TBI Evaluation and Management (TEaM) (TEaM)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04576715 |
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Recruitment Status :
Not yet recruiting
First Posted : October 6, 2020
Last Update Posted : January 20, 2021
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| Condition or disease | Intervention/treatment | Phase |
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| Mild Traumatic Brain Injury | Behavioral: TEaM Intervention Behavioral: Standard of Care | Not Applicable |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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).
Other Name: TEaM |
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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.
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Behavioral: Standard of Care
Continue with CHOA current best practices for mTBI:
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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.
| Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: David Wright, MD | 4047781709 | dwwrigh@emory.edu | |
| Contact: Rachel Bull | 404-778-7287 | rachel.bull@emory.edu |
| 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 | |
| Principal Investigator: | David Wright, MD | Emory University |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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mTBI Brain injury Emergency medicine Urgent care |
Primary care Concussion Pediatrics |
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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 |