Traumatic Brain Injury (TBI) Screening Instruments

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00875329
First received: April 1, 2009
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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
Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: TBI Screening Instruments and Processes for Clinical Follow-Up

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Responses from the TBI Clinical Reminder [ Time Frame: April 2007 to present ] [ Designated as safety issue: No ]
    Sensitivity and specificity of the VAs TBI Clinical Reminder screen.


Biospecimen Retention:   None Retained

As there are no biospecimans, there is no biospeciman description.


Enrollment: 97
Study Start Date: September 2010
Estimated Study Completion Date: February 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875329

Locations
United States, Florida
James A. Haley Veterans Hospital
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Investigators
Principal Investigator: Rodney D. Vanderploeg, PhD James A. Haley Veterans' Hospital
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00875329     History of Changes
Other Study ID Numbers: SDR 08-411
Study First Received: April 1, 2009
Last Updated: May 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Brain Injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014