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临床试验/NCT03221218
NCT03221218已完成不适用

Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury

University of British Columbia1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Family physician compliance with guidelines

研究概览

简要总结

The study will examine whether enhancing screening-informed follow-up letters will improve (i) family physician compliance with best practice guidelines for managing persistent symptoms following concussion, and (ii) clinical outcomes from concussion.

详细描述

Family physicians are well positioned to proactively manage symptoms in the weeks following MTBI, which could prevent chronicity and reduce the need for specialist treatment. Clinical practice guidelines are now available for MTBI management in primary care, such as those developed by the Ontario Neurotrauma Foundation (ONF). However, awareness and use of these guidelines may be low. Distilling the guidelines into a small number of actionable messages that are tailored to an individual patient may facilitate family physician implementation.

The ONF guidelines for MTBI propose that early intervention should prioritize the most readily treatable symptoms - mood (depression and anxiety), insomnia, and headaches. The present cluster randomized trial will evaluate whether screening for these conditions and sending family physicians treatment algorithms for positive screening test results will result in earlier evidence-based treatment.

Patients will be recruited from two concussion clinics that provide group education sessions. Following the education session, eligible participants will complete self-reported screening measures for depression, anxiety, insomnia, and headaches. Family physicians will be randomized to receive these screening test results with associated treatment algorithms from the ONF guidelines or a letter providing generic MTBI management recommendations from the ONF guidelines (currently done as usual care).

Patients will be assessed by telephone one month and three months after the intervention. The primary outcome will be patient-reported treatment utilization that is congruent with the ONF guidelines for depression, anxiety, insomnia, and headaches after MTBI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

盲法说明

Patients will be blinded to their group assignment. Family physicians will not be aware that they are involved in a research study until the completion of the study.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 60 years.
  • Has a family physician.
  • Physician diagnosed MTBI less than 3 months ago.
  • English reading comprehension sufficient for the consent form and standardized questionnaires.

排除标准

  • English reading comprehension not sufficient for the consent form and standardized questionnaires.

结局指标

主要结局

Family physician compliance with guidelines

时间窗: 1 month after intervention.

Patient recall of receiving advice, referrals, and prescriptions from their family physician.

次要结局

  • Family physician compliance with guidelines (chart review)(6 to 12 months post injury)
  • Personal Health Questionnaire-9 (PHQ-9)(1- and 3-months after intervention.)
  • Insomnia Severity Scale (ISI)(1- and 3-months after intervention.)
  • World Health Organization Disability Schedule (WHODAS-II) 12 item(1- and 3-months after intervention.)
  • Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)(1- and 3-months after intervention.)
  • Rivermead Post-Concussion Symptoms Questionnaire(1- and 3-months after intervention.)
  • Generalized Anxiety Disorder-7 (GAD-7)(1- and 3-months after intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noah Silverberg

Clinical Assistant Professor

University of British Columbia

研究点 (1)

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