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Completed

NCT Number: NCT04576715

TBI 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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEaM Intervention

Behavioral

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

Other names: TEaM

Standard of Care

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Primary Care Physician (PCP) follow up visits

    Time frame: 3 months post-intervention

    Number of PCP visits for concussion during 3 month follow-up period.

  2. Number of letters sent to school

    Time frame: 2 weeks post-injury

    Number of Primary care Physician (PCP) letters sent to school within 2 weeks post-injury

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Children's Healthcare of Atlanta

Registry information

Official study title

Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)

Acronym: TEaM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2020
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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