NCT03221218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

August 9, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

July 12, 2017

Last Update Submit

February 25, 2022

Conditions

Brain Concussion

Outcome Measures

Primary Outcomes (1)

  • Family physician compliance with guidelines

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

    1 month after intervention.

Secondary Outcomes (7)

  • Family physician compliance with guidelines (chart review)

    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.

  • +2 more secondary outcomes

Study Arms (2)

Enhanced screening-informed letter

EXPERIMENTAL

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

Standard letter

NO INTERVENTION

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.

Interventions

Enhanced screening-informed follow up letterOTHER

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.

Enhanced screening-informed letter

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • English reading comprehension not sufficient for the consent form and standardized questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehab Centre, 4255 Laurel Street

Vancouver, British Columbia, Canada

Location

Related Publications (2)

  • 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.

    PMID: 33382332DERIVED

  • 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.

    PMID: 33082178DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Noah Silverberg, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 18, 2017

Study Start

August 9, 2017

Primary Completion

October 30, 2019

Study Completion

June 22, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

CA(1)