Mild Traumatic Brain InjuryTEaMNCT04576715
TBI Evaluation and Management (TEaM)
A study testing TEaM Intervention in people with Mild Traumatic Brain Injury, run by Emory University at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- TEaM Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Aug 2022to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care Centers
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta- Primary Care Offices
Atlanta, Georgia, 30322
About this study
Official title: Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)
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.
Read the detailed description
Emergency, urgent care, and primary care providers participating in the study will be block randomized in a 1:1 ratio by practice type to receive the intervention or continue with their standard practice. All enrolled clinicians (both trained and control providers) patients they care for will be screened for inclusion in the trial.
Additionally, a pre/post intervention will be layered upon the randomized educational intervention to evaluate the effects of the information technology decision support tool (i.e. eMR) in isolation of the clinician education intervention. The 32-month mTBI patient enrollment period will be divided into two 16 months segments. The first 16 months will be without the eMR intervention being visible, and the remaining 16 months post eMR screening and decision support deployment in the ED and UC. This study design allows us to evaluate the independent and interactive effects of the decision support tool and educational intervention.
Enrolled children will be followed for up to three months post injury to ascertain the effect of the interventions on the primary aim (reduction of school problems/performance) and secondary aims.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- TEaM Intervention, Standard of Care
- Keywords
- mTBI, Brain injury, Emergency medicine, Urgent care, Primary care, Concussion, Pediatrics
- Medical subject headings
- Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEaM InterventionBehavioural
Also called TEaM
Multi-setting mTBI (mild traumatic brain injury) Evaluation and Management Intervention incorporates provider education and information technology support systems, based on the best available evidence and tailored to a specific environment (acute care setting vs primary care clinic). Facilitates linkages between providers (ED/UC to primary care) and systems (healthcare to school).
- Provider Training Modules: Training includes decision-making support alerted by positive triage screening and concussion-specific eMR template
- Management based on current best practices (however, may have additional education from the provider training)
- Return to school letters
- Primary Care Follow Up
Standard of CareBehavioural
Continue with CHOA current best practices for mTBI:
- No TEaM Provider training (but will be offered to all providers at end of study)
- Will not be trained on utilization and implementation of the concussion screening alert and eMR template
| Study group | Role | What they receive |
|---|---|---|
| TEaM Intervention Group | Experimental | Dedicated Provider Education plus Information Technology Support. The IT support includes addition of an eMR concussion screening, followed by an alert to the provider, followed by a structured assessment / evaluation template. Receives: Behavioral: TEaM Intervention |
| Control Group | Active comparator | Standard medical protocol for the management of mTBI in children. This group will not receive interventional Provider Training on the TEaM concussion evaluation examination and utilization of the eMR template. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CLASS survey score
Concussion Learning Assessment and School Survey (CLASS), identifies the types of problems students experienced across all grades. Total score range 0-42 (14 individual items rated 0-3, 0 = no problem, 3 = significant problem). Higher score reflects a greater problem/ worse outcome.
Measured: 1 week, 2 week and 1 month post return to school
Change in Post-concussion symptom inventory (PCSI) total score
Change in Post-concussion symptom inventory (PCSI). Total score range, 0-24 (4 symptoms on a 0-6 scaling). Higher score reflects a greater problem/worse outcome.
Measured: 1 week, 2 week and 1 month post return to school
Change in Peds-QL score
Pediatric Quality of Life (PedsQL) scale, includes 23 items, rated 0-4 (assesses different areas of function (physical, emotional, social, school) to determine if the child is having any problems with various tasks in each functional area and if so, how often the difficulty occurs).
4 sub scales (general health 8 items 0-4 scaling, 0-32 total; social 5 items, 0-4 scaling, 0-20; school 5 items, 0-4 scaling, 0-20; emotional 5 items, 0-4 scaling, 0-20, 0=it is never a problem, 4= it is almost always a problem). Higher raw score reflects worse overall quality of life. Items are calculated and transformed into an overall score with a range of 0-to-100 points, with 100 points indicating better HRQoL.
Measured: 1 week, 2 week and 1 month post return to school
Post-concussion symptom inventory (PCSI) total score at 3 months post injury
Persistent post-mTBI symptoms as measured by the PCSI total score at 3 months post injury.
Total score range, 0-24 (4 symptoms on a 0-6 scaling). Higher score reflects a greater problem/worse outcome.
Measured: 3 months post injury
Time to return to full activity post injury
Measured by serial PCSI and return to activity. PCSI Total score (PPCS-Persistent Post-Concussive Symptoms - will be calculated via the PCSI Total Score with scores classified as "Recovered" or "Non-Recovered (PPCS)" based on the Reliable Change Metrics that reflect recovery or not (e.g., for Parent and Adolescent PCSI Total RAPID score <5 indicates symptom recovery). Total score ranges from 0 to 100%. Lower % with PPCS in Intervention group compared to Control indicates better study outcome.
Measured: Up to 3 months post-intervention
Secondary outcomes (2)
Primary Care Physician (PCP) follow up visits
Number of PCP visits for concussion during 3 month follow-up period.
Measured: 3 months post-intervention
Number of letters sent to school
Number of Primary care Physician (PCP) letters sent to school within 2 weeks post-injury
Measured: 2 weeks post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start19 Aug 2022
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, David Wright, Emory University
- Investigators
- David Wright, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576715
- Sponsor's protocol ID
- IRB00108674
- Other IDs
- 2025P011539
- Acronym
- TEaM
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2020
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: information about the protocol and SAP will be shared no earlier that one year after study closure.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)
- ClinicalTrials.gov ID
- NCT04576715
- Acronym / sponsor ID
- TEaM / IRB00108674
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- mTBI, Brain injury, Emergency medicine, Urgent care, Primary care, Concussion, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta, Centers for Disease Control and Prevention
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Emergency, urgent care, and primary care providers participating in the study will be block randomized in a 1:1 ratio by practice type to receive the intervention or continue with their standard practice. All enrolled clinicians (both trained and control providers) patients they care for will be screened for inclusion in the trial.
Additionally, a pre/post intervention will be layered upon the randomized educational intervention to evaluate the effects of the information technology decision support tool (i.e. eMR) in isolation of the clinician education intervention. The 32-month mTBI patient enrollment period will be divided into two 16 months segments. The first 16 months will be without the eMR intervention being visible, and the remaining 16 months post eMR screening and decision support deployment in the ED and UC. This study design allows us to evaluate the independent and interactive effects of the decision support tool and educational intervention.
Enrolled children will be followed for up to three months post injury to ascertain the effect of the interventions on the primary aim (reduction of school problems/performance) and secondary aims.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEaM Intervention Group | Experimental | Behavioral: TEaM InterventionDedicated Provider Education plus Information Technology Support. The IT support includes addition of an eMR concussion screening, followed by an alert to the provider, followed by a structured assessment / evaluation template. |
| Control Group | Active comparator | Behavioral: Standard of CareStandard medical protocol for the management of mTBI in children. This group will not receive interventional Provider Training on the TEaM concussion evaluation examination and utilization of the eMR template. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEaM InterventionAlso: TEaMMulti-setting mTBI (mild traumatic brain injury) Evaluation and Management Intervention incorporates provider education and information technology support systems, based on the best available evidence and tailored to a specific environment (acute care setting vs primary care clinic). Facilitates linkages between providers (ED/UC to primary care) and systems (healthcare to school). * Provider Training Modules: Training includes decision-making support alerted by positive triage screening and concussion-specific eMR template * Management based on current best practices (however, may have additional education from the provider training) * Return to school letters * Primary Care Follow Up | Behavioural | TEaM Intervention Group |
| Standard of CareContinue with CHOA current best practices for mTBI: * No TEaM Provider training (but will be offered to all providers at end of study) * Will not be trained on utilization and implementation of the concussion screening alert and eMR template | Behavioural | Control Group |
Primary outcome
Change in CLASS survey score
Time frame: 1 week, 2 week and 1 month post return to school
Concussion Learning Assessment and School Survey (CLASS), identifies the types of problems students experienced across all grades. Total score range 0-42 (14 individual items rated 0-3, 0 = no problem, 3 = significant problem). Higher score reflects a greater problem/ worse outcome.
Change in Post-concussion symptom inventory (PCSI) total score
Time frame: 1 week, 2 week and 1 month post return to school
Change in Post-concussion symptom inventory (PCSI). Total score range, 0-24 (4 symptoms on a 0-6 scaling). Higher score reflects a greater problem/worse outcome.
Change in Peds-QL score
Time frame: 1 week, 2 week and 1 month post return to school
Pediatric Quality of Life (PedsQL) scale, includes 23 items, rated 0-4 (assesses different areas of function (physical, emotional, social, school) to determine if the child is having any problems with various tasks in each functional area and if so, how often the difficulty occurs). 4 sub scales (general health 8 items 0-4 scaling, 0-32 total; social 5 items, 0-4 scaling, 0-20; school 5 items, 0-4 scaling, 0-20; emotional 5 items, 0-4 scaling, 0-20, 0=it is never a problem, 4= it is almost always a problem). Higher raw score reflects worse overall quality of life. Items are calculated and transformed into an overall score with a range of 0-to-100 points, with 100 points indicating better HRQoL.
Post-concussion symptom inventory (PCSI) total score at 3 months post injury
Time frame: 3 months post injury
Persistent post-mTBI symptoms as measured by the PCSI total score at 3 months post injury. Total score range, 0-24 (4 symptoms on a 0-6 scaling). Higher score reflects a greater problem/worse outcome.
Time to return to full activity post injury
Time frame: Up to 3 months post-intervention
Measured by serial PCSI and return to activity. PCSI Total score (PPCS-Persistent Post-Concussive Symptoms - will be calculated via the PCSI Total Score with scores classified as "Recovered" or "Non-Recovered (PPCS)" based on the Reliable Change Metrics that reflect recovery or not (e.g., for Parent and Adolescent PCSI Total RAPID score <5 indicates symptom recovery). Total score ranges from 0 to 100%. Lower % with PPCS in Intervention group compared to Control indicates better study outcome.
2 secondary outcomes
Primary Care Physician (PCP) follow up visits
Time frame: 3 months post-intervention
Number of letters sent to school
Time frame: 2 weeks post-injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. information about the protocol and SAP will be shared no earlier that one year after study closure.
Related trials for Mild Traumatic Brain Injury
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Not yet recruiting
Sleep MAPP in the Polytrauma/TBI System of Care
Insomnia Disorder, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wright, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEaM Intervention in people with Mild Traumatic Brain Injury, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CLASS survey score (time frame: 1 week, 2 week and 1 month post return to school). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.