Trial Outcomes & Findings for SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE) (NCT NCT01141647)

Last Updated: 2017-05-11

Results Overview

To model the probability of obtaining CE, we first dichotomized CE as 'yes' or 'no'. The Competitive Employment Rate is reported in Outcome Measure 2. We then used unconditional logistic regression to model the probability of obtaining CE through a univariate modeling approach to determine statistically significant predictors of CE. Statistically significant predictors at the p\<0.10 criterion level were then explored in a final multivariate model. Demographic (age, race, marital status, etc.), clinical (severity of injury, comorbidities, time since injury, etc.), barriers and facilitators, and quality of life (depression, Satisfaction with Life, etc.) were considered for modeling. A final model was obtained by including all parameters meeting the p\<0.10 criterion into a final multivariate model.

Recruitment status

COMPLETED

Study phase

Target enrollment

1047 participants

Primary outcome timeframe

24-month phase with face-to-face quarterly interviews

Results posted on

2017-05-11

Participant Flow

1047 subjects were enrolled; 450 were ineligible for supported employment (SE) services and 318 were out of the SE recruitment window. 279 SE participants remained, and 66 were analyzed separately because of their previous participation in SE. For the purposes of reporting 213 subjects were included

Participant milestones

Participant milestones
Measure	24-Month Supported Employment Evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
Overall Study STARTED	213
Overall Study COMPLETED	167
Overall Study NOT COMPLETED	46

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	24-Month Supported Employment n=1047 Participants Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1047 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	53.3 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	1002 Participants n=5 Participants
Race/Ethnicity, Customized Caucasion	653 participants n=5 Participants
Race/Ethnicity, Customized African American	306 participants n=5 Participants
Race/Ethnicity, Customized Asian	13 participants n=5 Participants
Race/Ethnicity, Customized Native American	15 participants n=5 Participants
Race/Ethnicity, Customized Other/Unknown	60 participants n=5 Participants
Functional Independence Measure	71.5 units on a scale STANDARD_DEVIATION 27.2 • n=5 Participants
ASIA Impairment Scale (AIS) A	408 participants n=5 Participants
ASIA Impairment Scale (AIS) B	121 participants n=5 Participants
ASIA Impairment Scale (AIS) C	133 participants n=5 Participants
ASIA Impairment Scale (AIS) D	366 participants n=5 Participants
ASIA Impairment Scale (AIS) E	7 participants n=5 Participants
ASIA Impairment Scale (AIS) Missing	12 participants n=5 Participants
AIS and neurological Level High Tetraplegia, AIS, A, B, C	91 participants n=5 Participants
AIS and neurological Level Low Tetraplegia, AIS A,B,C	200 participants n=5 Participants
AIS and neurological Level Paraplegia, AIS A,B,C	371 participants n=5 Participants
AIS and neurological Level AIS D/E	372 participants n=5 Participants
AIS and neurological Level Missing	13 participants n=5 Participants
Marital Status Married	373 participants n=5 Participants
Marital Status Divorced	366 participants n=5 Participants
Marital Status Other	305 participants n=5 Participants
Marital Status Refused/NA	3 participants n=5 Participants
Education Years	13.8 years STANDARD_DEVIATION 2.4 • n=5 Participants
VA Benefits Recipient Yes	655 participants n=5 Participants
VA Benefits Recipient No	369 participants n=5 Participants
VA Benefits Recipient N/A	2 participants n=5 Participants
VA Benefits Recipient Missing/Other	21 participants n=5 Participants
Military Service-connected benefits for SCI Yes	331 participants n=5 Participants
Military Service-connected benefits for SCI No	237 participants n=5 Participants
Military Service-connected benefits for SCI N/A	444 participants n=5 Participants
Military Service-connected benefits for SCI Missing/Other	35 participants n=5 Participants
Military Service-connected 100% Yes	341 participants n=5 Participants
Military Service-connected 100% No	258 participants n=5 Participants
Military Service-connected 100% N/A	379 participants n=5 Participants
Military Service-connected 100% Missing	69 participants n=5 Participants
Non-Service-connected pension Yes	132 participants n=5 Participants
Non-Service-connected pension No	498 participants n=5 Participants
Non-Service-connected pension N/A	378 participants n=5 Participants
Non-Service-connected pension Missing/Other	39 participants n=5 Participants
Monthly Non-Service-connected pension	1078 Dollars STANDARD_DEVIATION 795.4 • n=5 Participants
Monthly Social Security Income Benefits	994 Dollars STANDARD_DEVIATION 485.2 • n=5 Participants
Monthly Social Security Disability Insurance Benefits	1215 Dollar STANDARD_DEVIATION 556.2 • n=5 Participants
Neither Social Security Income/Social Security Disability Insurance Recipient Neither	234 participants n=5 Participants
Neither Social Security Income/Social Security Disability Insurance Recipient One or more	798 participants n=5 Participants
Neither Social Security Income/Social Security Disability Insurance Recipient N/A	2 participants n=5 Participants
Neither Social Security Income/Social Security Disability Insurance Recipient Missing/Other	13 participants n=5 Participants
Measures of Handicap (CHART) Social Integration	88.6 units on a scale STANDARD_DEVIATION 14.5 • n=5 Participants
Measures of Handicap (CHART) Occupation	47.6 units on a scale STANDARD_DEVIATION 33.9 • n=5 Participants
Measures of Handicap (CHART) Mobility	76.8 units on a scale STANDARD_DEVIATION 23.9 • n=5 Participants
Measures of Handicap (CHART) Physical	85.4 units on a scale STANDARD_DEVIATION 20.9 • n=5 Participants
Measures of Handicap (CHART) Cognitive	90.7 units on a scale STANDARD_DEVIATION 16.2 • n=5 Participants
Measures of Handicap (CHART) Economic Self Sufficiency	57.9 units on a scale STANDARD_DEVIATION 42.1 • n=5 Participants
Quality of Life VR-36 Mental Component Scale	56.5 T-score STANDARD_DEVIATION 12.4 • n=5 Participants
Quality of Life VR-36 Physical Component Scale	27.2 T-score STANDARD_DEVIATION 8.6 • n=5 Participants

PRIMARY outcome

Timeframe: 24-month phase with face-to-face quarterly interviews

Outcome measures

Outcome measures
Measure	24-Month Supported Employment n=213 Participants Participants in Supported Employment.	Mid Stage Interview data from clinical staff from year 2.	Late Stage Interview data from clinical staff in year 3.
Identify Factors That Predict Employment After SCI.	3.56 Odds Ratio Interval 1.8 to 7.07	—	—

SECONDARY outcome

Timeframe: 24 Months

Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.

Outcome measures

Outcome measures
Measure	24-Month Supported Employment n=213 Participants Participants in Supported Employment.	Mid Stage Interview data from clinical staff from year 2.	Late Stage Interview data from clinical staff in year 3.
Employment Rate	43.2 percentage of participants with CE	—	—

SECONDARY outcome

Timeframe: 48-month phase with face-to-face quarterly interviews

Population: Number of participants in 24-month SE and 24-month SCI-VIP (previous study).

This measure is used to evaluate the participants who were both in SCI-VIP and PrOMOTE. It assesses the number of people who obtained CE in SCI-VIP and sustained the same CE through their time in the PrOMOTE study. The cohort of SCI-VIP SE participants in PrOMOTE were analyzed separately from the 213 PrOMOTE participants.

Outcome measures

Outcome measures
Measure	24-Month Supported Employment n=30 Participants Participants in Supported Employment.	Mid Stage Interview data from clinical staff from year 2.	Late Stage Interview data from clinical staff in year 3.
Determine Ongoing Effectiveness of SE Over Time.	5 participants	—	—

SECONDARY outcome

Timeframe: 24-month phase with face-to-face quarterly interviews

Population: Each stage comprised of two site visits. Please note that in the early stage fit of IPS model and audit and feedback were not assessed in either of the site visits, hence a value of zero is entered. Also note that in the late stage obtaining resources, fit of IPS model, and audit and feedback were only assessed at 1/2 of the site visits.

Level of implementation was assessed by interviewing clinical and vocational providers from the seven sites who were involved in or knowledgeable about the program. Values reported represent the numbers of clinical staff who cited having the VRS integrated on the clinical team, a full-time VRS, leadership support, engagement of staff, resources provided immediately, making adjustments to the implementation to fit with the local context, and having audit and feedback as supporting strong implementation

Outcome measures

Outcome measures
Measure	24-Month Supported Employment n=43 Participants Participants in Supported Employment.	Mid Stage n=40 Participants Interview data from clinical staff from year 2.	Late Stage n=36 Participants Interview data from clinical staff in year 3.
Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. Integration of vocational and clinical team	32 participants	30 participants	30 participants
Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. VRS	20 participants	14 participants	19 participants
Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. Leadership Support	17 participants	17 participants	13 participants
Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. Engagement of staff	21 participants	9 participants	13 participants
Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. Obtaining resources	10 participants	9 participants	6 participants
Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. Fit of IPS Model	0 participants	13 participants	4 participants
Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. Audit and Feedback	0 participants	0 participants	7 participants

SECONDARY outcome

Timeframe: 24-month phase with face-to-face quarterly interviews

Population: 213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study.

Total cost is the mean total cost per patient over 24 months in US dollars. The minimum value is 0 representing no cost in US dollars and larger numbers indicating higher costs in US dollars.

Outcome measures

Outcome measures
Measure	24-Month Supported Employment n=213 Participants Participants in Supported Employment.	Mid Stage n=76 Participants Interview data from clinical staff from year 2.	Late Stage Interview data from clinical staff in year 3.
Determine Total Cost Per Patient Over 24 Months	134,029 US dollars Standard Deviation 148,449	169,433 US dollars Standard Deviation 187,661	—

SECONDARY outcome

Timeframe: 24-month phase with face-to-face quarterly interviews

Population: 213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study.

QALYs are the mean quality adjusted life years per patient for the Supported Employment and Standard Care groups. The QALY is a non-negative number assessing the quality and length of life and not just the crude number of years. The minimum value is 0 representing no improvement in the quality of life or length of life and larger numbers indicate healthier and longer life. Maximum QALYs are limited only by the life span of study participants, but may not exceed 1 (perfect health) in any given year.

Outcome measures

Outcome measures
Measure	24-Month Supported Employment n=213 Participants Participants in Supported Employment.	Mid Stage n=76 Participants Interview data from clinical staff from year 2.	Late Stage Interview data from clinical staff in year 3.
Determine Cost-effectiveness.	1.27 years Standard Deviation 0.068	1.15 years Standard Deviation 0.058	—

Adverse Events

Baseline Sample (N=1047)

Serious events: 150 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Baseline Sample (N=1047) n=1047 participants at risk Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
Blood and lymphatic system disorders Hospitalization	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Cardiac disorders Hospitalization	0.19% 2/1047 • Number of events 2 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Gastrointestinal disorders Hospitalization	0.48% 5/1047 • Number of events 5 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Immune system disorders Hospitalization	0.19% 2/1047 • Number of events 2 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Infections and infestations Hospitalization	3.2% 33/1047 • Number of events 45 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Injury, poisoning and procedural complications Hospitalization	1.3% 14/1047 • Number of events 16 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Investigations Hospitalization	0.48% 5/1047 • Number of events 7 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Metabolism and nutrition disorders Hospitalization	0.19% 2/1047 • Number of events 3 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Musculoskeletal and connective tissue disorders Hospitalization	0.10% 1/1047 • Number of events 2 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Nervous system disorders Hospitalization	0.67% 7/1047 • Number of events 7 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Psychiatric disorders Hospitalization	0.76% 8/1047 • Number of events 10 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Renal and urinary disorders Hospitalization	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Respiratory, thoracic and mediastinal disorders Hospitalization	0.38% 4/1047 • Number of events 4 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Skin and subcutaneous tissue disorders Hospitalization	0.86% 9/1047 • Number of events 12 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Social circumstances Hospitalization	0.67% 7/1047 • Number of events 9 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Surgical and medical procedures Hospitalization	3.6% 38/1047 • Number of events 50 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Vascular disorders Hospitalization	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Psychiatric disorders Life Threatening	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.19% 2/1047 • Number of events 2 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Infections and infestations Other important medical event	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Musculoskeletal and connective tissue disorders Other important medical event	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Social circumstances Incarceration	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Cardiac disorders Death	0.29% 3/1047 • Number of events 3 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Infections and infestations Death	0.57% 6/1047 • Number of events 6 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	0.19% 2/1047 • Number of events 2 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Nervous system disorders Death	2.6% 27/1047 • Number of events 27 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Psychiatric disorders Death	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Respiratory, thoracic and mediastinal disorders Death	0.29% 3/1047 • Number of events 3 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Skin and subcutaneous tissue disorders Death	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Vascular disorders Death	0.10% 1/1047 • Number of events 1 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.

Other adverse events

Other adverse events
Measure	Baseline Sample (N=1047) n=1047 participants at risk Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
Social circumstances Hospitalization - Respite	1.3% 14/1047 • Number of events 21 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.
Surgical and medical procedures Hospitalization - Annual Exam	0.67% 7/1047 • Number of events 8 • 4 years Reports provided to the coordinating center by site coordinators at each of the project's seven sites. All reported events were determined by the local IRBs to be unrelated to the study.

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