RECOVER Clinical Pathway for Pediatric Concussion

Sponsor
University of Calgary (Other)
Overall Status
Completed
CT.gov ID
NCT05095012
Collaborator
Brain Canada (Other), Alberta Health services (Other)
2,878
1
1
14.7
196.4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Pediatric Acute Care Concussion Clinical Pathway
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2878 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Masking Description:
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.
Primary Purpose:
Health Services Research
Official Title:
Implementation of a Clinical Pathway for Paediatric Concussion in Acute Care Settings: Measuring Health Outcomes of the RECOVER Intervention Project
Actual Study Start Date :
Sep 10, 2018
Actual Primary Completion Date :
Nov 30, 2019
Actual Study Completion Date :
Nov 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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?

Secondary Outcome Measures

  1. Emergency Department satisfaction [Through study enrollment (Jan 30 - Nov 30, 2019) 11 months]

    Ratings of care received in the emergency department

  2. RECOVER web portal usage [1 year]

    Number of unique website hits per IP address

  3. 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

  4. 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)

  5. Rate of Head CT scans ordered [Through study enrollment (Jan 30 - Nov 30, 2019) 11 months]

    Rate of CT scans ordered per diagnosed concussion

  6. 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.

  7. Quality of life ratings [4 weeks post injury]

    Child and parent quality of life ratings measured by the Pediatric Quality of Life Inventory

Other Outcome Measures

  1. Health care utilization 1: Acute care length of stay [Through study enrollment (Jan 30 - Nov 30, 2019) 11 months]

    Duration of stay in the emergency department

  2. Health care utilization 2: Return visits within 72 hours of discharge [Within 72 hours of initial discharge from the emergency department]

    Numbers of patients that returned back to the emergency department for a subsequent visit

  3. Health care utilization 3: Number of subsequent outpatient visits [Within 3 months of initial discharge from the emergency department]

    Number of outpatient medical visits attended by patients

  4. Health care costs [Through study enrollment, plus a 3 follow-up period, 14 months]

    Cost of emergency department visit(s) and subsequent outpatient visits as determined by administrative data

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Calgary Calgary Alberta Canada T2N1N4

Sponsors and Collaborators

  • University of Calgary
  • Brain Canada
  • Alberta Health services

Investigators

  • Principal Investigator: Keith Yeates, PhD, University of Calgary

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
University of Calgary
ClinicalTrials.gov Identifier:
NCT05095012
Other Study ID Numbers:
  • REB18-0405
First Posted:
Oct 27, 2021
Last Update Posted:
May 27, 2022
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022