Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404, United States
NCT Number: NCT02400736
In response to the Rehabilitation Research and Development (RR&D) Deployment Health Research, this study addresses the delivery of an evidenced-based vocational rehabilitation, specifically Individual Placement and Support (IPS), for Veterans who are facing unemployment and mental illness as they try to recovery and re-establish civilian life. This study provides the requisite evidence needed to guide the Veterans Health Administration (VHA) as to whether to expand the target population for IPS to Veterans with any mental disorder, delivered directly within the primary care setting (i.e. Patient Aligned Care Team; PACT). Such modifications in VHA practice could substantially improve Veteran vocational rehabilitation access and outcomes, moving a significantly greater number of disabled Veterans back to full and productive lives in the community.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Tuscaloosa, Alabama, 35404, United States
Background: Veterans returning from Iraq and Afghanistan wars often confront unemployment as they reintegrate into civilian life. Over the past two decades, studies of Individual Placement and Support (IPS) supported employment have yielded remarkably robust and consistent vocational rehabilitation outcomes. However, IPS has predominantly only been studied in mental health settings and in the seriously mentally ill populations. Access to a mental health setting for recently deployed Veterans is often delayed by months or years, and thus, result in substantial delay of referrals to vocational rehabilitation programs which leave many Veterans vulnerable to continued unemployment and a deteriorating trajectory.
Methods: This single site, prospective, randomized, controlled study evaluated the efficacy of IPS when delivered within primary care Patient Aligned Care Teams (PACT). Participants were U.S. military Veterans who served in the Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn (OEF/OIF/OND) and/or any other Southwest Asia operations (i.e. since 1990) who were receiving care in a primary care PACT, currently unemployed and diagnosed with any mental disorder other than a serious mental illness. Eligible participants were randomized 1:1 to either IPS or VHA treatment as usual vocational rehabilitation (TAU-VR) which included prevocational counseling, community based supported employment, or most commonly Transitional Work assignment. Compared to TAU-VR (control condition), IPS delivered within a PACT was hypothesized to result in a higher rate of steady workers, as defined by working >/=50% of the weeks in the 12-month follow-up period in a competitive job (primary outcome), more weeks worked in a competitive job, and more income earned.
Significance: In an innovative approach, this study breaks from the diagnostic categorical approach and the mental health treatment setting and evaluates the efficacy of IPS when delivered in a primary care setting, specifically a PACT that serves Veterans who have returned from the Iraq, Afghanistan, and other Southwest Asia conflicts. Making a substantial paradigm shift, this study integrates IPS within a PACT for the first time ever. The research is directly linked to the RR&D priority areas of improving vocational outcomes and promoting recovery in Veterans.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Note: Veterans with history of mild traumatic brain injury (TBI) may be included in the study.
Exclusion criteria
Individual Placement and Support (IPS) is the evidenced based model of supported employment.
Other names: Supported Employment
Vocational Rehabilitation Treatment as Usual includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW).
Other names: Treatment as Usual, Transitional Work
Time frame: 12 months
Participants were categorized as a steady worker if they held a competitive job for 50% or more of the 12-month follow-up (i.e. 26 or more weeks out of 52 weeks).
Time frame: 12 months
Number of weeks out of 52 week follow-up in which the participant worked at least one hour in a competitive job.
Time frame: 12 months
The number of weeks from randomization until the participant worked in a competitive job.
Time frame: 12 months
For those participants, the income earned from any competitive jobs was added for the 52-week follow-up period.
Time frame: Change from baseline to month 12 (value at 12 months minus value at baseline) is shown below. Additionally, all relevant time points used in the calculation timeframe from baseline to 12 months (baseline, months 4, 6, 8, and 12) included in analysis.
Symptom Checklist-90-Revised (SCL-90-R): 90-item self-report survey; assesses nine dimensions. Each item is self-rated for level of discomfort/distress on scale of 0 "not at all" to 4 "extremely" for somatization (range 0 to 48), obsessive-compulsive symptoms (range 0 to 40), interpersonal sensitivity (range 0 to 36), depression (range 0 to 52), anxiety (range 0 to 40), hostility (range 0 to 24), phobic-anxiety (range 0 to 28), paranoid ideation (range 0 to 24), and psychoticism (range 0 to 40). Total score for a dimension is the sum of items and the distress score for each dimension is the sum divided by number of items in that dimension (range = 0 to 4). Global Severity Index is a mean of all items, calculated by dividing the sum of scores by the number of items (range 0 to 4). Higher score indicates greater distress and increase in score over time indicates worse outcome.
Time frame: 12 months
All income earned from competitive, transitional work, and other sources over the 12-month follow-up.
Time frame: Change from baseline to month 12 (value at 12 months minus value at baseline) is shown below. Additionally, all relevant time points used in the calculation timeframe from baseline to 12 months (baseline, months 4, 6, 8, 12) were included in mixed model.
Rosenberg Self-Esteem Scale (RSES) is a 10-item self-report Likert-type questionnaire that asks participants to indicate the degree of their agreement or disagreement with statements about their self-esteem and self-depreciation from 0 = "strongly agree" to 3 = "strongly disagree". The items are summed and the scoring ranges from 0 to 30, with higher scores indicating a higher degree of self-esteem; a positive change in score over time indicates improved self esteem. A score less than 15 may indicate low self esteem.
Time frame: 12 months
Income earned ($) from competitive jobs over 12 months was compared between groups for all randomized participants who held a competitive job at some point.
Time frame: 12 months
Community Reintegration of Service Members (CRIS) is a self-report instrument used to evaluate the Veteran's reintegration into the community. The correlations between the CRIS and the 36-Item Short Form Health Survey scales of role physical, role emotional, and social functioning were 0.44-0.80 and the CRIS has strong reliability, conceptual integrity, and construct validity. In pilot studies with 126 veterans, working subjects had better CRIS scores then unemployed subjects. Items on the CRIS cover 9 aspects of participation: Learning and Applying Knowledge, General Tasks and Demands, Communication, Mobility, Self-care, Domestic Life, Interpersonal Relationships, Major Life Areas, and Community, Social and Civic Life. Subscale scores for 1) extent of participation, 2) perceived limitations, and 3) satisfaction with participation are calculated. For each of the 3 subscales, the minimum score is 10, the maximum score is 70. Higher scores are indication of better outcomes.
VA Office of Research and Development
Fed
Efficacy of Supported Employment Within the OIF/OEF Patient Aligned Care Team
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