Clinical trial NCT04832802: Customized Employment for Veterans With Spinal Cord Injury
Official title: Achieving Competitive Customized Employment Through Specialized Services - Veterans: ACCESS-VETS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Rehabilitation
Randomized Clinical Trial
Disability
Vocational Rehabilitation
Employment
Clinical Intervention
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-04-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will use a 4-year, 2-armed, multi-site randomized controlled study design with concurrent mixed methods data collection at two VAMCs (Tampa and Richmond), to compare ACCESS-Vets intervention to treatment-as-usual (TAU), which is IPS.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Employment Status
timeFrame: 6, 9 12 months
Secondary outcomes:
measure: Change in Employment Satisfaction, Wages, Retention
timeFrame: 6, 9, 12 months
measure: Change in Quality of Life- Ability to Participate in Social Roles and Activities (SRA)
timeFrame: Baseline, 6, 9 12 months
measure: Change in Quality of Life- Satisfaction with SRA
timeFrame: Baseline, 6, 9, 12 months
measure: Changes in Quality of Life- Independence
timeFrame: Baseline, 6, 9, 12, months
measure: Change in Quality of Life- Positive Affect and Well-being
timeFrame: Baseline, 6, 9, 12 months
measure: Change in Quality of Life- Self Esteem
timeFrame: Baseline, 6, 9, 12 months
measure: Change in Self-sufficiency - Employment Hope Scale (EHS) SF-14
timeFrame: Baseline, 6, 9, 12 months
measure: Change in Self-Sufficiency- Perceived Barrier Scale (PEBS)
timeFrame: Baseline, 6, 9, 12 months
measure: Change in Impact on Quality of Life and Participation- Qualitative Interviews Veteran participants
timeFrame: baseline, 6-months, & 12 months
measure: Change in Employment Barriers- Employment Questionnaire
timeFrame: 6, 9, 12 months
measure: Change in Employment Barriers- Qualitative Interview -Veteran participants
timeFrame: baseline, 6-months, & 12 months
measure: Adaption of Intervention- Benchmarks of Quality Checklist (BQC)
timeFrame: Study Months 12, 18, 24 & 30.
measure: Change in Impact on Quality of Life and Participation- Qualitative Interviews Provider participants
timeFrame: After the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months
measure: Change in Employment Barriers- Qualitative Interview -Provider participants
timeFrame: After the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Lisa Ottomanelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: