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临床试验/NCT04832802
NCT04832802
已完成
不适用

Achieving Competitive Customized Employment Through Specialized Services - Veterans: ACCESS-VETS

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 100 人2022年2月14日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Spinal Cord Injury
发起方
VA Office of Research and Development
入组人数
100
试验地点
2
主要终点
Change in Employment Status
状态
已完成
最后更新
10个月前

概览

简要总结

The reason for conducting this study is to learn about the best ways to help Veterans with spinal cord injury (SCI) gain meaningful employment. Spinal cord injury is a medically complex disability that poses unique barriers to employment for Veterans. Returning to work after SCI improves health and quality of life, which in turn can lower risk for suicide in this high-risk population. Hence, the Department of Veterans Affairs (VA) supports interventions that help Veterans with SCI return to work and may prevent suicide.

Customized employment (CE) is an innovative strategy for tailoring vocational services to meet the needs of people with complex disabilities. To address barriers to employment faced by Veterans with SCI, this study will evaluate whether a customized employment intervention used in non-VA settings can be adapted for use by the VA as a part of SCI medical rehabilitation. The research goal is to evaluate how a CE intervention for Veterans with SCI (ACCESS-Vets) can help them discover their strengths to find and maintain competitive integrated employment in their communities. This study will compare ACCESS-Vets with the usual evidence-based supported employment program, known as Individual Placement and Support (IPS).

Veterans with SCI who chose to participate in this study will be randomly selected (i.e. by chance) to work with a vocational rehabilitation specialist as part of the ACCESS-Vets intervention or the usual IPS employment program for about 8 months. Study participants will complete study questionnaires before, during, and after their participation in the employment interventions. Some Veterans and their medical rehabilitation providers will be interviewed about their experiences with the employment interventions.

The study expects to find that Veterans who participate in ACCESS-Vets will have better employment and quality of life outcomes then those who participate in IPS. The study will provide information about the strategies used in the ACCESS-Vets and IPS interventions for addressing barriers to employment. Ultimately, this study may provide a model for making VA vocational services for Veterans with SCI more effective and sustainable.

详细描述

This randomized clinical trial (RCT) will test the effectiveness of a customized employment (CE) intervention, Achieving Competitive Customized Employment through Specialized Services (ACCESS-Vets), to complement clinical services for Veterans with spinal cord injury (SCI) and improve their employment outcomes. Background: Restoring employment is an important rehabilitation goal for Veterans with SCI because employment impacts both quality of life (QOL) and longevity. Due to the medical complexity of SCI, however, these Veterans face unique employment barriers that are not adequately addressed by current Department of Veterans Affairs (VA) vocational services. Vocational services for Veterans with SCI need to address these employment barriers, which relate to physical health, finances, time for job search, and caregiver issues. Customized employment, an innovative strategy for tailoring vocational services to meet individual needs of people with complex disabilities, could be adapted for use in SCI rehabilitation. This research will evaluate a CE intervention to help Veterans with SCI discover their strengths, customize employment plans, and find competitive integrated employment in their communities. The proposed intervention, ACCESS, is a user-driven, standardized CE program delivered by a trained employment specialist and is effective for a non-clinical, community-based population of adults with disabilities. This research is needed to test ACCESS as a complement to clinical services for a clinically defined population and to assess the potential of CE for subsequent implementation in the VA. Research Plan: The effectiveness of ACCESS-Vets will be tested with an RCT of 100 Veterans with SCI. The study will have a rolling enrollment period with an intervention period of 26 months. ACCESS-Vets is typically completed in 8 months and includes the following elements: discovery, CE planning, job development, CE negotiation, and accommodations and job retention supports. Individual Placement and Support (IPS), otherwise known as evidence-based supported employment, will serve as an active control group consistent with treatment as usual. ACCESS-Vets and IPS will be compared on changes in employment attainment. The investigators predict Veterans who participate in ACCESS-Vets will have a higher employment rate than Veterans who receiving IPS. Among Veterans who attain employment, the investigators predict those who received ACCESS-Vets will report higher job satisfaction, wages, and retention. The investigators predict, Veterans who attain employment will demonstrate statistically significant improvements in self-sufficiency, QOL, and participation in life roles compared with those who do not attain employment. Finally, qualitative interviews with Veterans and their providers will identify strategies used in IPS and ACCESS-Vets for addressing barriers to employment and how practitioners adapt the ACCESS-Vets intervention for use in a VA clinical setting. Significance: This study is responsive to Veterans' reported desire for individualized vocational rehabilitation services and to the Modernization Plan and the MISSION Act, which emphasize Veteran-centered, community-based approaches to care. The proposal goals align with the Transformation Plan of the Office of Mental Health and Suicide Prevention, which prioritizes evidence-informed, community-based employment services. Recognizing the rapid adoption of CE in state and federal agencies, VA is partnering with the Office of Disability and Employment Policy (U.S. Department of Labor) to introduce and train VA vocational staff on CE as a promising practice; however, integration of CE into standard VA clinical services has not yet been implemented. In support of VA efforts to assist Veterans to achieve competitive employment and reintegration into civilian life, this proposal will evaluate CE within the context of existing VA vocational services.

注册库
clinicaltrials.gov
开始日期
2022年2月14日
结束日期
2025年6月1日
最后更新
10个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Veteran inclusion criteria
  • English-Speaking Veterans
  • 18 years of age or older
  • Want to find work in their community
  • Have received or are currently receiving IPS VA provider inclusion criteria
  • CE providers and other clinical providers on the SCI interdisciplinary team and other stakeholders.

排除标准

  • Veteran exclusion criteria
  • Living more than a two hours drive from the VAMC
  • Progressive spinal cord disorder or terminal diagnosis, e.g., multiple sclerosis
  • Moderate to severe traumatic brain injury or Rancho Level of 6 or less on discharge from acute rehabilitation,
  • Diagnosis of or documented treatment for psychosis in previous 6 months
  • Untreated substance use disorder
  • Visual, hearing, or cognitive impairment preventing consent or ability to participate in essential elements of the intervention VA provider exclusion criteria
  • Providers who do not meet inclusion criteria

结局指标

主要结局

Change in Employment Status

时间窗: 6, 9 12 months

This questionnaire is administered by study staff and documents whether Competitive Integrated Employment is achieved.

次要结局

  • Change in Quality of Life- Satisfaction with SRA(Baseline, 6, 9, 12 months)
  • Change in Quality of Life- Self Esteem(Baseline, 6, 9, 12 months)
  • Change in Employment Satisfaction, Wages, Retention(6, 9, 12 months)
  • Change in Quality of Life- Positive Affect and Well-being(Baseline, 6, 9, 12 months)
  • Change in Impact on Quality of Life and Participation- Qualitative Interviews Veteran participants(baseline, 6-months, & 12 months)
  • Change in Impact on Quality of Life and Participation- Qualitative Interviews Provider participants(After the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months)
  • Change in Quality of Life- Ability to Participate in Social Roles and Activities (SRA)(Baseline, 6, 9 12 months)
  • Change in Self-sufficiency - Employment Hope Scale (EHS) SF-14(Baseline, 6, 9, 12 months)
  • Change in Self-Sufficiency- Perceived Barrier Scale (PEBS)(Baseline, 6, 9, 12 months)
  • Change in Employment Barriers- Qualitative Interview -Veteran participants(baseline, 6-months, & 12 months)
  • Change in Employment Barriers- Qualitative Interview -Provider participants(After the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months)
  • Changes in Quality of Life- Independence(Baseline, 6, 9, 12, months)
  • Change in Employment Barriers- Employment Questionnaire(6, 9, 12 months)
  • Adaption of Intervention- Benchmarks of Quality Checklist (BQC)(Study Months 12, 18, 24 & 30.)

研究点 (2)

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