TBI Evaluation and Management (TEaM)

NCT ID: NCT04576715

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-19
• Study Completion Date: 2027-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TEaM Intervention Group

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.

Group Type: EXPERIMENTAL

TEaM Intervention

Intervention Type: 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

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: 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

Interventions

TEaM Intervention

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

Intervention Type: BEHAVIORAL

Standard of Care

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

Intervention Type: BEHAVIORAL

Other Intervention Names

TEaM

Eligibility Criteria

Inclusion Criteria

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

• 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)

• 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

Exclusion Criteria

• Inability or unwillingness to provide written/electronic informed consent
• Unable to fulfill study training / education requirements

• 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

• 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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Healthcare of Atlanta

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

David Wright

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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

Atlanta, Georgia, United States

Site Status: RECRUITING

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

Atlanta, Georgia, United States

Site Status: RECRUITING

Children's Healthcare of Atlanta- Primary Care Offices

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Wright, MD

Role: CONTACT

dwwrigh@emory.edu

4047781709

Alex Hall, DHSc

Role: CONTACT

alex.hall@emory.edu

404-778-1585

Facility Contacts

David Wright, MD

Role: primary

dwwrigh@emory.edu

404-778-1709

David Wright, MD

Role: primary

dwwrigh@emory.edu

404-778-1709

Alex Hall, DHSc

Role: backup

alex.hall@emory.edu

4047781585

David Wright, MD

Role: primary

dwwrigh@emory.edu

404-778-1709

Alex Hall, DHSc

Role: backup

alex.hall@emory.edu

4047781585

Other Identifiers

IRB00108674

Identifier Type: -

Identifier Source: org_study_id