Skip to main content
OpenTrials
Completed

NCT Number: NCT03221218

Enhanced Screening for Early Treatment Targets After MTBI

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GF Strong Rehab Centre, 4255 Laurel Street

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced screening-informed follow up letter

Other

Family Physicians will be sent a letter that includes their screening test results and associated symptom-specific recommendations from the Ontario Neurotrauma Foundation clinical practice guidelines.

Primary outcomes

  1. 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

  1. Family physician compliance with guidelines (chart review)

    Time frame: 6 to 12 months post injury

    Advice, referrals, and prescriptions related to MTBI care, extracted from chart audits.

  2. Rivermead Post-Concussion Symptoms Questionnaire

    Time frame: 1- and 3-months after intervention.

  3. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 1- and 3-months after intervention.

  4. Personal Health Questionnaire-9 (PHQ-9)

    Time frame: 1- and 3-months after intervention.

  5. Insomnia Severity Scale (ISI)

    Time frame: 1- and 3-months after intervention.

  6. World Health Organization Disability Schedule (WHODAS-II) 12 item

    Time frame: 1- and 3-months after intervention.

  7. Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)

    Time frame: 1- and 3-months after intervention.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Fraser Health
  • Vancouver Coastal Health

Registry information

Official study title

Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Jul 18, 2017
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.