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Clinical Trials/NCT01118182
NCT01118182
Completed
Not Applicable

Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population: Prevalence, Validation, and Psychiatric Outcomes

VA Eastern Colorado Health Care System1 site in 1 country1,810 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
VA Eastern Colorado Health Care System
Enrollment
1810
Locations
1
Primary Endpoint
Ohio State University TBI Identification Method (OSU TBI-ID)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition of detailed information elicited by the four questions. Secondary aims include: 1) Determining if the addition of detailed information elicited by the TBI-4 results in increased specificity; 2) Determining whether the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous research; and 3) Determining whether psychiatric outcomes are worse for veterans with traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).

Detailed Description

The primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition of detailed information elicited by the four questions. Secondary aims include: 1) Determining if the addition of detailed information elicited by the TBI-4 results in increased specificity; 2) Determining whether the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous research; and 3) Determining whether psychiatric outcomes are worse for veterans with traumatic brain injury (TBI) than those with no traumatic brain injury(TBI). Primary Hypotheses: Hypothesis 1a: The sensitivity and specificity of the TBI-4 will be significantly greater than 0.75 and 0.80, respectively. Hypothesis 1b: The sensitivity and specificity of the TBI-4 with the addition of detailed information elicited by these questions (i.e., free text information entered by the clinician who administered the TBI-4) will be significantly greater than 0.75 and 0.80, respectively. Secondary Hypotheses: Hypothesis 1c: The specificity of the TBI-4 with the addition of detailed information elicited by these questions (i.e., free text information entered by the clinician who administered the TBI-4) will be significantly greater than that of the four questions alone. Hypothesis 2: A significant difference in psychiatric outcomes (psychiatric hospitalizations, suicidal ideation, suicide attempts and completions, and mental health-related contacts) will be identified in those with a history of TBI versus those without a history of TBI as determined, first, by the TBI-4 and, second, by the OSU TBI-ID. Hypothesis 3: The prevalence of Traumatic Brain Injury- Loss of Consciousness (TBI-LOC) in this population will be similar to that identified by Walker et al1 (31.7% of individuals will report 1 or more TBI-LOC).

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
August 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisa Brenner

Director, VA VISN 19 Mental Illness Research Education and Clinical Center (MIRECC)

VA Eastern Colorado Health Care System

Eligibility Criteria

Inclusion Criteria

  • Veteran must be at least 18 years of age.
  • Veteran must have had a mental health intake no earlier than January of 2007.

Exclusion Criteria

  • Failure to provide informed consent as evidenced by inability to respond to the above stated questions.
  • No Mental Health Intake note in the medical record.
  • Presence of a Mental Health Intake note in the computer which does not contain the TBI-4

Outcomes

Primary Outcomes

Ohio State University TBI Identification Method (OSU TBI-ID)

Time Frame: 1 day

Structured clinical interview used as the gold standard for establishing a lifetime history of TBI

Study Sites (1)

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