TBI Evaluation and Management (TEaM)

Emory University

Status: Enrolling

Conditions: Mild Traumatic Brain Injury

Treatments: Behavioral: Standard of Care; Behavioral: TEaM Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04576715

IRB00108674

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

TEaM Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: TEaM Intervention

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of Care