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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Other: Guideline implementation tool
* Other: Generic information about concussion management


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Minimally enhanced usual care<br>See intervention/treatment description | Other: Generic information about concussion management<br>* 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.<br>|
| Experimental: Arm 2: Guideline implementation tool<br>See intervention/treatment description | Other: Guideline implementation tool<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MINI version 7.0.2 for DSM-5 | Structured diagnostic interview | 26 weeks post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead Postconcussion Symptom Questionnaire | Standardized questionnaire | 2, 12, 26 weeks post injury | 
| World Health Organization Disability Assessment Schedule 2.0 12-item version | Standardized interview | 12 and 26 week post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion