Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury

Mild Traumatic Brain Injury Clinical Trial

— M4  

Official title:

Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04704037
• Other study ID #: H20-00562
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: October 30, 2025

Study information

• Verified date: December 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 537
• Est. completion date: October 30, 2025
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Guideline implementation tool
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.
• Generic information about concussion management
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.

Locations

Country	Name	City	State
Canada	Lion's Gate Hosital	North Vancouver	British Columbia
Canada	Urgent and Primary Care Center: North Vancouver	North Vancouver	British Columbia
Canada	University Hospital of Northern British Columbia	Prince George	British Columbia
Canada	Richmond Hospital	Richmond	British Columbia
Canada	Mount Saint Joseph's Hospital	Vancouver	British Columbia
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	University of British Columbia Hospital	Vancouver	British Columbia
Canada	Urgent and Primary Care Center: City Center	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MINI version 7.0.2 for DSM-5	Structured diagnostic interview	26 weeks post injury
Secondary	Rivermead Postconcussion Symptom Questionnaire	Standardized questionnaire	2, 12, 26 weeks post injury
Secondary	World Health Organization Disability Assessment Schedule 2.0 12-item version	Standardized interview	12 and 26 week post injury