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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Hospitals | Experimental | hospitals randomized to implement bedsidePEWS documentation system (vital sign assessment record) |
|
| Control Hospitals | Active Comparator | hospitals randomized to continue with their pre existing documentation system (vital sign assessment record) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation of Bedside Paediatric Early Warning System | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
For Hospitals:
For inpatient wards:
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:
For patients:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Parshuram, MD | The Hospital for Sick Children | Principal Investigator |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUDERF: Queen Fabiola Children's University Hospital | Brussels | Belgium | ||||
| Alberta Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38964797 | Derived | 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. | |
| 29486493 |
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|
| Hospital Standard of Care | 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. |
|
| for 26 weeks starting at Week 0 (baseline) and for 52 weeks starting at week 31 (intervention) |
| Study Chair |
| Vinay Nadkarni | Children's Hospital of Philadelphia | Study Chair |
| David Wensley | Provincial Health Services Authority British Columbia | Study Chair |
| Andrew Willan | The Hospital for Sick Children, Research Institute | Study Chair |
| Calgary |
| Alberta |
| Canada |
| Stollery Children's Hospital | Edmonton | Alberta | Canada |
| Victoria General Hospital | Victoria | British Columbia | L6X0R1 | 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 | L6X0R1 | Canada |
| Montreal Children's Hospital | Montreal | Quebec | L6X0R1 | 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 |
| Derived |
| 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. |
| 26033094 | Derived | 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. |