title: Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.
abstract: BACKGROUND
  The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways.
  
  
  METHODS
  We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits.
  
  
  CONCLUSIONS
  This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01815710.
authors.affiliation: Division of Emergency Medicine, Children's Hospital of Eastern Ontario, Ottawa, Canada. jabbour@cheo.on.ca
authors.forename: Mona
authors.initials: M
authors.lastname: Jabbour
authors.forename: Janet
authors.initials: J
authors.lastname: Curran
authors.forename: Shannon D
authors.initials: SD
authors.lastname: Scott
authors.forename: Astrid
authors.initials: A
authors.lastname: Guttman
authors.forename: Thomas
authors.initials: T
authors.lastname: Rotter
authors.forename: Francine M
authors.initials: FM
authors.lastname: Ducharme
authors.forename: M Diane
authors.initials: MD
authors.lastname: Lougheed
authors.forename: M Louise
authors.initials: ML
authors.lastname: McNaughton-Filion
authors.forename: Amanda
authors.initials: A
authors.lastname: Newton
authors.forename: Mark
authors.initials: M
authors.lastname: Shafir
authors.forename: Alison
authors.initials: A
authors.lastname: Paprica
authors.forename: Terry
authors.initials: T
authors.lastname: Klassen
authors.forename: Monica
authors.initials: M
authors.lastname: Taljaard
authors.forename: Jeremy
authors.initials: J
authors.lastname: Grimshaw
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
mesh_terms: D001249:Asthma / Q000191:economics / Q000628:therapy*; D002648:Child; D016000:Cluster Analysis; D003365:Costs and Cost Analysis; D019091:Critical Pathways / Q000191:economics / Q000458:organization & administration*; D004059:Diffusion of Innovation; D004636:Emergency Service, Hospital / Q000191:economics / Q000458:organization & administration*; D005759:Gastroenteritis / Q000191:economics / Q000628:therapy*; D006760:Hospitalization / Q000191:economics / Q000706:statistics & numerical data; D006764:Hospitals, Community; D006801:Humans; D008485:Medical Audit; D009864:Ontario; D010043:Outcome and Process Assessment, Health Care; D015397:Program Evaluation; D018401:Sample Size; D016896:Treatment Outcome; D014218:Triage