Clinical trial NCT04576715: TBI Evaluation and Management (TEaM)
Official title: Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: mTBI
Brain injury
Emergency medicine
Urgent care
Primary care
Concussion
Pediatrics
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
First posted: 2020-10-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in CLASS survey score
timeFrame: 1 week, 2 week and 1 month post return to school
measure: Change in Post-concussion symptom inventory (PCSI) total score
timeFrame: 1 week, 2 week and 1 month post return to school
measure: Change in Peds-QL score
timeFrame: 1 week, 2 week and 1 month post return to school
measure: Post-concussion symptom inventory (PCSI) total score at 3 months post injury
timeFrame: 3 months post injury
measure: Time to return to full activity post injury
timeFrame: Up to 3 months post-intervention
Secondary outcomes:
measure: Primary Care Physician (PCP) follow up visits
timeFrame: 3 months post-intervention
measure: Number of letters sent to school
timeFrame: 2 weeks post-injury
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care Centers
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta- Primary Care Offices
state: Georgia
Study officials:
affiliation: Emory University
name: David Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: