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TBI Evaluation and Management (TEaM) (TEaM)

Primary Purpose

Mild Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEaM Intervention
Standard of Care
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring mTBI, Brain injury, Emergency medicine, Urgent care, Primary care, Concussion, Pediatrics

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Healthcare of Atlanta (CHOA) - Egleston Emergency DepartmentRecruiting
  • Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care CentersRecruiting
  • Children's Healthcare of Atlanta- Primary Care OfficesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEaM Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Primary Care Physician (PCP) follow up visits
Number of PCP visits for concussion during 3 month follow-up period.
Number of letters sent to school
Number of Primary care Physician (PCP) letters sent to school within 2 weeks post-injury

Full Information

First Posted
October 1, 2020
Last Updated
August 30, 2023
Sponsor
Emory University
Collaborators
Children's Healthcare of Atlanta
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1. Study Identification

Unique Protocol Identification Number
NCT04576715
Brief Title
TBI Evaluation and Management (TEaM)
Acronym
TEaM
Official Title
Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Children's Healthcare of Atlanta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
mTBI, Brain injury, Emergency medicine, Urgent care, Primary care, Concussion, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEaM Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TEaM Intervention
Other Intervention Name(s)
TEaM
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in CLASS survey score
Description
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.
Time Frame
1 week, 2 week and 1 month post return to school
Title
Change in Post-concussion symptom inventory (PCSI) total score
Description
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.
Time Frame
1 week, 2 week and 1 month post return to school
Title
Change in Peds-QL score
Description
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.
Time Frame
1 week, 2 week and 1 month post return to school
Title
Post-concussion symptom inventory (PCSI) total score at 3 months post injury
Description
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.
Time Frame
3 months post injury
Title
Time to return to full activity post injury
Description
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.
Time Frame
Up to 3 months post-intervention
Secondary Outcome Measure Information:
Title
Primary Care Physician (PCP) follow up visits
Description
Number of PCP visits for concussion during 3 month follow-up period.
Time Frame
3 months post-intervention
Title
Number of letters sent to school
Description
Number of Primary care Physician (PCP) letters sent to school within 2 weeks post-injury
Time Frame
2 weeks post-injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Wright, MD
Phone
4047781709
Email
dwwrigh@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Bull
Phone
404-778-7287
Email
rachel.bull@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wright, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wright, MD
Phone
404-778-1709
Email
dwwrigh@emory.edu
Facility Name
Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care Centers
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wright, MD
Phone
404-778-1709
Email
dwwrigh@emory.edu
First Name & Middle Initial & Last Name & Degree
Rachel Bull
Phone
4047787287
Email
rachel.bull@emory.edu
Facility Name
Children's Healthcare of Atlanta- Primary Care Offices
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wright, MD
Phone
404-778-1709
Email
dwwrigh@emory.edu
First Name & Middle Initial & Last Name & Degree
Rachel Bull
Phone
4047787287
Email
rachel.bull@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
A year after study closure. No end date
IPD Sharing Access Criteria
Data will be publicly available via the internet in a way that the CDC/CIO dictate, through a CDC data repository, at which point the PIs will no longer have stewardship over the data.

Learn more about this trial

TBI Evaluation and Management (TEaM)

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