title: Evaluating processes of care and outcomes of children in hospital (EPOCH): study protocol for a randomized controlled trial.
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
  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 <18 years and are hospitalized in inpatient ward areas during all or part of their hospital admission. Randomization is to either BedsidePEWS or control (no severity of illness score) in a 1:1 ratio within two strata (<200, ≥ 200 hospital beds). All-cause hospital mortality is the selected primary outcome. It is objective, independent of do-not-resuscitate status and can be reliably measured. The secondary outcomes include (1) clinical outcomes: clinical deterioration, severity of illness at and during ICU admission, and potentially preventable cardiac arrest; (2) processes of care outcomes: immediate calls for assistance, hospital and ICU readmission, and perceptions of healthcare professionals; and (3) resource utilization: ICU days and use of ICU therapies.
  
  
  CONCLUSIONS
  Following funding by the Canadian Institutes of Health Research and local ethical approvals, site enrollment started in 2010 and was closed in February 2014. Patient enrollment is anticipated to be complete in July 2015. The results of EPOCH will strengthen the scientific basis for local, regional, provincial and national decision-making and for the recommendations of national and international bodies. If negative, the costs of hospital-wide implementation can be avoided. If positive, EPOCH will have provided a scientific justification for the major system-level changes required for implementation.
  
  
  BACKGROUND
  NCT01260831 ClinicalTrials.gov date: 14 December 2010.
authors.affiliation: Critical Care Program, Center for Safety Research, and Senior Scientist, Child Health Evaluative Sciences, The Research Institute, Hospital for Sick Children, Toronto, ON, M5G 1X8, Canada. christopher.parshuram@sickkids.ca.|Department of Paediatrics, University of Toronto, Toronto, ON, Canada. christopher.parshuram@sickkids.ca.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Parshuram
authors.affiliation: Critical Care Program, Center for Safety Research Hospital for Sick Children, Toronto, ON, Canada. Karen.Dryden-Palmer@sickkids.ca.
authors.forename: Karen
authors.initials: K
authors.lastname: Dryden-Palmer
authors.affiliation: CHU-St. Justine, Montreal, QC, Canada. catherine.farrell.hsj@ssss.gouv.qc.ca.
authors.forename: Catherine
authors.initials: C
authors.lastname: Farrell
authors.affiliation: Montreal Children's Hospital, Montreal, QC, Canada. ronald.gottesman@muhc.mcgill.ca.
authors.forename: Ronald
authors.initials: R
authors.lastname: Gottesman
authors.affiliation: St. George's Hospital, Tooting, London, UK. m.gray@sgul.ac.uk.
authors.forename: Martin
authors.initials: M
authors.lastname: Gray
authors.affiliation: Hospital for Sick Children, Toronto, ON, Canada. jamie.hutchison@sickkids.ca.
authors.forename: James S
authors.initials: JS
authors.lastname: Hutchison
authors.affiliation: Children's Hospital of Philadelphia, Philadelphia, PA, USA. mmsjc@aol.com.
authors.forename: Mark
authors.initials: M
authors.lastname: Helfaer
authors.affiliation: The Johns Hopkins Hospital, Baltimore, MD, USA. doctorbetsy@yahoo.com.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hunt
authors.affiliation: Stollery Children's Hospital, Edmonton, AB, Canada. ari.joffe@albertahealthservices.ca.
authors.forename: Ari
authors.initials: A
authors.lastname: Joffe
authors.affiliation: CHU-St. Justine, Montreal, QC, Canada. jacques_lacroix@ssss.gouv.qc.ca.
authors.forename: Jacques
authors.initials: J
authors.lastname: Lacroix
authors.affiliation: Children's Hospital of Philadelphia, Philadelphia, PA, USA. NADKARNI@email.chop.edu.
authors.forename: Vinay
authors.initials: V
authors.lastname: Nadkarni
authors.affiliation: Hospital for Sick Children, Toronto, ON, Canada. patricia.parkin@sickkids.ca.
authors.forename: Patricia
authors.initials: P
authors.lastname: Parkin
authors.affiliation: BC Children's Hospital, Vancouver, BC, Canada. dwensley@cw.bc.ca.
authors.forename: David
authors.initials: D
authors.lastname: Wensley
authors.affiliation: Hospital for Sick Children, Toronto, ON, Canada. andy@andywillan.com.
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Willan
mesh_terms: D000293:Adolescent; D002170:Canada; D002648:Child; D046688:Child Mortality; D002675:Child, Preschool; D003661:Decision Support Techniques; D042241:Early Diagnosis; D005260:Female; D006302:Health Services Research; D006323:Heart Arrest / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D017052:Hospital Mortality; D006761:Hospitals; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D015278:Intensive Care Units, Pediatric; D008297:Male; D011237:Predictive Value of Tests; D017064:Process Assessment, Health Care; D012017:Referral and Consultation; D012107:Research Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome