Clinical Trial on Brain Injuries, Multiple Trauma, Blast Injuries - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Gainesville, Florida, United States, 32608
    - North Florida/South Georgia Veterans Health System
  - Tampa, Florida, United States, 33612
    - James A. Haley Veterans Hospital, Tampa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

Inclusion Criteria:

Diagnosis of OEF/OIF related polytraumatic injuries

Exclusion Criteria:

Polytraumatic injuries unrelated to OEF/OIF service

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Single, in-depth qualitative interviews Time Frame: Single administration	Single administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Demographic Checklist Time Frame: Single administration	Single administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

University of Florida

Investigators

Principal Investigator: Elizabeth M. Hannold, PhD MS BS, North Florida/South Georgia Veterans Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria