RECOVER Clinical Pathway for Pediatric Concussion (RECOVER)
Primary Purpose
Concussion, Brain, Pediatric Disorder, Mild Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pediatric Acute Care Concussion Clinical Pathway
Sponsored by
About this trial
This is an interventional health services research trial for Concussion, Brain
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
Sites / Locations
- University of Calgary
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Clinical Pathway Participation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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?
Secondary Outcome Measures
Emergency Department satisfaction
Ratings of care received in the emergency department
RECOVER web portal usage
Number of unique website hits per IP address
Adherence to discharge recommendations
Rate of patient and parent reported adherence to physician discharge instructions
Rate of diagnosed concussions
Rate of diagnosed concussions per visit (as noted by billing codes)
Rate of Head CT scans ordered
Rate of CT scans ordered per diagnosed concussion
Post-concussive symptom ratings
Child and parent symptoms ratings measured using the Health and Behaviour Inventory. Measured weekly from injury to resolution of symptoms.
Quality of life ratings
Child and parent quality of life ratings measured by the Pediatric Quality of Life Inventory
Full Information
NCT ID
NCT05095012
First Posted
September 8, 2021
Last Updated
May 24, 2022
Sponsor
University of Calgary
Collaborators
Brain Canada, Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT05095012
Brief Title
RECOVER Clinical Pathway for Pediatric Concussion
Acronym
RECOVER
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Brain Canada, Alberta Health services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain, Pediatric Disorder, Mild Traumatic Brain Injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
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.
Allocation
N/A
Enrollment
2878 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Pathway Participation
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pediatric Acute Care Concussion Clinical Pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Process Outcome
Description
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.
Time Frame
Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Title
Clinical Outcome
Description
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?
Time Frame
Through study enrollment, plus a 6 follow-up period, 15 months
Secondary Outcome Measure Information:
Title
Emergency Department satisfaction
Description
Ratings of care received in the emergency department
Time Frame
Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Title
RECOVER web portal usage
Description
Number of unique website hits per IP address
Time Frame
1 year
Title
Adherence to discharge recommendations
Description
Rate of patient and parent reported adherence to physician discharge instructions
Time Frame
Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Title
Rate of diagnosed concussions
Description
Rate of diagnosed concussions per visit (as noted by billing codes)
Time Frame
Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Title
Rate of Head CT scans ordered
Description
Rate of CT scans ordered per diagnosed concussion
Time Frame
Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Title
Post-concussive symptom ratings
Description
Child and parent symptoms ratings measured using the Health and Behaviour Inventory. Measured weekly from injury to resolution of symptoms.
Time Frame
Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Title
Quality of life ratings
Description
Child and parent quality of life ratings measured by the Pediatric Quality of Life Inventory
Time Frame
4 weeks post injury
Other Pre-specified Outcome Measures:
Title
Health care utilization 1: Acute care length of stay
Description
Duration of stay in the emergency department
Time Frame
Through study enrollment (Jan 30 - Nov 30, 2019) 11 months
Title
Health care utilization 2: Return visits within 72 hours of discharge
Description
Numbers of patients that returned back to the emergency department for a subsequent visit
Time Frame
Within 72 hours of initial discharge from the emergency department
Title
Health care utilization 3: Number of subsequent outpatient visits
Description
Number of outpatient medical visits attended by patients
Time Frame
Within 3 months of initial discharge from the emergency department
Title
Health care costs
Description
Cost of emergency department visit(s) and subsequent outpatient visits as determined by administrative data
Time Frame
Through study enrollment, plus a 3 follow-up period, 14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Yeates, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N1N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33546684
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.
Results Reference
background
Links:
URL
http://www.recoverconcussion.ca
Description
Related Info
Learn more about this trial
RECOVER Clinical Pathway for Pediatric Concussion
We'll reach out to this number within 24 hrs