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

NCT01141647 | Completed Results

• 1 other identifier: O7814-R
• Study Type: interventional
• Target: 1,047
• Locations: 1 country
• Sites: 7

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.

Conditions

Spinal Cord Injuries

Keywords

Adult; Depression; Supported Employment; Health Service; Humans; Outcomes; Quality of Life; Veterans/rh (rehabilitation); Workplace; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Employment Rate

  24 Months

• Determine Ongoing Effectiveness of SE Over Time.

  48-month phase with face-to-face quarterly interviews

• Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites.

  24-month phase with face-to-face quarterly interviews

• Determine Total Cost Per Patient Over 24 Months

  24-month phase with face-to-face quarterly interviews

• Determine Cost-effectiveness.

  24-month phase with face-to-face quarterly interviews

Study Arms (1)

24-Month Supported Employment

EXPERIMENTAL

Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services

Behavioral: Vocational Rehabilitation

Interventions

Vocational Rehabilitation BEHAVIORAL

SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services

24-Month Supported Employment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old
• Spinal Cord Injury
• Medically and neurologically stable
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (7)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

Related Publications (5)

• 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.

  PMID: 25762857 RESULT

• 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.

  PMID: 25577499 RESULT

• 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.

  PMID: 29434460 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.

  PMID: 28594193 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.

  PMID: 28115071 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Depression

Interventions

Rehabilitation, Vocational

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Majority of sample is male.

Results Point of Contact

• Title: Lisa Ottomanelli, PhD
• Organization: James A. Haley Veterans' Hospital

lisa.ottomanelli-slone@va.gov

813-558-3917

Study Officials

• Lisa Ottomanelli, PhD

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 10, 2010
• Study Start: August 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 11, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)