Clinical trial NCT05095012: RECOVER Clinical Pathway for Pediatric Concussion
Official title: Implementation of a Clinical Pathway for Paediatric Concussion in Acute Care Settings: Measuring Health Outcomes of the RECOVER Intervention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Pediatric Disorder
Mild Traumatic Brain Injury
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Brain Canada
name: Alberta Health services
First posted: 2021-10-27
Enrollment: 2878
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The project will involve a stepped wedge time series design to evaluate the implementation of the Maternal Newborn and Child Health clinical pathway for the acute care of pediatric concussion.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The project encompasses the development and implementation of an acute care, pediatric concussion clinical pathway at 5 pediatric emergency departments in the province of Alberta (Canada).

Detailed description: Clinical pathways (CPs) do not currently guide the care of children with concussions presenting to acute care settings in Alberta. The Alberta Health Services Maternal Newborn Child \& Youth (MNCY) Strategic Clinical Network established a work group to develop best-practice, evidence-based Clinical Practice Guidelines for the management of concussion that are being translated into specific CPs for different clinical settings.

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.

Eligibility criteria: Inclusion Criteria:

* Children evaluated for concussion (including their parents) January 30 - November 30, 2019 at the 5 participating emergency departments

Exclusion Criteria:

* moderate to severe brain injury

Primary outcomes:
measure: Process Outcome
timeFrame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
measure: Clinical Outcome
timeFrame: Through study enrollment, plus a 6 follow-up period, 15 months
Secondary outcomes:
measure: Emergency Department satisfaction
timeFrame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
measure: RECOVER web portal usage
timeFrame: 1 year
measure: Adherence to discharge recommendations
timeFrame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
measure: Rate of diagnosed concussions
timeFrame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
measure: Rate of Head CT scans ordered
timeFrame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
measure: Post-concussive symptom ratings
timeFrame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
measure: Quality of life ratings
timeFrame: 4 weeks post injury
Other outcomes:
measure: Health care utilization 1: Acute care length of stay
timeFrame: Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
measure: Health care utilization 2: Return visits within 72 hours of discharge
timeFrame: Within 72 hours of initial discharge from the emergency department
measure: Health care utilization 3: Number of subsequent outpatient visits
timeFrame: Within 3 months of initial discharge from the emergency department
measure: Health care costs
timeFrame: Through study enrollment, plus a 3 follow-up period, 14 months
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Keith Yeates, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.