Trial Outcomes & Findings for Traumatic Brain Injury (TBI) Screening Instruments (NCT NCT00875329)
NCT ID: NCT00875329
Last Updated: 2015-07-03
Results Overview
The presence or absence of symptomatic TBI as determined by the VA TBI Clinical Reminder screen was compared to presence or absence of a deployment-related TBI as determined by the study's criterion standard (i.e., the VA TBI Clinical Identification Interview) to determine concordance and calculate sensitivity and specificity of the VA TBI Clinical Reminder screen. Sensitivity of the screen was the percent of positive screens of those determined to be true positives by the VA TBI Clinical Identification Interview. Specificity was the percentage of negatives screens that were determined to be true negatives by the VA TBI Clinical Identification Interview.
COMPLETED
97 participants
April 2007 January 2012
2015-07-03
Participant Flow
Participant milestones
| Measure |
Convenience Sample
A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder were included. This included all ages, both sexes, and all races and ethnicities. All participants provided responses to demographic information, a TBI Re-screen, and a semi-structured TBI Identification Clinical Interview.
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|---|---|
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Overall Study
STARTED
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97
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Overall Study
COMPLETED
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97
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Traumatic Brain Injury (TBI) Screening Instruments
Baseline characteristics by cohort
| Measure |
Group 1
n=97 Participants
A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
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|---|---|
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Age, Continuous
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41.6 years
STANDARD_DEVIATION 11.14 • n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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87 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: April 2007 January 2012The presence or absence of symptomatic TBI as determined by the VA TBI Clinical Reminder screen was compared to presence or absence of a deployment-related TBI as determined by the study's criterion standard (i.e., the VA TBI Clinical Identification Interview) to determine concordance and calculate sensitivity and specificity of the VA TBI Clinical Reminder screen. Sensitivity of the screen was the percent of positive screens of those determined to be true positives by the VA TBI Clinical Identification Interview. Specificity was the percentage of negatives screens that were determined to be true negatives by the VA TBI Clinical Identification Interview.
Outcome measures
| Measure |
Convenience Sample
n=97 Participants
A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
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|---|---|
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Responses From the TBI Clinical Reminder
Sensitivity
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61 percentage of participants
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Responses From the TBI Clinical Reminder
Specificity
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88 percentage of participants
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Adverse Events
Convenience Sample
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place