Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2878 participants
INTERVENTIONAL
2018-09-10
2019-11-30
Brief Summary
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Detailed Description
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The research has three key objectives:
1. Design an evidence-based, knowledge-user informed, and theory-driven approach to implementation of a clinical pathway for acute care of pediatric concussion. Guided by the Theoretical Domains Framework (TDF), the investigators will assess barriers and facilitators likely to influence uptake of the CP in acute care settings. The results of that assessment will inform implementation strategy design, again guided by the TDF.
2. Evaluate the impact of the implementation of the CP on patient-centered outcomes using a stepped wedge cluster randomised trial. Within the context of a stepped wedge cluster randomised trial, the investigators will assess relevant process and clinical outcomes to determine whether implementation of the CP results in significant uptake of the pathway, as well as higher patient satisfaction and better health outcomes following concussion.
3. Determine whether the implementation and use of a CP for acute care of pediatric concussion is associated with changes in health care utilization and associated costs. Health care utilization and costs associated with care of concussion will be compared before and after the implementation of the CP. Utilization and costs are expected to remain stable or decline following implementation of the CP.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Clinical Pathway Participation
Patients that are seen in an emergency department participating in the clinical pathway will not be aware of any changes, other than be given a specific education handout at discharge and be advised to visit the recoverconcussion.ca web portal. Specialty referrals for high risk patients will automatically be made during the emergency visit, through the clinical pathway.
Pediatric Acute Care Concussion Clinical Pathway
MD assessment will be partially standardized to assess for patients at higher risk of becoming persistently symptomatic. These patients scoring as 'high risk' will be referred to one of three specialty clinics. High risk is defined as scoring 9 or higher out of 12 on the 5P score.
Interventions
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Pediatric Acute Care Concussion Clinical Pathway
MD assessment will be partially standardized to assess for patients at higher risk of becoming persistently symptomatic. These patients scoring as 'high risk' will be referred to one of three specialty clinics. High risk is defined as scoring 9 or higher out of 12 on the 5P score.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Years
17 Years
ALL
No
Sponsors
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Brain Canada
OTHER
Alberta Health services
OTHER
University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Keith Yeates, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary
Calgary, Alberta, Canada
Countries
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References
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Ly A, Zemek R, Wright B, Zwicker J, Schneider K, Mikrogianakis A, Conradi A, Johnson D, Clark B, Barlow K, Burey J, Kolstad A, Yeates KO. "What is the actual goal of the pathway?": examining emergency department physician and nurse perspectives on the implementation of a pediatric concussion pathway using the theoretical domains framework. BMC Health Serv Res. 2021 Feb 5;21(1):119. doi: 10.1186/s12913-021-06110-2.
Yeates KO, Barlow KM, Wright B, Tang K, Barrett O, Berdusco E, Black AM, Clark B, Conradi A, Godfrey H, Kolstad AT, Ly A, Mikrogianakis A, Purser R, Schneider K, Stang AS, Zemek R, Zwicker JD, Johnson DW. Health care impact of implementing a clinical pathway for acute care of pediatric concussion: a stepped wedge, cluster randomised trial. CJEM. 2023 Jul;25(7):627-636. doi: 10.1007/s43678-023-00530-1. Epub 2023 Jun 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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REB18-0405
Identifier Type: -
Identifier Source: org_study_id
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