Promoting Recovery in Children Who Sustain a Mild Traumatic Brain Injury: mTBI Evaluation and Management (TEaM)
Overview
- Phase
- Not Applicable
- Intervention
- TEaM Intervention
- Conditions
- Mild Traumatic Brain Injury
- Sponsor
- Emory University
- Enrollment
- 101
- Locations
- 3
- Primary Endpoint
- Time to return to full activity post injury
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
David Wright
Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •PROVIDER INCLUSION CRITERIA
- •Actively practicing physician or APP in the CHOA System
- •Primary practice in either ED, UC, and/or PCP
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
Arms & Interventions
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.
Intervention: TEaM Intervention
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.
Intervention: Standard of Care
Outcomes
Primary Outcomes
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.
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 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.
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.
Secondary Outcomes
- Primary Care Physician (PCP) follow up visits(3 months post-intervention)
- Number of letters sent to school(2 weeks post-injury)