Mild Traumatic Brain Injury
Conditions
Keywords
mTBI, Brain injury, Emergency medicine, Urgent care, Primary care, Concussion, Pediatrics
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.
Interventions
BEHAVIORALTEaM 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
BEHAVIORALStandard 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
Sponsors
Emory University
Children's Healthcare of Atlanta
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CLASS survey score | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Primary Care Physician (PCP) follow up visits | 3 months post-intervention | Number of PCP visits for concussion during 3 month follow-up period. |
| Number of letters sent to school | 2 weeks post-injury | Number of Primary care Physician (PCP) letters sent to school within 2 weeks post-injury |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Wright, MD
Emory University
Outcome results
None listed