Enhanced Screening for Early Treatment Targets After MTBI

Sponsor
University of British Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT03221218
Collaborator
Vancouver Coastal Health (Other), Fraser Health (Other)
150
1
2
46.4
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Enhanced screening-informed follow up letter
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
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.
Primary Purpose:
Health Services Research
Official Title:
Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury
Actual Study Start Date :
Aug 9, 2017
Actual Primary Completion Date :
Oct 30, 2019
Actual Study Completion Date :
Jun 22, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Family physician compliance with guidelines [1 month after intervention.]

    Patient recall of receiving advice, referrals, and prescriptions from their family physician.

Secondary Outcome Measures

  1. Family physician compliance with guidelines (chart review) [6 to 12 months post injury]

    Advice, referrals, and prescriptions related to MTBI care, extracted from chart audits.

  2. Rivermead Post-Concussion Symptoms Questionnaire [1- and 3-months after intervention.]

  3. Generalized Anxiety Disorder-7 (GAD-7) [1- and 3-months after intervention.]

  4. Personal Health Questionnaire-9 (PHQ-9) [1- and 3-months after intervention.]

  5. Insomnia Severity Scale (ISI) [1- and 3-months after intervention.]

  6. World Health Organization Disability Schedule (WHODAS-II) 12 item [1- and 3-months after intervention.]

  7. Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS) [1- and 3-months after intervention.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GF Strong Rehab Centre, 4255 Laurel Street Vancouver British Columbia Canada

Sponsors and Collaborators

  • University of British Columbia
  • Vancouver Coastal Health
  • Fraser Health

Investigators

  • Principal Investigator: Noah Silverberg, PhD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noah Silverberg, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier:
NCT03221218
Other Study ID Numbers:
  • H17-00584
First Posted:
Jul 18, 2017
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022