Evaluation of VA's Traumatic Brain Injury (TBI) Clinical Reminder and Comprehensive TBI Evaluation (CTBIE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00852527
First received: February 25, 2009
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The purpose of the proposed study is to determine the clinical validity and reliability of the VA's Traumatic Brain Injury (TBI) Clinical Reminder and the Comprehensive TBI Evaluation used to screen for mild traumatic brain injury. Examining the reliability of the two screens will determine whether they are dependable. Verifying the clinical validity is important because valid screening and evaluation of mild TBI leads to accurate diagnosis and timely treatment. Accurate screening also improves clinical efficiency and ensures that resources are provided to those who need them most. The project findings are expected to advance the science of screening and diagnosis of a mild TBI event.


Condition
Mild Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of VA's TBI Clinical Reminder And Secondary Level Evaluation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • VA TBI Clinical Reminder [ Time Frame: All OEF/OIF Veterans to receive upon enrollment in VA ] [ Designated as safety issue: No ]
    The mandatory 4-items screen addresses events that may increase the risk of TBI, immediate symptoms following the event, new or worsening symptoms following the event and current symptoms.


Secondary Outcome Measures:
  • VA Comprehensive TBI Evaluation (CTE) [ Time Frame: Within 30-days of a positive screen on the TBI Clinical Reminder ] [ Designated as safety issue: No ]
    The CTE documents a historical event and the immediate sequelae including any period of loss or a decreased level of consciousness, post-traumatic amnesia, alteration in mental state at the time of the injury, or neurological deficits that may/may not be transient.

  • Historical TBI Scale [ Time Frame: Following the TCR and CTE ] [ Designated as safety issue: No ]
    The HTS is a comprehensive assessment battery used to diagnose a historical mild TBI. It is used as a criterion for the CTE.


Enrollment: 456
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Detailed Description:

A. Anticipated Impacts on Veterans' Healthcare: Determining the clinical validity of the VA's TBI Clinical Reminder and Comprehensive TBI Evaluation is critical because valid screening and evaluation of mild traumatic brain injury (mTBI) leads to accurate diagnosis and timely treatment. Accurate screening improves clinical efficiency and ensures that resources are provided to those who need them most. The project findings are expected to advance the science of screening and diagnosis by clarifying whether symptoms are consistent with post-concussion syndrome due to an mTBI event. Findings are also expected to inform the development of the next generation of VA screening instruments for mild TBI.

B. Project Background/Rationale: Traumatic brain injury (TBI) is a leading injury among military personnel serving in the Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) combat theaters due largely to improvised explosive devices. While TBI severities range from mild to severe, mTBI is particularly difficult to identify, diagnose and treat. The VA modified a version of the Defense and Veterans Brain Injury Center (DVBIC) tool, which is used to screen returning OEF/OIF service members. The VA's modified screen, the TBI Clinical Reminder, is used to screen a slightly different population. Therefore, results of the validity study for the DVBIC tool are not directly applicable. As a result, the General Accountability Office (GAO) recommended the VA expeditiously evaluate the clinical validity and reliability of its TBI screening tool.

C. Primary Study Objectives are: (1) Develop the Experts' Diagnostic Assessment Battery for use as a proxy gold standard, and (2) Evaluate and compare the performance characteristics of the TBI Clinical Reminder and the Comprehensive TBI Evaluation using the Experts' Diagnostic Assessment Battery. These objectives will be realized via: (a) An examination the performance characteristics (diagnostic validity) of the TBI Clinical Reminder and the Comprehensive TBI Evaluation relative to the Experts' Diagnostic Assessment Battery to determine sensitivity and specificity, (b) Determining whether false positives and/or false negatives are related to Post Traumatic Stress Disorder (PTSD) and how the performance characteristics of the tests differ for PTSD, (c) Ascertaining the concordance among measures of functional impairment, the TBI Clinical Reminder and the Comprehensive TBI Evaluation, (d) Establishing the concurrent validity between the diagnosis of presence or absence of post-concussion syndrome due to mTBI and measures of functional impairment, (e) Verifying the test/retest reliability for the TBI Clinical Reminder and the Comprehensive TBI Evaluation and (f) Identifying whether clusters of symptoms or subjects reporting similar patterns of symptoms correspond with clinical sub-groups (e.g., mTBI with PTSD, PTSD alone).

D. Project Methods: An online Delphi process and will be conducted with mTBI experts to inform the development of the Experts' Diagnostic Assessment Battery. A sample of 720 OEF/OIF veterans will be recruited over 12-months at three VA Polytrauma Network Sites. The OEF/OIF veterans will have symptoms consistent with either a mild TBI event (True Positive) or symptoms inconsistent with such an event (True Negative). All subjects will be assessed by research clinicians using the TBI Clinical Reminder, the Comprehensive TBI Evaluation and the Experts' Diagnostic Assessment Battery. Analysis will determine the sensitivity and specificity as well as the test/retest reliability of the TBI Clinical Reminder and the Comprehensive TBI Evaluation. The performance characteristics for the Experts' Diagnostic Assessment Battery will be ascertained and used to further our understanding of how best to distinguish mTBI symptoms from related and/or comorbid conditions (e.g., PTSD, anxiety, and depression).

  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

Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) Veterans

Criteria

Inclusion Criteria:

Patients included are those service members or Veterans who have been deployed in the OEF/OIF conflict and have screened positive or negative on the TBI Clinical Reminder.

Exclusion Criteria:

Exclusion criteria include those service members or Veterans diagnosed with a moderate to severe TBI or a psychiatric disorder unrelated to TBI.

  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: NCT00852527

Locations
United States, Arizona
Southern AZ VA Health Care System (Tucson)
Tucson, Arizona, United States, 85723
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Kentucky
VA Medical Center, Lexington
Lexington, Kentucky, United States, 40502
Sponsors and Collaborators
Investigators
Principal Investigator: Judi L Babcock-Parziale, PhD Southern AZ VA Health Care System (Tucson)
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00852527     History of Changes
Other Study ID Numbers: SDR 08-377
Study First Received: February 25, 2009
Last Updated: August 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Traumatic Brain Injury
Screening
Diagnosis
Rehabilitation Outcome

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