Improving care for children with mild traumatic brain injury
Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)
This study tests a new approach to help doctors better diagnose and treat mild brain injuries in kids to see if it improves their school performance and recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT04576715 on ClinicalTrials.gov |
What this trial studies
This study evaluates a multi-disciplinary intervention aimed at enhancing the diagnosis and management of mild traumatic brain injury (mTBI) in children. Emergency, urgent care, and primary care providers will be randomly assigned to either receive the intervention or continue with standard practices. The study incorporates a decision support tool to assist clinicians and will follow enrolled children for three months post-injury to assess the impact on school performance and other outcomes. The design allows for the evaluation of both educational and technological interventions in improving care.
Who should consider this trial
Good fit: Ideal candidates for this study are school-aged children (5-18 years) who have been evaluated for mTBI within 72 hours of their injury.
Not a fit: Patients who do not speak English or have a history of severe developmental delays or psychiatric issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to better management of mTBI in children, resulting in improved recovery and school performance.
How similar studies have performed: Other studies have shown promise in improving outcomes for mTBI through similar multi-disciplinary approaches, suggesting potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
PROVIDER INCLUSION CRITERIA * Actively practicing physician or APP in the CHOA System * Primary practice in either ED, UC, and/or PCP PROVIDER EXCLUSION CRITERIA * Inability or unwillingness to provide written/electronic informed consent * Unable to fulfill study training / education requirements CHILD INCLUSION CRITERIA - RETROSPECTIVE * School age (5-18 yoa) * Evaluated in ED / UC / PCP within 72 hours of injury * Discharged home from ED / UC / PCP (e.g., not admitted to hospital) CHILD EXCLUSION CRITERIA - RETROSPECTIVE * Non-English speaking * Known severe developmental delay or known severe psychiatric history * Known prior severe brain injury * Known mTBI within past 3 months * First mTBI visit outside of CHOA network CHILD INCLUSION CRITERIA - PROSPECTIVE * Meets above inclusion for retrospective portion plus: * mTBI likely present as defined by: * Positive diagnosis by clinician or mTBI OR * Positive triage screen plus positive symptom checklist CHILD EXCLUSION CRITERIA - PROSPECTIVE * Does not meet above exclusion for retrospective portion plus: * Requests to Opt-Out via e-mail or first phone contact * Inability or unwillingness to provide verbal informed telephone consent/assent
Where this trial is running
Atlanta, Georgia and 2 other locations
- Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department — Atlanta, Georgia, United States (Recruiting)
- Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care Centers — Atlanta, Georgia, United States (Recruiting)
- Children's Healthcare of Atlanta- Primary Care Offices — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: David Wright, MD — Emory University
- Study coordinator: David Wright, MD
- Email: dwwrigh@emory.edu
- Phone: 4047781709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.