RECOVER Clinical Pathway for Pediatric Concussion

NCT05095012 | Completed DMC

• 1 other identifier: REB18-0405
• Study Type: interventional
• Target: 2,878
• Locations: 1 country
• Sites: 1

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).

Conditions

Concussion, Brain; Pediatric Disorder; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Emergency Department satisfaction

  Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

• RECOVER web portal usage

  1 year

• Adherence to discharge recommendations

  Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

• Rate of diagnosed concussions

  Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

• Rate of Head CT scans ordered

  Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

Other Outcomes (4)

• Health care utilization 1: Acute care length of stay

  Through study enrollment (Jan 30 - Nov 30, 2019) 11 months

• Health care utilization 2: Return visits within 72 hours of discharge

  Within 72 hours of initial discharge from the emergency department

• Health care utilization 3: Number of subsequent outpatient visits

  Within 3 months of initial discharge from the emergency department

Study Arms (1)

Clinical Pathway Participation

OTHER

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

Interventions

Pediatric Acute Care Concussion Clinical Pathway OTHER

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.

Clinical Pathway Participation

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• moderate to severe brain injury

Sponsors & Collaborators

• University of Calgary: lead
• Brain Canada: collaborator
• Alberta Health services: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

Related Publications (2)

• 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.

  PMID: 33546684 BACKGROUND

• 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.

  PMID: 37351798 DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Keith Yeates, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Each site will be randomized to a start date. Once a site starts the clinical pathway, the clinical pathway tools (assessment, education and referral tools) will be utilized by staff in that particular emergency department. Patients and parents will be unaware of clinical pathway.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 27, 2021
• Study Start: September 10, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: May 27, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)