National Institute on Disability and Rehabilitation Research (NIDRR) Traumatic Brain Injury (TBI) Model System Database

F
Flora Hammond, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
250 participants needed
1 Location

Brief description of study

What is the purpose of this study?
The primary objective of this study is to provide data for research to improve care and outcomes for individuals with traumatic brain injuries. The Traumatic Brain Injury Model System National Database is a multi-center, prospective, longitudinal study used for descriptive analyses of outcome, correlation of injury severity and for monitoring trends over time. Information being collected will include demographic, date of birth, height, weight, substance and tobacco use history, disability ratings, injury information, level of function, types of treatment received and quality of life. Subjects in the study authorize further contact regarding research studies or new services that may be of benefit to them. Subjects will be contacted periodically to gather follow-up recovery and outcome information.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential subject will be identified upon admission to the rehabilitation facility through admissions reports. Eligible individuals will be randomly selected to participate in the research. Through a Pilot portion of the study any potential subject with disorders of consciousness will be identified and included in the study without randomization. Study staff will introduce the substudies to eligible participants over the phone at the end of the existing data collection measures or as a separate phone call. Study staff may also approach subjects in-person to introduce substudies for which they are eligible.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Traumatic brain injury, TBI
  • Age: 18 years - 100 years
  • Gender: All

Main Study:  
    Moderate to severe TBI (post-traumatic amnesia>24 hrs or loss of consciousness>30 minutes or Glasgow Coma Scale in Emergency Department<13 or intracranial neuroimaging abnormalities)
    Admitted to system’s hospital emergency department (i.e., Level I Trauma Center at Indiana University Health Methodist Hospital; IUH-M or Level II Trauma Center at St. Vincent’s Hospital; StV) within 72 hours of injury.
    16 years of age or older at the time of injury 
    Receives acute care and comprehensive inpatient rehabilitation within the model system hospitals (i.e., IUH-M, StV, Rehabilitation Hospital of Indiana; RHI)
    Informed consent is signed by patient, family or guardian.

ENRICH
ENRICH Aim 2.2 Interview Inclusion Criteria
Inclusion:
-    Completed BTACT at least 2 times

ENRICH Aim 2.3 Interview Inclusion Criteria
Inclusion:
-    TBIMS participants who, at some point in the first 5 years after TBI, endorsed suicidal ideation and/or attempt at a prior interview.
-    Existing TBIMS participants who, at some point in the first 5 years after TBI, met our empirically-based definition of “high suicide risk:” either:
o    (1) a score ≥1 on item 9 of PHQ-9 (i.e., “Thoughts that you would be better off dead, or thoughts of hurting yourself in some way” on “Several days,” “More than half the days,” or “Nearly every day” in the past 2 weeks, AND/OR
o    (2) past-year suicide attempt, AND/OR 
o    (3) past-year suicide hospitalization. 

ENRICH:
ENRICH Aim 2.2 Interview Exclusion Criteria
- Incarcerated
- Severe psychosis
- Non-English speaking

ENRICH Aim 2.3 Interview Exclusion Criteria
- Incarcerated
- Non-English speaking

State Supports Cognitive Interviewing: 
- Incarcerated

Updated on 13 Feb 2025. Study ID: PHMR-NIDILRR-HAMMOND-TBIMS, 1211010085
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