Predictive Outcome Model Over Time for Employment (PROMOTE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,047
- 试验地点
- 14
- 主要终点
- Identify Factors That Predict Employment After SCI.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Identify Factors That Predict Employment After SCI.
时间窗: 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.
次要结局
- 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)