Supported Employment in Patient Aligned Care Teams

Major Depressive Disorder Clinical Trial

Official title:

Efficacy of Supported Employment Within the OIF/OEF Patient Aligned Care Team

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400736
• Other study ID #: D1489-I
• Status: Completed
• Phase: N/A
• Start date: August 3, 2015
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Disorder
• Mental Disorders
• Posttraumatic Stress Disorder
• Psychotic Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Individual Placement and Support (IPS)
Individual Placement and Support (IPS) is the evidenced based model of supported employment.

Other:
• Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR)
Vocational Rehabilitation Treatment as Usual includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW).

Locations

Country	Name	City	State
United States	Tuscaloosa VA Medical Center, Tuscaloosa, AL	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Community Reintegration of Service Members	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.	12 months
Primary	Steady Worker	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).	12 months
Secondary	Weeks Worked in a Competitive Job	Number of weeks out of 52 week follow-up in which the participant worked at least one hour in a competitive job.	12 months
Secondary	Time to First Competitive Job	The number of weeks from randomization until the participant worked in a competitive job.	12 months
Secondary	Income Earned From Competitive Jobs	For those participants, the income earned from any competitive jobs was added for the 52-week follow-up period.	12 months
Secondary	Symptom Checklist-90-Revised Change From Baseline to Month 12.	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.	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.
Secondary	Income Earned From All Sources	All income earned from competitive, transitional work, and other sources over the 12-month follow-up.	12 months
Secondary	Rosenberg Self-Esteem Scale Change From Baseline to 12 Months.	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.	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.
Secondary	Income Earned From Competitive Jobs in Participants Who Held a Competitive Job	Income earned ($) from competitive jobs over 12 months was compared between groups for all randomized participants who held a competitive job at some point.	12 months

External Links

•   Methods and Baseline paper