NCT04832802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

February 14, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

3.1 years

First QC Date

March 26, 2021

Last Update Submit

June 9, 2025

Conditions

Keywords

Spinal Cord InjuryRehabilitationRandomized Clinical TrialDisabilityVocational RehabilitationEmploymentClinical InterventionVeterans

Outcome Measures

Primary Outcomes (1)

  • Change in Employment Status

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

    6, 9 12 months

Secondary Outcomes (14)

  • Change in Employment Satisfaction, Wages, Retention

    6, 9, 12 months

  • Change in Quality of Life- Ability to Participate in Social Roles and Activities (SRA)

    Baseline, 6, 9 12 months

  • Change in Quality of Life- Satisfaction with SRA

    Baseline, 6, 9, 12 months

  • Changes in Quality of Life- Independence

    Baseline, 6, 9, 12, months

  • Change in Quality of Life- Positive Affect and Well-being

    Baseline, 6, 9, 12 months

  • +9 more secondary outcomes

Study Arms (2)

ACCESS-Vets Intervention Group

EXPERIMENTAL

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

Behavioral: ACCESS

IPS (Usual Care) Group

ACTIVE COMPARATOR

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

Behavioral: IPS

Interventions

ACCESSBEHAVIORAL

ACCESS-Vets is a customized employment intervention adapted for use in VA healthcare to help Veterans with SCI achieve competitive integrated employment. ACCESS-Vets includes the following elements: discovery, customized employment planning, job development, customized employment negotiation, and accommodations and job retention supports.

ACCESS-Vets Intervention Group
IPSBEHAVIORAL

IPS is an evidenced-based practice of supported employment that helps persons with disabilities find and maintain integrated competitive employment. IPS follows eight standardized principles: zero exclusion, integrated services, rapid job search, competitive employment, worker preferences, systematic job development, benefits planning, and time-unlimited supports.

IPS (Usual Care) Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-Speaking Veterans
  • years of age or older
  • Want to find work in their community
  • CE providers and other clinical providers on the SCI interdisciplinary team and other stakeholders.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Lisa Ottomanelli, PhD

    James A. Haley Veterans' Hospital, Tampa, FL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 6, 2021

Study Start

February 14, 2022

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations