Clinical trial NCT01554891: INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
Official title: Reliability and Initial Validation of the INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries, Traumatic
Keywords: brain injuries, traumatic
military personnel
classification
diagnosis
instrumentation
Lead sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2012-03-15
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort 1: Active duty OEF/OIF/OND military personnel ages 18-60 who have recently screened positive for TBI following deployment.

Cohort 2: OEF/OIF/OND veterans ages 18-60 who have recently screened positive for TBI.

Cohort 3: Participants ages 18-60 in the INTRuST Consortium Brain Indices Study at WRNMMC or FBCH.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Test-retest Reliability SAFE-TBI
timeFrame: Up to 6 weeks
measure: Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.
timeFrame: baseline
measure: Sensitivity and Specificity of the SAFE-TBI
timeFrame: 6-months after medical evacuation
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed National Military Medical Center
state: District of Columbia
city: Augusta
country: United States
facility: Togus VA Medical Center
state: Maine
city: Manchester
country: United States
facility: Manchester VA Medical Center
state: New Hampshire
city: White River Junction
country: United States
facility: White River Junction VA Medical Center
state: Vermont
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hopsital (FBCH)
state: Virginia
city: Fort Lewis
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Laura A. Flashman, PhD
role: PRINCIPAL_INVESTIGATOR
References: