INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | February 2012 |
| End Date: | March 2015 |
Reliability and Initial Validation of the INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
The current study will evaluate the initial reliability and validity of a new instrument,
the INTRuST Structured Assessment for Evaluation of TBI (SAFE-TBI), in three samples of
Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)
veterans. The SAFE-TBI is a relatively brief measure developed by INTRuST consortium
investigators and designed to be given by a trained administrator. It allows for a
determination of the level of evidence for exposure to a mild traumatic brain injury (TBI)
using the following categories: Strong, Moderate, Weak, or No Evidence of mild TBI. The
first objective is to determine the reliability (both test-retest and inter-rater) in a
sample of 100 veterans recently returned from deployment at Joint Base Lewis-McChord and
Fort Bragg (Cohort 1), who have screened positive for TBI on the Post-Deployment Health
Assessment. The second objective is to determine the concordance between the SAFE-TBI and
the VA TBI Screen in 100 OEF/OIF/OND veterans within the Northern New England VA Research
Consortium (Cohort 2). The third objective, to be carried out in a sample of 200 Walter Reed
National Military Medical Center (WRNMMC) and Fort Belvoir Community Hospital OEF/OIF/OND
patients (Cohort 3), is to determine the sensitivity and specificity of the SAFE-TBI using
the INTRuST study "Brain Indices of Risk for Posttraumatic Stress Disorder after Mild
Traumatic Brain Injury" initial evaluation as the "gold standard" for TBI assessment.
the INTRuST Structured Assessment for Evaluation of TBI (SAFE-TBI), in three samples of
Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)
veterans. The SAFE-TBI is a relatively brief measure developed by INTRuST consortium
investigators and designed to be given by a trained administrator. It allows for a
determination of the level of evidence for exposure to a mild traumatic brain injury (TBI)
using the following categories: Strong, Moderate, Weak, or No Evidence of mild TBI. The
first objective is to determine the reliability (both test-retest and inter-rater) in a
sample of 100 veterans recently returned from deployment at Joint Base Lewis-McChord and
Fort Bragg (Cohort 1), who have screened positive for TBI on the Post-Deployment Health
Assessment. The second objective is to determine the concordance between the SAFE-TBI and
the VA TBI Screen in 100 OEF/OIF/OND veterans within the Northern New England VA Research
Consortium (Cohort 2). The third objective, to be carried out in a sample of 200 Walter Reed
National Military Medical Center (WRNMMC) and Fort Belvoir Community Hospital OEF/OIF/OND
patients (Cohort 3), is to determine the sensitivity and specificity of the SAFE-TBI using
the INTRuST study "Brain Indices of Risk for Posttraumatic Stress Disorder after Mild
Traumatic Brain Injury" initial evaluation as the "gold standard" for TBI assessment.
Inclusion Criteria:
Cohort 1:
1. Military personnel returning to Joint Base Lewis-McChord and Fort Bragg from
deployment in support of OEF/OIF/OND between the ages of 18-60.
2. Screen positive on the PDHA TBI screen and referred to the Madigan Army Medical
Center TBI clinic and Womack Army Medical Center.
3. Capable of giving informed consent.
Cohort 2:
1. Veterans of OEF/OIF/OND between the ages of 18-60, receiving care at any of the three
VAMCs that comprise the Northern New England VA Research Consortium (White River
Junction, VT; Manchester, NH; Togus, ME).
2. Screen positive on the VA Level 1 TBI screen.
3. Capable of giving informed consent.
Cohort 3:
Military Personnel participating in the INTRuST Consortium Brain Indices Study at Walter
Reed National Military Medical Center and Fort Belvoir Community Hospital. This study has
the following Inclusion Criteria:
1. Must be a patient at WRNMMC or FBCH
2. Must be Defense Enrollment Eligibility Reporting System (DEERS) eligible.
3. Must be diagnosed TBI positive or certified as TBI negative by a licensed medical
practitioner using Department of Defense (DoD) criteria
4. For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale
5. Aged 18-60
Exclusion Criteria:
Cohort 1:
1. Speech/language deficit of sufficient severity to preclude answering interview
questions
2. Unable or unwilling to provide informed consent and Health Insurance Portability and
Accountability Act (HIPAA)authorization ("unable" includes cases in which the
potential subject cannot read and understand English well enough to provide informed
consent).
Cohort 2:
1. Speech/language deficit of sufficient severity to preclude answering interview
questions.
2. Unable or unwilling to provide informed consent and HIPAA authorization ("unable"
includes cases in which the potential subject cannot read and understand English well
enough to provide informed consent).
3. Second level in-depth TBI evaluation done prior to SAFE TBI interview
Cohort 3:
Exclusion criteria for Cohort will be those used in the WRNMMC and Fort Belvoir Community
Hospital Brain Indices Study as follows:
1. Unable or unwilling to provide informed consent and HIPAA authorization ("unable"
includes cases in which the potential subject cannot read and understand English well
enough to provide informed consent).
2. Penetrating head injury.
3. Record of drug or alcohol abuse or dependence in the past six months as documented in
medical chart.
4. Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
Disorders -IV (SCID) reveals current or lifetime PTSD diagnosis related to life
events that occurred prior to most recent deployment.
5. Taking intravenous medications for pain; participation will be delayed until such
medication has been discontinued.
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