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TEaM Intervention for Traumatic Brain Injury (TEaM Trial)

N/A

Recruiting

Led By David Wright, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PROVIDER

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week, 2 week and 1 month post return to school

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a multi-disciplinary intervention can improve outcomes for children who have experienced a mild TBI.

Who is the study for?

This trial is for children who have had a mild traumatic brain injury (mTBI). It's also for healthcare providers within the CHOA System, specifically those working in emergency departments, urgent care, or as primary care physicians.

What is being tested?

The TEaM Intervention is being tested against the standard of care to see if it improves outcomes after a child has suffered an mTBI. The study focuses on enhancing diagnosis and management practices by clinicians.

What are the potential side effects?

Since this trial involves evaluating clinical practices rather than medication, there are no direct side effects like you'd expect with drugs. However, changes in management may affect patient recovery experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week, 2 week and 1 month post return to school

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week, 2 week and 1 month post return to school

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 2 week and 1 month post return to school for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in CLASS survey score

Change in Peds-QL score

Change in Post-concussion symptom inventory (PCSI) total score

+2 more

Secondary study objectives

Number of letters sent to school

Primary Care Physician (PCP) follow up visits

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TEaM Intervention GroupExperimental Treatment1 Intervention

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 II: Control GroupActive Control1 Intervention

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.

0 / 1Eligibility criteria met