Best Strategies for Implementation of Clinical Pathways in Emergency Department Settings
Condition: Asthma; Diarrhea & Vomiting
MeSH terms: Emergencies; Vomiting; Diarrhea
Study type: Observational

Summary: 
      An Ontario-wide study to identify best strategies to promote uptake of high quality, expert
      developed Clinical Pathways (CPs) within Emergency Departments.

      The investigators will work with 16 Community EDs across Ontario to i) tailor an
      implementation strategy that works for each ED, ii) assist with the implementation of one
      pediatric emergency CP (Asthma or Gastroenteritis) at each site, and iii) evaluate the impact
      on health professionals, patient outcomes and economic costs. The investigators will conduct
      a 3.5 - year mixed methods health services research project with four study objectives: 1) to
      design a theory-based and knowledge user-informed intervention strategy to successfully
      implement two provincial pediatric emergency clinical pathways into practice in community
      Emergency Departments (EDs); 2) to evaluate the effectiveness of this implementation
      strategy; 3) to conduct a process evaluation to assess the implementation strategy; and 4) to
      conduct an economic analysis to evaluate implementation costs and benefits.
    

Detailed description: 
      To meet the first objective, we will use Michie's Theoretical Domains Framework (TDF) to
      identify and organize CP-relevant behaviours. We will conduct qualitative interviews, guided
      by the TDF and involving knowledge users from participating sites, to identify barriers and
      facilitators for change relevant to the proposed CP implementation. Experience from other
      implementation initiatives will also be used to guide the intervention. An intervention
      mapping technique will be used to select and organize appropriate strategies to affect
      behaviour changes. Further input will be sought from knowledge user site partners. The
      intervention will begin with a site visit to assess readiness for adoption, infrastructure
      requirements, and ability to implement the pathway.

      To meet objective two, we will use a cluster randomized control trial (RCT) design, through
      measurement of relevant clinical and process outcomes in 16 community EDs in Ontario. Using a
      balanced incomplete block design, we will study this implementation intervention with two
      clinical pathways: i) Asthma and ii) Vomiting & Diarrhea (V&D). We will recruit and randomize
      16 community EDs to receive the intervention for one of the CPs and serve as control for the
      alternate pathway. Primary clinical outcomes for each CP include the following: i) Asthma:
      the proportion of asthmatic patients with moderate to severe exacerbation who received
      steroids within 60 minutes from ED presentation; and ii) V&D: the proportion of children with
      mild to moderate dehydration treated with oral rehydration therapy. The primary process
      outcome measure will be the presence of an appropriately completed CP, as per pre-defined
      criteria, on the chart for relevant patients. Secondary clinical outcomes include
      disease-specific treatments, ED length of stay, revisits and hospitalizations. Secondary
      process outcomes include CP use based on shift-level data relating to the busyness of the ED.
      A mixed methods evaluation will be used to assess clinical and process outcomes. Data sources
      include chart audits, administrative databases, environmental scans and knowledge user
      interviews. Sample size calculations for the primary process outcome yielded the highest
      number of required charts. A total sample size of 6400 patient charts is required to detect
      an absolute difference of 12% between control and intervention hospitals using a two-sided
      test at the 5% level of significance.

      To meet objective three, a process log will be used to track progress with site deadline
      targets, implementation issues, degree of uptake, local adaptations and adherence.

      And finally, to meet objective four, comparisons of CP implementation and health care costs
      will be done for all patients with Asthma or V&D in the pre and post implementation phases at
      all sites. Additional costs and outcomes will be synthesized in an incremental
      cost-effectiveness ratio (ICER) comparing intervention and control sites. Cost-effectiveness
      analyses (CEAs) will be done to relate ICERs to the primary clinical outcome for each CP.
    

Intervention name(s): Pediatric Asthma Clinical Pathway; Vomiting & Diarrhea Pathway
Intervention type(s): Other; Other
Intervention description(s): Implementation of a clinical pathway outlining standardized, evidence-based care for pediatric patients with asthma. These clinical pathways use organized, time-sequenced interventions to achieve optimal patient outcomes.; Implementation of a clinical pathway outlining standardized, evidence-based care for pediatric patients with vomiting and diarrhea. These clinical pathways use organized, time-sequenced interventions to achieve optimal patient outcomes.
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Community hospitals in a variety of local health integration networks across Ontario (very
        high to low volume).
      
Keywords: Clinical Pathways; Knowledge translation; Evaluation