Spinal Cord Injury Vocational Integration Program (SCI-VIP)

NCT ID: NCT00117806

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2011-09-30

Brief Summary

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. The investigators 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.

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

SCI-VIP: Supported employment implemented for veterans with spinal cord injury

Group Type: EXPERIMENTAL

Arm 1

Intervention Type: BEHAVIORAL

SCI-VIP: Supported employment implemented for veterans with spinal cord injury.

Arm 2

Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center

Group Type: PLACEBO_COMPARATOR

Arm 2

Intervention Type: BEHAVIORAL

Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center

Interventions

Arm 1

SCI-VIP: Supported employment implemented for veterans with spinal cord injury.

Intervention Type: BEHAVIORAL

Arm 2

Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Ottomanelli, PhD

Role: PRINCIPAL_INVESTIGATOR

James A. Haley Veterans' Hospital, Tampa, FL

Locations

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

VA Medical Center, St Louis

St Louis, Missouri, United States

VA Medical Center, Cleveland

Cleveland, Ohio, United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, United States

Countries

United States

References

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. doi: 10.1682/jrrd.2006.06.0072. No abstract available.

Reference Type: BACKGROUND

PMID: 17551852 (View on PubMed)

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. doi: 10.1080/10790268.2009.11754553.

Reference Type: BACKGROUND

PMID: 20025147 (View on PubMed)

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. doi: 10.1682/jrrd.2008.10.0145.

Reference Type: BACKGROUND

PMID: 20104414 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 25479192 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22541306 (View on PubMed)

Ottomanelli L, Barnett SD, Goetz LL. A prospective examination of the impact of a supported employment program and employment on health-related quality of life, handicap, and disability among Veterans with SCI. Qual Life Res. 2013 Oct;22(8):2133-41. doi: 10.1007/s11136-013-0353-5. Epub 2013 Jan 24.

Reference Type: RESULT

PMID: 23345022 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24316325 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24486426 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24752942 (View on PubMed)

Ottomanelli L, Barnett SD, Toscano R. Individual placement and support (IPS) in physical rehabilitation and medicine: the VA spinal cord injury experience. Psychiatr Rehabil J. 2014 Jun;37(2):110-2. doi: 10.1037/prj0000079.

Reference Type: RESULT

PMID: 24912059 (View on PubMed)

LePage J, Ottomanelli L, Barnett SD, Njoh EN. Spinal cord injury combined with felony history: effect on supported employment for Veterans. J Rehabil Res Dev. 2014;51(10):1497-504. doi: 10.1682/JRRD.2014.02.0045.

Reference Type: RESULT

PMID: 25856266 (View on PubMed)

Ottomanelli L, Barnett SD, Goetz LL, Toscano R. Vocational rehabilitation in spinal cord injury: what vocational service activities are associated with employment program outcome? Top Spinal Cord Inj Rehabil. 2015 Winter;21(1):31-9. doi: 10.1310/sci2101-31.

Reference Type: RESULT

PMID: 25762858 (View on PubMed)

Other Identifiers

B3773-R

Identifier Type: -

Identifier Source: org_study_id