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Enhanced Screening for Early Treatment Targets After MTBI

Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03221218
Enrollment
150
Registered
2017-07-18
Start date
2017-08-09
Completion date
2021-06-22
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Concussion

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.

Interventions

OTHEREnhanced 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.

Sponsors

Vancouver Coastal Health
CollaboratorOTHER_GOV
Fraser Health
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Family physician compliance with guidelines1 month after intervention.Patient recall of receiving advice, referrals, and prescriptions from their family physician.

Secondary

MeasureTime frameDescription
Rivermead Post-Concussion Symptoms Questionnaire1- and 3-months after intervention.
Generalized Anxiety Disorder-7 (GAD-7)1- and 3-months after intervention.
Personal Health Questionnaire-9 (PHQ-9)1- and 3-months after intervention.
Family physician compliance with guidelines (chart review)6 to 12 months post injuryAdvice, referrals, and prescriptions related to MTBI care, extracted from chart audits.
World Health Organization Disability Schedule (WHODAS-II) 12 item1- and 3-months after intervention.
Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)1- and 3-months after intervention.
Insomnia Severity Scale (ISI)1- and 3-months after intervention.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026