Clinical trial NCT04704037: Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
Official title: Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Concussion
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-01-11
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: MINI version 7.0.2 for DSM-5
timeFrame: 26 weeks post injury
Secondary outcomes:
measure: Rivermead Postconcussion Symptom Questionnaire
timeFrame: 2, 12, 26 weeks post injury
measure: World Health Organization Disability Assessment Schedule 2.0 12-item version
timeFrame: 12 and 26 week post injury
Other outcomes:
Locations:
city: North Vancouver
country: Canada
facility: Urgent and Primary Care Center: North Vancouver
state: British Columbia
city: North Vancouver
country: Canada
facility: Lion's Gate Hosital
state: British Columbia
city: Prince George
country: Canada
facility: University Hospital of Northern British Columbia
state: British Columbia
city: Richmond
country: Canada
facility: Richmond Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Mount Saint Joseph's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Urgent and Primary Care Center: City Center
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Noah Silverberg
role: PRINCIPAL_INVESTIGATOR
References:
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.