Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury (M4)
Primary Purpose
Mild Traumatic Brain Injury
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Guideline implementation tool
Generic information about concussion management
Sponsored by
About this trial
This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Concussion
Eligibility Criteria
Inclusion Criteria:
- Age 18-69 years old,
- presentation to emergency department within 72 hours of injury,
- probable mTBI diagnosis per emergency department chart review and interview based on World Health Organization Neurotrauma Task Force diagnostic criteria,
- fluent in English,
- primary residence in British Columbia,
- designate a specific family physician or walk-in clinic where they plan to seek follow-up care
Exclusion Criteria:
- Pre-existing unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.)
- Pre-existing unstable/severe mental illness (e.g., schizophrenia requiring hospital admission in past year)
Sites / Locations
- Urgent and Primary Care Center: North Vancouver
- Lion's Gate Hosital
- University Hospital of Northern British Columbia
- Richmond Hospital
- Mount Saint Joseph's Hospital
- Vancouver General Hospital
- University of British Columbia Hospital
- Urgent and Primary Care Center: City Center
- St. Paul's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1: Minimally enhanced usual care
Arm 2: Guideline implementation tool
Arm Description
See intervention/treatment description
See intervention/treatment description
Outcomes
Primary Outcome Measures
MINI version 7.0.2 for DSM-5
Structured diagnostic interview
Secondary Outcome Measures
Rivermead Postconcussion Symptom Questionnaire
Standardized questionnaire
World Health Organization Disability Assessment Schedule 2.0 12-item version
Standardized interview
Full Information
NCT ID
NCT04704037
First Posted
January 7, 2021
Last Updated
November 22, 2022
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT04704037
Brief Title
Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
Acronym
M4
Official Title
Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mental health problems frequently complicate recovery from mild traumatic brain injury (mTBI) but are under-recognized and under-treated. Our research program aims to identify evidence-based strategies for closing this knowledge-practice gap. Building on a successful pilot trial, the reseachers will evaluate the effectiveness of a clinical practice guideline implementation tool designed to support proactive management of mental health complications after mTBI in primary care.
Detailed Description
Goal: To determine if a clinical practice guideline implementation tool, designed to support proactive management of mental health complications, can improve clinical outcomes from mild traumatic brain injury (mTBI).
Background: Up to 1 in 4 people who sustain an mTBI develop depression or an anxiety disorder within the first 3 months. Mental health problems triple the risk of long-term disability after mTBI. However, mental health disorders after mTBI are under-detected and under-treated. Canadian clinical practice guidelines for mTBI developed by the Ontario Neurotrauma Foundation (ONF) recommend that family physicians proactively screen and initiate treatment for mental health disorders.
Aims: To evaluate the effectiveness of an implementation intervention designed to facilitate timely detection and treatment of mental health complications in primary care.
Approach: Triple-blinded (treatment provider, patient, assessor) cluster randomized controlled trial with two arms. The intervention involves collecting screening test results from patients and a complex intervention with two components: sharing the screening test results in an actionable format with their family physician and activating patients for the clinical encounter with the family physician by sharing education materials about mental health problems and treatment options after mTBI. The comparison group is usual care.
Hypotheses: The researchers hypothesize that the guideline implementation tool will be associated with lower rates of mental health complications at 26 weeks post-injury, compared to usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Concussion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
537 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Minimally enhanced usual care
Arm Type
Active Comparator
Arm Description
See intervention/treatment description
Arm Title
Arm 2: Guideline implementation tool
Arm Type
Experimental
Arm Description
See intervention/treatment description
Intervention Type
Other
Intervention Name(s)
Guideline implementation tool
Intervention Description
Family physicians will receive a tailored letter with their patient's mental health screening test results and associated mental health treatment recommendations from the Ontario Neurotrauma Foundation guidelines, as well as a list of mental health treatment resources. In addition, the patient will receive a written information package about mental health problems after mTBI and treatment options to discuss with their family physician.
Intervention Type
Other
Intervention Name(s)
Generic information about concussion management
Intervention Description
Family physicians will receive a generic letter drawing their attention to Canadian clinical practice guidelines for mild Traumatic Brain Injury (developed by the Ontario Neurotrauma Foundation). Patients will receive instructions about how to access generic education materials about mTBI (from concussion.vch.ca/), which they should have received anyway as part of usual care.
Primary Outcome Measure Information:
Title
MINI version 7.0.2 for DSM-5
Description
Structured diagnostic interview
Time Frame
26 weeks post injury
Secondary Outcome Measure Information:
Title
Rivermead Postconcussion Symptom Questionnaire
Description
Standardized questionnaire
Time Frame
2, 12, 26 weeks post injury
Title
World Health Organization Disability Assessment Schedule 2.0 12-item version
Description
Standardized interview
Time Frame
12 and 26 week post injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-69 years old,
presentation to emergency department within 72 hours of injury,
probable mTBI diagnosis per emergency department chart review and interview based on World Health Organization Neurotrauma Task Force diagnostic criteria,
fluent in English,
primary residence in British Columbia,
designate a specific family physician or walk-in clinic where they plan to seek follow-up care
Exclusion Criteria:
Pre-existing unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.)
Pre-existing unstable/severe mental illness (e.g., schizophrenia requiring hospital admission in past year)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Silverberg
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urgent and Primary Care Center: North Vancouver
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 1A5
Country
Canada
Facility Name
Lion's Gate Hosital
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada
Facility Name
University Hospital of Northern British Columbia
City
Prince George
State/Province
British Columbia
ZIP/Postal Code
V2M 1S2
Country
Canada
Facility Name
Richmond Hospital
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V6X 1A2
Country
Canada
Facility Name
Mount Saint Joseph's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5T 3N4
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
University of British Columbia Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Urgent and Primary Care Center: City Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 0A3
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon reasonable request
IPD Sharing Time Frame
October 2025
Citations:
PubMed Identifier
35728892
Citation
Silverberg ND, Otamendi T, Brasher PM, Brubacher JR, Li LC, Lizotte PP, Panenka WJ, Scheuermeyer FX, Archambault P; Canadian Traumatic Brain Injury Research Consortium (CTRC). Effectiveness of a guideline implementation tool for supporting management of mental health complications after mild traumatic brain injury in primary care: protocol for a randomised controlled trial. BMJ Open. 2022 Jun 21;12(6):e062527. doi: 10.1136/bmjopen-2022-062527.
Results Reference
derived
Learn more about this trial
Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
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