- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04576715
TBI Evaluation and Management (TEaM) (TEaM)
Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Wright, MD
- Phone Number: 4047781709
- Email: dwwrigh@emory.edu
Study Contact Backup
- Name: Rachel Bull
- Phone Number: 404-778-7287
- Email: rachel.bull@emory.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department
-
Contact:
- David Wright, MD
- Phone Number: 404-778-1709
- Email: dwwrigh@emory.edu
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care Centers
-
Contact:
- David Wright, MD
- Phone Number: 404-778-1709
- Email: dwwrigh@emory.edu
-
Contact:
- Rachel Bull
- Phone Number: 4047787287
- Email: rachel.bull@emory.edu
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Children's Healthcare of Atlanta- Primary Care Offices
-
Contact:
- David Wright, MD
- Phone Number: 404-778-1709
- Email: dwwrigh@emory.edu
-
Contact:
- Rachel Bull
- Phone Number: 4047787287
- Email: rachel.bull@emory.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TEaM Intervention Group
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.
|
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).
Other Names:
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Active Comparator: Control Group
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.
|
Continue with CHOA current best practices for mTBI:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in CLASS survey score
Time Frame: 1 week, 2 week and 1 month post return to school
|
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
|
Change in Post-concussion symptom inventory (PCSI) total score
Time Frame: 1 week, 2 week and 1 month post return to school
|
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
|
Change in Peds-QL score
Time Frame: 1 week, 2 week and 1 month post return to school
|
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
|
Post-concussion symptom inventory (PCSI) total score at 3 months post injury
Time Frame: 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
|
Time to return to full activity post injury
Time Frame: Up to 3 months post-intervention
|
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.
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Up to 3 months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Care Physician (PCP) follow up visits
Time Frame: 3 months post-intervention
|
Number of PCP visits for concussion during 3 month follow-up period.
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3 months post-intervention
|
Number of letters sent to school
Time Frame: 2 weeks post-injury
|
Number of Primary care Physician (PCP) letters sent to school within 2 weeks post-injury
|
2 weeks post-injury
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Wright, MD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00108674
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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