RECOVER Clinical Pathway for Pediatric Concussion (RECOVER)

Implementation of a Clinical Pathway for Paediatric Concussion in Acute Care Settings: Measuring Health Outcomes of the RECOVER Intervention Project

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).

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury; Pediatric Disorder; Concussion, Brain
• Intervention / Treatment: Other: Pediatric Acute Care Concussion Clinical Pathway

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 Type: Interventional
• Enrollment (Actual): 2878
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N1N4
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process Outcome	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.	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Clinical Outcome	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?	Through study enrollment, plus a 6 follow-up period, 15 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care utilization 1: Acute care length of stay	Duration of stay in the emergency department	Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Health care utilization 2: Return visits within 72 hours of discharge	Numbers of patients that returned back to the emergency department for a subsequent visit	Within 72 hours of initial discharge from the emergency department
Health care utilization 3: Number of subsequent outpatient visits	Number of outpatient medical visits attended by patients	Within 3 months of initial discharge from the emergency department
Health care costs	Cost of emergency department visit(s) and subsequent outpatient visits as determined by administrative data	Through study enrollment, plus a 3 follow-up period, 14 months

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Health services; Brain Canada
• Investigators: Principal Investigator: Keith Yeates, PhD, University of Calgary

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2018
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (ACTUAL): October 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: REB18-0405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No