Spinal Cord Injury Vocational Integration Program (SCI-VIP) - Full Text View

Purpose

This study involves research about how to help veterans with spinal cord injury (SCI) gain employment. During the first couple of years following SCI, many people are concentrating on their rehabilitation and are unable to afford the time for return to work. However, studies have shown people often regain the necessary strength and function about two years after SCI to resume activities of daily living very similar to what they experienced prior to the SCI. Even though many social and legal efforts have been made in the last decade to improve chances for people with disabilities to return to work, veterans with SCI are sometimes hindered in finding employment because of age, past work history, and many other factors. Other veterans with SCI are very successful at finding employment either working for themselves or working for a company. We know very little about what issues veterans with SCI face when they attempt to find employment after SCI. The study will analyze both quantitative and qualitative measures to maximize its findings.

Condition	Intervention
Spinal Cord Injuries	Behavioral: Arm 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Spinal Cord Injury Vocational Integration Program: Implementation and Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Employment Indices, Employment History, Functional Abilities and Impairments, Quality of Life, Depression. [ Time Frame: 12-month active phase ] [ Designated as safety issue: No ]
Employment indices, Employment history, measures of functional abilities and impairments (FIMS Score), quality of life (VR-36), depression (PHQ-9 & QIDS-SR)
Competitive Employment-Total Jobs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Competitive Employment-Participants With Competitive Employment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Competitive Employment-Percentage of Participants With Competitive Employment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Employment outcomes during year 1 among those subjects obtaining competitive employment.


Enrollment:	249
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2015
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 SCI-VIP: Supported employment implemented for veterans with spinal cord injury	Behavioral: Arm 1 SCI-VIP: Supported employment implemented for veterans with spinal cord injury.
Placebo Comparator: Arm 2 Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center

Detailed Description:

Legal mandates, such as the Rehabilitation Act of 1973 and the Americans with Disabilities Act, have been implemented to improve employment opportunities for disabled persons and yet the proportion of persons with spinal cord injury (SCI) who are employed remains about 9%. For the veteran population with SCI, the return to work rate is most likely much lower. This study will be conducted to evaluate whether a vocational rehabilitation program patterned after the VA Community Employment and Support approach improves rehabilitation outcomes for the SCI veteran population as compared with vocational rehabilitation practices currently used in most Veteran Affairs Medical Centers (VAMCs). The vocational rehabilitation program developed for the SCI veterans is referred to as SCI-VIP and it will be implemented at the Dallas VA Medical Center (VAMC), Houston VAMC, San Diego VAMC, and Cleveland VAMC. A five year evaluative research will be conducted to test the following hypothesized outcomes (HO) from the subjects who participate in the SCI-VIP program and a control group of subjects who receive conventional methods of vocational rehabilitation:

Primary HO: Veterans with SCI who participate in the SCI-VIP will demonstrate significantly greater changes in vocational rehabilitation after twelve months than those who do not receive this intervention. Vocational rehabilitation will be a measure of change from baseline to one-year in the subject's scores on instruments which measure employment indices, perceived barriers to employment, level of handicap, quality of life, depression, and sustaining care needs.

Secondary HO 1: Veterans with SCI who participate in the SCI-VIP will exhibit lower VA and non-VA costs for medical, non-rehabilitation treatment, offsetting the higher SCI-VIP program costs.

Secondary HO 2: The program fidelity will be equally adequate in terms of accomplishing program objectives relative to operations, cost-benefit balance, subject and stakeholder satisfaction, and outcomes when comparing the four SCI-VIP programs and when comparing conventional vocational rehabilitation approaches applied at six different VAMCs.

Program evaluation and cost-benefit analysis will be conducted using a fidelity instrument developed by the researchers and patterned after fidelity instruments conventionally used to evaluate psychiatric rehabilitation programs. Veterans at each VAMC who express an interest in vocational rehabilitation and consent to participate in this study will be randomized to either the experimental or the control group. It is expected that at least 96 subjects will participate in the SCI-VIP approach to vocational rehabilitation and 144 veterans who receive conventional vocational rehabilitation will form the control group.

Data will be collected from subjects upon enrollment into either the experimental or control group and every three months for one year. Descriptive analysis will be used to compare differences between groups of subjects drawn from each VAMC and to compare participants in the experimental and control groups. Analysis of variance will be computed to determine degree of difference between experimental group and control group subjects' scores on each dependent variable. The study hypotheses will be tested using the Mann-Whitney U, Chi-square, and odds ratio statistical procedures. The Cochran-Mantel-Haenszel along with relative risk scores will indicate the likelihood that any change in performance between baseline and program completion for ether experimental or control group subjects could be attributed to the subjects' degree of participation in the SCI-VIP, which VAMC vocational rehabilitation services were received, SCI factors, and age.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between the ages of 18 and 65 years old - Spinal cord injured as a result of trauma or disease
Medically and neurologically stable
Lives within the metropolitan area that is proximal to the VAMC (Cleveland, Dallas, Houston, San Diego, St. Louis)
Has access to transportation
Expresses an interest in competitive employment as an outcome of participation
Willingly signs a consent form indicating voluntary and informed participation in the study

Exclusion Criteria:

Medically and/or surgically unstable
Unwilling to complete the consenting process
Mentally impaired such that independent reasoning and judgment jeopardize safety of self and others
Currently involved in untreated alcohol and/or drug dependency
Employed in a compensated job at the time of recruitment and earning above SGA ($940/month in 2008) - Lives more than approximately 100 miles from the participating VAMC SCI Center

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: NCT00117806

Locations


United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33637
United States, Missouri
VA Medical Center, St Louis
St Louis, Missouri, United States, 63106
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Principal Investigator:	Lisa Ottomanelli, PhD	James A. Haley Veterans' Hospital, Tampa, FL

More Information

Publications:

Ottomanelli L, Goetz LL, Suris A, McGeough C, Sinnott PL, Toscano R, Barnett SD, Cipher DJ, Lind LM, Dixon TM, Holmes SA, Kerrigan AJ, Thomas FP. Effectiveness of supported employment for veterans with spinal cord injuries: results from a randomized multisite study. Arch Phys Med Rehabil. 2012 May;93(5):740-7. doi: 10.1016/j.apmr.2012.01.002.

Smith-Morris C, Lopez G, Ottomanelli L, Goetz L, Dixon-Lawson K. Ethnography, fidelity, and the evidence that anthropology adds: supplementing the fidelity process in a clinical trial of supported employment. Med Anthropol Q. 2014 Jun;28(2):141-61. doi: 10.1111/maq.12093. Epub 2014 Apr 21.

Ottomanelli L, Barnett SD, Goetz LL. Effectiveness of supported employment for veterans with spinal cord injury: 2-year results. Arch Phys Med Rehabil. 2014 Apr;95(4):784-90. doi: 10.1016/j.apmr.2013.11.012. Epub 2013 Dec 4.

Sinnott PL, Joyce V, Su P, Ottomanelli L, Goetz LL, Wagner TH. Cost-effectiveness of supported employment for veterans with spinal cord injuries. Arch Phys Med Rehabil. 2014 Jul;95(7):1254-61. doi: 10.1016/j.apmr.2014.01.010. Epub 2014 Jan 31.

Ottomanelli L, Goetz LL, McGeough C, Kashner TM. Building research capacity through partnerships: Spinal Cord Injury-Vocational Integration Program Implementations and Outcomes inaugural meeting. J Rehabil Res Dev. 2007;44(1):vii-xii.

Ottomanelli L, Lind L. Review of critical factors related to employment after spinal cord injury: implications for research and vocational services. J Spinal Cord Med. 2009;32(5):503-31. Review.

Ottomanelli L, Goetz L, McGeough C, Suris A, Sippel J, Sinnott P, Wagner TH, Cipher DJ. Methods of a multisite randomized clinical trial of supported employment among veterans with spinal cord injury. J Rehabil Res Dev. 2009;46(7):919-30.

Thomas FP, Goetz LL, Dixon T, Ho C, Holmes SA, Sandford P, Smith S, Ottomanelli L. Optimizing medical care to facilitate and sustain employment after spinal cord injury. J Rehabil Res Dev. 2014;51(6):xi-xxii. doi: 10.1682/JRRD.2014.05.0119.


Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00117806 History of Changes
Other Study ID Numbers:	B3773-R
Study First Received:	July 1, 2005
Results First Received:	October 24, 2014
Last Updated:	February 5, 2015
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:


Adult Depression Employment, supported Health Service/ut Humans	Outcomes Quality of life Veterans/rh (rehabilitation) Workplace Spinal Cord Injuries

Additional relevant MeSH terms:


Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases	Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

ClinicalTrials.gov processed this record on March 03, 2015