Customized Employment for Spinal Cord Injury

(ACCESS-Vets Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans with spinal cord injuries find meaningful jobs by testing two different employment programs. One group will try an innovative approach called ACCESS-Vets, while the other will follow the usual program, Individual Placement and Support (IPS). The researchers aim to determine which program improves job satisfaction and quality of life for Veterans. Veterans who speak English, want to work in their community, and have previously used the IPS program might be suitable participants.

As an unphased trial, this study offers Veterans the chance to explore new employment strategies that could enhance their job satisfaction and quality of life.

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 prior data suggests that this customized employment intervention is safe for Veterans with spinal cord injury?

Research has shown that programs like ACCESS-Vets help Veterans with spinal cord injuries find meaningful work. ACCESS-Vets offers a service approach, not a medical treatment, so specific safety data is not available. However, these programs are generally safe, as they provide support and resources rather than medical procedures or drugs.

The Individual Placement and Support (IPS) program is a well-known employment support service widely used in the VA system and beyond. It has a strong record of safely and effectively helping people with disabilities find and keep jobs. Since IPS does not involve medical treatments, there are no medical risks.

Both programs aim to improve quality of life and job outcomes without medical intervention, allowing participants to feel confident about their safety from medical side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Customized Employment for Spinal Cord Injury trial because it explores new ways to help veterans with spinal cord injuries get back to work. Unlike the usual Individual Placement and Support (IPS) program, which is a standard job support service, the ACCESS-Vets intervention is specially tailored for veterans using VA healthcare. This customized approach could potentially offer more personalized support, addressing the specific needs and challenges faced by veterans with spinal cord injuries. The hope is that by adapting employment strategies to fit individual circumstances, more veterans will find meaningful employment and improve their quality of life.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that customized employment (CE) strategies hold promise for people with complex disabilities. Early results suggest that CE can be adapted to help individuals identify their strengths and find meaningful jobs. This trial will compare two approaches: the ACCESS-Vets intervention, a customized employment strategy adapted for use in VA healthcare, and IPS (Individual Placement and Support), the usual evidence-based supported employment program in VA. This is particularly important for Veterans with spinal cord injuries (SCI), as returning to work can greatly enhance their quality of life and mental health. While specific data on ACCESS-Vets is still being collected, this approach is based on successful non-VA CE models. These models have effectively helped people with disabilities find and keep jobs, potentially reducing the risk of depression and suicide. ^{1 2 3 6 7}

Who Is on the Research Team?

Lisa Ottomanelli, PhD

Principal Investigator

James A. Haley Veterans' Hospital, Tampa, FL

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6800461/

Spinal Cord Injury Veterans' Disability Benefits, Outcomes ...

Reports based on data from the National Spinal Cord Injury Database (NSCID) estimate that the average lifetime costs for a 25-year-old ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11044724/

Healthcare utilization and outcomes of spinal cord injured ...

Of those with SCI, up to 80% will develop a pressure injury (PI) at some point during their life, while more than one-third are estimated to ...

3.

research.va.gov

research.va.gov/topics/sci.cfm

Spinal Cord Injury

VA research on SCI focuses on returning motor and sensory function to Veterans with these injuries. Researchers look at areas including neural engineering, ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04832802

Customized Employment for Veterans With Spinal Cord Injury

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 ...

5.

pva.org

pva.org/wp-content/uploads/2021/09/cpg_outcomes-following-traumatic-sci.pdf

Outcomes Following Traumatic Spinal Cord Injury

The panel considers the evidence from the Model Systems' database on functional outcomes to be very strong descriptive data and quite appropriate for ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1936657416300899

Engaging Veterans with spinal cord injury in discussions of ...

A total of 18 Veterans with SCI were recruited and 9 (50.0%) completed participation in the study while 9 were lost to follow-up. The majority of participants ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6419631/

Implementation and initial outcomes of a spinal cord injury ...

Persons with complete spinal cord injury incurred significantly more cost both in the first year after injury, as well as subsequent years. Comorbid conditions ...