Spinal Cord Injury Vocational Integration Program (SCI-VIP) (SCI-VIP)
|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|
- 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.
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||June 2015|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117806
|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|
|Principal Investigator:||Lisa Ottomanelli, PhD||James A. Haley Veterans' Hospital, Tampa, FL|