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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24-Month Supported Employment | Experimental | Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vocational Rehabilitation | Behavioral | SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24-month phase with face-to-face quarterly interviews |
| Measure | Description | Time Frame |
|---|---|---|
| Employment Rate | Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study. | 24 Months |
| Determine Ongoing Effectiveness of SE Over Time. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Ottomanelli, PhD | James A. Haley Veterans' Hospital, Tampa, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States | ||
| James A. Haley Veterans' Hospital, Tampa, FL |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25762857 | Result | Cotner BA, Njoh EN, Trainor JK, O'Connor DR, Barnett SD, Ottomanelli L. Facilitators and barriers to employment among veterans with spinal cord injury receiving 12 months of evidence-based supported employment services. Top Spinal Cord Inj Rehabil. 2015 Winter;21(1):20-30. doi: 10.1310/sci2101-20. | |
| 25577499 | Result |
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Data will only be presented de-identified.
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 24-Month Supported Employment | Evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 90% Confidence Interval | Odds Ratio | 24-month phase with face-to-face quarterly interviews |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline Sample (N=1047) | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization - Respite | Social circumstances | Non-systematic Assessment |
Majority of sample is male.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Ottomanelli, PhD | James A. Haley Veterans' Hospital | 813-558-3917 | lisa.ottomanelli-slone@va.gov |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D003863 | Depression |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D012050 | Rehabilitation, Vocational |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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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.
| 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 | 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. | 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. | 24-month phase with face-to-face quarterly interviews |
| Tampa |
| Florida |
| 33612 |
| United States |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | United States |
| VA Medical Center, Cleveland | Cleveland | Ohio | 44106 | United States |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216 | United States |
| Michael E. DeBakey VA Medical Center (152) | Houston | Texas | 77030 | United States |
| Hunter Holmes McGuire VA Medical Center, Richmond, VA | Richmond | Virginia | 23249 | United States |
| Sutton BS, Ottomanelli L, Njoh E, Barnett SD, Goetz LL. The impact of social support at home on health-related quality of life among veterans with spinal cord injury participating in a supported employment program. Qual Life Res. 2015 Jul;24(7):1741-7. doi: 10.1007/s11136-014-0912-4. Epub 2015 Jan 11. |
| 29434460 | Derived | Goetz LL, Ottomanelli L, Barnett SD, Sutton B, Njoh E. Relationship Between Comorbidities and Employment Among Veterans with Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018 Winter;24(1):44-53. doi: 10.1310/sci16-00047. Epub 2017 Sep 27. |
| 28594193 | Derived | Budd MA, Dixon TM, Barnett SD, Njoh E, Goetz LL, Ottomanelli L. Examination of traumatic brain injury exposure among veterans with spinal cord injury. Rehabil Psychol. 2017 Aug;62(3):345-352. doi: 10.1037/rep0000129. Epub 2017 Jun 8. |
| 28115071 | Derived | Ottomanelli L, Goetz LL, Barnett SD, Njoh E, Dixon TM, Holmes SA, LePage JP, Ota D, Sabharwal S, White KT. Individual Placement and Support in Spinal Cord Injury: A Longitudinal Observational Study of Employment Outcomes. Arch Phys Med Rehabil. 2017 Aug;98(8):1567-1575.e1. doi: 10.1016/j.apmr.2016.12.010. Epub 2017 Jan 20. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Functional Independence Measure | This measure contains 18 items composed of 13 motor-related tasks and 5 cognitive-related tasks. Each task is rated on a 7-point ordinal (1=total assistance (or complete dependence) to 7=complete independence). The range of scores is 18 to 126, with the lower score indicating greater dependence. | Mean | Standard Deviation | units on a scale |
|
| ASIA Impairment Scale (AIS) | ASIA Impairment is used to describe an individual's functional level impairment due to spinal cord injury. Ranging from level A indicating greatest impairment to level E all functioning having returned. | Number | participants |
|
| AIS and neurological Level | High Tetraplegia, AIS, A, B, C: high cervical injury with upper and lower extremities motor and/or sensory impairment. Low Tetraplegia, AIS, A, B, C low cervical injury with upper and lower extremities motor and/or sensory impairment. Paraplegia, AIS, A, B,C: an injury to the thoracic or lumbar area of the spinal cord resulting in motor and/or sensory impairment of the lower extremities. Tetraplegia or Paraplegia AIS D/E: cervical, thoracic or lumbar injury with the least amount of motor and/or sensory impairment. | Number | participants |
|
| Marital Status | Number | participants |
|
| Education Years | Mean | Standard Deviation | years |
|
| VA Benefits Recipient | Number | participants |
|
| Military Service-connected benefits for SCI | Service connected disability compensation is a monetary benefit paid to Veterans who are determined by VA to be disabled by an injury or illness that was incurred or aggravated during active military service. The level of benefit is indicated as a percentages in intervals of 10 starting at 0. Ratings of 10% or higher are monetarily compensated. To be Spinal Cord Injury service connected 100% is the highest level of compensation for a SCI that was incurred or aggravated during active military service. | Number | participants |
|
| Military Service-connected 100% | Number | participants |
|
| Non-Service-connected pension | Number | participants |
|
| Monthly Non-Service-connected pension | Mean | Standard Deviation | Dollars |
|
| Monthly Social Security Income Benefits | Mean | Standard Deviation | Dollars |
|
| Monthly Social Security Disability Insurance Benefits | Mean | Standard Deviation | Dollar |
|
| Neither Social Security Income/Social Security Disability Insurance Recipient | Number | participants |
|
| Measures of Handicap (CHART) | The CHART is a tool assessing an individuals level of handicap with six subscales. It consists of 32 items which assess six dimensions (cognitive independence, physical independence, mobility, occupation, social integration, and economic self-sufficiency). The scores for each subscale range from 0-100, with a score of 100 indicates no handicap in a given dimension. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life VR-36 | The VR-36 is used to measure health related quality of life. Assesses 8 domains (general health, physical functioning, role limitations, pain, energy-fatigue, social functioning and mental health). The 36 items have a 5-point ordinal response and result in providing two scores, physical component score (PCS) and mental component score (MCS). Items are summed with a range of 0-100. The PCS and MCS are standardized using a T-score and normed to a U.S. population (1990 population) score of 50 and standard deviation of 10.Higher scores means better outcome. | Mean | Standard Deviation | T-score |
|
Participants in Supported Employment. |
|
|
|
| Secondary | Employment Rate | Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study. | Posted | Number | percentage of participants with CE | 24 Months |
|
|
|
| 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. | Number of participants in 24-month SE and 24-month SCI-VIP (previous study). | Posted | Number | participants | 48-month phase with face-to-face quarterly interviews |
|
|
|
| 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 | 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. | Posted | Number | participants | 24-month phase with face-to-face quarterly interviews |
|
|
|
| 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. | 213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study. | Posted | Mean | Standard Deviation | US dollars | 24-month phase with face-to-face quarterly interviews |
|
|
|
| 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. | 213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study. | Posted | Mean | Standard Deviation | years | 24-month phase with face-to-face quarterly interviews |
|
|
|
| 150 |
| 1,047 |
| 21 |
| 1,047 |
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hospitalization | Immune system disorders | Non-systematic Assessment |
|
| Hospitalization | Infections and infestations | Non-systematic Assessment |
|
| Hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hospitalization | Investigations | Non-systematic Assessment |
|
| Hospitalization | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hospitalization | Nervous system disorders | Non-systematic Assessment |
|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
|
| Hospitalization | Renal and urinary disorders | Non-systematic Assessment |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalization | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hospitalization | Social circumstances | Non-systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | Non-systematic Assessment |
|
| Hospitalization | Vascular disorders | Non-systematic Assessment |
|
| Life Threatening | Psychiatric disorders | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Other important medical event | Infections and infestations | Non-systematic Assessment |
|
| Other important medical event | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Incarceration | Social circumstances | Non-systematic Assessment |
|
| Death | Cardiac disorders | Non-systematic Assessment |
|
| Death | Infections and infestations | Non-systematic Assessment |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Death | Nervous system disorders | Non-systematic Assessment |
|
| Death | Psychiatric disorders | Non-systematic Assessment |
|
| Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Death | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Death | Vascular disorders | Non-systematic Assessment |
|
| Hospitalization - Annual Exam | Surgical and medical procedures | Non-systematic Assessment |
|
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| D014947 | Wounds and Injuries |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
|
| Leadership Support |
|
| Engagement of staff |
|
| Obtaining resources |
|
| Fit of IPS Model |
|
| Audit and Feedback |
|