TBI Evaluation and Management (TEaM) (NCT04576715) | Clinical Trial Compass
CompletedNot Applicable
TBI Evaluation and Management (TEaM)
United States101 participantsStarted 2022-08-19
Plain-language summary
The purpose of this study is to evaluate a multi-disciplinary, multi-setting intervention with the goal of improving outcomes for children who have experienced a mild traumatic brain injury (mTBI). The project aims to improve and support mTBI diagnosis and management, and improve critical decision making by clinicians during their interaction with the injured child, their family, and their school.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at concussion recovery in kids using tools like the Post-Concussion Symptom Inventory and tracked how long it took them to return to full activity — based on what that research found, what does a typical recovery timeline look like for a mild TBI, and are there any red flags that would suggest my child's recovery is taking longer than expected?
2The trial measured quality of life using the Peds-QL score at multiple points — does that kind of data give you any guidance on how to support my child's overall wellbeing, not just their physical symptoms, during recovery from a concussion?
3Since this study is now completed, have the results been published or shared anywhere, and do those findings change how you'd approach managing my child's concussion compared to what you were already doing?
4The trial tracked symptoms at 3 months post-injury specifically — is there a point where lingering post-concussion symptoms become a serious concern, and what would you want to do differently if my child is still struggling at that mark?
5This study measured return to full activity as a key outcome — how do you personally decide when it's safe for my child to go back to school, sports, and screens, and is your approach informed by research like this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in CLASS survey score
Timeframe: 1 week, 2 week and 1 month post return to school
2
Change in Post-concussion symptom inventory (PCSI) total score
Timeframe: 1 week, 2 week and 1 month post return to school
3
Change in Peds-QL score
Timeframe: 1 week, 2 week and 1 month post return to school
4
Post-concussion symptom inventory (PCSI) total score at 3 months post injury