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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01554891
First received: March 12, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition
Brain Injuries, Traumatic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability and Initial Validation of the INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)

Resource links provided by NLM:


Further study details as provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:

Primary Outcome Measures:
  • SAFE-TBI [ Time Frame: Change from baseline at six weeks ] [ Designated as safety issue: No ]
    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)

  • Concordance rate of current VA screening instruments and the SAFE-TBI. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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)

  • Sensitivity and specificity of the SAFE-TBI [ Time Frame: 6-months after medical evacuation ] [ Designated as safety issue: No ]
    Sensitivity and specificity of the SAFE-TBI as determined by 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. SAFE-TBI will be administered about 6 months after return. (Cohort 3)


Estimated Enrollment: 400
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
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
Cohort 3
200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554891

Contacts
Contact: Laura A. Flashman, PhD (603) 650-0404 Laura.A.Flashman@hitchcock.org

Locations
United States, District of Columbia
Walter Reed National Military Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Jennifer Teng    202-553-9612    jennifer.teng.ctr@usuhs.edu   
Principal Investigator: Louis French, PsyD, DAC         
United States, Maine
Togus VA Medical Center Recruiting
Augusta, Maine, United States, 04330
Contact: Nancy Fischer       Nancy.Fischer2@va.gov   
Principal Investigator: James R. Sisung II, Psy.D         
United States, New Hampshire
Manchester VA Medical Center Recruiting
Manchester, New Hampshire, United States, 03104
Contact: Mike Macklin    603-624-4366 ext 6815    Mike.Macklin@va.gov   
Principal Investigator: Mark Gilbertson, PhD         
United States, Vermont
White River Junction VA Medical Center Recruiting
White River Junction, Vermont, United States, 05009-0001
Contact: Leigh Chesnut    802-295-9363 ext 5415    Leigh.Chesnut@va.gov   
Principal Investigator: Lanier Summerall, MD, MPH         
United States, Virginia
Fort Belvoir Community Hopsital (FBCH) Recruiting
Fort Belvoir, Virginia, United States, 22060
Contact: Ronell Wix, RN, CRRN, CCM    (571) 231-2936    ronell.iandolo@us.army.mil   
Principal Investigator: Heechin Chae, MD         
United States, Washington
Madigan Army Medical Center Recruiting
Fort Lewis, Washington, United States, 98431
Contact: Elissa Thomas LPN, CCRC    253-968-3919    elissa.k.thomas@us.army.mil   
Principal Investigator: Greg Gahm, PhD         
Sponsors and Collaborators
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Laura A. Flashman, PhD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier: NCT01554891     History of Changes
Other Study ID Numbers: INTRuST-SAFE-TBI
Study First Received: March 12, 2012
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:
brain injuries, traumatic
military personnel
classification
diagnosis
instrumentation

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014