Brain InjuryNCT00875329
Traumatic Brain Injury (TBI) Screening Instruments
An observational study of Brain Injury, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injury
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Feb 2015
- 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: All those who have served in OEF/OIF who have been or need to be screened using the TBI Clinical Reminder
Who may be able to join
- Served in OEF/OIF
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
Official title: TBI Screening Instruments and Processes for Clinical Follow-Up
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.
Read the 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:
- Operationalize a gold standard for TBI identification, using a national panel of experts.
- Identify patient characteristics and levels of Polytrauma care that predict a delay in or failure to complete the TBI Clinical Reminder screen
- Using the gold standard, evaluate the validity (sensitivity and specificity) and reliability of the current TBI Clinical Reminder Screen.
- 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.
- Conditions
- Brain Injury
- Keywords
- Brain Injury
- Medical subject headings
- Brain Injuries
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responses From the TBI Clinical Reminder
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.
Measured: April 2007 January 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionFeb 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rodney D. Vanderploeg, PhD, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875329
- Sponsor's protocol ID
- SDR 08-411
- Status last verified
- Jun 2015
- First submitted
- 1 Apr 2009
- Last updated
- 3 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22426242Vanderploeg 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.
PubMed 22773258
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBI Screening Instruments and Processes for Clinical Follow-Up
- ClinicalTrials.gov ID
- NCT00875329
- Acronym / sponsor ID
- SDR 08-411
- Conditions
- Brain Injury
- Keywords
- Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 12 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Operationalize a gold standard for TBI identification, using a national panel of experts.
- Identify patient characteristics and levels of Polytrauma care that predict a delay in or failure to complete the TBI Clinical Reminder screen
- Using the gold standard, evaluate the validity (sensitivity and specificity) and reliability of the current TBI Clinical Reminder Screen.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All those who have served in OEF/OIF who have been or need to be screened using the TBI Clinical Reminder
Key inclusion criteria (1 listed)
- Served in OEF/OIF
Key exclusion criteria (1 listed)
- None
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22426242Belanger 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.
- Results publication: PubMed 22773258Vanderploeg 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.
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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.
Rodney D. Vanderploeg, PhD principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury, run by US Department of Veterans Affairs at 1 site 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 12 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?
Responses From the TBI Clinical Reminder (time frame: April 2007 January 2012). 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 NCT00875329, which also lists 2 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 3 Jul 2015; AzTrials last refreshed its copy on 2 Nov 2026.