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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01141647
Recruitment Status : Completed
First Posted : June 10, 2010
Results First Posted : March 31, 2017
Last Update Posted : May 11, 2017
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Vocational Rehabilitation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1047 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predictive Outcome Model Over Time for Employment (PROMOTE)
Study Start Date : August 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 24-Month Supported Employment
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Employment Rate [ Time Frame: 24 Months ]
    Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.

  2. Determine Ongoing Effectiveness of SE Over Time. [ Time Frame: 48-month phase with face-to-face quarterly interviews ]
    This measure is used to evaluate the participants who were both in SCI-VIP and PrOMOTE. It assesses the number of people who obtained CE in SCI-VIP and sustained the same CE through their time in the PrOMOTE study. The cohort of SCI-VIP SE participants in PrOMOTE were analyzed separately from the 213 PrOMOTE participants.

  3. Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. [ Time Frame: 24-month phase with face-to-face quarterly interviews ]
    Level of implementation was assessed by interviewing clinical and vocational providers from the seven sites who were involved in or knowledgeable about the program. Values reported represent the numbers of clinical staff who cited having the VRS integrated on the clinical team, a full-time VRS, leadership support, engagement of staff, resources provided immediately, making adjustments to the implementation to fit with the local context, and having audit and feedback as supporting strong implementation

  4. Determine Total Cost Per Patient Over 24 Months [ Time Frame: 24-month phase with face-to-face quarterly interviews ]
    Total cost is the mean total cost per patient over 24 months in US dollars. The minimum value is 0 representing no cost in US dollars and larger numbers indicating higher costs in US dollars.

  5. Determine Cost-effectiveness. [ Time Frame: 24-month phase with face-to-face quarterly interviews ]
    QALYs are the mean quality adjusted life years per patient for the Supported Employment and Standard Care groups. The QALY is a non-negative number assessing the quality and length of life and not just the crude number of years. The minimum value is 0 representing no improvement in the quality of life or length of life and larger numbers indicate healthier and longer life. Maximum QALYs are limited only by the life span of study participants, but may not exceed 1 (perfect health) in any given year.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01141647

United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Lisa Ottomanelli, PhD James A. Haley Veterans' Hospital, Tampa, FL

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT01141647     History of Changes
Other Study ID Numbers: O7814-R
First Posted: June 10, 2010    Key Record Dates
Results First Posted: March 31, 2017
Last Update Posted: May 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will only be presented de-identified.

Keywords provided by VA Office of Research and Development:
Supported Employment
Health Service
Quality of Life
Veterans/rh (rehabilitation)
Spinal Cord Injuries

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries