Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 537
- 试验地点
- 18
- 主要终点
- MINI version 7.0.2 for DSM-5
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
MINI version 7.0.2 for DSM-5
时间窗: 26 weeks post injury
Structured diagnostic interview
次要结局
- Rivermead Postconcussion Symptom Questionnaire(2, 12, 26 weeks post injury)
- World Health Organization Disability Assessment Schedule 2.0 12-item version(12 and 26 week post injury)
研究者
Noah Silverberg
Principal Investigator
University of British Columbia