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Clinical Trials/NCT03221218
NCT03221218
Completed
Not Applicable

Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury

University of British Columbia1 site in 1 country150 target enrollmentAugust 9, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Concussion
Sponsor
University of British Columbia
Enrollment
150
Locations
1
Primary Endpoint
Family physician compliance with guidelines
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 9, 2017
End Date
June 22, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noah Silverberg

Clinical Assistant Professor

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Family physician compliance with guidelines

Time Frame: 1 month after intervention.

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

Secondary Outcomes

  • 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.)

Study Sites (1)

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