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

Study 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.

Official Title
-----------------
Predictive Outcome Model Over Time for Employment (PROMOTE)

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Behavioral: Vocational Rehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24-Month Supported Employment<br>Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services | Behavioral: Vocational Rehabilitation<br>* SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify Factors That Predict Employment After SCI. | 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. | 24-month phase with face-to-face quarterly interviews | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Employment Rate | Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study. | 24 Months | 
| Determine Ongoing Effectiveness of SE Over Time. | 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. | 48-month phase with face-to-face quarterly interviews | 
| Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | 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 | 24-month phase with face-to-face quarterly interviews | 
| Determine Total Cost Per Patient Over 24 Months | 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. | 24-month phase with face-to-face quarterly interviews | 
| Determine Cost-effectiveness. | 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. | 24-month phase with face-to-face quarterly interviews | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Humans, Supported Employment, Adult, Depression, Health Service, Outcomes, Quality of Life, Veterans/rh (rehabilitation), Workplace, Spinal Cord Injuries