Trial Outcomes & Findings for Spinal Cord Injury Vocational Integration Program (SCI-VIP) (NCT NCT00117806)
NCT ID: NCT00117806
Last Updated: 2016-03-03
Results Overview
Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
249 participants
Primary outcome timeframe
12 months
Results posted on
2016-03-03
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Treatment As Usual
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
76
|
|
Overall Study
COMPLETED
|
43
|
60
|
|
Overall Study
NOT COMPLETED
|
38
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spinal Cord Injury Vocational Integration Program (SCI-VIP)
Baseline characteristics by cohort
| Measure |
Supported Employment
n=81 Participants
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.
|
Treatment As Usual
n=76 Participants
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
49.8 years
STANDARD_DEVIATION 9.8 • n=107 Participants
|
49.2 years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
37 participants
n=99 Participants
|
33 participants
n=107 Participants
|
70 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
29 participants
n=99 Participants
|
37 participants
n=107 Participants
|
66 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 participants
n=99 Participants
|
5 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Functional Independence Measure
Total
|
98.9 units on a scale
STANDARD_DEVIATION 23.8 • n=99 Participants
|
98.2 units on a scale
STANDARD_DEVIATION 23.7 • n=107 Participants
|
98.6 units on a scale
STANDARD_DEVIATION 23.6 • n=206 Participants
|
|
Functional Independence Measure
Cognitive
|
33.8 units on a scale
STANDARD_DEVIATION 2.3 • n=99 Participants
|
33.7 units on a scale
STANDARD_DEVIATION 2.8 • n=107 Participants
|
33.8 units on a scale
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Functional Independence Measure
Motor
|
66.9 units on a scale
STANDARD_DEVIATION 21.6 • n=99 Participants
|
66.4 units on a scale
STANDARD_DEVIATION 22.2 • n=107 Participants
|
66.6 units on a scale
STANDARD_DEVIATION 21.8 • n=206 Participants
|
|
Measures of Handicap (CHART)
Social Integration
|
82.0 units on a scale
STANDARD_DEVIATION 13.6 • n=99 Participants
|
84.7 units on a scale
STANDARD_DEVIATION 12.7 • n=107 Participants
|
83.3 units on a scale
STANDARD_DEVIATION 13.1 • n=206 Participants
|
|
Measures of Handicap (CHART)
Mobility
|
80.4 units on a scale
STANDARD_DEVIATION 17.0 • n=99 Participants
|
80.4 units on a scale
STANDARD_DEVIATION 22.4 • n=107 Participants
|
80.4 units on a scale
STANDARD_DEVIATION 19.7 • n=206 Participants
|
|
Measures of Handicap (CHART)
Cognitive
|
89.4 units on a scale
STANDARD_DEVIATION 16.6 • n=99 Participants
|
90.8 units on a scale
STANDARD_DEVIATION 14.9 • n=107 Participants
|
90.1 units on a scale
STANDARD_DEVIATION 15.7 • n=206 Participants
|
|
Measures of Handicap (CHART)
Occupation
|
51.5 units on a scale
STANDARD_DEVIATION 32.9 • n=99 Participants
|
50.4 units on a scale
STANDARD_DEVIATION 30.6 • n=107 Participants
|
51.0 units on a scale
STANDARD_DEVIATION 31.7 • n=206 Participants
|
|
Measures of Handicap (CHART)
Physical
|
85.7 units on a scale
STANDARD_DEVIATION 20.9 • n=99 Participants
|
87.2 units on a scale
STANDARD_DEVIATION 22.1 • n=107 Participants
|
86.4 units on a scale
STANDARD_DEVIATION 21.4 • n=206 Participants
|
|
Measures of Handicap (CHART)
Economic Self Sufficiency
|
51.5 units on a scale
STANDARD_DEVIATION 37.8 • n=99 Participants
|
52.6 units on a scale
STANDARD_DEVIATION 36.9 • n=107 Participants
|
52.1 units on a scale
STANDARD_DEVIATION 15.7 • n=206 Participants
|
|
Quality of Life VR-36
Mental Component Score
|
54.7 units on a scale
STANDARD_DEVIATION 13.8 • n=99 Participants
|
55.6 units on a scale
STANDARD_DEVIATION 12.9 • n=107 Participants
|
55.1 units on a scale
STANDARD_DEVIATION 13.3 • n=206 Participants
|
|
Quality of Life VR-36
Physical Component Score
|
27.7 units on a scale
STANDARD_DEVIATION 7.5 • n=99 Participants
|
28.1 units on a scale
STANDARD_DEVIATION 8.4 • n=107 Participants
|
27.9 units on a scale
STANDARD_DEVIATION 7.9 • n=206 Participants
|
|
ASIA Impairment Scale (AIS)
A-Complete
|
26 participants
n=99 Participants
|
20 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
ASIA Impairment Scale (AIS)
B-Sensory Incomplete
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
ASIA Impairment Scale (AIS)
C-Motor Incomplete
|
18 participants
n=99 Participants
|
18 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
ASIA Impairment Scale (AIS)
D-Motor Incomplete
|
25 participants
n=99 Participants
|
21 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
ASIA Impairment Scale (AIS)
E-Normal
|
0 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
AIS and neurological Level
High tetraplegia, AIS A, B,C
|
12 participants
n=99 Participants
|
13 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
AIS and neurological Level
Low tetraplegia, AIS A, B, C
|
5 participants
n=99 Participants
|
10 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
AIS and neurological Level
Paraplegia, AIS A, B, C
|
38 participants
n=99 Participants
|
27 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
AIS and neurological Level
AIS D/E
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Marital Status
Married
|
30 participants
n=99 Participants
|
15 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Marital Status
Divorced
|
28 participants
n=99 Participants
|
34 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
Marital Status
Other
|
23 participants
n=99 Participants
|
27 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Education Years
|
13.1 years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
13.5 years
STANDARD_DEVIATION 1.9 • n=107 Participants
|
13.3 years
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
VA benefits recipient
|
50 participants
n=99 Participants
|
43 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
Service-connected benefits for SCI recipient
|
19 participants
n=99 Participants
|
15 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Service-connected 100%
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
No Service-connected/Non-service-connected benefits
|
26 participants
n=99 Participants
|
20 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Non-service-connected pension
|
18 participants
n=99 Participants
|
18 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Monthly non-service-connected amount
|
1024 dollars
STANDARD_DEVIATION 482 • n=99 Participants
|
986 dollars
STANDARD_DEVIATION 421 • n=107 Participants
|
1005.7 dollars
STANDARD_DEVIATION 447.9 • n=206 Participants
|
|
Social Security Income recipient
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Social Security Disability Insurance recipient
|
45 participants
n=99 Participants
|
46 participants
n=107 Participants
|
91 participants
n=206 Participants
|
|
Neither Social Security Income/Social Security Disability Insurance recipient
|
26 participants
n=99 Participants
|
20 participants
n=107 Participants
|
46 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsCompetitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Outcome measures
| Measure |
Supported Employment
n=81 Participants
Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury.
|
Treatment As Usual
n=76 Participants
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
|
|---|---|---|
|
Competitive Employment-Total Jobs
|
50 Total Competitive Employments
|
21 Total Competitive Employments
|
PRIMARY outcome
Timeframe: 12 monthsCompetitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.
Outcome measures
| Measure |
Supported Employment
n=81 Participants
Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury.
|
Treatment As Usual
n=76 Participants
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
|
|---|---|---|
|
Competitive Employment-Participants With Competitive Employment
|
21 Participants with competitive employment
|
8 Participants with competitive employment
|
PRIMARY outcome
Timeframe: 12 monthsEmployment outcomes during year 1 among those subjects obtaining competitive employment.
Outcome measures
| Measure |
Supported Employment
n=81 Participants
Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury.
|
Treatment As Usual
n=76 Participants
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
|
|---|---|---|
|
Competitive Employment-Percentage of Participants With Competitive Employment
|
25.9 percentage of participants
Interval 17.6 to 36.5
|
10.5 percentage of participants
Interval 3.6 to 17.4
|
Adverse Events
Supported Employment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment As Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lisa Ottomanelli, PhD
James A. Haley Veterans' Hospital
Phone: 813-558-3917
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place