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

Brain Injuries, Traumatic Clinical Trial

— SAFE-TBI  

Official title:

Reliability and Initial Validation of the INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554891
• Other study ID #: INTRuST-SAFE-TBI
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: March 2, 2016
• Start date: February 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2016
• Source: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic

Locations

Country	Name	City	State
United States	Togus VA Medical Center	Augusta	Maine
United States	Fort Belvoir Community Hopsital (FBCH)	Fort Belvoir	Virginia
United States	Madigan Army Medical Center	Fort Lewis	Washington
United States	Manchester VA Medical Center	Manchester	New Hampshire
United States	Walter Reed National Military Medical Center	Washington	District of Columbia
United States	White River Junction VA Medical Center	White River Junction	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-retest Reliability SAFE-TBI	Reliability of SAFE-TBI, as determined by test-retest and inter-rater reliability, in a sample of 100 veterans recently returned from deployment (Cohort 1) Cohort 1: The primary endpoints for this sub-study (cohort) are the degree of agreement for SAFE-TBI outcome (no evidence of TBI vs. at least, weak evidence of TBI) across the two assessment time points (initial vs. 4 to 6 weeks) as well as the two rater types TRC vs. TBIC. (Speci?c Aim 1).	Up to 6 weeks	No
Primary	Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.	Concordance rate of current VA TBI screening instruments and the SAFE-TBI in 100 OEF/OIF/OND veterans who have screened positive for TBI (Cohort 2) Cohort 2: The primary endpoint for this sub-study is the distribution of SAFE-TBI outcome (percent assigned to each evidence category of the SAFE-TBI) in a group of veterans who have screened positive on the VA TBI screen. (Speci?c Aim 2).	baseline	No
Primary	Sensitivity and Specificity of the SAFE-TBI	Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives) Cutoff 2 = At least moderate evidence of TBI vs. no or weak evidence of TBI	6-months after medical evacuation	No