Clinical trial NCT02400736: Supported Employment in Patient Aligned Care Teams
Official title: Efficacy of Supported Employment Within the OIF/OEF Patient Aligned Care Team
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Substance Use Disorders
Posttraumatic Stress Disorder
Major Depressive Disorder
Anxiety Disorder
Keywords: Veterans
Patient Aligned Care Team
Primary Care
Mental Disorders
Substance Use Disorders
Posttraumatic Stress disorder
Major Depression
Individual Placement and Support
Supported Employment
Vocational Rehabilitation
Transitional Work
Anxiety Disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-03-27
Enrollment: 119
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 19\* (\<19 years of age is the state of Alabama defined minor)
* Receiving primary care treatment in the Tuscaloosa VA Medical Center (TVAMC) PACT, called the Transition Center (i.e. served during the OEF/OIF/OND/other Southwest Asia conflicts) or other Primary Care PACT providing care for OEF/OIF/OND/other Southwest Asia Veteran
* Otherwise eligible for TVAMC vocational rehabilitation services, in the event that the Veteran is randomized to TW
* diagnosis that is disabling or potentially disabling (i.e. depressive, bipolar II, anxiety, obsessive-compulsive, trauma- and stressor-related, dissociative, impulse- control, and substance related/addictive (other than caffeine and nicotine) disorder classifications), other than those listed as exclusionary, within past 90 days according to Diagnostic and Statistical Manual 5th edition.
* Currently unemployed, defined as not working in a competitive job for a wage or under-employed, defined as (defined as: working less than 20 hours per week in a job that is low wage and is not in keeping with the Veteran's ability, aptitude, or skills)
* Expression of interest in competitive employment
* Willing and able to give informed consent.

Note: Veterans with history of mild traumatic brain injury (TBI) may be included in the study.

Exclusion Criteria:

* Current diagnosis of (i) schizophrenia, (ii) schizoaffective, (iii) bipolar I disorder, or major depression with psychotic features, since these Veterans may receive IPS in mental health
* Diagnosis of dementia (evidenced in the medical record)
* Clinically significant unstable or severe medical condition, or terminal illness, that would contraindicate study participation or expose them to an undue risk of a significant adverse event
* Unlikely that participant can complete the study, e.g. expected deployment, incarceration, long-term hospitalization, or relocation from the vicinity of the TVAMC during the study period
* Active suicidal or homicidal ideation making it unsafe for Veteran to be included in study
* Current participation in another interventional trial.

Primary outcomes:
measure: Steady Worker
timeFrame: 12 months
Secondary outcomes:
measure: Weeks Worked in a Competitive Job
timeFrame: 12 months
measure: Time to First Competitive Job
timeFrame: 12 months
measure: Income Earned From Competitive Jobs
timeFrame: 12 months
measure: Symptom Checklist-90-Revised Change From Baseline to Month 12.
timeFrame: 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.
measure: Income Earned From All Sources
timeFrame: 12 months
measure: Rosenberg Self-Esteem Scale Change From Baseline to 12 Months.
timeFrame: 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.
measure: Income Earned From Competitive Jobs in Participants Who Held a Competitive Job
timeFrame: 12 months
Other outcomes:
measure: Community Reintegration of Service Members
timeFrame: 12 months
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center, Tuscaloosa, AL
state: Alabama
Study officials:
affiliation: Tuscaloosa VA Medical Center, Tuscaloosa, AL
name: Lori L Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis LL, Blansett CM, Mumba MN, MacVicar D, Toscano R, Pilkinton P, Gay W, Bartolucci A. The methods and baseline characteristics of a VA randomized controlled study evaluating supported employment provided in primary care patient aligned care teams. BMC Med Res Methodol. 2020 Feb 17;20(1):33. doi: 10.1186/s12874-020-0919-1.
citation: Davis LL, Mumba MN, Toscano R, Pilkinton P, Blansett CM, McCall K, MacVicar D, Bartolucci A. A Randomized Controlled Trial Evaluating the Effectiveness of Supported Employment Integrated in Primary Care. Psychiatr Serv. 2022 Jun;73(6):620-627. doi: 10.1176/appi.ps.202000926. Epub 2021 Sep 15.