RECOVER Clinical Pathway for Pediatric Concussion

Not Applicable

Completed

• Conditions: Concussion, Brain; Pediatric Disorder; Mild Traumatic Brain Injury
• Interventions: Other: Pediatric Acute Care Concussion Clinical Pathway

• Registration Number: NCT05095012
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2018-09-10
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2021-08
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-27
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2878

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical Pathway Participation	Pediatric Acute Care Concussion Clinical Pathway	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.

Primary Outcome Measures

Name	Time	Method
Clinical Outcome	Through study enrollment, plus a 6 follow-up period, 15 months	Time to symptom resolution using weekly ratings by patients and parents of whether patient has returned to pre-injury status. Parents and children were asked asked to complete a numeric scale of 0 to 10 (where 0 is very bad and 10 is back to normal), how do you feel now?
Process Outcome	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months	Measurement of clinician utilization of the newly implemented clinical pathway. Clinician utilization was represented by proportion of clinician-completed 5P assessments per diagnosed concussion. Data was also collected on the number of high risk referrals made through the clinical pathway and the number of handouts provided by the clinician to patients and families.

Secondary Outcome Measures

Name	Time	Method
Emergency Department satisfaction	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months	Ratings of care received in the emergency department
Rate of Head CT scans ordered	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months	Rate of CT scans ordered per diagnosed concussion
Post-concussive symptom ratings	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months	Child and parent symptoms ratings measured using the Health and Behaviour Inventory. Measured weekly from injury to resolution of symptoms.
Quality of life ratings	4 weeks post injury	Child and parent quality of life ratings measured by the Pediatric Quality of Life Inventory
Adherence to discharge recommendations	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months	Rate of patient and parent reported adherence to physician discharge instructions
RECOVER web portal usage	1 year	Number of unique website hits per IP address
Rate of diagnosed concussions	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months	Rate of diagnosed concussions per visit (as noted by billing codes)

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada