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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 11, 2014
Last verified: August 2014
  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)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141647

Contacts
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

Locations
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, 33637
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   
Sponsors and Collaborators
Investigators
Principal Investigator: Lisa Ottomanelli, PhD James A. Haley Veterans' Hospital, Tampa, FL
  More Information

Publications:
Unable to connect to PubMed to validate 0, last attempt on August 11, 2014 at 2:10 PM EDT

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: August 11, 2014
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
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014