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Spinal Cord Injury Vocational Integration Program (SCI-VIP)

A Spinal Cord Injury Vocational Integration Program: Implementation and Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00117806
Acronym
SCI-VIP
Enrollment
249
Registered
2005-07-08
Start date
2006-04-30
Completion date
2011-09-30
Last updated
2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Adult, Depression, Employment, supported, Health Service/ut, Humans, Outcomes, Quality of life, Veterans/rh (rehabilitation), Workplace, Spinal Cord Injuries

Brief summary

This study involves research about how to help Veterans with spinal cord injury (SCI) gain employment. During the first couple of years following SCI, many people are concentrating on their rehabilitation and are unable to afford the time for return to work. However, studies have shown people often regain the necessary strength and function about two years after SCI to resume activities of daily living very similar to what they experienced prior to the SCI. Even though many social and legal efforts have been made in the last decade to improve chances for people with disabilities to return to work, Veterans with SCI are sometimes hindered in finding employment because of age, past work history, and many other factors. Other Veterans with SCI are very successful at finding employment either working for themselves or working for a company. The investigators know very little about what issues Veterans with SCI face when they attempt to find employment after SCI. The study will analyze both quantitative and qualitative measures to maximize its findings.

Detailed description

Legal mandates, such as the Rehabilitation Act of 1973 and the Americans with Disabilities Act, have been implemented to improve employment opportunities for disabled persons and yet the proportion of persons with spinal cord injury (SCI) who are employed remains about 9%. For the Veteran population with SCI, the return to work rate is most likely much lower. This study will be conducted to evaluate whether a vocational rehabilitation program patterned after the VA Community Employment and Support approach improves rehabilitation outcomes for the SCI Veteran population as compared with vocational rehabilitation practices currently used in most Veteran Affairs Medical Centers (VAMCs). The vocational rehabilitation program developed for the SCI Veterans is referred to as SCI-VIP and it will be implemented at the Dallas VA Medical Center (VAMC), Houston VAMC, San Diego VAMC, and Cleveland VAMC. A five year evaluative research will be conducted to test the following hypothesized outcomes (HO) from the subjects who participate in the SCI-VIP program and a control group of subjects who receive conventional methods of vocational rehabilitation: Primary HO: Veterans with SCI who participate in the SCI-VIP will demonstrate significantly greater changes in vocational rehabilitation after twelve months than those who do not receive this intervention. Vocational rehabilitation will be a measure of change from baseline to one-year in the subject's scores on instruments which measure employment indices, perceived barriers to employment, level of handicap, quality of life, depression, and sustaining care needs. Secondary HO 1: Veterans with SCI who participate in the SCI-VIP will exhibit lower VA and non-VA costs for medical, non-rehabilitation treatment, offsetting the higher SCI-VIP program costs. Secondary HO 2: The program fidelity will be equally adequate in terms of accomplishing program objectives relative to operations, cost-benefit balance, subject and stakeholder satisfaction, and outcomes when comparing the four SCI-VIP programs and when comparing conventional vocational rehabilitation approaches applied at six different VAMCs. Program evaluation and cost-benefit analysis will be conducted using a fidelity instrument developed by the researchers and patterned after fidelity instruments conventionally used to evaluate psychiatric rehabilitation programs. Veterans at each VAMC who express an interest in vocational rehabilitation and consent to participate in this study will be randomized to either the experimental or the control group. It is expected that at least 96 subjects will participate in the SCI-VIP approach to vocational rehabilitation and 144 Veterans who receive conventional vocational rehabilitation will form the control group. Data will be collected from subjects upon enrollment into either the experimental or control group and every three months for one year. Descriptive analysis will be used to compare differences between groups of subjects drawn from each VAMC and to compare participants in the experimental and control groups. Analysis of variance will be computed to determine degree of difference between experimental group and control group subjects' scores on each dependent variable. The study hypotheses will be tested using the Mann-Whitney U, Chi-square, and odds ratio statistical procedures. The Cochran-Mantel-Haenszel along with relative risk scores will indicate the likelihood that any change in performance between baseline and program completion for ether experimental or control group subjects could be attributed to the subjects' degree of participation in the SCI-VIP, which VAMC vocational rehabilitation services were received, SCI factors, and age.

Interventions

BEHAVIORALArm 1

SCI-VIP: Supported employment implemented for veterans with spinal cord injury.

BEHAVIORALArm 2

Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Between the ages of 18 and 65 years old - Spinal cord injured as a result of trauma or disease * Medically and neurologically stable * Lives within the metropolitan area that is proximal to the VAMC (Cleveland, Dallas, Houston, San Diego, St. Louis) * Has access to transportation * Expresses an interest in competitive employment as an outcome of participation * Willingly signs a consent form indicating voluntary and informed participation in the study

Exclusion criteria

* Medically and/or surgically unstable * Unwilling to complete the consenting process * Mentally impaired such that independent reasoning and judgment jeopardize safety of self and others * Currently involved in untreated alcohol and/or drug dependency * Employed in a compensated job at the time of recruitment and earning above SGA ($940/month in 2008) - Lives more than approximately 100 miles from the participating VAMC SCI Center

Design outcomes

Primary

MeasureTime frameDescription
Competitive Employment-Total Jobs12 monthsCompetitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Competitive Employment-Participants With Competitive Employment12 monthsCompetitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Competitive Employment-Percentage of Participants With Competitive Employment12 monthsEmployment outcomes during year 1 among those subjects obtaining competitive employment.

Countries

United States

Participant flow

Pre-assignment details

Two-hundred forty-nine subjects were enrolled in the study which, 48 were excluded for various reasons including benefits (n=19), age \>65 (n=10), currently employed (n=6), and other (n=13), leaving 201 subjects. For the purposes of reporting the 44 veterans in the observational site were not included, therefore there are only 157 subjects included.

Participants by arm

ArmCount
Supported Employment
SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury.
81
Treatment As Usual
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
76
Total157

Baseline characteristics

CharacteristicSupported EmploymentTreatment As UsualTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
81 Participants76 Participants157 Participants
Age, Continuous48.7 years
STANDARD_DEVIATION 9.8
49.8 years
STANDARD_DEVIATION 9.8
49.2 years
STANDARD_DEVIATION 9.8
AIS and neurological Level
AIS D/E
25 participants25 participants50 participants
AIS and neurological Level
High tetraplegia, AIS A, B,C
12 participants13 participants25 participants
AIS and neurological Level
Low tetraplegia, AIS A, B, C
5 participants10 participants15 participants
AIS and neurological Level
Paraplegia, AIS A, B, C
38 participants27 participants65 participants
ASIA Impairment Scale (AIS)
A-Complete
26 participants20 participants46 participants
ASIA Impairment Scale (AIS)
B-Sensory Incomplete
11 participants13 participants24 participants
ASIA Impairment Scale (AIS)
C-Motor Incomplete
18 participants18 participants36 participants
ASIA Impairment Scale (AIS)
D-Motor Incomplete
25 participants21 participants46 participants
ASIA Impairment Scale (AIS)
E-Normal
0 participants4 participants4 participants
Education Years13.1 years
STANDARD_DEVIATION 2.3
13.5 years
STANDARD_DEVIATION 1.9
13.3 years
STANDARD_DEVIATION 2.2
Functional Independence Measure
Cognitive
33.8 units on a scale
STANDARD_DEVIATION 2.3
33.7 units on a scale
STANDARD_DEVIATION 2.8
33.8 units on a scale
STANDARD_DEVIATION 2.5
Functional Independence Measure
Motor
66.9 units on a scale
STANDARD_DEVIATION 21.6
66.4 units on a scale
STANDARD_DEVIATION 22.2
66.6 units on a scale
STANDARD_DEVIATION 21.8
Functional Independence Measure
Total
98.9 units on a scale
STANDARD_DEVIATION 23.8
98.2 units on a scale
STANDARD_DEVIATION 23.7
98.6 units on a scale
STANDARD_DEVIATION 23.6
Marital Status
Divorced
28 participants34 participants62 participants
Marital Status
Married
30 participants15 participants45 participants
Marital Status
Other
23 participants27 participants50 participants
Measures of Handicap (CHART)
Cognitive
89.4 units on a scale
STANDARD_DEVIATION 16.6
90.8 units on a scale
STANDARD_DEVIATION 14.9
90.1 units on a scale
STANDARD_DEVIATION 15.7
Measures of Handicap (CHART)
Economic Self Sufficiency
51.5 units on a scale
STANDARD_DEVIATION 37.8
52.6 units on a scale
STANDARD_DEVIATION 36.9
52.1 units on a scale
STANDARD_DEVIATION 15.7
Measures of Handicap (CHART)
Mobility
80.4 units on a scale
STANDARD_DEVIATION 17
80.4 units on a scale
STANDARD_DEVIATION 22.4
80.4 units on a scale
STANDARD_DEVIATION 19.7
Measures of Handicap (CHART)
Occupation
51.5 units on a scale
STANDARD_DEVIATION 32.9
50.4 units on a scale
STANDARD_DEVIATION 30.6
51.0 units on a scale
STANDARD_DEVIATION 31.7
Measures of Handicap (CHART)
Physical
85.7 units on a scale
STANDARD_DEVIATION 20.9
87.2 units on a scale
STANDARD_DEVIATION 22.1
86.4 units on a scale
STANDARD_DEVIATION 21.4
Measures of Handicap (CHART)
Social Integration
82.0 units on a scale
STANDARD_DEVIATION 13.6
84.7 units on a scale
STANDARD_DEVIATION 12.7
83.3 units on a scale
STANDARD_DEVIATION 13.1
Monthly non-service-connected amount1024 dollars
STANDARD_DEVIATION 482
986 dollars
STANDARD_DEVIATION 421
1005.7 dollars
STANDARD_DEVIATION 447.9
Neither Social Security Income/Social Security Disability Insurance recipient26 participants20 participants46 participants
Non-service-connected pension18 participants18 participants36 participants
No Service-connected/Non-service-connected benefits26 participants20 participants46 participants
Quality of Life VR-36
Mental Component Score
54.7 units on a scale
STANDARD_DEVIATION 13.8
55.6 units on a scale
STANDARD_DEVIATION 12.9
55.1 units on a scale
STANDARD_DEVIATION 13.3
Quality of Life VR-36
Physical Component Score
27.7 units on a scale
STANDARD_DEVIATION 7.5
28.1 units on a scale
STANDARD_DEVIATION 8.4
27.9 units on a scale
STANDARD_DEVIATION 7.9
Race/Ethnicity, Customized
African American
29 participants37 participants66 participants
Race/Ethnicity, Customized
Hispanic
5 participants1 participants6 participants
Race/Ethnicity, Customized
Other
10 participants5 participants15 participants
Race/Ethnicity, Customized
White
37 participants33 participants70 participants
Service-connected 100%16 participants13 participants29 participants
Service-connected benefits for SCI recipient19 participants15 participants34 participants
Sex: Female, Male
Female
4 Participants4 Participants8 Participants
Sex: Female, Male
Male
77 Participants72 Participants149 Participants
Social Security Disability Insurance recipient45 participants46 participants91 participants
Social Security Income recipient10 participants11 participants21 participants
VA benefits recipient50 participants43 participants93 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 810 / 76
serious
Total, serious adverse events
0 / 810 / 76

Outcome results

Primary

Competitive Employment-Participants With Competitive Employment

Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.

Time frame: 12 months

ArmMeasureValue (NUMBER)
Supported EmploymentCompetitive Employment-Participants With Competitive Employment21 Participants with competitive employment
Treatment As UsualCompetitive Employment-Participants With Competitive Employment8 Participants with competitive employment
Primary

Competitive Employment-Percentage of Participants With Competitive Employment

Employment outcomes during year 1 among those subjects obtaining competitive employment.

Time frame: 12 months

ArmMeasureValue (NUMBER)
Supported EmploymentCompetitive Employment-Percentage of Participants With Competitive Employment25.9 percentage of participants
Treatment As UsualCompetitive Employment-Percentage of Participants With Competitive Employment10.5 percentage of participants
p-value: 0.008Chi-squared
Primary

Competitive Employment-Total Jobs

Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.

Time frame: 12 months

ArmMeasureValue (NUMBER)
Supported EmploymentCompetitive Employment-Total Jobs50 Total Competitive Employments
Treatment As UsualCompetitive Employment-Total Jobs21 Total Competitive Employments

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026