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Clinical Trials/NCT01141647
NCT01141647
Completed
Not Applicable

Predictive Outcome Model Over Time for Employment (PROMOTE)

VA Office of Research and Development7 sites in 1 country1,047 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
VA Office of Research and Development
Enrollment
1047
Locations
7
Primary Endpoint
Identify Factors That Predict Employment After SCI.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
March 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

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

Outcomes

Primary Outcomes

Identify Factors That Predict Employment After SCI.

Time Frame: 24-month phase with face-to-face quarterly interviews

To model the probability of obtaining CE, we first dichotomized CE as 'yes' or 'no'. The Competitive Employment Rate is reported in Outcome Measure 2. We then used unconditional logistic regression to model the probability of obtaining CE through a univariate modeling approach to determine statistically significant predictors of CE. Statistically significant predictors at the p\<0.10 criterion level were then explored in a final multivariate model. Demographic (age, race, marital status, etc.), clinical (severity of injury, comorbidities, time since injury, etc.), barriers and facilitators, and quality of life (depression, Satisfaction with Life, etc.) were considered for modeling. A final model was obtained by including all parameters meeting the p\<0.10 criterion into a final multivariate model.

Secondary Outcomes

  • Employment Rate(24 Months)
  • Determine Ongoing Effectiveness of SE Over Time.(48-month phase with face-to-face quarterly interviews)
  • Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites.(24-month phase with face-to-face quarterly interviews)
  • Determine Total Cost Per Patient Over 24 Months(24-month phase with face-to-face quarterly interviews)
  • Determine Cost-effectiveness.(24-month phase with face-to-face quarterly interviews)

Study Sites (7)

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