Clinical trial NCT01141647: SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE)
Official title: Predictive Outcome Model Over Time for Employment (PROMOTE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Adult
Depression
Supported Employment
Health Service
Humans
Outcomes
Quality of Life
Veterans/rh (rehabilitation)
Workplace
Spinal Cord Injuries
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-06-10
Enrollment: 1047
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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: Identify factors that predict employment after SCI.

Secondary HO 1: Determine ongoing effectiveness of SE over time.

Secondary HO 2: Evaluate the effectiveness of implementation strategy and level of SE model implementation across sites.

Secondary HO 3: Determine costs, health care utilization over time and cost-effectiveness.

Eligibility 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

Primary outcomes:
measure: Identify Factors That Predict Employment After SCI.
timeFrame: 24-month phase with face-to-face quarterly interviews
Secondary outcomes:
measure: Employment Rate
timeFrame: 24 Months
measure: Determine Ongoing Effectiveness of SE Over Time.
timeFrame: 48-month phase with face-to-face quarterly interviews
measure: Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites.
timeFrame: 24-month phase with face-to-face quarterly interviews
measure: Determine Total Cost Per Patient Over 24 Months
timeFrame: 24-month phase with face-to-face quarterly interviews
measure: Determine Cost-effectiveness.
timeFrame: 24-month phase with face-to-face quarterly interviews
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Lisa Ottomanelli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Winter;21(1):20-30. doi: 10.1310/sci2101-20.
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. doi: 10.1007/s11136-014-0912-4. Epub 2015 Jan 11.
citation: Goetz LL, Ottomanelli L, Barnett SD, Sutton B, Njoh E. Relationship Between Comorbidities and Employment Among Veterans with Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018 Winter;24(1):44-53. doi: 10.1310/sci16-00047. Epub 2017 Sep 27.
citation: Budd MA, Dixon TM, Barnett SD, Njoh E, Goetz LL, Ottomanelli L. Examination of traumatic brain injury exposure among veterans with spinal cord injury. Rehabil Psychol. 2017 Aug;62(3):345-352. doi: 10.1037/rep0000129. Epub 2017 Jun 8.
citation: Ottomanelli L, Goetz LL, Barnett SD, Njoh E, Dixon TM, Holmes SA, LePage JP, Ota D, Sabharwal S, White KT. Individual Placement and Support in Spinal Cord Injury: A Longitudinal Observational Study of Employment Outcomes. Arch Phys Med Rehabil. 2017 Aug;98(8):1567-1575.e1. doi: 10.1016/j.apmr.2016.12.010. Epub 2017 Jan 20.