Clinical trial NCT01118182: Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population
Official title: Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population: Prevalence, Validation, and Psychiatric Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Veterans
Psychiatric Disorders
Suicide
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: Colorado Traumatic Brain Injury Trust Fund
name: Ohio State University
name: University of Colorado, Denver
First posted: 2010-05-06
Enrollment: 1810
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indivduals with a history of completing the 4 Traumatic Brain Injury (TBI) screening questions during a mental health intake.

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).

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

Primary outcomes:
measure: Ohio State University TBI Identification Method (OSU TBI-ID)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
Study officials:
affiliation: VISN 19 MIRECC
name: Lisa A Brenner, PhD
role: PRINCIPAL_INVESTIGATOR
References: