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

Critically Ill Children Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260831
• Other study ID #: 1000018562
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2010
• Last updated: June 20, 2017
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: June 2017
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144539
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	HUDERF: Queen Fabiola Children's University Hospital	Brussels
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	London Health Sciences Center University Hospital	London	Ontario
Canada	Centre hospitalier universitaire Sainte-Justine	Montreal	Quebec
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Centre hospitalier universitaire de Québec (CHUQ)	Quebec
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	Victoria General Hospital	Victoria	British Columbia
Ireland	Children's University Hospital	Dublin
Ireland	Our Lady's Children's Hospital	Dublin
Italy	Bambino Gesù Children's Hospital	Rome
Netherlands	Erasmus MC-Sophia	Rotterdam
New Zealand	Starship Children's Health	Auckland
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Significant Clinical Deterioration Events	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.	for 26 weeks starting at Week 0 (baseline) and for 52 weeks starting at week 31 (intervention)