Interventional Cooperative Agreement Program - Vocational Intervention Demonstration

Spinal Cord Injuries Clinical Trial

Official title:

Interventional Cooperative Agreement Program - Vocational Intervention Demonstration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05508802
• Other study ID #: L-1171-21B
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 2026

Study information

• Verified date: August 2022
• Source: Kessler Foundation
• Contact: John O'Neill, Ph.D.
• Phone: 973-324-8387
• Email: joneill[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For many people with spinal cord injury or brain injury, seeking employment after injury is an important goal. There are services available to help people with disabilities. However, the best ways to coordinate and deliver these services are not yet known. This project will compare two ways of coordinating and delivering services that are designed to help people with spinal cord injury or brain injury obtain employment.

Description:

Employment is important for financial security, social connection, and life satisfaction. Unfortunately, rates of unemployment remain high among people with spinal cord injury (SCI) and brain injury (BI). To help address this challenge, the investigators are conducting a single-site, randomized, controlled trial to compare two programs intended to increase rates of employment among people with SCI or BI. In one program, services are coordinated by a counselor employed by the New Jersey State Division of Vocational Rehabilitation Services, a state-based agency that assists people with disabilities who are interested in pursuing employment. In the other program, services are coordinated by a facilitator who is employed by the rehabilitation hospital at which the participant receives inpatient care. Services provided in both programs will be customized to the participant's needs and goals. Services will begin in inpatient rehabilitation and may include education, therapy, equipment provision, counseling, and other interventions.

The project will enroll 500 participants who are interested in becoming employed or returning to work. Information about employment status, earnings, benefits use, community participation, and health will be collected through a combination of surveys, medical record review, and information available in state and federal administrative databases. Analyses will examine the rate of participants employed at 1 year after enrollment in each group, time to employment, earnings, benefits usage, community participation, and well-being. Findings from this study will be used to determine which ways of delivering services are most effective in enabling employment, and to provide information to help other rehabilitation centers adopt effective programs.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 2026
• Est. primary completion date: September 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

Inclusion Criteria:

• Adults aged 18-62

• New Jersey resident

• Admitted to Kessler Institute for Rehabilitation (KIR) due to a spinal cord injury (SCI) or brain injury (BI)

• Receiving inpatient rehabilitation at KIR

• Community living in the state of New Jersey after discharge from KIR

Related Conditions & MeSH terms

• Brain Injuries
• Employment
• Spinal Cord Diseases
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• State Counselor-Coordinated Services
A counselor affiliated with the New Jersey State Division of Vocational Rehabilitation Services coordinates services that consider the participant's condition, needs and goals. Services they may receive include: Education on programs designed to help people with spinal cord injury or brain injury pursue employment. Advice and guidance from professional counselors who have special training in helping people with disabilities pursue employment. Help completing applications for services. Assistance communicating with my employer about my needs and ways to accommodate them. Referrals to and services from other health care or technology providers.
• Center Facilitator-Coordinated Services
A facilitator affiliated with Kessler Institute for Rehabilitation coordinates services that consider the participant's condition, needs and goals. Services they may receive include: Education on programs designed to help people with spinal cord injury or brain injury pursue employment. Advice and guidance from professional counselors who have special training in helping people with disabilities pursue employment. Help completing applications for services. Assistance communicating with my employer about my needs and ways to accommodate them. Referrals to and services from other health care or technology providers.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	Mathematica Policy Research, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Employment Status	Proportion of participants in each group in competitive employment	12-months post-enrollment
Secondary	Earnings	Earnings within the first 12 months post-enrollment as obtained from New Jersey Unemployment Insurance (UI) data	12-months post-enrollment
Secondary	SSI and SSDI Benefit Applications	Proportion of participants who report via survey that they applied for Supplemental Security Income (SSI) and Social Security Disability Insurance (SSDI) benefits	12-months post-enrollment
Secondary	SSI and SSDI Benefit Awards	Proportion of participants who report via survey that they were awarded SSI and SSDI benefits	12-months post-enrollment
Secondary	Job Satisfaction	Survey to assess job satisfaction and attitudes toward work	12-months post-enrollment
Secondary	Satisfaction with Services	Survey to assess satisfaction with services provided	12-months post-enrollment
Secondary	Self-Reported Health and Well-Being	Survey to assess emotional well-being, current general health status, and extent to which current health limits ability to work	12-months post-enrollment