Clinical trial NCT00875329: Traumatic Brain Injury (TBI) Screening Instruments
Official title: TBI Screening Instruments and Processes for Clinical Follow-Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Keywords: Brain Injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-04-03
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All those who have served in OEF/OIF who have been or need to be screened using the TBI Clinical Reminder

Brief summary: Goal: The ultimate goal of this research program is to improve the health and quality of life for wounded warriors from Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) through screening, risk assessment, and outcome measurement.

Purpose: The purpose of this study is to evaluate the reliability and validity of the existing Traumatic Brain Injury (TBI) Clinical Reminder Screen for OEF/OIF Veterans.

Detailed description: Objectives: To meet a VA-wide need for early diagnosis of mild traumatic brain injuries (TBI) in returning soldiers, in April 2007 VA established policy and procedures for screening and evaluation of possible TBI in OEF and OIF veterans. Although the screening process has been in effect for over a year, the validity, reliability, false positive rates, and false negative rates of the TBI Clinical Reminder are unknown. The purpose of this research is to develop a gold standard and then assess the validity/reliability of the TBI Clinical Reminder screen. Specific short-term objectives for this study include:

1. Operationalize a gold standard for TBI identification, using a national panel of experts.
2. Identify patient characteristics and levels of Polytrauma care that predict a delay in or failure to complete the TBI Clinical Reminder screen
3. Using the gold standard, evaluate the validity (sensitivity and specificity) and reliability of the current TBI Clinical Reminder Screen.
4. Identify approaches to improve the TBI Clinical Reminder screening protocol, including screening instrument and process.

Research Design: Methodologies for this study include both prospective and retrospective approaches. Experts will convene in Tampa to operationalize a gold standard for TBI identification (Objective 1). Retrospective, population-based cohort analyses of extant databases will provide insight into current practices and findings to address Objective 2. The gold standard developed in Objective1 will be implemented with a small time-limited prospective cohort so that psychometric analysis of the TBI screen can be conducted (Objective 3). Findings from these analyses will help identify potential improvement in the TBI Screening process to address Objective 4.

Collaboration: This study is responsive to the RFP (#410127, TBI Screen, 8/7/2008). The Tampa HSR\&D REAP is partnering with investigators at the Boston VAMC; Tampa investigators are taking the lead on the psychometric evaluation of the TBI screen, while Boston investigators will use the same cohort to evaluate the Second Level TBI Evaluation. Researchers from both sites are co-investigators on each of the proposals to enhance collaboration and linkage of findings.

Anticipated Impact: Traumatic brain injury (TBI), and particularly mild TBI, is said to be the "signature injury" of the current conflicts. These injuries are currently a focus of post-deployment assessment and treatment within the VA and are likely to continue to be the focus of treatment for many years to come. To ensure that OEF/OIF veterans with TBI are identified and treated, the VA TBI Clinical Reminder was instituted in the form of a four-item screening tool for use in VA. While the VA-TBI screening reminder rolled out on April 2, 2007, the utility and psychometric properties of this screening are unknown. The proposed project will address these gaps by operationalizing a gold standard for TBI identification and then using that gold standard to evaluate the reliability and validity of the current TBI screen. By completing this project, we propose to identify specific improvements to the TBI protocol instrument and screening process.

Eligibility criteria: Inclusion Criteria:

* Served in OEF/OIF

Exclusion Criteria:

* None

Primary outcomes:
measure: Responses From the TBI Clinical Reminder
timeFrame: April 2007 January 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Rodney D. Vanderploeg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belanger HG, Vanderploeg RD, Soble JR, Richardson M, Groer S. Validity of the Veterans Health Administration's traumatic brain injury screen. Arch Phys Med Rehabil. 2012 Jul;93(7):1234-9. doi: 10.1016/j.apmr.2012.03.003. Epub 2012 Mar 15.
citation: Vanderploeg RD, Groer S, Belanger HG. Initial developmental process of a VA semistructured clinical interview for TBI identification. J Rehabil Res Dev. 2012;49(4):545-56. doi: 10.1682/jrrd.2011.04.0069.