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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vocational Rehabilitation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Adult, Depression, Supported Employment, Health Service, Humans, Outcomes, Quality of Life, Veterans/rh (rehabilitation), Workplace, Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA
  • James A. Haley Veterans' Hospital, Tampa, FL
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • VA Medical Center, Cleveland
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  • Michael E. DeBakey VA Medical Center (152)
  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

24-Month Supported Employment

Arm Description

Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2010
Last Updated
April 4, 2017
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01141647
Brief Title
SCI-VIP: Predictive Outcome Model Over Time for Employment (PrOMOTE)
Acronym
PrOMOTE
Official Title
Predictive Outcome Model Over Time for Employment (PROMOTE)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Adult, Depression, Supported Employment, Health Service, Humans, Outcomes, Quality of Life, Veterans/rh (rehabilitation), Workplace, Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1047 (Actual)

8. Arms, Groups, and Interventions

Arm Title
24-Month Supported Employment
Arm Type
Experimental
Arm Description
Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services
Intervention Type
Behavioral
Intervention Name(s)
Vocational Rehabilitation
Intervention Description
SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
Primary Outcome Measure Information:
Title
Identify Factors That Predict Employment After SCI.
Description
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
Secondary Outcome Measure Information:
Title
Employment Rate
Description
Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.
Time Frame
24 Months
Title
Determine Ongoing Effectiveness of SE Over Time.
Description
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
Title
Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites.
Description
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
Title
Determine Total Cost Per Patient Over 24 Months
Description
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
Title
Determine Cost-effectiveness.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Ottomanelli, PhD
Organizational Affiliation
James A. Haley Veterans' Hospital, Tampa, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
VA Medical Center, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center (152)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center, Richmond, VA
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will only be presented de-identified.
Citations:
PubMed Identifier
25762857
Citation
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.
Results Reference
result
PubMed Identifier
25577499
Citation
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.
Results Reference
result
PubMed Identifier
29434460
Citation
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.
Results Reference
derived
PubMed Identifier
28594193
Citation
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.
Results Reference
derived
PubMed Identifier
28115071
Citation
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.
Results Reference
derived

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

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