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Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury (M4)

University of British Columbia logo

University of British Columbia

Status

Active, not recruiting

Conditions

Mild Traumatic Brain Injury

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04704037
H20-00562

Details and patient eligibility

About

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.

Full 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.

Enrollment

537 patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

537 participants in 2 patient groups

Arm 1: Minimally enhanced usual care
Active Comparator group
Description:
See intervention/treatment description
Treatment:
Other: Generic information about concussion management
Arm 2: Guideline implementation tool
Experimental group
Description:
See intervention/treatment description
Treatment:
Other: Guideline implementation tool

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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