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Supported Employment in Patient Aligned Care Teams

Primary Purpose

Mental Disorder, Substance Use Disorders, Posttraumatic Stress Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Individual Placement and Support (IPS)

Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR)

About this trial

This is an interventional treatment trial for Mental Disorder focused on measuring 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

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individual Placement and Support (IPS)

Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)

Arm Description

Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the PACT; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study.

Treatment as Usual Vocational Rehabilitation includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: The TW specialist does not provide long-term follow-up after the first job is obtained.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Time to First Competitive Job

The number of weeks from randomization until the participant worked in a competitive job.

Income Earned From Competitive Jobs

For those participants, the income earned from any competitive jobs was added for the 52-week follow-up period.

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.

Income Earned From All Sources

All income earned from competitive, transitional work, and other sources over the 12-month follow-up.

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.

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.

Full Information

NCT ID

NCT02400736

First Posted

March 10, 2015

Last Updated

February 15, 2022

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT02400736

Brief Title

Supported Employment in Patient Aligned Care Teams

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

August 3, 2015 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Individual Placement and Support (IPS)

Arm Type

Experimental

Arm Description

Arm Title

Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Individual Placement and Support (IPS)

Other Intervention Name(s)

Supported Employment

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR)

Other Intervention Name(s)

Treatment as Usual, Transitional Work

Intervention Description

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

Primary Outcome Measure Information:

Title

Steady Worker

Description

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

Secondary Outcome Measure Information:

Title

Weeks Worked in a Competitive Job

Description

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

Title

Time to First Competitive Job

Description

The number of weeks from randomization until the participant worked in a competitive job.

Time Frame

12 months

Title

Income Earned From Competitive Jobs

Description

For those participants, the income earned from any competitive jobs was added for the 52-week follow-up period.

Time Frame

12 months

Title

Symptom Checklist-90-Revised Change From Baseline to Month 12.

Description

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.

Title

Income Earned From All Sources

Description

All income earned from competitive, transitional work, and other sources over the 12-month follow-up.

Time Frame

12 months

Title

Rosenberg Self-Esteem Scale Change From Baseline to 12 Months.

Description

Time Frame

Title

Income Earned From Competitive Jobs in Participants Who Held a Competitive Job

Description

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

Other Pre-specified Outcome Measures:

Title

Community Reintegration of Service Members

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lori L Davis, MD

Organizational Affiliation

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tuscaloosa VA Medical Center, Tuscaloosa, AL

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35404

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No individual participant data will be shared.

Citations:

PubMed Identifier

32066380

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.

Results Reference

background

PubMed Identifier

34521208

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.

Results Reference

derived

Links:

URL

http://doi.org/10.1186/s12874-020-0919-1

Description

Methods and Baseline paper

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