Spinal Cord Injuries
Conditions
Keywords
Adult, Depression, Supported Employment, Health Service, Humans, Outcomes, Quality of Life, Veterans/rh (rehabilitation), Workplace, Spinal Cord Injuries
Brief summary
This study will be an extension of the Spinal Cord Injury Vocational Integration Program (SCI-VIP). The study involves research about how to help Veterans with spinal cord injury (SCI) gain employment. Vocational rehabilitation is a special field of service aimed at putting persons with disabilities in the best possible position to become employed. The Veterans Administration has a long history of providing vocational rehabilitation for Veterans with mental health issues and has recently started providing similar services to persons with physical disabilities, including SCI. Past research has shown that vocational rehabilitation is effective in helping some Veterans with spinal cord injury (SCI) gain employment. The extension of this work through PrOMOTE study will establish a large national database of over 2000 Veterans with SCI, containing extensive employment, medical, functional and psychosocial data. The study will analyze both quantitative and qualitative measures to maximize its findings.
Detailed description
Extending SCI-VIP through PrOMOTE will operationalize the critical features of supported employment that lead to obtaining and maintaining employment over time in spinal cord injury. There are no current studies that examine how the level and intensity of supported employment services by Veterans with SCI impacts employment outcomes. This extension will allow the examination of longitudinal factors associated with successful employment that are not possible within the time constrains of SCI-VIP and to extend the cost-effectiveness analysis and budget impact analysis to include longer term and costs of quality of life outcomes. The study will include a more comprehensive qualitative analysis across several sites of factors that contribute to program success. The PrOMOTE study will add three more sites. This expansion will allow examination of outcomes in areas where there is a high penetration of OIF/OEF Veterans as well as sites where there are other vocational programs available. Primary HO: Identify factors that predict employment after SCI. Secondary HO 1: Determine ongoing effectiveness of SE over time. Secondary HO 2: Evaluate the effectiveness of implementation strategy and level of SE model implementation across sites. Secondary HO 3: Determine costs, health care utilization over time and cost-effectiveness.
Interventions
BEHAVIORALVocational Rehabilitation
SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
All Veterans who meet inclusion criteria will be approached about completing a baseline interview to gather information on employment, health, and quality of life after spinal cord injury. Inclusion criteria for the baseline interview include: * 18 to 65 years old * Spinal Cord Injury * Medically and neurologically stable At the end of the baseline interview, some of these Veterans who meet additional inclusion criteria will be enrolled to receive the SE intervention or other available vocational services and complete longitudinal follow-up interviews every three months while participating in the study. The additional inclusion criteria for enrollment in vocational services include: * Unemployed * Living within 100 mile radius of the enrolling VA Medical Center * Desiring competitive employment A subsample of Veterans who consent to the study will be selected for participation in qualitative interviews. Family members and/or caregivers identified by these Veterans may also be included in qualitative interviews. A representative sample of VA staff members who provide care to these Veterans will also be approached to participate in qualitative interviews.
Exclusion criteria
* Medically and/or surgically unstable * Mentally impaired such that independent reasoning and judgment jeopardize safety of self or others * Active alcohol and/or drug dependency that is untreated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify Factors That Predict Employment After SCI. | 24-month phase with face-to-face quarterly interviews | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Employment Rate | 24 Months | Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study. |
| Determine Ongoing Effectiveness of SE Over Time. | 48-month phase with face-to-face quarterly interviews | 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. |
| Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | 24-month phase with face-to-face quarterly interviews | 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 |
| Determine Total Cost Per Patient Over 24 Months | 24-month phase with face-to-face quarterly interviews | 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. |
| Determine Cost-effectiveness. | 24-month phase with face-to-face quarterly interviews | 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. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 24-Month Supported Employment 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 | 1,047 |
| Total | 1,047 |
Baseline characteristics
| Characteristic | 24-Month Supported Employment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1047 Participants |
| Age, Continuous | 53.3 years STANDARD_DEVIATION 10.1 |
| AIS and neurological Level AIS D/E | 372 participants |
| AIS and neurological Level High Tetraplegia, AIS, A, B, C | 91 participants |
| AIS and neurological Level Low Tetraplegia, AIS A,B,C | 200 participants |
| AIS and neurological Level Missing | 13 participants |
| AIS and neurological Level Paraplegia, AIS A,B,C | 371 participants |
| ASIA Impairment Scale (AIS) A | 408 participants |
| ASIA Impairment Scale (AIS) B | 121 participants |
| ASIA Impairment Scale (AIS) C | 133 participants |
| ASIA Impairment Scale (AIS) D | 366 participants |
| ASIA Impairment Scale (AIS) E | 7 participants |
| ASIA Impairment Scale (AIS) Missing | 12 participants |
| Education Years | 13.8 years STANDARD_DEVIATION 2.4 |
| Functional Independence Measure | 71.5 units on a scale STANDARD_DEVIATION 27.2 |
| Marital Status Divorced | 366 participants |
| Marital Status Married | 373 participants |
| Marital Status Other | 305 participants |
| Marital Status Refused/NA | 3 participants |
| Measures of Handicap (CHART) Cognitive | 90.7 units on a scale STANDARD_DEVIATION 16.2 |
| Measures of Handicap (CHART) Economic Self Sufficiency | 57.9 units on a scale STANDARD_DEVIATION 42.1 |
| Measures of Handicap (CHART) Mobility | 76.8 units on a scale STANDARD_DEVIATION 23.9 |
| Measures of Handicap (CHART) Occupation | 47.6 units on a scale STANDARD_DEVIATION 33.9 |
| Measures of Handicap (CHART) Physical | 85.4 units on a scale STANDARD_DEVIATION 20.9 |
| Measures of Handicap (CHART) Social Integration | 88.6 units on a scale STANDARD_DEVIATION 14.5 |
| Military Service-connected 100% Missing | 69 participants |
| Military Service-connected 100% N/A | 379 participants |
| Military Service-connected 100% No | 258 participants |
| Military Service-connected 100% Yes | 341 participants |
| Military Service-connected benefits for SCI Missing/Other | 35 participants |
| Military Service-connected benefits for SCI N/A | 444 participants |
| Military Service-connected benefits for SCI No | 237 participants |
| Military Service-connected benefits for SCI Yes | 331 participants |
| Monthly Non-Service-connected pension | 1078 Dollars STANDARD_DEVIATION 795.4 |
| Monthly Social Security Disability Insurance Benefits | 1215 Dollar STANDARD_DEVIATION 556.2 |
| Monthly Social Security Income Benefits | 994 Dollars STANDARD_DEVIATION 485.2 |
| Neither Social Security Income/Social Security Disability Insurance Recipient Missing/Other | 13 participants |
| Neither Social Security Income/Social Security Disability Insurance Recipient N/A | 2 participants |
| Neither Social Security Income/Social Security Disability Insurance Recipient Neither | 234 participants |
| Neither Social Security Income/Social Security Disability Insurance Recipient One or more | 798 participants |
| Non-Service-connected pension Missing/Other | 39 participants |
| Non-Service-connected pension N/A | 378 participants |
| Non-Service-connected pension No | 498 participants |
| Non-Service-connected pension Yes | 132 participants |
| Quality of Life VR-36 Mental Component Scale | 56.5 T-score STANDARD_DEVIATION 12.4 |
| Quality of Life VR-36 Physical Component Scale | 27.2 T-score STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized African American | 306 participants |
| Race/Ethnicity, Customized Asian | 13 participants |
| Race/Ethnicity, Customized Caucasion | 653 participants |
| Race/Ethnicity, Customized Native American | 15 participants |
| Race/Ethnicity, Customized Other/Unknown | 60 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 1002 Participants |
| VA Benefits Recipient Missing/Other | 21 participants |
| VA Benefits Recipient N/A | 2 participants |
| VA Benefits Recipient No | 369 participants |
| VA Benefits Recipient Yes | 655 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 1,047 |
| serious Total, serious adverse events | 150 / 1,047 |
Outcome results
Primary
Identify Factors That Predict Employment After SCI.
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.
Time frame: 24-month phase with face-to-face quarterly interviews
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 24-Month Supported Employment | Identify Factors That Predict Employment After SCI. | 3.56 Odds Ratio |
90% CI: [1.8, 7.07]
Secondary
Determine Cost-effectiveness.
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 24-Month Supported Employment | Determine Cost-effectiveness. | 1.27 years | Standard Deviation 0.068 |
| Mid Stage | Determine Cost-effectiveness. | 1.15 years | Standard Deviation 0.058 |
Secondary
Determine Ongoing Effectiveness of SE Over Time.
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.
Time frame: 48-month phase with face-to-face quarterly interviews
Population: Number of participants in 24-month SE and 24-month SCI-VIP (previous study).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 24-Month Supported Employment | Determine Ongoing Effectiveness of SE Over Time. | 5 participants |
Secondary
Determine Total Cost Per Patient Over 24 Months
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 24-Month Supported Employment | Determine Total Cost Per Patient Over 24 Months | 134,029 US dollars |
| Mid Stage | Determine Total Cost Per Patient Over 24 Months | 169,433 US dollars |
Secondary
Employment Rate
Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 24-Month Supported Employment | Employment Rate | 43.2 percentage of participants with CE |
Secondary
Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites.
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
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 24-Month Supported Employment | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | VRS | 20 participants |
| 24-Month Supported Employment | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Obtaining resources | 10 participants |
| 24-Month Supported Employment | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Engagement of staff | 21 participants |
| 24-Month Supported Employment | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Integration of vocational and clinical team | 32 participants |
| 24-Month Supported Employment | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Audit and Feedback | 0 participants |
| 24-Month Supported Employment | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Fit of IPS Model | 0 participants |
| 24-Month Supported Employment | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Leadership Support | 17 participants |
| Mid Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Engagement of staff | 9 participants |
| Mid Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Integration of vocational and clinical team | 30 participants |
| Mid Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | VRS | 14 participants |
| Mid Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Leadership Support | 17 participants |
| Mid Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Obtaining resources | 9 participants |
| Mid Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Fit of IPS Model | 13 participants |
| Mid Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Audit and Feedback | 0 participants |
| Late Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Obtaining resources | 6 participants |
| Late Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | VRS | 19 participants |
| Late Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Audit and Feedback | 7 participants |
| Late Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Fit of IPS Model | 4 participants |
| Late Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Engagement of staff | 13 participants |
| Late Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Leadership Support | 13 participants |
| Late Stage | Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites. | Integration of vocational and clinical team | 30 participants |