Trial Outcomes & Findings for INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI) (NCT NCT01554891)
NCT ID: NCT01554891
Last Updated: 2016-03-03
Results Overview
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).
COMPLETED
305 participants
Up to 6 weeks
2016-03-03
Participant Flow
This difference is due to screened patients who were enrolled, but then found ineligible,were unreachable, or withdrew from study.
Participant milestones
| Measure |
Test-Retest Reliability of SAFE-TBI
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).
|
Comparison of SAFE-TBI and VA 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 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.
|
Sensitivity and Specificity of SAFE-TBI
200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
120
|
57
|
|
Overall Study
COMPLETED
|
98
|
115
|
55
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
Baseline characteristics by cohort
| Measure |
Test-Retest Reliability of SAFE-TBI
n=98 Participants
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
|
Comparison of SAFE-TBI and VA Screen
n=115 Participants
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
|
Sensitivity and Specificity of SAFE-TBI
n=55 Participants
200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.29 years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
33.03 years
STANDARD_DEVIATION 8.68 • n=7 Participants
|
29.20 years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
31.33 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
249 Participants
n=4 Participants
|
|
Presence of TBI
|
91 participants
n=5 Participants
|
115 participants
n=7 Participants
|
55 participants
n=5 Participants
|
261 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: Analyses done on Cohort 1, and a subset of Cohort 2 and 3 who got repeat interview.
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).
Outcome measures
| Measure |
Test-Retest Reliability of SAFE-TBI
n=98 Participants
Cohort 1 was used to determine test-retest reliability of the SAFE-TBI instrument.
|
|---|---|
|
Test-retest Reliability SAFE-TBI
Cutoff (no, weak, moderate vs. strong)
|
0.581 kappa (reliability)
Interval 0.412 to 0.75
|
|
Test-retest Reliability SAFE-TBI
Cutoff 1 (no vs. at least weak evidence)
|
0.372 kappa (reliability)
Interval 0.055 to 0.69
|
|
Test-retest Reliability SAFE-TBI
Cutoff 2 (no or weak vs. at least moderate evid)
|
0.504 kappa (reliability)
Interval 0.298 to 0.711
|
PRIMARY outcome
Timeframe: baselinePopulation: Analyses done for Cohort 2 only.
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).
Outcome measures
| Measure |
Test-Retest Reliability of SAFE-TBI
n=115 Participants
Cohort 1 was used to determine test-retest reliability of the SAFE-TBI instrument.
|
|---|---|
|
Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.
Strong Evidence
|
64.35 percentage of participants
Interval 55.59 to 73.1
|
|
Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.
Moderate Evidence
|
11.3 percentage of participants
Interval 5.52 to 17.09
|
|
Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.
Weak Evidence
|
14.78 percentage of participants
Interval 8.3 to 21.27
|
|
Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.
No Evidence
|
9.57 percentage of participants
Interval 4.19 to 14.94
|
PRIMARY outcome
Timeframe: 6-months after medical evacuationPopulation: Data were only collected for cohort 3.
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
Outcome measures
| Measure |
Test-Retest Reliability of SAFE-TBI
n=55 Participants
Cohort 1 was used to determine test-retest reliability of the SAFE-TBI instrument.
|
|---|---|
|
Sensitivity and Specificity of the SAFE-TBI
Sensitivity for Cutoff 2
|
93 percentage
|
|
Sensitivity and Specificity of the SAFE-TBI
Specificity for Cutoff 2
|
50 percentage
|
Adverse Events
Test-Retest Reliability of SAFE-TBI
Comparison of SAFE-TBI and VA Screen
Sensitivity and Specificity of SAFE-TBI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Laura A. Flashman, Ph.D.
Geisel School of Medicine at Dartmouth
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place