study protocol for a randomized controlled trial - Springer Link
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study protocol for a randomized controlled trial - Springer Link
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TRIALS
STUDY PROTOCOL
Open Access
Evaluating processes of care and outcomes of children in hospital (EPOCH): study protocol for a randomized controlled trial Christopher S. Parshuram1,2*, Karen Dryden-Palmer3, Catherine Farrell4, Ronald Gottesman5, Martin Gray6, James S. Hutchison7, Mark Helfaer8, Elizabeth Hunt9, Ari Joffe10, Jacques Lacroix4, Vinay Nadkarni8, Patricia Parkin7, David Wensley11, Andrew R Willan7 and For the Canadian Critical Care Trials Group
Abstract Background: The prevention of near and actual cardiopulmonary arrest in hospitalized children is a patient safety imperative. Prevention is contingent upon the timely identification, referral and treatment of children who are deteriorating clinically. We designed and validated a documentation-based system of care to permit identification and referral as well as facilitate provision of timely treatment. We called it the Bedside Paediatric Early Warning System (BedsidePEWS). Here we describe the rationale for the design, intervention and outcomes of the study entitled Evaluating Processes and Outcomes of Children in Hospital (EPOCH). Methods/Design: EPOCH is a cluster-randomized trial of the BedsidePEWS. The unit of randomization is the participating hospital. Eligible hospitals have a Pediatric Intensive Care Unit (PICU), are anticipated to have organizational stability throughout the study, are not using a severity of illness score in hospital wards and are willing to be randomized. Patients are >37 weeks gestational age and
