Enhanced Screening for Early Treatment Targets After MTBI

Brain Concussion Clinical Trial

Official title:

Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221218
• Other study ID #: H17-00584
• Status: Completed
• Phase: N/A
• Start date: August 9, 2017
• Est. completion date: June 22, 2021

Study information

• Verified date: February 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 22, 2021
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	GF Strong Rehab Centre, 4255 Laurel Street	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Fraser Health, Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family physician compliance with guidelines	Patient recall of receiving advice, referrals, and prescriptions from their family physician.	1 month after intervention.
Secondary	Family physician compliance with guidelines (chart review)	Advice, referrals, and prescriptions related to MTBI care, extracted from chart audits.	6 to 12 months post injury
Secondary	Rivermead Post-Concussion Symptoms Questionnaire		1- and 3-months after intervention.
Secondary	Generalized Anxiety Disorder-7 (GAD-7)		1- and 3-months after intervention.
Secondary	Personal Health Questionnaire-9 (PHQ-9)		1- and 3-months after intervention.
Secondary	Insomnia Severity Scale (ISI)		1- and 3-months after intervention.
Secondary	World Health Organization Disability Schedule (WHODAS-II) 12 item		1- and 3-months after intervention.
Secondary	Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)		1- and 3-months after intervention.