NCT04576715

TBI Evaluation and Management (TEaM)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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
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

Timeline

• Start date: 2022-08-19
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2020-10-06
• Last updated: 2026-03-13

Locations

3 sites across 1 country: United States