Early Intervention to Promote Return to Work for People With Spinal Cord Injury

For many people with spinal cord 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 obtain employment.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Diseases; Spinal Cord Injuries
• Intervention / Treatment: Other: State Counselor-Coordinated Services; Other: Center Facilitator-Coordinated Services

Detailed 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). To help address this challenge, the Northern New Jersey Spinal Cord Injury System (NNJSCIS) is conducting a single-site, randomized, controlled trial to compare two programs intended to increase rates of employment among people with SCI. The project will enroll 162 recently injured adults with SCI who are interested in becoming employed or returning to work and will compare different ways of delivering employment-related services in the first year after injury. Services will begin in inpatient rehabilitation and may include education, therapy, equipment provision, counseling, and other interventions. Information about employment status, earnings, community participation, and health will be collected through a combination of questionnaires and databases. Participants and service providers will also share their impressions of the programs via survey and focus groups. Analyses will examine the rate of participants employed at 1 year in each group, time to employment, earnings, community participation, and other aspects of well-being. Findings from this study will be used to determine which ways of delivering services are most effective in enabling employment by 1 year after injury, and to provide information to help other rehabilitation centers adopt effective programs.

• Study Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trevor Dyson-Hudson, M.D.; Phone Number: 973-324-3576; Email: tdysonhudson@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adults age 18 to 62
• a neurological impairment secondary to an SCI that occurred less than 12 months prior to enrollment
• receiving inpatient rehabilitation at Kessler Institute for Rehabilitation (KIR)
• community living in the state of NJ after discharge from KIR
• have a goal to pursue competitive integrated employment or education/retraining leading to competitive integrated employment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: State Counselor-Coordinated Services; In this program, services are coordinated by a counselor employed by the New Jersey State Division of Vocational Rehabilitation Services (NJDVRS), a state-based agency that assists people with disabilities who are interested in pursuing employment. While the participant is in inpatient rehabilitation or soon after their discharge, a member of the research team will assist them in completing the necessary documentation to apply for services from this agency. Services for which they are eligible will be provided directly through NJDVRS.	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 participants 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.
Other: Center Facilitator-Coordinated Services; In this program, services are coordinated by a facilitator who is employed by Kessler Institute for Rehabilitation and works cooperatively with NJDVRS. The facilitator will begin working with the participant during inpatient rehabilitation, or soon after discharge, depending on when they enroll in the study. Some services for which they are eligible will be provided through NJDVRS and others will be provided to them by the facilitator.	Other: Center Facilitator-Coordinated Services; A facilitator affiliated with Kessler Institute for Rehabilitation coordinates services that consider the participant's condition, needs and goals. Services participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Employment Status (Percent Employed)	Proportion of participants in each group in competitive employment.	12-months post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Employment Efficiency (Median Time to Employment)	Median number of months from date of enrollment to date of competitive integrated employment; obtained through self-report.	12-months post-enrollment
Income	Earnings within the first 12 months post-enrollment as obtained from New Jersey Unemployment Insurance (UI) data.	12-months post-enrollment
Satisfaction with Life Scale (SWLS)	5 item (2 minute) scale that provides global measure of life satisfaction.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
International SCI Quality of Life Basic Data Set	3 item (~1 minute) assessment of satisfaction with life as a whole, physical health, psychological health.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Craig Handicap Assessment and Reporting Technique (CHART)	Subscales examine several objective physical independence, cognitive independence, mobility, occupation, social integration, and economic self-sufficiency; includes personal care assistance use.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Spinal Cord Injury Quality of Life: Satisfaction with Social Roles and Activities (SCI-QoL)	10 item short form (<5 minutes) examining extent of satisfaction or disappointment with social roles and activities; complements CHART.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Patient Health Questionnaire (PHQ-9)	Measure of depressive symptomology (9 items; 3 minutes).	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Spinal Cord Injury Quality of Life: Self-Esteem	8 item (<5 minute) short form; assesses emotional, evaluative, and cognitive perceptions of personal competence and worth.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Spinal Cord Injury Quality of Life: Independence	8 item (<5 minute) short form.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Exit Survey	Includes rating scale and open-ended items pertaining to satisfaction with the program and suggestions for optimization of the programs.	12-months post-enrollment

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Trevor Dyson-Hudson, M.D., Kessler Foundation; Principal Investigator: John O'Neill, Ph.D., Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2022
• Primary Completion (Anticipated): February 28, 2026
• Study Completion (Anticipated): August 31, 2026

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: employment; vocational rehabilitation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: L-1171-21A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All individual participant data (IPD), except if/when limited by data use agreements established with the New Jersey Department of Labor, will be shared via the Interuniversity Consortium for Political and Social Research (ICPSR), the preferred data repository for the National Institute on Disability, Independent Living, and Rehabilitation Research. Data shared via ICPSR will include data from measures collected at baseline and follow-ups for purposes of sample characterization and/or outcomes assessment. All data will be de-identified and labeled with subject identification numbers established for the study rather than names or initials.
• IPD Sharing Time Frame: Data will be made available within 6-12 months of the completion of the study and will remain available indefinitely.
• IPD Sharing Access Criteria: Requests for data access will be coordinated through the Interuniversity Consortium for Political and Social Research (ICPSR) according to their established procedures.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No