Clinical trial NCT03221218: Enhanced Screening for Early Treatment Targets After MTBI
Official title: Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health
name: Fraser Health
First posted: 2017-07-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Family physician compliance with guidelines
timeFrame: 1 month after intervention.
Secondary outcomes:
measure: Family physician compliance with guidelines (chart review)
timeFrame: 6 to 12 months post injury
measure: Rivermead Post-Concussion Symptoms Questionnaire
timeFrame: 1- and 3-months after intervention.
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 1- and 3-months after intervention.
measure: Personal Health Questionnaire-9 (PHQ-9)
timeFrame: 1- and 3-months after intervention.
measure: Insomnia Severity Scale (ISI)
timeFrame: 1- and 3-months after intervention.
measure: World Health Organization Disability Schedule (WHODAS-II) 12 item
timeFrame: 1- and 3-months after intervention.
measure: Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)
timeFrame: 1- and 3-months after intervention.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehab Centre, 4255 Laurel Street
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Noah Silverberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.