Spinal Cord InjuriesPrOMOTENCT01141647
SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE)
A study testing Vocational Rehabilitation in people with Spinal Cord Injuries, run by VA Office of Research and Development at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Vocational Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,047 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
Official title: Predictive Outcome Model Over Time for Employment (PROMOTE)
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Vocational Rehabilitation
- Keywords
- Adult, Depression, Supported Employment, Health Service, Humans, Outcomes, Quality of Life, Veterans/rh (rehabilitation), Workplace, Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocational RehabilitationBehavioural
SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
| Study group | Role | What they receive |
|---|---|---|
| 24-Month Supported Employment | Experimental | Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services Receives: Behavioral: Vocational Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-month phase with face-to-face quarterly interviews
Secondary outcomes (5)
Employment Rate
Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 24-month phase with face-to-face quarterly interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startAug 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,047 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa Ottomanelli, PhD, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141647
- Sponsor's protocol ID
- O7814-R
- Acronym
- PrOMOTE
- Status last verified
- Apr 2017
- First submitted
- 8 Jun 2010
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data will only be presented de-identified.
Publications
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.
PubMed 25762857Sutton 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.
PubMed 25577499Goetz 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.
PubMed 29434460Budd 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.
PubMed 28594193Ottomanelli 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.
PubMed 28115071
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Outcome Model Over Time for Employment (PROMOTE)
- ClinicalTrials.gov ID
- NCT01141647
- Acronym / sponsor ID
- PrOMOTE / O7814-R
- Conditions
- Spinal Cord Injuries
- Keywords
- Adult, Depression, Supported Employment, Health Service, Humans, Outcomes, Quality of Life, Veterans/rh (rehabilitation)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,047 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Aug 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 24-Month Supported Employment | Experimental | Behavioral: Vocational RehabilitationEvidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vocational RehabilitationSCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services | Behavioural | 24-Month Supported Employment |
Primary outcome
Identify Factors That Predict Employment After SCI.
Time frame: 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.
5 secondary outcomes
Employment Rate
Time frame: 24 Months
Determine Ongoing Effectiveness of SE Over Time.
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.
Time frame: 24-month phase with face-to-face quarterly interviews
Determine Total Cost Per Patient Over 24 Months
Time frame: 24-month phase with face-to-face quarterly interviews
Determine Cost-effectiveness.
Time frame: 24-month phase with face-to-face quarterly interviews
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25762857Cotner 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.
- Results publication: PubMed 25577499Sutton 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.
- Derived from this study: PubMed 29434460Goetz 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.
- Derived from this study: PubMed 28594193Budd 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.
- Derived from this study: PubMed 28115071Ottomanelli 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.
- Individual participant dataSharing planned: No. Data will only be presented de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Ottomanelli, PhD principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocational Rehabilitation in people with Spinal Cord Injuries, run by VA Office of Research and Development at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify Factors That Predict Employment After SCI. (time frame: 24-month phase with face-to-face quarterly interviews). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01141647, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.