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

NCT ID: NCT01141647

Last Updated: 2017-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1047 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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24-Month Supported Employment

Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services

Group Type EXPERIMENTAL

Vocational Rehabilitation

Intervention Type BEHAVIORAL

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

Interventions

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Vocational Rehabilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 to 65 years old
* Spinal Cord Injury
* Medically and neurologically stable



* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Ottomanelli, PhD

Role: PRINCIPAL_INVESTIGATOR

James A. Haley Veterans' Hospital, Tampa, FL

Locations

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VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

Site Status

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Site Status

VA Medical Center, Cleveland

Cleveland, Ohio, United States

Site Status

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Site Status

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, United States

Site Status

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25762857 (View on PubMed)

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.

Reference Type RESULT
PMID: 25577499 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29434460 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28594193 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28115071 (View on PubMed)

Other Identifiers

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O7814-R

Identifier Type: -

Identifier Source: org_study_id

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