INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)

NCT ID: NCT01554891

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 305 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-03-31

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.

Conditions

Brain Injuries, Traumatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen

No interventions assigned to this group

Cohort 2

100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen

No interventions assigned to this group

Cohort 3

200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).

No interventions assigned to this group

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:

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura A. Flashman, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Walter Reed National Military Medical Center

Washington D.C., District of Columbia, United States

Togus VA Medical Center

Augusta, Maine, United States

Manchester VA Medical Center

Manchester, New Hampshire, United States

White River Junction VA Medical Center

White River Junction, Vermont, United States

Fort Belvoir Community Hopsital (FBCH)

Fort Belvoir, Virginia, United States

Madigan Army Medical Center

Fort Lewis, Washington, United States

Countries

United States

Other Identifiers

INTRuST-SAFE-TBI

Identifier Type: -

Identifier Source: org_study_id