Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population

NCT ID: NCT01118182

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1810 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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).

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Traumatic Brain Injury (TBI)

Veterans with a positive history of TBI

No interventions assigned to this group

No Traumatic Brain Injury (TBI)

Veterans with a negative history of TBI

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Colorado Traumatic Brain Injury Trust Fund

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

VA Eastern Colorado Health Care System

FED

Sponsor Role lead

Responsible Party

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Lisa Brenner

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa A Brenner, PhD

Role: PRINCIPAL_INVESTIGATOR

VISN 19 MIRECC

Locations

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Denver VA Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

Related Links

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https://www.mirecc.va.gov/mirecc/visn19/

Rocky Mountain MIRECC website

Other Identifiers

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COMIRB08-0001

Identifier Type: -

Identifier Source: org_study_id

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