Enhanced Screening for Early Treatment Targets After MTBI
Primary Purpose
Brain Concussion
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Enhanced screening-informed follow up letter
Sponsored by
About this trial
This is an interventional health services research trial for Brain Concussion
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.
Sites / Locations
- GF Strong Rehab Centre, 4255 Laurel Street
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Enhanced screening-informed letter
Standard letter
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Family physician compliance with guidelines
Patient recall of receiving advice, referrals, and prescriptions from their family physician.
Secondary Outcome Measures
Family physician compliance with guidelines (chart review)
Advice, referrals, and prescriptions related to MTBI care, extracted from chart audits.
Rivermead Post-Concussion Symptoms Questionnaire
Generalized Anxiety Disorder-7 (GAD-7)
Personal Health Questionnaire-9 (PHQ-9)
Insomnia Severity Scale (ISI)
World Health Organization Disability Schedule (WHODAS-II) 12 item
Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)
Full Information
NCT ID
NCT03221218
First Posted
July 12, 2017
Last Updated
February 25, 2022
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health, Fraser Health
1. Study Identification
Unique Protocol Identification Number
NCT03221218
Brief Title
Enhanced Screening for Early Treatment Targets After MTBI
Official Title
Enhanced Screening for Early Treatment Targets After Mild Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
June 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health, Fraser Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced screening-informed letter
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard letter
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced screening-informed follow up letter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Family physician compliance with guidelines
Description
Patient recall of receiving advice, referrals, and prescriptions from their family physician.
Time Frame
1 month after intervention.
Secondary Outcome Measure Information:
Title
Family physician compliance with guidelines (chart review)
Description
Advice, referrals, and prescriptions related to MTBI care, extracted from chart audits.
Time Frame
6 to 12 months post injury
Title
Rivermead Post-Concussion Symptoms Questionnaire
Time Frame
1- and 3-months after intervention.
Title
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame
1- and 3-months after intervention.
Title
Personal Health Questionnaire-9 (PHQ-9)
Time Frame
1- and 3-months after intervention.
Title
Insomnia Severity Scale (ISI)
Time Frame
1- and 3-months after intervention.
Title
World Health Organization Disability Schedule (WHODAS-II) 12 item
Time Frame
1- and 3-months after intervention.
Title
Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)
Time Frame
1- and 3-months after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Silverberg, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
GF Strong Rehab Centre, 4255 Laurel Street
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
33382332
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.
Results Reference
derived
PubMed Identifier
33082178
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.
Results Reference
derived
Learn more about this trial
Enhanced Screening for Early Treatment Targets After MTBI
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