SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE)
This study will be an extension of the Spinal Cord Injury Vocational Integration Program (SCI-VIP). The study involves research about how to help veterans with spinal cord injury (SCI) gain employment. Vocational rehabilitation is a special field of service aimed at putting persons with disabilities in the best possible position to become employed. The Veterans Administration has a long history of providing vocational rehabilitation for Veterans with mental health issues and has recently started providing similar services to persons with physical disabilities, including SCI. Past research has shown that vocational rehabilitation is effective in helping some Veterans with spinal cord injury (SCI) gain employment. The extension of this work through PrOMOTE study will establish a large national database of over 2000 veterans with SCI, containing extensive employment, medical, functional and psychosocial data. The study will analyze both quantitative and qualitative measures to maximize its findings.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Predictive Outcome Model Over Time for Employment (PROMOTE)|
- Status of Employment [ Time Frame: 12-month active phase with face-to-face quarterly interviews, second 12-month follow-up phase with brief quarterly phone interviews ] [ Designated as safety issue: No ]
- Levels of Supported Employment and Cost Effectiveness [ Time Frame: 12-month active phase with face-to-face quarterly interviews ] [ Designated as safety issue: No ]
- Measures of functional abilities and impairments, quality of life, depression [ Time Frame: 12-month active phase with face-to-face quarterly interviews ] [ Designated as safety issue: No ]
- Health Status Information [ Time Frame: 12-month active phase with face-to-face quarterly interviews, 12-month follow-up phase with mailed VR-36 form ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services
Behavioral: Vocational Rehabilitation
SCI-VIP: PrOMOTE evidence-based supported employment implemented for veterans with spinal cord injury or other available vocational services
Extending SCI-VIP through PrOMOTE will operationalize the critical features of supported employment that lead to obtaining and maintaining employment over time in spinal cord injury. There are no current studies that examine how the level and intensity of supported employment services by veterans with SCI impacts employment outcomes. This extension will allow the examination of longitudinal factors associated with successful employment that are not possible within the time constrains of SCI-VIP and to extend the cost-effectiveness analysis and budget impact analysis to include longer term and costs of quality of life outcomes. The study will include a more comprehensive qualitative analysis across several sites of factors that contribute to program success. The PrOMOTE study will add three more sites. This expansion will allow examination of outcomes in areas where there is a high penetration of OIF/OEF veterans as well as sites where there are other vocational programs available.
Primary HO: Higher levels of SE will be associated with a higher incidence of employment.
Secondary HO 1: Higher levels of SE will be cost-effective compared to lower levels of SE.
Secondary HO 2: When compared to the standard care group of SCI-VIP, the higher employment rate of the SCI-VIP SE group will endure longitudinally.
Secondary HO 3: Continued vocational services versus discontinued vocational services will result in sustained employment outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141647
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA|
|Palo Alto, California, United States, 94304-1290|
|United States, Florida|
|James A. Haley Veterans' Hospital, Tampa, FL|
|Tampa, Florida, United States, 33637|
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|
|Boston, Massachusetts, United States, 02130|
|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|
|United States, Virginia|
|Hunter Holmes McGuire VA Medical Center, Richmond, VA|
|Richmond, Virginia, United States, 23249|
|Principal Investigator:||Lisa Ottomanelli, PhD||James A. Haley Veterans' Hospital, Tampa, FL|