SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Spinal Cord Injuries |
Behavioral: Vocational Rehabilitation |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 2000 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All veterans who meet inclusion criteria will be approached about completing a baseline interview to gather information on employment, health, and quality of life after spinal cord injury.
Inclusion criteria for the baseline interview include:
- 18 to 65 years old
- Spinal Cord Injury
- Medically and neurologically stable
At the end of the baseline interview, some of these veterans who meet additional inclusion criteria will be enrolled to receive the SE intervention or other available vocational services and complete longitudinal follow-up interviews every three months while participating in the study.
The additional inclusion criteria for enrollment in vocational services include:
- Unemployed
- Living within 100 mile radius of the enrolling VA Medical Center
- Desiring competitive employment
A subsample of veterans who consent to the study will be selected for participation in qualitative interviews. Family members and/or caregivers identified by these veterans may also be included in qualitative interviews. A representative sample of VA staff members who provide care to these veterans will also be approached to participate in qualitative interviews.
Exclusion Criteria:
- Medically and/or surgically unstable
- Mentally impaired such that independent reasoning and judgment jeopardize safety of self or others
- Active alcohol and/or drug dependency that is untreated
Contacts and Locations| Contact: Lisa Ottomanelli, PhD | (813) 558-3917 | Lisa.Ottomanelli@va.gov |
| Contact: Leah M Drasher-Phillips, MPH | (813) 558-7670 | Leah.Drasher-Phillips@va.gov |
| United States, California | |
| VA Palo Alto Health Care System, Palo Alto, CA | Recruiting |
| Palo Alto, California, United States, 94304-1290 | |
| Contact: Elizabeth Packer 650-493-5000 ext 69256 elizabeth.packer@va.gov | |
| United States, Florida | |
| James A. Haley Veterans' Hospital, Tampa, FL | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Lisa Ottomanelli, PhD 813-558-3917 Lisa.Ottomanelli@va.gov | |
| Principal Investigator: Lisa Ottomanelli, PhD | |
| Sub-Investigator: Scott Barnett, PhD MSPH BS | |
| United States, Massachusetts | |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: Kandarp Mehta, MS 857-203-6626 kandarp.mehta2@va.gov | |
| United States, Ohio | |
| VA Medical Center, Cleveland | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Bianca L Goodman, MPH 216-791-3800 ext 6581 bianca.goodman@va.gov | |
| United States, Texas | |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Jones Lisa 214-857-4237 Lisa.Jones6@va.gov | |
| Michael E. DeBakey VA Medical Center (152) | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Daisy Courtade, MS 713-791-1414 ext 4233 Daisy.Courtade@va.gov | |
| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center, Richmond, VA | Recruiting |
| Richmond, Virginia, United States, 23249 | |
| Contact: Mindy Perilla, MPH 804-675-5000 ext 4963 mindy.perilla@va.gov | |
| Principal Investigator: | Lisa Ottomanelli, PhD | James A. Haley Veterans' Hospital, Tampa, FL |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01141647 History of Changes |
| Other Study ID Numbers: | O7814-R |
| Study First Received: | June 8, 2010 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Adult Depression Supported Employment Health Service Humans |
Outcomes Quality of Life Veterans/rh (rehabilitation) Workplace Spinal Cord Injuries |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013