Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH) (EPOCH)
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| ClinicalTrials.gov Identifier: NCT01260831 |
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Recruitment Status :
Completed
First Posted : December 15, 2010
Last Update Posted : June 21, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critically Ill Children | Other: Implementation of Bedside Paediatric Early Warning System Other: Hospital Standard of Care | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 144539 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 Start Date : | January 2011 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention Hospitals
hospitals randomized to implement bedsidePEWS documentation system (vital sign assessment record)
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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. |
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Active Comparator: Control Hospitals
hospitals randomized to continue with their pre existing documentation system (vital sign assessment record)
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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. |
- 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.
- 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.
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| Ages Eligible for Study: | 1 Day to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260831
Show 22 study locations
| 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 |
| Responsible Party: | Christopher Parshuram, Staff Physician, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT01260831 |
| Other Study ID Numbers: |
1000018562 |
| First Posted: | December 15, 2010 Key Record Dates |
| Last Update Posted: | June 21, 2017 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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BedsidePEWS Intensive Care |
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Critical Illness Disease Attributes Pathologic Processes |