SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE) (PrOMOTE)
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|ClinicalTrials.gov Identifier: NCT01141647|
Recruitment Status : Completed
First Posted : June 10, 2010
Results First Posted : March 31, 2017
Last Update Posted : May 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Behavioral: Vocational Rehabilitation||Not Applicable|
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)|
|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|
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
- 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.
- Employment Rate [ Time Frame: 24 Months ]Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.
- 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.
- 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
- 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.
- 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.
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 ClinicalTrials.gov 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|
|Principal Investigator:||Lisa Ottomanelli, PhD||James A. Haley Veterans' Hospital, Tampa, FL|