Asthma Clinical Trial
Official title:
Best Strategies for Implementation of Clinical Pathways in Emergency Department Settings
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.
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.
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