Customized Employment for Spinal Cord Injury

(ACCESS-Vets Trial)

Recruiting at 1 trial location

Overseen By Areana Cruz, MSEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Progressive spinal disorder, Traumatic brain injury, Psychosis, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment ACCESS-Vets, IPS for spinal cord injury?

Research shows that the Individual Placement and Support (IPS) program significantly increased employment rates for veterans with spinal cord injury, a group that often struggles to find work. This suggests that the treatment ACCESS-Vets, IPS could be effective in helping these individuals gain employment. ^{1 2 3 4 5}

Is the Customized Employment treatment for spinal cord injury safe for humans?

The Individual Placement and Support (IPS) program, which is part of the Customized Employment treatment, has been used safely to help Veterans with spinal cord injury find work. There is no mention of safety concerns in the studies reviewed. ^{1 3 4 6 7}

How does the treatment ACCESS-Vets, IPS differ from other treatments for spinal cord injury?

ACCESS-Vets, IPS is unique because it focuses on helping veterans with spinal cord injury find employment through a supported employment program called Individual Placement and Support (IPS). Unlike traditional treatments that may focus solely on physical rehabilitation, this approach integrates vocational support into the rehabilitation process, aiming to improve employment outcomes and overall quality of life for participants. ^{1 2 3 8 9}

Research Team

Lisa Ottomanelli, PhD

Principal Investigator

James A. Haley Veterans' Hospital, Tampa, FL

Eligibility Criteria

This trial is for English-speaking Veterans aged 18-65 with spinal cord injury who want to work in their community. They must be living within a two-hour drive from the VAMC, not have progressive disorders like multiple sclerosis, severe brain injuries, psychosis treated in the last 6 months, untreated substance abuse, or impairments that prevent consent.

Inclusion Criteria

Veterans who have received or are currently receiving care from a specific VA provider.

It seems like the given phrase is incomplete or not clearly related to clinical trial exclusion criteria. Could you please provide more context or clarify the request?

You have already received or are currently receiving treatment from a specific healthcare provider.

Exclusion Criteria

Veterans who have trouble seeing, hearing, or thinking clearly and cannot understand or take part in important parts of the study.

I am a veteran with a serious brain injury, rated Rancho Level 6 or lower.

Veterans who have not received treatment for substance use disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the ACCESS-Vets customized employment intervention or the usual IPS employment program

8 months

Regular meetings with vocational rehabilitation specialists

Follow-up

Participants are monitored for employment outcomes, quality of life, and self-sufficiency

4 months

Data collection at 6, 9, and 12 months

Qualitative Interviews

Qualitative interviews with Veterans and providers to assess the perceived value of the interventions

Throughout the study

Treatment Details

Interventions

• ACCESS-Vets
• IPS

Trial Overview The study tests whether Customized Employment (ACCESS-Vets) can help Veterans with SCI find and keep jobs better than the usual job support program (IPS). Participants will be randomly assigned to either ACCESS-Vets or IPS and followed for about 8 months.

Participant Groups

Group I: ACCESS-Vets Intervention Group Experimental Treatment 1 Intervention

This group will receive ACCESS-Vets, a customized employment intervention adapted for use in VA healthcare.

Group II: IPS (Usual Care) Group Active Control 1 Intervention

This group will receive IPS (Individual Placement and Support), the usual evidence-based supported employment program in VA.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

In a 24-month program of Individual Placement and Support (IPS) for veterans with spinal cord injury (SCI), 43.2% of participants secured competitive jobs, indicating the program's effectiveness in improving employment outcomes.

Among veterans without a history of traumatic brain injury, the employment rate was even higher at 52.2%, suggesting that IPS may be particularly beneficial for this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Placement and Support in Spinal Cord Injury: A Longitudinal Observational Study of Employment Outcomes. Ottomanelli, L., Goetz, LL., Barnett, SD., et al.[2018]

In a study involving 201 veterans with spinal cord injuries, those participating in the Supported Employment (SE) program were significantly more likely to secure competitive employment (30.8%) compared to those receiving Treatment as Usual (TAU) (10.5% and 2.3% for different TAU groups).

The SE program, based on the individual placement and support model, showed that most employment was achieved within the first year, with an average time to first job of about 17 weeks, highlighting the importance of early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of supported employment for veterans with spinal cord injury: 2-year results. Ottomanelli, L., Barnett, SD., Goetz, LL.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

Provider-identified barriers and facilitators to implementing a supported employment program in spinal cord injury. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Individual Placement and Support in Spinal Cord Injury: A Longitudinal Observational Study of Employment Outcomes. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Scoping review of resources for integrating evidence-based supported employment into spinal cord injury rehabilitation. [2020]

4. Sweden pubmed.ncbi.nlm.nih.gov

Return to work five years after spinal cord injury inpatient rehabilitation: is it related to wheelchair capacity at discharge? [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of supported employment for veterans with spinal cord injury: 2-year results. [2014]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

iPS cell transplantation for traumatic spinal cord injury. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Human Embryonic Stem Cell-Derived Oligodendrocyte Progenitor Cells: Preclinical Efficacy and Safety in Cervical Spinal Cord Injury. [2020]

8. Australia pubmed.ncbi.nlm.nih.gov

Back2Work: a new model of early vocational rehabilitation for people with spinal cord injury. [2022]

9. England pubmed.ncbi.nlm.nih.gov

An interdisciplinary approach to job matching: developing an occupation-specific job matching tool for reintegrating persons with spinal cord injury into the labor market. [2021]