Enhanced Screening for Early Treatment Targets After MTBI

Not Applicable

Completed

• Conditions: Brain Concussion
• Interventions: Other: Enhanced screening-informed follow up letter

• Registration Number: NCT03221218
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-18
• Study Start: 2017-08-09
• Primary Completion: 2019-10-30
• Study Completion: 2021-06-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced screening-informed letter	Enhanced screening-informed follow up letter	Family physicians will receive a letter that includes their patient's screening test results and associated symptom-specific recommendations from the Ontario Neurotrauma Foundation clinical practice guidelines for MTBI (2013).

Primary Outcome Measures

Name	Time	Method
Family physician compliance with guidelines	1 month after intervention.	Patient recall of receiving advice, referrals, and prescriptions from their family physician.

Secondary Outcome Measures

Name	Time	Method
Family physician compliance with guidelines (chart review)	6 to 12 months post injury	Advice, referrals, and prescriptions related to MTBI care, extracted from chart audits.
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.

Trial Locations

Locations (1)

GF Strong Rehab Centre, 4255 Laurel Street; 🇨🇦 Vancouver, British Columbia, Canada