TBI Evaluation and Management (TEaM)

NCT04576715 | Completed

• 2 other identifiers: IRB001086742025P011539
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Mild Traumatic Brain Injury

Keywords

mTBI; Brain injury; Emergency medicine; Urgent care; Primary care; Concussion; Pediatrics

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Up to 3 months post-intervention

Secondary Outcomes (2)

• Primary Care Physician (PCP) follow up visits

  3 months post-intervention

• Number of letters sent to school

  2 weeks post-injury

Study Arms (2)

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.

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.

Behavioral: Standard of Care

Interventions

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

Also known as: TEaM

TEaM Intervention Group

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

Control Group

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Actively practicing physician or APP in the CHOA System
• Primary practice in either ED, UC, and/or PCP

You may not qualify if:

• Inability or unwillingness to provide written/electronic informed consent
• Unable to fulfill study training / education requirements
• 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)
• 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
• mTBI likely present as defined by:
• Positive diagnosis by clinician or mTBI OR
• Positive triage screen plus positive symptom checklist
• Requests to Opt-Out via e-mail or first phone contact
• Inability or unwillingness to provide verbal informed telephone consent/assent

Sponsors & Collaborators

• Centers for Disease Control and Prevention: collaborator
• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (3)

Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department

Atlanta, Georgia, 30322, United States

Location

Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care Centers

Atlanta, Georgia, 30322, United States

Location

Children's Healthcare of Atlanta- Primary Care Offices

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• David Wright, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 6, 2020
• Study Start: August 19, 2022
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: A year after study closure. No end date
• Access Criteria: Data will be publicly available via the internet in a way that the CDC/CIO dictate, through a CDC data repository, at which point the PIs will no longer have stewardship over the data.

Locations

US (3)