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

Spinal Cord Injuries Clinical Trial

— PrOMOTE  

Official title:

Predictive Outcome Model Over Time for Employment (PROMOTE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141647
• Other study ID #: O7814-R
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: January 7, 2016
• Start date: August 2011
• Est. completion date: March 2015

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Behavioral:
• Vocational Rehabilitation
SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts
United States	VA Medical Center, Cleveland	Cleveland	Ohio
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California
United States	Hunter Holmes McGuire VA Medical Center, Richmond, VA	Richmond	Virginia
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cotner BA, Njoh EN, Trainor JK, O'Connor DR, Barnett SD, Ottomanelli L. Facilitators and barriers to employment among veterans with spinal cord injury receiving 12 months of evidence-based supported employment services. Top Spinal Cord Inj Rehabil. 2015 W — View Citation

Sutton BS, Ottomanelli L, Njoh E, Barnett SD, Goetz LL. The impact of social support at home on health-related quality of life among veterans with spinal cord injury participating in a supported employment program. Qual Life Res. 2015 Jul;24(7):1741-7. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Status of Employment		12-month active phase with face-to-face quarterly interviews, second 12-month follow-up phase with brief quarterly phone interviews	No
Secondary	Levels of Supported Employment and Cost Effectiveness		12-month active phase with face-to-face quarterly interviews	No
Secondary	Measures of functional abilities and impairments, quality of life, depression		12-month active phase with face-to-face quarterly interviews	No
Secondary	Health Status Information		12-month active phase with face-to-face quarterly interviews, 12-month follow-up phase with mailed VR-36 form	No