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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01260831




Registration number
NCT01260831
Ethics application status
Date submitted
14/12/2010
Date registered
15/12/2010

Titles & IDs
Public title
Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH)
Scientific title
Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH): a Cluster Randomized Trial of the Bedside Paediatric Early Warning System
Secondary ID [1] 0 0
1000018562
Universal Trial Number (UTN)
Trial acronym
EPOCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill Children 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Implementation of Bedside Paediatric Early Warning System
Other interventions - Hospital Standard of Care

Experimental: Intervention Hospitals - hospitals randomized to implement bedsidePEWS documentation system (vital sign assessment record)

Active comparator: Control Hospitals - hospitals randomized to continue with their pre existing documentation system (vital sign assessment record)


Other 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.

Other interventions: 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All Cause Hospital Mortality (Intervention Phase)
Timepoint [1] 0 0
for 52 weeks starting at Week 31
Secondary outcome [1] 0 0
Number of Significant Clinical Deterioration Events
Timepoint [1] 0 0
for 26 weeks starting at Week 0 (baseline) and for 52 weeks starting at week 31 (intervention)

Eligibility
Key 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.
Minimum age
1 Day
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
144539
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Ireland
State/province [8] 0 0
Dublin
Country [9] 0 0
Italy
State/province [9] 0 0
Rome
Country [10] 0 0
Netherlands
State/province [10] 0 0
Rotterdam
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
The Hospital for Sick Children
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Parshuram, MD
Address 0 0
The Hospital for Sick Children
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01260831