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Customized Employment for Veterans With Spinal Cord Injury (ACCESS-Vets)

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACCESS
IPS
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Rehabilitation, Randomized Clinical Trial, Disability, Vocational Rehabilitation, Employment, Clinical Intervention, Veterans

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Veteran inclusion criteria

  • Community-dwelling, English-Speaking Veterans
  • 18-65 years old
  • Want to find work in their community
  • Have received or are currently receiving IPS VA provider inclusion criteria
  • CE providers and other clinical providers on the SCI interdisciplinary team and other stakeholders.

Exclusion Criteria:

Veteran exclusion criteria

  • Living more than an hour's 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
  • Visual, hearing, or cognitive impairment preventing consent or ability to participate in essential elements of the intervention VA provider exclusion criteria
  • Providers who do not meet inclusion criteria

Sites / Locations

  • James A. Haley Veterans' Hospital, Tampa, FLRecruiting
  • Hunter Holmes McGuire VA Medical Center, Richmond, VARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACCESS-Vets Intervention Group

IPS (Usual Care) Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Employment Satisfaction, Wages, Retention
Employee satisfaction survey and Employment questionnaire are administered by study staff to document job satisfaction, wages, and retention. The investigators will continue to collect data for the employed group until the investigators will have 3 post-employment time points or until the data collection period ends
Change in Quality of Life- Ability to Participate in Social Roles and Activities (SRA)
SCI-QOL Scale subset assesses participation in social roles and activities (Short Form-10 items). Item responses range from 1 (Never) to 5 (always) with a min score of 10 and a max score of 50. Higher score indicated higher QOL for Ability to Participate in SRA.
Change in Quality of Life- Satisfaction with SRA
SCI-QOL Scale subset assesses satisfaction with social roles and activities (SRA). (SF -10 items) Item responses range from 1 (Not at All) to 5 (Very Much) with a min score of 10 and a max score of 50. Higher score indicated higher QOL for satisfaction with SRA.
Changes in Quality of Life- Independence
SCI-QOL Scale subset assesses independence (SF - 8 items). Item responses range from 1 (Never) to 5 (Always) with a min score of 8 and a max score of 40. Higher score indicates higher QOL in regards to independence.
Change in Quality of Life- Positive Affect and Well-being
SCI-QOL Scale subset integrates constructs of positive affect and emotional well-being into SCI research and clinical practice (SF- 10 items). Item responses range from 1 (Never) to 5 (Always) with a min score of 10 and a max score of 50. Higher score indicates higher QOL for positive affect and well-being.
Change in Quality of Life- Self Esteem
SCI-QOL Scale subset assesses cognitive, emotional, and evaluative perceptions of the self (SF- 8 items). Item responses range from 1 (Never) to 5 (Always) with a min score of 8 and a max score of 40. Higher score indicates higher QOL in regards to Self esteem.
Change in Self-sufficiency - Employment Hope Scale (EHS) SF-14
EHS is a 14-item measures psychological empowerment (4 items), futuristic self-motivation (2 items), utilization of skills and resources (4 items), and goal orientation (4 items) for career attainment. Items are ranked from 0 (strongly disagree) to 10 (strongly agree). Min score is 0 and maximum score of 140. Higher score indicates increased hope for employment.
Change in Self-Sufficiency- Perceived Barrier Scale (PEBS)
PEBS is a 27-item Likert-type scale assessing extent to which job seekers perceive various barriers as limiting the ability to find a job. Items are scored from 1 (Not a Barrier) to 5 (Strong Barrier) with a minimum score of 27 and a maximum score of 135. A higher score indicated increased perception of barriers limiting ability to find a job.
Change in Impact on Quality of Life and Participation- Qualitative Interviews Veteran participants
Qualitative interviews will contain open-ended questions about the perceived value of intervention in addressing QOL and participation.
Change in Employment Barriers- Employment Questionnaire
Open-ended questions from the Employment Questionnaire on on accommodations, supports, transportation, and barriers at work.
Change in Employment Barriers- Qualitative Interview -Veteran participants
Qualitative interviews contain open-ended questions about the perceived value of intervention in addressing employment barriers.
Adaption of Intervention- Benchmarks of Quality Checklist (BQC)
Benchmarks of Quality Checklist (BQC) is a structured CE provider form to document ACCESS omissions, modifications, and adaptations. Each item of the employment process is rated as completed, not completed, or partially completed. This form contains sections for staff to describe adaptions to the intervention. At study months 12. 18, 24, & 30, the qualitative researchers will review the BQCs that are completed on each study participant to identify how the intervention was adapted for use in the VA.
Change in Impact on Quality of Life and Participation- Qualitative Interviews Provider participants
Qualitative interviews with providers will contain open-ended questions about the perceived value of intervention in addressing QOL and participation.
Change in Employment Barriers- Qualitative Interview -Provider participants
Qualitative interviews with providers contain open-ended questions about the perceived value of intervention in addressing employment barriers.

Full Information

First Posted
March 26, 2021
Last Updated
February 7, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04832802
Brief Title
Customized Employment for Veterans With Spinal Cord Injury
Acronym
ACCESS-Vets
Official Title
Achieving Competitive Customized Employment Through Specialized Services - Veterans: ACCESS-VETS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This randomized clinical trial (RCT) will test the effectiveness of a customized employment (CE) intervention, Achieving Competitive Customized Employment through Specialized Services (ACCESS-Vets), to complement clinical services for Veterans with spinal cord injury (SCI) and improve their employment outcomes. Background: Restoring employment is an important rehabilitation goal for Veterans with SCI because employment impacts both quality of life (QOL) and longevity. Due to the medical complexity of SCI, however, these Veterans face unique employment barriers that are not adequately addressed by current Department of Veterans Affairs (VA) vocational services. Vocational services for Veterans with SCI need to address these employment barriers, which relate to physical health, finances, time for job search, and caregiver issues. Customized employment, an innovative strategy for tailoring vocational services to meet individual needs of people with complex disabilities, could be adapted for use in SCI rehabilitation. This research will evaluate a CE intervention to help Veterans with SCI discover their strengths, customize employment plans, and find competitive integrated employment in their communities. The proposed intervention, ACCESS, is a user-driven, standardized CE program delivered by a trained employment specialist and is effective for a non-clinical, community-based population of adults with disabilities. This research is needed to test ACCESS as a complement to clinical services for a clinically defined population and to assess the potential of CE for subsequent implementation in the VA. 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 intervention period of 26 months. ACCESS-Vets is typically completed in 8 months and includes the following elements: discovery, CE planning, job development, CE negotiation, and accommodations and job retention supports. Individual Placement and Support (IPS), otherwise known as evidence-based supported employment, will serve as an active control group consistent with treatment as usual. ACCESS-Vets and IPS will be compared on changes in employment attainment. The investigators predict Veterans who participate in ACCESS-Vets will have a higher employment rate than Veterans who receiving IPS. Among Veterans who attain employment, the investigators predict those who received ACCESS-Vets will report higher job satisfaction, wages, and retention. The investigators predict, Veterans who attain employment will demonstrate statistically significant improvements in self-sufficiency, QOL, and participation in life roles compared with those who do not attain employment. Finally, qualitative interviews with Veterans and their providers will identify strategies used in IPS and ACCESS-Vets for addressing barriers to employment and how practitioners adapt the ACCESS-Vets intervention for use in a VA clinical setting. Significance: This study is responsive to Veterans' reported desire for individualized vocational rehabilitation services and to the Modernization Plan and the MISSION Act, which emphasize Veteran-centered, community-based approaches to care. The proposal goals align with the Transformation Plan of the Office of Mental Health and Suicide Prevention, which prioritizes evidence-informed, community-based employment services. Recognizing the rapid adoption of CE in state and federal agencies, VA is partnering with the Office of Disability and Employment Policy (U.S. Department of Labor) to introduce and train VA vocational staff on CE as a promising practice; however, integration of CE into standard VA clinical services has not yet been implemented. In support of VA efforts to assist Veterans to achieve competitive employment and reintegration into civilian life, this proposal will evaluate CE within the context of existing VA vocational services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, Rehabilitation, Randomized Clinical Trial, Disability, Vocational Rehabilitation, Employment, Clinical Intervention, Veterans

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACCESS-Vets Intervention Group
Arm Type
Experimental
Arm Description
This group will receive ACCESS-Vets, a customized employment intervention adapted for use in VA healthcare.
Arm Title
IPS (Usual Care) Group
Arm Type
Active Comparator
Arm Description
This group will receive IPS (Individual Placement and Support), the usual evidence-based supported employment program in VA.
Intervention Type
Behavioral
Intervention Name(s)
ACCESS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IPS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Employment Status
Description
This questionnaire is administered by study staff and documents whether Competitive Integrated Employment is achieved.
Time Frame
6, 9 12 months
Secondary Outcome Measure Information:
Title
Change in Employment Satisfaction, Wages, Retention
Description
Employee satisfaction survey and Employment questionnaire are administered by study staff to document job satisfaction, wages, and retention. The investigators will continue to collect data for the employed group until the investigators will have 3 post-employment time points or until the data collection period ends
Time Frame
6, 9, 12 months
Title
Change in Quality of Life- Ability to Participate in Social Roles and Activities (SRA)
Description
SCI-QOL Scale subset assesses participation in social roles and activities (Short Form-10 items). Item responses range from 1 (Never) to 5 (always) with a min score of 10 and a max score of 50. Higher score indicated higher QOL for Ability to Participate in SRA.
Time Frame
Baseline, 6, 9 12 months
Title
Change in Quality of Life- Satisfaction with SRA
Description
SCI-QOL Scale subset assesses satisfaction with social roles and activities (SRA). (SF -10 items) Item responses range from 1 (Not at All) to 5 (Very Much) with a min score of 10 and a max score of 50. Higher score indicated higher QOL for satisfaction with SRA.
Time Frame
Baseline, 6, 9, 12 months
Title
Changes in Quality of Life- Independence
Description
SCI-QOL Scale subset assesses independence (SF - 8 items). Item responses range from 1 (Never) to 5 (Always) with a min score of 8 and a max score of 40. Higher score indicates higher QOL in regards to independence.
Time Frame
Baseline, 6, 9, 12, months
Title
Change in Quality of Life- Positive Affect and Well-being
Description
SCI-QOL Scale subset integrates constructs of positive affect and emotional well-being into SCI research and clinical practice (SF- 10 items). Item responses range from 1 (Never) to 5 (Always) with a min score of 10 and a max score of 50. Higher score indicates higher QOL for positive affect and well-being.
Time Frame
Baseline, 6, 9, 12 months
Title
Change in Quality of Life- Self Esteem
Description
SCI-QOL Scale subset assesses cognitive, emotional, and evaluative perceptions of the self (SF- 8 items). Item responses range from 1 (Never) to 5 (Always) with a min score of 8 and a max score of 40. Higher score indicates higher QOL in regards to Self esteem.
Time Frame
Baseline, 6, 9, 12 months
Title
Change in Self-sufficiency - Employment Hope Scale (EHS) SF-14
Description
EHS is a 14-item measures psychological empowerment (4 items), futuristic self-motivation (2 items), utilization of skills and resources (4 items), and goal orientation (4 items) for career attainment. Items are ranked from 0 (strongly disagree) to 10 (strongly agree). Min score is 0 and maximum score of 140. Higher score indicates increased hope for employment.
Time Frame
Baseline, 6, 9, 12 months
Title
Change in Self-Sufficiency- Perceived Barrier Scale (PEBS)
Description
PEBS is a 27-item Likert-type scale assessing extent to which job seekers perceive various barriers as limiting the ability to find a job. Items are scored from 1 (Not a Barrier) to 5 (Strong Barrier) with a minimum score of 27 and a maximum score of 135. A higher score indicated increased perception of barriers limiting ability to find a job.
Time Frame
Baseline, 6, 9, 12 months
Title
Change in Impact on Quality of Life and Participation- Qualitative Interviews Veteran participants
Description
Qualitative interviews will contain open-ended questions about the perceived value of intervention in addressing QOL and participation.
Time Frame
baseline, 6-months, & 12 months
Title
Change in Employment Barriers- Employment Questionnaire
Description
Open-ended questions from the Employment Questionnaire on on accommodations, supports, transportation, and barriers at work.
Time Frame
6, 9, 12 months
Title
Change in Employment Barriers- Qualitative Interview -Veteran participants
Description
Qualitative interviews contain open-ended questions about the perceived value of intervention in addressing employment barriers.
Time Frame
baseline, 6-months, & 12 months
Title
Adaption of Intervention- Benchmarks of Quality Checklist (BQC)
Description
Benchmarks of Quality Checklist (BQC) is a structured CE provider form to document ACCESS omissions, modifications, and adaptations. Each item of the employment process is rated as completed, not completed, or partially completed. This form contains sections for staff to describe adaptions to the intervention. At study months 12. 18, 24, & 30, the qualitative researchers will review the BQCs that are completed on each study participant to identify how the intervention was adapted for use in the VA.
Time Frame
Study Months 12, 18, 24 & 30.
Title
Change in Impact on Quality of Life and Participation- Qualitative Interviews Provider participants
Description
Qualitative interviews with providers will contain open-ended questions about the perceived value of intervention in addressing QOL and participation.
Time Frame
After the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months
Title
Change in Employment Barriers- Qualitative Interview -Provider participants
Description
Qualitative interviews with providers contain open-ended questions about the perceived value of intervention in addressing employment barriers.
Time Frame
After the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Veteran inclusion criteria Community-dwelling, English-Speaking Veterans 18-65 years old Want to find work in their community Have received or are currently receiving IPS VA provider inclusion criteria CE providers and other clinical providers on the SCI interdisciplinary team and other stakeholders. Exclusion Criteria: Veteran exclusion criteria 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 Visual, hearing, or cognitive impairment preventing consent or ability to participate in essential elements of the intervention VA provider exclusion criteria Providers who do not meet inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Ottomanelli, PhD
Phone
(813) 558-3917
Email
Lisa.ottomanelli@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Areana Cruz, MSEd
Phone
(813) 797-8969
Email
areana.cruz@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Ottomanelli, PhD
Organizational Affiliation
James A. Haley Veterans' Hospital, Tampa, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Ottomanelli, PhD
Phone
813-558-3917
Email
Lisa.ottomanelli@va.gov
First Name & Middle Initial & Last Name & Degree
Areana Cruz, MSEd
Phone
(813) 797-8969
Email
areana.cruz@va.gov
First Name & Middle Initial & Last Name & Degree
Lisa Ottomanelli, PhD
Facility Name
Hunter Holmes McGuire VA Medical Center, Richmond, VA
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott McDonald, PhD
Phone
804-675-5000
Ext
3633
Email
scott.mcdonald@va.gov
First Name & Middle Initial & Last Name & Degree
Lance Goetz, MD
Phone
8046755000
Ext
2475
Email
lance.goetz@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Customized Employment for Veterans With Spinal Cord Injury

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