Traumatic Brain InjuryTBINCT00852527
Evaluation of VA's Traumatic Brain Injury (TBI) Clinical Reminder and Comprehensive TBI Evaluation (CTBIE)
An observational study of Traumatic Brain Injury, run by US Department of Veterans Affairs at 3 sites in United States.
Trial summary
The purpose of the proposed study is to determine the clinical validity and reliability of the VA's Traumatic Brain Injury (TBI) Clinical Reminder Screen and the Comprehensive TBI Evaluation used to screen for mild traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 456 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) Veterans
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria include those service members or Veterans diagnosed with a moderate to severe TBI or a psychiatric disorder unrelated to TBI.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
VA Medical Center, Lexington
Lexington, Kentucky, 40502
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723
About this study
Official title: Evaluation of VA's TBI Clinical Reminder And Secondary Level Evaluation
The purpose of the proposed study is to determine the clinical validity and reliability of the VA's Traumatic Brain Injury (TBI) Clinical Reminder Screen 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.
Read the detailed description
- Anticipated Impacts on Veterans' Healthcare: Determining the clinical validity of the VA's TBI Clinical Reminder Screen 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.
- 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 severity ranges 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 Screen, 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.
- Primary Study Objectives are: (1) Develop the Diagnostic Assessment Battery for use as a proxy gold standard, and (2) Evaluate and compare the performance characteristics of the TBI Clinical Reminder Screen and the Comprehensive TBI Evaluation using the Diagnostic Assessment Battery. These objectives will be realized via: (a) An examination the performance characteristics (diagnostic validity) of the TBI Clinical Reminder Screen and the Comprehensive TBI Evaluation relative to the 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 Screen 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 Screen 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).
- Project Methods: An online Delphi process and will be conducted with mTBI experts to inform the development of the Diagnostic Assessment Battery. A sample of 500 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 Screen, the Comprehensive TBI Evaluation and the 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 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).
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Screening, Diagnosis, Rehabilitation Outcome
- Medical subject headings
- Brain Injuries, Traumatic, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with mild TBI | Presence of mild TBI defined by positive reference test | |
| Subjects without mild TBI | Absence of mild TBI defined by negative reference test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)
Patients were initially assessed with the TBI Clinical Screen at their local VA. To assess the diagnostic accuracy of the TCRS, a dual-criterion approach was used. The VA Comprehensive TBI Evaluation (CTBIE), a secondary evaluation, served as the first criterion and the Structured TBI Diagnostic Interview (STDI) as the second criterion.
Measured: All OEF/OIF Veterans to receive TCRS upon enrollment in VA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Judi L Babcock-Parziale, PhD, Principal investigator, Southern Arizona VA Health Care System, Tucson, AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852527
- Sponsor's protocol ID
- SDR 08-377
- Acronym
- TBI
- Status last verified
- Aug 2014
- First submitted
- 25 Feb 2009
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pape TL, High WM Jr, St Andre J, Evans C, Smith B, Shandera-Ochsner AL, Wingo J, Moallem I, Baldassarre M, Babcock-Parziale J. Diagnostic accuracy studies in mild traumatic brain injury: a systematic review and descriptive analysis of published evidence. PM R. 2013 Oct;5(10):856-81. doi: 10.1016/j.pmrj.2013.06.007.
PubMed 24160300Shandera-Ochsner AL, Berry DT, Harp JP, Edmundson M, Graue LO, Roach A, High WM Jr. Neuropsychological effects of self-reported deployment-related mild TBI and current PTSD in OIF/OEF veterans. Clin Neuropsychol. 2013;27(6):881-907. doi: 10.1080/13854046.2013.802017. Epub 2013 Jun 11.
PubMed 23755991Combs HL, Berry DT, Pape T, Babcock-Parziale J, Smith B, Schleenbaker R, Shandera-Ochsner A, Harp JP, High WM Jr. The Effects of Mild Traumatic Brain Injury, Post-Traumatic Stress Disorder, and Combined Mild Traumatic Brain Injury/Post-Traumatic Stress Disorder on Returning Veterans. J Neurotrauma. 2015 Jul 1;32(13):956-66. doi: 10.1089/neu.2014.3585. Epub 2015 Feb 26.
PubMed 25350012
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of VA's TBI Clinical Reminder And Secondary Level Evaluation
- ClinicalTrials.gov ID
- NCT00852527
- Acronym / sponsor ID
- TBI / SDR 08-377
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Screening, Diagnosis, Rehabilitation Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 5 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to determine the clinical validity and reliability of the VA's Traumatic Brain Injury (TBI) Clinical Reminder Screen 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.
Detailed description
- Anticipated Impacts on Veterans' Healthcare: Determining the clinical validity of the VA's TBI Clinical Reminder Screen 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.
- 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 severity ranges 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 Screen, 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.
- Primary Study Objectives are: (1) Develop the Diagnostic Assessment Battery for use as a proxy gold standard, and (2) Evaluate and compare the performance characteristics of the TBI Clinical Reminder Screen and the Comprehensive TBI Evaluation using the Diagnostic Assessment Battery. These objectives will be realized via: (a) An examination the performance characteristics (diagnostic validity) of the TBI Clinical Reminder Screen and the Comprehensive TBI Evaluation relative to the 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 Screen 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 Screen 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).
- Project Methods: An online Delphi process and will be conducted with mTBI experts to inform the development of the Diagnostic Assessment Battery. A sample of 500 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 Screen, the Comprehensive TBI Evaluation and the 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 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with mild TBI | – | –Presence of mild TBI defined by positive reference test |
| Subjects without mild TBI | – | –Absence of mild TBI defined by negative reference test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) Veterans
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria include those service members or Veterans diagnosed with a moderate to severe TBI or a psychiatric disorder unrelated to TBI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)
Time frame: All OEF/OIF Veterans to receive TCRS upon enrollment in VA
Patients were initially assessed with the TBI Clinical Screen at their local VA. To assess the diagnostic accuracy of the TCRS, a dual-criterion approach was used. The VA Comprehensive TBI Evaluation (CTBIE), a secondary evaluation, served as the first criterion and the Structured TBI Diagnostic Interview (STDI) as the second criterion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24160300Pape TL, High WM Jr, St Andre J, Evans C, Smith B, Shandera-Ochsner AL, Wingo J, Moallem I, Baldassarre M, Babcock-Parziale J. Diagnostic accuracy studies in mild traumatic brain injury: a systematic review and descriptive analysis of published evidence. PM R. 2013 Oct;5(10):856-81. doi: 10.1016/j.pmrj.2013.06.007.
- Results publication: PubMed 23755991Shandera-Ochsner AL, Berry DT, Harp JP, Edmundson M, Graue LO, Roach A, High WM Jr. Neuropsychological effects of self-reported deployment-related mild TBI and current PTSD in OIF/OEF veterans. Clin Neuropsychol. 2013;27(6):881-907. doi: 10.1080/13854046.2013.802017. Epub 2013 Jun 11.
- Results publication: PubMed 25350012Combs HL, Berry DT, Pape T, Babcock-Parziale J, Smith B, Schleenbaker R, Shandera-Ochsner A, Harp JP, High WM Jr. The Effects of Mild Traumatic Brain Injury, Post-Traumatic Stress Disorder, and Combined Mild Traumatic Brain Injury/Post-Traumatic Stress Disorder on Returning Veterans. J Neurotrauma. 2015 Jul 1;32(13):956-66. doi: 10.1089/neu.2014.3585. Epub 2015 Feb 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judi L Babcock-Parziale, PhD principal investigator
Southern Arizona VA Health Care System, Tucson, AZ
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by US Department of Veterans Affairs at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS) (time frame: All OEF/OIF Veterans to receive TCRS upon enrollment in VA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00852527, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.