Ethics Approval and Consent to Participate
This study is approved by the Tuscaloosa VA Medical Center Institutional Review Board (i.e. local human research subjects protections program’s ethics committee) and is conducted in accordance with the Declaration of Helsinki. All participants in the study provide written informed consent prior to participating in any study procedures. The study maintains Institutional Review Board approvals on an annual basis. The study is monitored by an independent Data and Safety Monitoring Board and has a Certificate of Confidentiality approved by the National Institute of Mental Health.
Overview of Design, Aim, and Hypotheses
Supported by VA Rehabilitation Research and Development, investigators at the Tuscaloosa VA Medical Center are currently conducting a single-site, randomized, controlled study to determine the effectiveness and feasibility of IPS when delivered within a primary care PACT in veterans who are unemployed and have a mental health diagnosis other than an SMI. The hypotheses are that, compared to TAU-VR (control), IPS delivered within a PACT will result in a higher rate of steady workers, defined as working ≥26 weeks in the 12-month follow-up period in a competitive job (primary); improved quality of life and self-esteem (secondary); very good veteran satisfaction and acceptability (tertiary); improved community re-integration (exploratory); and lower rates of high intensity crisis services (exploratory). Participants are recruited from outpatient primary care PACT clinics and community settings.
Veterans who are ≥ 19 years of age, receiving primary care in a PACT clinic, currently unemployed and interested in competitive employment, willing to be randomized to either existing TUA-VR or IPS services, and otherwise eligible for vocational rehabilitation services are eligible for study participation. Veterans must also be diagnosed with a current disabling or potentially disabling mental disorder, excluding a current diagnosis of schizophrenia, schizoaffective, bipolar I disorder, or major depression with psychotic features. Veterans who are unable to provide consent, unlikely to complete the study, actively suicidal or homicidal, have a diagnosis of dementia, or involved in another vocational study are ineligible for study participation. Veterans are not excluded based on gender, sexual orientation, race, ethnicity, or social class.
Randomization and Follow-up Schedule
After signing informed consent, eligible participants are randomized to either IPS delivered in the PACT or TAU-VR services, which may include transitional work assignment at the Tuscaloosa VA Medical Center. Randomization utilizes a permuted block design of randomly varying block sizes. After randomization, the participants, providers, and outcomes assessors are openly aware of the treatment assignment. During the 12-month follow-up period, the participants are assessed monthly for employment outcomes and every two months for all other outcome assessments, except for the community reintegration assessment, which is conducted every four months.
Information collected at baseline include demographics, military service history, employment history, status and type of housing, number of dependents, type of transportation, disability status, and family care burden. Baseline assessments include the MINI International Neuropsychiatric Interview Version 7 (MINI) to assess concurrent mental disorders for DSM-5,16 the Cumulative Illness Rating Scale (CIRS)17-18 to asses general medical conditions and determine medical burden, and the Ohio State University Traumatic Brain Injury Identification Method – Short Form to assess lifetime history and severity of traumatic brain injury.19 Repeated measures include: Rosenberg Self-Esteem Scale (RSES),20 Quality of Life Inventory (QOLI),21 Community Reintegration of Service Members (CRIS),22 Symptom Checklist-90-Revised (SCL-90-R),23 Client Satisfaction Questionnaire-8 (CSQ-8),24 and Sheehan Suicidality Tracking Scale.25 Additionally, the Clinical Research Coordinator (CRC) completes an Inventory of Crisis Events that assesses the number of emergency room visits, contacts with the legal system, and days of inpatient treatment, nights spent homeless, and days of substance misuse at baseline and follow-up visits.
Employment Outcome Assessments
The primary outcome of “steady worker” is defined as holding competitive employment for at least 50% of the weeks during the 12-month follow-up (i.e., ≥ 26 of the 52 weeks), and “competitive employment” is defined as a job for salary, wages, or commission in a setting that is not set aside or enclaved (i.e., the same job could be held by people without mental illness or disability). Cash-based or transient jobs, such as yard work, babysitting, day labor, and military drill do not count as competitive employment. A week is recorded as “employed” if the participant holds a competitive job for ≥1 hour/day for ≥1 day/week. Weeks do not have to be consecutively worked to count toward the threshold of “steady worker.” At baseline and reinforced at all follow-up visits, the participants are instructed to maintain a study-formatted Employment Calendar Diary, retain a copy of any pay records or tax forms, and bring the documents to the follow-up visits. In addition to reviewing these documents, the CRC reviews notes in the participant’s electronic medical record and conducts a semi-structured interview focused on employment activities. Based on these combined sources, the CRC records the following employment data for each week: 1) did the participant work for pay (Yes, No, Unknown); 2) type of work (transitional work, competitive, or other); 3) type of job(s) coded using the Hollingshead Categories from the Addictions Severity Index;26 4) number of days worked, 5) number of hours worked, 6) gross income earned, and 7) whether the job was new for each referenced week.
Patient Aligned Care Team (PACT) Setting
PACT is a patient-driven, team-based approach to deliver efficient, comprehensive and continuous care that includes these domains: Patient-driven: Medical care is focused on the person rather than the condition or disease. The patients’ needs and preferences are the centerpiece of a partnership among the primary care team, the patient and their family or caregiver. The patient is informed about the management of their health care and takes an active part in the clinical decision-making. Team-based Care: Medical care is delivered by an interdisciplinary team, including the patient as a member and the specialist(s) as an expansion of the integrated core team. Efficient Services: Through open access, technologies, performance measurements, systems redesign, patient education, and enhanced communications, the patient receives timely, appropriate, and responsive care. All team members work at the top of their competencies to maximize their clinical impact within a time sensitive period. Comprehensive Care: The PACT addresses all medical, behavioral, psychosocial and functional status issues on an ongoing basis. Psychologists and social workers are embedded in the primary care PACT. The PACT involves community partners and providers when necessary, to provide a full spectrum of care. Continuous Care: A continuous, longitudinal relationship between the Veteran and PACT provides for all the patient’s health care needs, either directly or collaboratively with specialists. The PACT adjusts over time to the patient’s needs, depending on the complexity of the care and stage of illness. Communication: Reliable, accessible, and culturally sensitive communication between the patient and the PACT promotes an honest dialogue without fear of judgment or repercussions and allows the PACT to make informed recommendations, meanwhile, respecting the patient as the locus of control. Coordination: The partnership between the patient and PACT allows care to be implemented through a coordinated and active interdisciplinary approach across specialties and settings, facilitated by information technology, access to health information and other means to assure that the patient makes informed choices and gets the agreed upon appropriate care. There is coordination of care between the core PACT and the expanded team that involves specialty consultants, to ensure that high risk transitions are managed appropriately and seamlessly.
Individual Placement and Support Intervention
IPS is an evidence-based vocational rehabilitation intervention that focuses on the client obtaining and sustaining competitive employment that aligns with their skills, abilities, and preferences, without prevocational training or transitional work assignments.27,28 An IPS specialist serves a caseload of up to 20 clients and carries out all phases of employment services, e.g. intake, assessment, job development, job coaching, and follow-along supports in the context of a competitive job. IPS involves the following domains: Eligibility Based on Client Choice: IPS embraces the notion of “zero exclusion” whereby clients who want to work are eligible for IPS services; Personalized Benefits Counseling: IPS help clients navigate complex systems and obtain personalized information about their VA, Social Security, Medicaid, and other government entitlements; Rapid Job Search: IPS Specialists use a rapid job search to help clients obtain jobs directly, rather than starting with pre-employment testing and training; Systematic Job Development: IPS Specialists spend most of their time in the community cultivating relationships between their clients and potential employers, working to build an employer network based on clients’ interests; Competitive Employment: IPS assists participants to seek and obtain competitive jobs that are consistent with their interests, skills, abilities, and preferences, and that not in sheltered settings; Integration of IPS and Treatment Team: IPS is integrated with the treatment team (in this case primary care PACT) and the IPS specialist encourages the client to adhere to treatment in order to achieve employment and recovery goals; Follow-Along Support: Individualized follow-along support in the employment and treatment settings is continued for as long as needed.
Treatment-as-Usual Vocational Rehabilitation Services
The Tuscaloosa VA Medical Center provides a broad array of prevocational assessments and vocational rehabilitation services; however, for purposes of this study, treatment consists of the client either obtaining a transitional work assignment within the local VHA setting or working with a vocational rehabilitation specialist who assists with community job placement and brief follow-up support. The rationale for transitional work is the belief that clients with a mental illness need a gradual introduction into regaining work capacity, because of their limited skills and experience, and/or their sensitivity to stress in the competitive work environment. After gaining experience in a protected work setting, it is assumed that clients are more capable of succeeding in competitive employment. The transitional work assignments are set-aside and time-limited and are typically entry-level unskilled positions that are not necessarily matched to the client’s skills and preferences. The vocational rehabilitation specialists provide some guidance for competitive community-based job searches and placement, but they do not provide long-term follow-up after the first competitive job is obtained or the transitional work assignment ends. TAU-VR specialists serve a larger caseload than that of an IPS specialist and are not integrated within a mental health or PACT clinic.
IPS Specialist Training and Fidelity Monitoring
At the beginning of the study, the IPS Specialist attended a 6-week web-based IPS course sponsored by the IPS Employment Center (affiliated with Westat, Inc.). Throughout the course of the study, the IPS fidelity monitor (RT) holds weekly teleconferences and intermittent on-site visits with the IPS specialists to provide technical assistance. The IPS fidelity monitor conducts a 2-day fidelity monitoring review at least three times per year which includes observation of the IPS specialist in the field during job development and participant interactions, interviews with participants, clinical treatment providers and leadership, and review of the VA electronic medical record. The IPS fidelity monitor evaluates the site using the 25-item Supported Employment Fidelity Scale.29-31 The IPS fidelity monitor also evaluates the TAU-VR control to ensure that the control group does not receive supported employment (i.e. should score <55 on the Supported Employment Fidelity Scale). The IPS fidelity monitor provides feedback on the fidelity ratings to the IPS Specialists and investigators.
Sample Size and Planned Primary Outcome Analysis
Using SamplePower 3.0 to estimate the statistical power necessary to test the primary hypothesis, the target sample size of 120 participants (60 per group) provides 84% power to detect a 25% or greater absolute difference between groups in the percent of participants achieving ‘steady worker’ primary outcome success status (e.g., 40% in the IPS arm vs. 15% in the control arm), at the .05 level of significance, assuming a 10% attrition. With 60 per group we can lower the power to 0.80 for two sided α=0.05 with a minimal detectable difference of 40% vs. 17%, respectively.
The primary outcome, defined as the proportion of steady workers, will be analyzed using a logistic regression model to calculate an odds ratio. Weekly employment data values will be summed over the total follow-up period to provide a score for each Veteran. Participants with cumulative scores of ≥26 weeks worked in a competitive job are considered a steady worker primary outcome success and those with cumulative scores <26 weeks are considered a primary outcome failure. For purposes of primary outcome analysis, missing data will be counted as “not worked.” Adhering to the principle of intent-to-treat, participants may discontinue the treatment intervention, but are encouraged to remain in the study for outcome assessments for the 12-month follow-up period. Analyses of the employment outcomes will also include total time worked (days or weeks), income earned from competitive sources and all sources, and type of jobs held. Total mean time worked will be compared using an analysis of variance (ANOVA) adjusted for site or the Kruskal–Wallis test if the data are not normally distributed.
The effect of treatment on each of secondary and tertiary outcome measures will be analyzed using a longitudinal mixed-effects regression model.32-33 The group by time interaction will test for the treatment effect, as we expect the equivalent groups at baseline to diverge over the follow-up period, with the IPS group showing greater gains than the control group. Mixed-effects regression methods assume that data are missing at random and use all available data to estimate the model parameters. In aggregate, there is one statistical model for the primary hypothesis, and there are two for the secondary hypotheses; therefore, there is no compelling reason to adjust the alpha level downward in order to avoid Type I errors. However, to provide assurance and control for multiple comparisons, a sequentially rejective procedure will be conducted to determine statistical significance for the treatment comparisons for secondary outcomes using an overall Type I error of 5% (two-sided).34