Clinical trial NCT01815710: Best Strategies for Implementation of Clinical Pathways in Emergency Department Settings
Official title: Best Strategies for Implementation of Clinical Pathways in Emergency Department Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Diarrhea & Vomiting
Keywords: Clinical Pathways
Knowledge translation
Evaluation
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
name: Institute for Clinical Evaluative Sciences
First posted: 2013-03-21
Enrollment: 6330
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
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).

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Selecting from 149 community EDs in Ontario, we will recruit EDs that do not have a CP in place for either Pediatric Asthma or Pediatric V\&D. To minimize contamination between sites, we will request data from Health Force Ontario, an organization that assists with physician coverage at different EDs, to ensure ED physicians are not working at more than one study site. An additional inclusion criterion is commitment to the implementation intervention by an administrative lead on behalf of the hospital. Specific inclusion/exclusion criteria for use with patients have been defined for each CP.
* Medical records departments at each site will be asked to pull relevant charts, using International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes for all diagnoses related to our index conditions (Asthma and with V\&D) during the defined study periods. In our experience, this approach has worked successfully with community ED studies. Chart auditors will review all records to ensure eligibility criteria are met. All retrieved and eligible patient charts will be audited.

Primary outcomes:
measure: Received appropriate care based on evidence-based treatments recommended in the CP.
timeFrame: 18 months
Secondary outcomes:
measure: Asthma - PRAM
timeFrame: 18 months
measure: V&D - Gorelick and intravenous therapy.
timeFrame: 18 months
Other outcomes:
measure: Completed CP on relevant patient charts.
timeFrame: 18 months
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Mona Jabbour, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jabbour M, Newton AS, Johnson D, Curran JA. Defining barriers and enablers for clinical pathway implementation in complex clinical settings. Implement Sci. 2018 Nov 12;13(1):139. doi: 10.1186/s13012-018-0832-8.
citation: Jabbour M, Curran J, Scott SD, Guttman A, Rotter T, Ducharme FM, Lougheed MD, McNaughton-Filion ML, Newton A, Shafir M, Paprica A, Klassen T, Taljaard M, Grimshaw J, Johnson DW. Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 May 22;8:55. doi: 10.1186/1748-5908-8-55.