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Customized Employment for Spinal Cord Injury (ACCESS-Vets Trial)

N/A
Waitlist Available
Led By Lisa Ottomanelli, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-65 years old
Be older than 18 years old
Must not have
Veterans with moderate to severe traumatic brain injury or Rancho Level of 6 or less on discharge from acute rehabilitation
Veterans living more than a two hours drive from the VAMC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is being done to study whether an innovative employment strategy, Customized Employment, can help Veterans with Spinal Cord Injuries (SCI) find and maintain competitive integrated employment.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves employment interventions rather than medical treatments, traditional side effects are not applicable. However, participants may experience stress or anxiety related to job search and employment activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a veteran with a serious brain injury, rated Rancho Level 6 or lower.
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I live more than two hours away from the Veterans Affairs Medical Center.
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I am a veteran treated for psychosis in the last 6 months.
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I am a veteran with a worsening spinal condition or a terminal illness like multiple sclerosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and after the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Employment Status
Secondary study objectives
Adaption of Intervention- Benchmarks of Quality Checklist (BQC)
Change in Employment Barriers- Employment Questionnaire
Change in Employment Barriers- Qualitative Interview -Provider participants
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ACCESS-Vets Intervention GroupExperimental Treatment1 Intervention
This group will receive ACCESS-Vets, a customized employment intervention adapted for use in VA healthcare.
Group II: IPS (Usual Care) GroupActive Control1 Intervention
This group will receive IPS (Individual Placement and Support), the usual evidence-based supported employment program in VA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACCESS
2017
N/A
~800

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,818 Total Patients Enrolled
Lisa Ottomanelli, PhDPrincipal InvestigatorJames A. Haley Veterans' Hospital, Tampa, FL
2 Previous Clinical Trials
1,296 Total Patients Enrolled

Media Library

ACCESS-Vets Clinical Trial Eligibility Overview. Trial Name: NCT04832802 — N/A
Spinal Cord Injury Research Study Groups: ACCESS-Vets Intervention Group, IPS (Usual Care) Group
Spinal Cord Injury Clinical Trial 2023: ACCESS-Vets Highlights & Side Effects. Trial Name: NCT04832802 — N/A
ACCESS-Vets 2023 Treatment Timeline for Medical Study. Trial Name: NCT04832802 — N/A
~4 spots leftby Apr 2025