Clinical trial NCT01260831: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Critically Ill Children
Keywords: BedsidePEWS
Intensive Care
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 144539
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: All Cause Hospital Mortality (Intervention Phase)
timeFrame: for 52 weeks starting at Week 31
Secondary outcomes:
measure: Number of Significant Clinical Deterioration Events
timeFrame: for 26 weeks starting at Week 0 (baseline) and for 52 weeks starting at week 31 (intervention)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: HUDERF: Queen Fabiola Children's University Hospital
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center University Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier universitaire Sainte-Justine
state: Quebec
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Quebec
country: Canada
facility: Centre hospitalier universitaire de Québec (CHUQ)
city: Dublin
country: Ireland
facility: Children's University Hospital
city: Dublin
country: Ireland
facility: Our Lady's Children's Hospital
city: Rome
country: Italy
facility: Bambino Gesù Children's Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus MC-Sophia
city: Auckland
country: New Zealand
facility: Starship Children's Health
city: London
country: United Kingdom
facility: Barts Health - The London NHS Trust
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital - Imperial College Healthcare
Study officials:
affiliation: The Hospital for Sick Children
name: Christopher Parshuram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Patricia Parkin
role: STUDY_CHAIR
affiliation: The Hospital for Sick Children
name: James Hutchison
role: STUDY_CHAIR
affiliation: Sainte Justine's Hospital
name: Catherine Farrell
role: STUDY_CHAIR
affiliation: St. George's Health Care NHS Trust
name: Martin Gray
role: STUDY_CHAIR
affiliation: Montreal Children's Hospital of the MUHC
name: Ronald Gottesman
role: STUDY_CHAIR
affiliation: Children's Hospital of Philadelphia
name: Mark Helfaer
role: STUDY_CHAIR
affiliation: Johns Hopkins University
name: Elizabeth Hunt
role: STUDY_CHAIR
affiliation: Stollery Children's Hospital
name: Ari Joffe
role: STUDY_CHAIR
affiliation: Sainte Justine's Hospital
name: Jacques LaCroix
role: STUDY_CHAIR
affiliation: Children's Hospital of Philadelphia
name: Vinay Nadkarni
role: STUDY_CHAIR
affiliation: Provincial Health Services Authority
name: David Wensley
role: STUDY_CHAIR
affiliation: The Hospital for Sick Children, Research Institute
name: Andrew Willan
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.