An interventional study of Vocational Rehabilitation in Spinal Cord Injuries, sponsored by VA Office of Research and Development. Completed at 7 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-11.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 1,047 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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:
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:
Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services
Behavioral: Vocational Rehabilitation
SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
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
Employment Rate
Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.
Time frame: 24 Months
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
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
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
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
| Milestone | 24-Month Supported Employment |
|---|---|
| Started | 213 |
| Completed | 167 |
| Not completed | 46 |
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.
| Odds Ratio | 24-Month Supported Employment |
|---|---|
| Identify Factors That Predict Employment After SCI. | 3.56 (1.80 to 7.07) |
Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.
| percentage of participants with CE | 24-Month Supported Employment |
|---|---|
| Employment Rate | 43.2 |
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.
| participants | 48-Month Supported Employment |
|---|---|
| Determine Ongoing Effectiveness of SE Over Time. | 5 |
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
| participants | Early Stage | Mid Stage | Late Stage |
|---|---|---|---|
| Integration of vocational and clinical team | 32 | 30 | 30 |
| VRS | 20 | 14 | 19 |
| Leadership Support | 17 | 17 | 13 |
| Engagement of staff | 21 | 9 | 13 |
| Obtaining resources | 10 | 9 | 6 |
| Fit of IPS Model | 0 | 13 | 4 |
| Audit and Feedback | 0 | 0 | 7 |
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.
| US dollars | 24-Month Supported Employment | Participants in SCI-VIP Standard Care |
|---|---|---|
| Determine Total Cost Per Patient Over 24 Months | 134,029 ± 148,449 | 169,433 ± 187,661 |
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.
| years | 24-Month Supported Employment | Participants in SCI-VIP Standard Care |
|---|---|---|
| Determine Cost-effectiveness. | 1.27 ± 0.068 | 1.15 ± 0.058 |
Collected over 4 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baseline Sample (N=1047) | — | 150/1,047 (14.3%) | 21/1,047 (2%) |
| Event | Baseline Sample (N=1047) |
|---|---|
| HospitalizationSurgical and medical procedures | 38/1047 |
| HospitalizationInfections and infestations | 33/1047 |
| DeathNervous system disorders | 27/1047 |
| HospitalizationInjury, poisoning and procedural complications | 14/1047 |
| HospitalizationSkin and subcutaneous tissue disorders | 9/1047 |
| HospitalizationPsychiatric disorders | 8/1047 |
| HospitalizationNervous system disorders | 7/1047 |
| HospitalizationSocial circumstances | 7/1047 |
| DeathInfections and infestations | 6/1047 |
| HospitalizationGastrointestinal disorders | 5/1047 |
| Event | Baseline Sample (N=1047) |
|---|---|
| Hospitalization - RespiteSocial circumstances | 14/1047 |
| Hospitalization - Annual ExamSurgical and medical procedures | 7/1047 |
| Age, Categorical(Participants) | 24-Month Supported Employment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1047 |
| >=65 years | 0 |
| Age, Continuous(years) | 24-Month Supported Employment |
|---|---|
| Mean | 53.3 ± 10.1 |
| Sex: Female, Male(Participants) | 24-Month Supported Employment |
|---|---|
| Female | 45 |
| Male | 1002 |
| Race/Ethnicity, Customized(participants) | 24-Month Supported Employment |
|---|---|
| Caucasion | 653 |
| African American | 306 |
| Asian | 13 |
| Native American | 15 |
| Other/Unknown | 60 |
| Functional Independence Measure(units on a scale) | 24-Month Supported Employment |
|---|---|
| Mean | 71.5 ± 27.2 |
| ASIA Impairment Scale (AIS)(participants) | 24-Month Supported Employment |
|---|---|
| A | 408 |
| B | 121 |
| C | 133 |
| D | 366 |
| E | 7 |
| Missing | 12 |
| AIS and neurological Level(participants) | 24-Month Supported Employment |
|---|---|
| High Tetraplegia, AIS, A, B, C | 91 |
| Low Tetraplegia, AIS A,B,C | 200 |
| Paraplegia, AIS A,B,C | 371 |
| AIS D/E | 372 |
| Missing | 13 |
| Marital Status(participants) | 24-Month Supported Employment |
|---|---|
| Married | 373 |
| Divorced | 366 |
| Other | 305 |
| Refused/NA | 3 |
11 further baseline measures are reported on the registry.
Plan to share: No — Data will only be presented de-identified.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development