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Spinal Cord Injury Vocational Integration Program (SCI-VIP) (SCI-VIP)

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm 1
Arm 2
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Adult, Depression, Employment, supported, Health Service/ut, Humans, Outcomes, Quality of life, Veterans/rh (rehabilitation), Workplace, Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James A. Haley Veterans' Hospital, Tampa, FL
  • VA Medical Center, St Louis
  • VA Medical Center, Cleveland
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  • Michael E. DeBakey VA Medical Center (152)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Competitive Employment-Total Jobs
Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Competitive Employment-Participants With Competitive Employment
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
Employment outcomes during year 1 among those subjects obtaining competitive employment.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2005
Last Updated
February 3, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00117806
Brief Title
Spinal Cord Injury Vocational Integration Program (SCI-VIP)
Acronym
SCI-VIP
Official Title
A Spinal Cord Injury Vocational Integration Program: Implementation and Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Adult, Depression, Employment, supported, Health Service/ut, Humans, Outcomes, Quality of life, Veterans/rh (rehabilitation), Workplace, Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
SCI-VIP: Supported employment implemented for veterans with spinal cord injury
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
Intervention Type
Behavioral
Intervention Name(s)
Arm 1
Intervention Description
SCI-VIP: Supported employment implemented for veterans with spinal cord injury.
Intervention Type
Behavioral
Intervention Name(s)
Arm 2
Intervention Description
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
Primary Outcome Measure Information:
Title
Competitive Employment-Total Jobs
Description
Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Time Frame
12 months
Title
Competitive Employment-Participants With Competitive Employment
Description
Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Time Frame
12 months
Title
Competitive Employment-Percentage of Participants With Competitive Employment
Description
Employment outcomes during year 1 among those subjects obtaining competitive employment.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Ottomanelli, PhD
Organizational Affiliation
James A. Haley Veterans' Hospital, Tampa, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
VA Medical Center, St Louis
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
VA Medical Center, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center (152)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17551852
Citation
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.
Results Reference
background
PubMed Identifier
20025147
Citation
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.
Results Reference
background
PubMed Identifier
20104414
Citation
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.
Results Reference
background
PubMed Identifier
25479192
Citation
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.
Results Reference
background
PubMed Identifier
22541306
Citation
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.
Results Reference
result
PubMed Identifier
23345022
Citation
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.
Results Reference
result
PubMed Identifier
24316325
Citation
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.
Results Reference
result
PubMed Identifier
24486426
Citation
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.
Results Reference
result
PubMed Identifier
24752942
Citation
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.
Results Reference
result
PubMed Identifier
24912059
Citation
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.
Results Reference
result
PubMed Identifier
25856266
Citation
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.
Results Reference
result
PubMed Identifier
25762858
Citation
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.
Results Reference
result

Learn more about this trial

Spinal Cord Injury Vocational Integration Program (SCI-VIP)

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