NCT02400736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

August 3, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 30, 2021

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

4.2 years

First QC Date

March 10, 2015

Results QC Date

October 14, 2020

Last Update Submit

February 15, 2022

Conditions

Keywords

VeteransPatient Aligned Care TeamPrimary CareMental DisordersSubstance Use DisordersPosttraumatic Stress disorderMajor DepressionIndividual Placement and SupportSupported EmploymentVocational RehabilitationTransitional WorkAnxiety Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Weeks Worked in a Competitive Job

    12 months

  • Time to First Competitive Job

    12 months

  • Income Earned From Competitive Jobs

    12 months

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

    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.

  • Income Earned From All Sources

    12 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Community Reintegration of Service Members

    12 months

Study Arms (2)

Individual Placement and Support (IPS)

EXPERIMENTAL

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.

Behavioral: Individual Placement and Support (IPS)

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

ACTIVE COMPARATOR

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.

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

Interventions

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

Also known as: Supported Employment
Individual Placement and Support (IPS)

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

Also known as: Treatment as Usual, Transitional Work
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404, United States

Location

Related Publications (2)

  • 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.

    PMID: 32066380BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Mental DisordersSubstance-Related DisordersStress Disorders, Post-TraumaticDepressive Disorder, MajorAnxiety Disorders

Interventions

Palliative CareEmployment, SupportedTherapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersDepressive DisorderMood Disorders

Intervention Hierarchy (Ancestors)

Patient CareHealth ServicesHealth Care Facilities Workforce and ServicesEmploymentSocioeconomic FactorsPopulation CharacteristicsRehabilitation, VocationalRehabilitation

Limitations and Caveats

Limitations: single-site, veterans only, under representation of women, and the site only achieved "fair" level of implementation of IPS based on the IPS Fidelity Scale. Transitional work assignments may have weakened employment outcomes in control group; but only half of the control group held a TW assignment. Strengths: randomized approach, credible control group, 12-month follow-up, broad eligibility criteria, and novel setting (i.e. primary care setting).

Results Point of Contact

Title
Lori L. Davis, M.D.
Organization
Tuscaloosa VA Medical Center

Study Officials

  • Lori L Davis, MD

    Tuscaloosa VA Medical Center, Tuscaloosa, AL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 27, 2015

Study Start

August 3, 2015

Primary Completion

September 30, 2019

Study Completion

September 30, 2020

Last Updated

March 9, 2022

Results First Posted

March 30, 2021

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared.

Locations