Trial Outcomes & Findings for Evaluation of VA's Traumatic Brain Injury (TBI) Clinical Reminder and Comprehensive TBI Evaluation (CTBIE) (NCT NCT00852527)
NCT ID: NCT00852527
Last Updated: 2015-04-28
Results Overview
Patients were initially assessed with the TBI Clinical Screen at their local VA. To assess the diagnostic accuracy of the TCRS, a dual-criterion approach was used. The VA Comprehensive TBI Evaluation (CTBIE), a secondary evaluation, served as the first criterion and the Structured TBI Diagnostic Interview (STDI) as the second criterion.
COMPLETED
456 participants
All OEF/OIF Veterans to receive TCRS upon enrollment in VA
2015-04-28
Participant Flow
456 participants were selected from three VA Polytrauma Network Sites and represent urban, suburban, and rural catchment areas. 438 completed all assessments necessary for analysis.
Participant milestones
| Measure |
Positive Mild TBI
Participants who screened positive on the TBI Clinical Reminder Screen
|
Negative Mild TBI
Participants who screened negative on the TBI Clinical Reminder Screen
|
|---|---|---|
|
Overall Study
STARTED
|
196
|
242
|
|
Overall Study
COMPLETED
|
196
|
242
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of VA's Traumatic Brain Injury (TBI) Clinical Reminder and Comprehensive TBI Evaluation (CTBIE)
Baseline characteristics by cohort
| Measure |
OEF/OIF Veterans
n=438 Participants
Operation Enduring Freedom /Operation Iraqi Freedom (OEF/OIF) Veterans seeking care at one of three VA Polytrauma Network Sites (PNS) who screen positive or negative for mild traumatic brain injury.
|
|---|---|
|
Age, Continuous
Age
|
33 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
392 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
39 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
330 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
25 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
438 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All OEF/OIF Veterans to receive TCRS upon enrollment in VAPopulation: Although 456 participants were consented and enrolled in the study, data for 13 participants had missing assessment data and another 5 were determined to have moderate TBI resulting in 438 cases for the analysis.
Patients were initially assessed with the TBI Clinical Screen at their local VA. To assess the diagnostic accuracy of the TCRS, a dual-criterion approach was used. The VA Comprehensive TBI Evaluation (CTBIE), a secondary evaluation, served as the first criterion and the Structured TBI Diagnostic Interview (STDI) as the second criterion.
Outcome measures
| Measure |
Veterans Assessed With the Comprehensive TBI Evaluation
n=438 Participants
|
Veterans Assessed With the Structured TBI Diagnostic Interview
n=438 Participants
|
|---|---|---|
|
Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)
Sensitivity
|
71 Percentage of participants
Interval 64.0 to 78.0
|
79 Percentage of participants
Interval 73.0 to 84.0
|
|
Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)
Specificity
|
74 Percentage of participants
Interval 68.0 to 79.0
|
85 Percentage of participants
Interval 80.0 to 90.0
|
|
Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)
Positive Predictive Value
|
32 Percentage of participants
Interval 28.0 to 37.0
|
49 Percentage of participants
Interval 41.0 to 57.0
|
|
Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)
Negative Predictive Value
|
94 Percentage of participants
Interval 92.0 to 95.0
|
96 Percentage of participants
Interval 95.0 to 97.0
|
Adverse Events
OEF/OIF Veterans
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Judith Babcock-Parziale, PI
Southern AZ VA Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place