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Traumatic Brain Injury (TBI) Screening Instruments

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ClinicalTrials.gov Identifier: NCT00875329
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : December 12, 2014
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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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.


Condition or disease
Brain Injury

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.

Study Design
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Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: TBI Screening Instruments and Processes for Clinical Follow-Up
Study Start Date : September 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : February 2015
Groups and Cohorts
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Group/Cohort
Group 1
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.


Outcome Measures
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Primary Outcome Measures :
  1. Responses From the TBI Clinical Reminder [ Time Frame: April 2007 January 2012 ]
    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.


Biospecimen Retention:   None Retained
As there are no biospecimans, there is no biospeciman description.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • Served in OEF/OIF

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875329


Locations
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United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Rodney D. Vanderploeg, PhD James A. Haley Veterans' Hospital, Tampa, FL
More Information
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Publications of Results:

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00875329    
Other Study ID Numbers: SDR 08-411
First Posted: April 3, 2009    Key Record Dates
Results First Posted: December 12, 2014
Last Update Posted: July 3, 2015
Last Verified: June 2015
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System