Locations

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

Montreal Children's Hospital

Montreal, Quebec, Canada

Centre hospitalier universitaire de Québec (CHUQ)

Québec, , Canada

Children's University Hospital

Dublin, , Ireland

Our Lady's Children's Hospital

Dublin, , Ireland

Bambino Gesù Children's Hospital

Rome, , Italy

Erasmus MC-Sophia

Rotterdam, , Netherlands

Starship Children's Health

Auckland, , New Zealand

Barts Health - The London NHS Trust

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

Royal Brompton Hospital

London, , United Kingdom

St. George's Hospital

London, , United Kingdom

St. Mary's Hospital - Imperial College Healthcare

London, , United Kingdom

Countries

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

References

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.

Reference Type: DERIVED

PMID: 38964797 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29486493 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26033094 (View on PubMed)

Other Identifiers

1000018562

Identifier Type: -

Identifier Source: org_study_id