Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury (M4)
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| ClinicalTrials.gov Identifier: NCT04704037 |
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Recruitment Status :
Not yet recruiting
First Posted : January 11, 2021
Last Update Posted : January 11, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mild Traumatic Brain Injury | Other: Guideline implementation tool Other: Usual care letter | Not Applicable |
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: We 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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 535 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury |
| Estimated Study Start Date : | February 1, 2021 |
| Estimated Primary Completion Date : | October 30, 2023 |
| Estimated Study Completion Date : | October 30, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm 1: Usual care control
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.
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Other: Usual care letter
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. |
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Experimental: Arm 2: 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.
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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. |
- MINI version 7.0.2 for DSM-5 [ Time Frame: Six months post injury ]Structured diagnostic interview
- Rivermead Postconcussion Symptom Questionnaire [ Time Frame: 2, 12, 26 weeks post injury ]Standardized questionnaire
- World Health Organization Disability Assessment Schedule 2.0 12-item version [ Time Frame: 12 and 26 week post injury ]Standardized interview
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| Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(i) Age 18-69 years old, (ii) presentation to emergency department within 72 hours of injury, (iii) probable mTBI diagnosis per emergency department chart review and interview based on World Health Organization Neurotrauma Task Force diagnostic criteria, (iv) fluent in English, (v) primary residence in British Columbia, (vi) designate a specific family physician or walk-in clinic where they plan to seek follow-up care, and
Exclusion Criteria:
(i) Pre-existing unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.) (ii) Pre-existing unstable/severe mental illness (e.g., schizophrenia requiring hospital admission in past year)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704037
| Contact: Noah Silverberg | 604-714-4106 | noah.silverberg@ubc.ca | |
| Contact: Tasha Klotz | 6047341313 ext 2316 | tasha.klotz@ubc.ca |
| Canada, British Columbia | |
| Urgent and Primary Care Center: North Vancouver | |
| North Vancouver, British Columbia, Canada, V7L 1A5 | |
| Contact: Afshin Khazei afshin.khazei@gmail.com | |
| Lion's Gate Hosital | |
| North Vancouver, British Columbia, Canada, V7L 2L7 | |
| Contact: Hazel Park Hazel.Park@vch.ca | |
| University Hospital of Northern British Columbia | |
| Prince George, British Columbia, Canada, V2M 1S2 | |
| Contact: Floyd Besserer fbesserer@gmail.com | |
| Richmond Hospital | |
| Richmond, British Columbia, Canada, V6X 1A2 | |
| Contact: Kevin Shi dr.kevinshi@gmail.com | |
| Mount Saint Joseph's Hospital | |
| Vancouver, British Columbia, Canada, V5T 3N4 | |
| Contact: Frank Scheuermeyer frank.scheuermeyer@gmail.com | |
| Vancouver General Hospital | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Jeff Brubacher jbrubacher@shaw.ca | |
| University of British Columbia Hospital | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Contact: Jeff Brubacher jbrubacher@shaw.ca | |
| Urgent and Primary Care Center: City Center | |
| Vancouver, British Columbia, Canada, V6Z 0A3 | |
| Contact: Afshin Khazei afshin.khazei@gmail.com | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Contact: Frank Scheuermeyer frank.scheuermeyer@gmail.com | |
| Principal Investigator: | Noah Silverberg | University of British Columbia |
Documents provided by Noah Silverberg, University of British Columbia:
| Responsible Party: | Noah Silverberg, Principal Investigator, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT04704037 |
| Other Study ID Numbers: |
H20-00562 |
| First Posted: | January 11, 2021 Key Record Dates |
| Last Update Posted: | January 11, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Concussion |
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Brain Injuries Brain Injuries, Traumatic Brain Concussion Wounds and Injuries Brain Diseases Craniocerebral Trauma |
Trauma, Nervous System Head Injuries, Closed Wounds, Nonpenetrating Central Nervous System Diseases Nervous System Diseases |