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TBI Evaluation and Management (TEaM) (TEaM)

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ClinicalTrials.gov Identifier: NCT04576715
Recruitment Status : Not yet recruiting
First Posted : October 6, 2020
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
David Wright, Emory University

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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Behavioral: TEaM Intervention Behavioral: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


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.
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
Other Name: TEaM

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.
Behavioral: 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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.


  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576715


Contacts
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Contact: David Wright, MD 4047781709 dwwrigh@emory.edu
Contact: Rachel Bull 404-778-7287 rachel.bull@emory.edu

Locations
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United States, Georgia
Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department
Atlanta, Georgia, United States, 30322
Contact: David Wright, MD    404-778-1709    dwwrigh@emory.edu   
Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care Centers
Atlanta, Georgia, United States, 30322
Contact: David Wright, MD    404-778-1709    dwwrigh@emory.edu   
Contact: Rachel Bull    4047787287    rachel.bull@emory.edu   
Children's Healthcare of Atlanta- Primary Care Offices
Atlanta, Georgia, United States, 30322
Contact: David Wright, MD    404-778-1709    dwwrigh@emory.edu   
Contact: Rachel Bull    4047787287    rachel.bull@emory.edu   
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
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Principal Investigator: David Wright, MD Emory University
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Responsible Party: David Wright, Professor, Emory University
ClinicalTrials.gov Identifier: NCT04576715    
Other Study ID Numbers: IRB00108674
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: A year after study closure. No end date
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Wright, Emory University:
mTBI
Brain injury
Emergency medicine
Urgent care
Primary care
Concussion
Pediatrics
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Central Nervous System Diseases
Nervous System Diseases