Multiple TraumaNCT00872690
Factors Affecting Return to Work Among OEF/OIF Veterans With Polytrauma
An observational study of Multiple Trauma and Blast Injuries, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The goal of this study is to examine things that make it easy or hard for OEF/OIF veterans with polytrauma to live independently or do things "on their own" at home and in the community. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Trauma, Blast Injuries, Brain Injuries
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Diagnosis of OEF/OIF related polytraumatic injuries
Who cannot join
- Polytraumatic injuries unrelated to OEF/OIF service
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612
About this study
The goal of this study is to examine things that make it easy or hard for OEF/OIF veterans with polytrauma to live independently or do things "on their own" at home and in the community.
Read the detailed description
The Department of Veterans Affairs (VA) identifies employment as a priority issue for OEF/OIF veterans. However, OEF/OIF veterans with polytrauma represent a new and unique VA sub-population. Polytraumatic injuries are more complex than injuries sustained in any previous conflict. Returning to work, therefore, may prove especially challenging. Among individuals with severe disabilities, employment outcomes are closely tied to the individual's level of success with Independent Living (IL). IL refers to the ability to reside in the community and participate in activities of choice by managing available resources, negotiating barriers and exercising self-determination. IL often is viewed as a prerequisite to employment for severely disabled individuals, because barriers and facilitators to independence at home and in the community also influence success in the workplace. Thus, IL will be a critical first step to pursuing vocational/employment goals for OEF/OIF veterans with polytrauma. To date, no published studies have investigated IL among veterans with polytrauma. This pilot study will be the first project in a line of research to promote the independence and employability OEF/OIF veterans. The goals of the study are twofold. Goal 1 of the study is to investigate the barriers and facilitators to IL identified by community dwelling OEF/OIF veterans with polytrauma, caregivers, and IL service providers, and perceptions of how these factors may affect veterans' return to work. This goal will be accomplished by using qualitative methods for data collection and analyses. Qualitative interviewing will be used to elicit the perspectives of veterans with polytrauma and caregivers living in Florida, and Florida-based Vocational Rehabilitation and Employment IL service providers. Qualitative data will be coded, and then analyzed using the constant comparative method. Goal #2 of the study is to evaluate the feasibility of using the data collection tools and procedures for a future planned study. An efficacy evaluation will be used to test and refine the data collection tools (interview guides and demographic checklists). To evaluate data collection procedures, field notes will be recorded and analyzed to identify optimal organizational procedures and time parameters to minimize subject burden. Findings will be used to plan and design a large, national study of factors affecting return to work among OEF/OIF veterans with polytrauma living throughout the United States. Findings also will be used to develop future proposals to fund longitudinal research and implementation projects to improve employability outcomes among veterans with polytrauma.
- Conditions
- Multiple Trauma, Blast Injuries, Brain Injuries
- Keywords
- Multiple Trauma, Blast Injuries, Brain Injuries, Rehabilitation, Vocational, Consumer participation
- Medical subject headings
- Multiple Trauma, Blast Injuries, 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 | OEF/OIF veterans with polytrauma who have been referred by the Tampa VA Polytrauma Rehabilitation Center (PRC) to the VA VR\&E Regional Office in St. Petersburg, Florida for Chapter 31 (IL) services. | |
| Group 2 | Caregivers of the veterans who enroll in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single, in-depth qualitative interviews
Measured: Single administration
Secondary outcomes (1)
Demographic Checklist
Measured: Single administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple TraumaStudies 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
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Elizabeth M. Hannold, PhD MS BS, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872690
- Sponsor's protocol ID
- D6661-R
- Status last verified
- Mar 2015
- First submitted
- 27 Mar 2009
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Return to Work Among OEF/OIF Veterans With Polytrauma
- ClinicalTrials.gov ID
- NCT00872690
- Acronym / sponsor ID
- D6661-R
- Conditions
- Multiple Trauma, Blast Injuries, Brain Injuries
- Keywords
- Multiple Trauma, Blast Injuries, Brain Injuries, Rehabilitation, Vocational, Consumer participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Florida
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine things that make it easy or hard for OEF/OIF veterans with polytrauma to live independently or do things "on their own" at home and in the community.
Detailed description
The Department of Veterans Affairs (VA) identifies employment as a priority issue for OEF/OIF veterans. However, OEF/OIF veterans with polytrauma represent a new and unique VA sub-population. Polytraumatic injuries are more complex than injuries sustained in any previous conflict. Returning to work, therefore, may prove especially challenging. Among individuals with severe disabilities, employment outcomes are closely tied to the individual's level of success with Independent Living (IL). IL refers to the ability to reside in the community and participate in activities of choice by managing available resources, negotiating barriers and exercising self-determination. IL often is viewed as a prerequisite to employment for severely disabled individuals, because barriers and facilitators to independence at home and in the community also influence success in the workplace. Thus, IL will be a critical first step to pursuing vocational/employment goals for OEF/OIF veterans with polytrauma. To date, no published studies have investigated IL among veterans with polytrauma. This pilot study will be the first project in a line of research to promote the independence and employability OEF/OIF veterans. The goals of the study are twofold. Goal 1 of the study is to investigate the barriers and facilitators to IL identified by community dwelling OEF/OIF veterans with polytrauma, caregivers, and IL service providers, and perceptions of how these factors may affect veterans' return to work. This goal will be accomplished by using qualitative methods for data collection and analyses. Qualitative interviewing will be used to elicit the perspectives of veterans with polytrauma and caregivers living in Florida, and Florida-based Vocational Rehabilitation and Employment IL service providers. Qualitative data will be coded, and then analyzed using the constant comparative method. Goal #2 of the study is to evaluate the feasibility of using the data collection tools and procedures for a future planned study. An efficacy evaluation will be used to test and refine the data collection tools (interview guides and demographic checklists). To evaluate data collection procedures, field notes will be recorded and analyzed to identify optimal organizational procedures and time parameters to minimize subject burden. Findings will be used to plan and design a large, national study of factors affecting return to work among OEF/OIF veterans with polytrauma living throughout the United States. Findings also will be used to develop future proposals to fund longitudinal research and implementation projects to improve employability outcomes among veterans with polytrauma.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –OEF/OIF veterans with polytrauma who have been referred by the Tampa VA Polytrauma Rehabilitation Center (PRC) to the VA VR\&E Regional Office in St. Petersburg, Florida for Chapter 31 (IL) services. |
| Group 2 | – | –Caregivers of the veterans who enroll in the study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- Diagnosis of OEF/OIF related polytraumatic injuries
Key exclusion criteria (1 listed)
- Polytraumatic injuries unrelated to OEF/OIF service
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
Single, in-depth qualitative interviews
Time frame: Single administration
1 secondary outcome
Demographic Checklist
Time frame: Single administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
Elizabeth M. Hannold, PhD MS BS principal investigator
North Florida/South Georgia Veterans Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma and Blast Injuries, run by US Department of Veterans Affairs at 2 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Single, in-depth qualitative interviews (time frame: Single administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015.