TBI Evaluation and Management (TEaM)

Mild Traumatic Brain Injury Clinical Trial

— TEaM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04576715
• Other study ID #: IRB00108674
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2022
• Est. completion date: January 2025

Study information

• Verified date: August 2023
• Source: Emory University
• Contact: David Wright, MD
• Phone: 4047781709
• Email: dwwrigh[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department	Atlanta	Georgia
United States	Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care Centers	Atlanta	Georgia
United States	Children's Healthcare of Atlanta- Primary Care Offices	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Primary Care Physician (PCP) follow up visits	Number of PCP visits for concussion during 3 month follow-up period.	3 months post-intervention
Secondary	Number of letters sent to school	Number of Primary care Physician (PCP) letters sent to school within 2 weeks post-injury	2 weeks post-injury