SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE)

This study is currently recruiting participants.
Verified May 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01141647
First received: June 8, 2010
Last updated: May 13, 2013
Last verified: May 2013

June 8, 2010
May 13, 2013
August 2011
March 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01141647 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE)
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injuries
Behavioral: Vocational Rehabilitation
SCI-VIP: PrOMOTE evidence-based supported employment implemented for veterans with spinal cord injury or other available vocational services
Experimental: Arm 1
Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services
Intervention: Behavioral: Vocational Rehabilitation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
June 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
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
 
NCT01141647
O7814-R
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Lisa Ottomanelli, PhD James A. Haley Veterans' Hospital, Tampa, FL
Department of Veterans Affairs
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP