Enhanced Screening for Early Treatment Targets After MTBI

Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: Brain Concussion
• Intervention / Treatment: Other: Enhanced screening-informed follow up letter

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • GF Strong Rehab Centre, 4255 Laurel Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family physician compliance with guidelines	Patient recall of receiving advice, referrals, and prescriptions from their family physician.	1 month after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rivermead Post-Concussion Symptoms Questionnaire		1- 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.
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.

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Fraser Health; Vancouver Coastal Health
• Investigators: Principal Investigator: Noah Silverberg, PhD, University of British Columbia

Publications and helpful links

General Publications

• Cassetta BD, Cairncross M, Brasher PMA, Panenka WJ, Silverberg ND. Avoidance and endurance coping after mild traumatic brain injury are associated with disability outcomes. Rehabil Psychol. 2021 May;66(2):160-169. doi: 10.1037/rep0000372. Epub 2020 Dec 31.
• Silverberg ND, Panenka WJ, Lizotte PP, Bayley MT, Dance D, Li LC. Promoting early treatment for mild traumatic brain injury in primary care with a guideline implementation tool: a pilot cluster randomised trial. BMJ Open. 2020 Oct 20;10(10):e035527. doi: 10.1136/bmjopen-2019-035527.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: H17-00584

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No