Article Text

Protocol
Effectiveness of a guideline implementation tool for supporting management of mental health complications after mild traumatic brain injury in primary care: protocol for a randomised controlled trial
  1. Noah D Silverberg1,2,
  2. Thalia Otamendi3,
  3. Penelope MA Brasher4,
  4. Jeffrey R Brubacher5,
  5. Linda C Li6,
  6. Pierre-Paul Lizotte7,
  7. William J Panenka8,
  8. Frank X Scheuermeyer5,9,
  9. Patrick Archambault10
  10. on behalf of the Canadian Traumatic Brain Injury Research Consortium (CTRC)
  1. 1Department of Psychology, University of British Columbia, Vancouver, British Columbia, Canada
  2. 2Rehabilitation Research Program, Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada
  3. 3Rehabilitation Sciences, University of British Columbia, Vancouver, British Columbia, Canada
  4. 4Centre for Clinical Epidemiology & Evaluation, Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada
  5. 5Department of Emergency Medicine, University of British Columbia, Vancouver, British Columbia, Canada
  6. 6Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada
  7. 7Department of Family Practice, University of British Columbia, Vancouver, British Columbia, Canada
  8. 8Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada
  9. 9Department of Emergency Medicine, St. Paul's Hospital, Vancouver, British Columbia, Canada
  10. 10Department of Family and Emergency Medicine, Université Laval, Québec, Québec, Canada
  1. Correspondence to Dr Noah D Silverberg; noah.silverberg{at}ubc.ca

Abstract

Introduction Mental health problems frequently interfere with recovery from mild traumatic brain injury (mTBI) but are under-recognised and undertreated. Consistent implementation of clinical practice guidelines for proactive detection and treatment of mental health complications after mTBI will require evidence-based knowledge translation strategies. This study aims to determine if a guideline implementation tool can reduce the risk of mental health complications following mTBI. If effective, our guideline implementation tool could be readily scaled up and/or adapted to other healthcare settings.

Methods and analysis We will conduct a triple-blind cluster randomised trial to evaluate a clinical practice guideline implementation tool designed to support proactive management of mental health complications after mTBI in primary care. We will recruit 535 adults (aged 18–69 years) with mTBI from six emergency departments and two urgent care centres in the Greater Vancouver Area, Canada. Upon enrolment at 2 weeks post-injury, they will complete mental health symptom screening tools and designate a general practitioner (GP) or primary care clinic where they plan to seek follow-up care. Primary care clinics will be randomised into one of two arms. In the guideline implementation tool arm, GPs will receive actionable mental health screening test results tailored to their patient and their patients will receive written education about mental health problems after mTBI and treatment options. In the usual care control arm, GPs and their patients will receive generic information about mTBI. Patient participants will complete outcome measures remotely at 2, 12 and 26 weeks post-injury. The primary outcome is rate of new or worsened mood, anxiety or trauma-related disorder on the Mini International Neuropsychiatric Interview at 26 weeks.

Ethics and dissemination Study procedures were approved by the University of British Columbia’s research ethics board (H20-00562). The primary report for the trial results will be published in a peer-reviewed journal. Our knowledge user team members (patients, GPs, policymakers) will co-create a plan for public dissemination.

Trial registration number ClinicalTrials.gov Registry (NCT04704037).

  • Protocols & guidelines
  • PRIMARY CARE
  • Depression & mood disorders
  • Neurological injury
  • REHABILITATION MEDICINE
  • Clinical trials
http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Twitter @silverberg_lab, @LLi_1, @patarchambault

  • Contributors NS conceived of the study, led its design and implementation, and drafted the manuscript. PB calculated the sample size requirements and created the statistical analysis plan. P-PL co-created the guideline implementation tool and participated in the Knowledge User Committee. All authors (NS, TO, PB, JRB, LCL, WP, FXS and PA) contributed to the study design and funding application, and critically reviewed the manuscript. The Canadian TBI Research Consortium (CTRC) contributed to this study by hosting presentations from the named authors, facilitating discussion about the study, and providing advice that strengthened the design and conduct of the study.

  • Funding Canadian Institutes for Health Research (CIHR).

  • Disclaimer The funder played no role in the decision to publish the study findings.

  • Competing interests NS has a private neuropsychological consulting practice and has received honoraria for providing continuing medical education. The other authors have no potential conflicts to declare.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.