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| ID | Type | Description | Link |
|---|---|---|---|
| 2025P011539 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| Children's Healthcare of Atlanta | OTHER |
| Centers for Disease Control and Prevention | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEaM Intervention Group | Experimental | 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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| Control Group | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEaM Intervention | Behavioral | 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).
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week, 2 week and 1 month post return to school |
| 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. | 1 week, 2 week and 1 month post return to school |
| 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. | 1 week, 2 week and 1 month post return to school |
| 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. | 3 months post injury |
| Time to return to full activity post injury |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Care Physician (PCP) follow up visits | Number of PCP visits for concussion during 3 month follow-up period. | 3 months post-intervention |
| Number of letters sent to school | Number of Primary care Physician (PCP) letters sent to school within 2 weeks post-injury |
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PROVIDER INCLUSION CRITERIA
PROVIDER EXCLUSION CRITERIA
CHILD INCLUSION CRITERIA - RETROSPECTIVE
CHILD EXCLUSION CRITERIA - RETROSPECTIVE
CHILD INCLUSION CRITERIA - PROSPECTIVE
CHILD EXCLUSION CRITERIA - PROSPECTIVE
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| Name | Affiliation | Role |
|---|---|---|
| David Wright, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta (CHOA) - Egleston Emergency Department | Atlanta | Georgia | 30322 | United States | ||
information about the protocol and SAP will be shared no earlier that one year after study closure.
A year after study closure. No end date
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2024 | Mar 11, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Behavioral | Continue with CHOA current best practices for mTBI:
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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.
| Up to 3 months post-intervention |
| 2 weeks post-injury |
| Children's Healthcare of Atlanta- Forsyth, Northpoint and Town Center Urgent Care Centers |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Children's Healthcare of Atlanta- Primary Care Offices | Atlanta | Georgia | 30322 | United States |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |