Enhanced Screening for Early Treatment Targets After MTBI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-09

Study Completion Date

2021-06-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Concussion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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Enhanced screening-informed 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).

Group Type EXPERIMENTAL

Enhanced screening-informed follow up letter

Intervention Type 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.

Standard letter

Family physicians will receive a letter that includes generic recommendations for managing MTBI based on the Ontario Neurotrauma Foundation clinical practice guidelines (2013). Screening test results will not be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced screening-informed follow up letter

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.

Intervention Type OTHER

Eligibility Criteria

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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.