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

• Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium (Other)
• Overall Status: Completed
• CT.gov ID: NCT01554891
• Collaborator: U.S. Army Medical Research and Development Command (U.S. Fed)
• Enrollment: 305
• Locations: 6
• Duration (Months): 36.9
• Patients Per Site: 50.8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries, Traumatic

Study Design

• Study Type: Observational
• Actual Enrollment: 305 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Reliability and Initial Validation of the INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

1. Test-retest Reliability SAFE-TBI [Up to 6 weeks]

   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. (Specific Aim 1).

2. Concordance Rate of Current VA Screening Instruments and the SAFE-TBI. [baseline]

   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. (Specific Aim 2).

3. Sensitivity and Specificity of the SAFE-TBI [6-months after medical evacuation]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Walter Reed National Military Medical Center	Washington	District of Columbia	United States	20307
2	Togus VA Medical Center	Augusta	Maine	United States	04330
3	Manchester VA Medical Center	Manchester	New Hampshire	United States	03104
4	White River Junction VA Medical Center	White River Junction	Vermont	United States	05009-0001
5	Fort Belvoir Community Hopsital (FBCH)	Fort Belvoir	Virginia	United States	22060
6	Madigan Army Medical Center	Fort Lewis	Washington	United States	98431

Sponsors and Collaborators

• INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• U.S. Army Medical Research and Development Command

Investigators

• Principal Investigator: Laura A. Flashman, PhD, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• ClinicalTrials.gov Identifier: NCT01554891
• Other Study ID Numbers: INTRuST-SAFE-TBI
• First Posted: Mar 15, 2012
• Last Update Posted: Mar 3, 2016
• Last Verified: Mar 1, 2016

• 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 Injuries, Traumatic

Study Results

Participant Flow

Pre-assignment Detail	This difference is due to screened patients who were enrolled, but then found ineligible,were unreachable, or withdrew from study.

Arm/Group Title	Test-Retest Reliability of SAFE-TBI	Comparison of SAFE-TBI and VA Screen	Sensitivity and Specificity of SAFE-TBI
Arm/Group Description	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. This component of the project assessed test-retest reliability (4-6 weeks), as well as the effects of different raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 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 This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI. Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI.	200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
Period Title: Overall Study
STARTED	105	120	57
COMPLETED	98	115	55
NOT COMPLETED	7	5	2

Baseline Characteristics

Arm/Group Title	Test-Retest Reliability of SAFE-TBI	Comparison of SAFE-TBI and VA Screen	Sensitivity and Specificity of SAFE-TBI	Total
Arm/Group Description	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	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	200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).	Total of all reporting groups
Overall Participants	98	115	55	268
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.29 (9.30)	33.03 (8.68)	29.20 (8.56)	31.33 (8.5)
Sex: Female, Male (Count of Participants)
Female	7 7.1%	6 5.2%	6 10.9%	19 7.1%
Male	91 92.9%	109 94.8%	49 89.1%	249 92.9%
Presence of TBI (participants) [Number]
Number [participants]	91 92.9%	115 100%	55 100%	261 97.4%

Outcome Measures

1. Primary Outcome

Title	Test-retest Reliability SAFE-TBI
Description	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. (Specific Aim 1).
Time Frame	Up to 6 weeks

Outcome Measure Data

Analysis Population Description

Analyses done on Cohort 1, and a subset of Cohort 2 and 3 who got repeat interview.

Arm/Group Title	Test-Retest Reliability of SAFE-TBI
Arm/Group Description	Cohort 1 was used to determine test-retest reliability of the SAFE-TBI instrument.
Measure Participants	98
Cutoff 1 (no vs. at least weak evidence)	0.372
Cutoff 2 (no or weak vs. at least moderate evid)	0.504
Cutoff (no, weak, moderate vs. strong)	0.581

2. Primary Outcome

Title	Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.
Description	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. (Specific Aim 2).
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

Analyses done for Cohort 2 only.

Arm/Group Title	Comparison of SAFE-TBI and VA Screen
Arm/Group Description	Veterans
Measure Participants	115
Strong Evidence	64.35 65.7%
Moderate Evidence	11.3 11.5%
Weak Evidence	14.78 15.1%
No Evidence	9.57 9.8%

3. Primary Outcome

Title	Sensitivity and Specificity of the SAFE-TBI
Description	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
Time Frame	6-months after medical evacuation

Outcome Measure Data

Analysis Population Description

Data were only collected for cohort 3.

Arm/Group Title	Sensitivity and Specificity of SAFE-TBI
Arm/Group Description	Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives)
Measure Participants	55
Sensitivity for Cutoff 2	93
Specificity for Cutoff 2	50

Adverse Events

Time Frame	3 years
Arm/Group Title	Test-Retest Reliability of SAFE-TBI		Comparison of SAFE-TBI and VA Screen		Sensitivity and Specificity of SAFE-TBI
Arm/Group Description	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. This component of the project assessed test-retest reliability (4-6 weeks), as well as the effects of different raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 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 This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI. Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI.		200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
All Cause Mortality
	Test-Retest Reliability of SAFE-TBI		Comparison of SAFE-TBI and VA Screen		Sensitivity and Specificity of SAFE-TBI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Test-Retest Reliability of SAFE-TBI		Comparison of SAFE-TBI and VA Screen		Sensitivity and Specificity of SAFE-TBI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/115 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Test-Retest Reliability of SAFE-TBI		Comparison of SAFE-TBI and VA Screen		Sensitivity and Specificity of SAFE-TBI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/115 (0%)		0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.