2.1. Development Phase
2.1.1. Project advisory board. In collaboration with our local community mental health system (Genesee Health System; GHS), we will establish a project advisory board of 6-8 justice-involved individuals with SMI who have served as peer navigators or supervisors in other settings. We will also include individuals who have served as peer mentors for justice-involved individuals with SMI. Our advisory board members will provide periodic input throughout the project, including providing their pragmatic experiences to guide manual adaptation and study recruitment.
2.1.2. Manual development. We will draw content from the Chicago Health Disparities Center (CHDC) peer navigators’ training manual developed for homeless African Americans with SMI and adapt it for use by justice-involved individuals with SMI. The CHDC manual was designed to help clients engage with and benefit from primary care. This manual will be our starting document because it has a strong evidence base[9, 12] and was found to be effective in linking a marginalized SMI population to primary care services[12]. Adaptation of the CHDC manual will involve keeping the basic structures and principles of the peer navigation intervention and expanding the manual to include reentry specific components described in Table 1 below.
Table 1: The MAPS intervention manual
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Current contents
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Population specific additions
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Instrumental support for treatment engagement and recovery
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Principles in helping relationships
Basic helper principles in your life
Advocacy
Engaging people through goal setting
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Steps to peer navigation before anticipated date of release
Assist with completion of important paperwork
Link individuals with organizations that provide ID services
Ensure access to transportation
Housing, employment, etc in the context of a criminal record
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Informational support for tx engagement & recovery
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Provide information about food pantries
Inform clients about sliding scale and fee waivers
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Information about treatment options for SMI
Help clients identify appropriate providers
Information on accessing mental health, medical, and substance use care
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Emotional support for tx engagement and recovery
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Reflective listening skills
Strengths based model
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Unconditional acceptance & reassurance
Adherence support (encouraging adherence)
Going with clients to agencies to provide emotional and practical support
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Social norms around treatment engagement and recovery
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Setting boundaries
Managing burnout
The big picture
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Sharing own experiences with SMI and justice-involvement
Working with the justice system
Acting as role models
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The manual will be adapted and expanded to include specific information related to working with justice-involved individuals with SMI and potential ways to effectively engage with them after re-entry (see Table 1). For example, content related to working with the justice system, how to assist with paperwork, the art of self-disclosure, meeting basic needs of clients (i.e. housing, food), identifying providers, access to community services, etc. will be added.
2.1.3. Focus group discussions. We will conduct focus group discussions (FGDs) to aid in manual development and to provide feedback to help ensure that the MAPS peer navigation intervention meets the needs of our target population. Five FGDs of 6-8 people each (for 30-40 people total) will be conducted: 2 groups with experienced peer navigators and 3 groups with individuals in jail with SMI. The FGDs will explore perspectives of potential clients and peer navigators regarding the effectiveness, acceptability and gender and cultural appropriateness of peer navigators, and the most important approaches for them to take with justice-involved individuals with SMI. FGDs with peer navigators will ask about: (1) the most essential peer navigation skills, (2) lessons they have learned in their careers to date, (3) local services for individuals re-entering the community, and (4) how to initiate and maintain a culturally competent peer navigation service for individuals re-entering the community. We will also interview 4 peer navigators working with prisons from other states to understand experiences across the country using the topic guide described above. With potential client groups, we will explore (1) how peer navigators can best gain their trust; (2) their greatest needs in overcoming barriers to (post-release) treatment engagement, (3) what would assist their treatment engagement and how peer navigators could help with that, and (4) feedback on the proposed MAPS intervention outline. To understand the challenges after re-entry, we will include participants who have had re-entry experiences. The peer navigators’ focus group discussions will focus on how peer navigators can best help participants overcome misconceptions, mental health stigma, and other barriers to service linkage.
We will conduct qualitative coding and analysis of FGD data. FGDs will be facilitated by a moderator and a note taker. FGDs will be audio-recorded. The audio files will be transcribed verbatim. With the assistance of the Co-investigators, the Principal Investigator will lead the qualitative analysis and interpretation. Major topics and sub-topics will be coded. Additional codes will be generated for topics that invariably arise and that may have significance to the project. A descriptive summary will be developed to represent key content of each FGD. To enhance rigor and facilitate the quality of data management, we will use NVIVO version 12. We will conduct member checking with selected study participants to validate the fit, credibility and transferability of the results from the FGDs. We will refine and adapt our intervention for our target population based on the recommendations of focus group participants.
2.1.4. Open pilot trial. We will conduct an open pilot trial with 15 justice-involved individuals with SMI who meet the same inclusion criteria as participants in the randomized trial. Participants will complete all research procedures (see below) and receive MAPS, allowing us to gain experience with and assess the feasibility of the intervention, strategies for recruitment and retention of participants, recruitment and supervision of peer navigators, and participants’ compliance with the study protocol. Participants will be requested to complete an intervention-specific End-of-Treatment Questionnaire[14] assessing perceived helpfulness of the intervention and their comfort with the research processes and assessments. We will also conduct exit interviews with participants and peer navigators. In the exit interviews, we will collect information on what went well, what needs to be improved or added to the manual.
During the open trial, we will carefully evaluate and document our training methods, recruitment and retention procedures and the fit and adaptability of the treatment manual. We will collect data on what went well and what needs to be improved. We will use our experiences with the recruitment process, intervention, participant tracing, follow-up assessments, data from training of peer navigators, the End-of-Treatment Questionnaire, and feedback from the exit interviews to further refine the manual.
2.2. Pilot Study Phase
2.2.1. Study design and setting. The study will be conducted in Genesee County in Flint, Michigan. We partnered with Office of the Genesee County Sheriff and the Genesee Health System, a community mental health center in Genesee County. The study participants will be recruited from Genesee County Jail and from a network of peer navigators working with the Genesee Health System.
2.2.2. Sampling and recruitment. The open trial (n = 15) and randomized pilot study (n = 40) will use the same inclusion criteria. Participants will be (1) incarcerated in the Genesee County Jail, (2) aged 18 or above, (3) with lifetime DSM-5 diagnosis of SMI (including primary psychotic disorder [schizophrenia, schizoaffective disorder, or delusional disorder], bipolar disorder, and/or a major depressive disorder with psychotic features) as assessed by the Structured Clinical Interview for DSM-5 (SCID-5)[15], and (4) anticipating release in the following two months. We will exclude individuals who: (1) expect to be sentenced to prison (i.e., expect to go directly to prison, not home, from the jail), (2) cannot provide name and contact information of at least two locator persons, and/or (3) do not have access to any telephone. Some individuals are intoxicated, high, manic, and/or flagrantly psychotic when arrested and brought to the jail. We will exclude individuals who are too impaired to provide informed consent (i.e., are unable to respond coherently to the screening and consent process). If someone reports being or appears to be intoxicated or high, screening and consent procedures will be postponed until later and jail protocols for referral to care will be followed.
The study research assistant (RA) will consent and screen potential participants privately. The RA will explain all aspects of the study, including confidentiality and its limits, and address questions. If the participant agrees, s/he will sign an informed consent form and complete the baseline assessment. The RA will offer to read the consent forms aloud. The RA will emphasize that enrollment in the study is completely voluntary. Those who consent to participate will be provided with a copy of the study information sheet and an informed consent document.
2.2.3. The control condition. The control condition for this study will be Standard of Care (SOC). SOC consists of SOC + monitoring and emergency referral, as is required to fulfill ethical obligations to trial participants. To determine the naturalistic effects and costs of adding peer navigation intervention, participants in both conditions can receive any other treatment available to them. Participants who may be receiving other treatments will not be excluded. As part of our service utilization assessment, we will carefully characterize SOC for each condition.
2.2.4. The intervention. The peer navigation intervention is based on social support theory [16]. Peer navigators will help participants overcome the significant structural barriers to treatment engagement at community re-entry by providing instrumental (i.e., practical), informational, and emotional support for treatment engagement through activities such as: helping with the referral navigation process, keeping track of appointments and paperwork, following up with clients to make sure they went to appointments, problem-solving challenges, providing information about free care, helping clients make informed decisions about care by providing patient education, and creating peer connections. In addition, sharing their own stories of treatment and recovery and acting as role models shifts social norms toward treatment engagement and recovery [12, 17].
Participants assigned to the intervention group will receive the MAPS peer navigation intervention for six months (1-month pre-release, 5 months post-release). Approximately a month before release, the study research assistant will introduce consenting eligible individuals to a peer navigator who will help them navigate through community mental health, medical care or substance use services. All peer navigators will disclose their history of criminal justice involvement, SMI and/or co-morbid substance use during the initial introduction. In the weeks before release, the peer navigators will meet their clients at private locations within the jail to conduct strengths and needs assessments, fill out insurance forms, provide information on steps required to establish their insurance eligibility and residence IDs, and help set up community treatment appointments as needed. Peer navigators will maintain regular contact with participants at least once a week in the jail until they are released. Information obtained as part of the pre-release visits will be used to plan the rest of the peer navigation process after re-entry.
After re-entry, peer navigators will meet with their clients (in person or by phone) up to three times a week in the first two months and once a week in the following 3 months after release for a session no less than 60 minutes. Peer navigators will meet their clients within the first week of re-entry, preferably within the first 24-72 hours after release. In-person meetings will take place in the community at safe locations convenient for participants (i.e., libraries, treatment facilities, public buildings, etc.). The peer navigators will review participants’ activities since they left jail and problem-solve any barriers to service linkage or access that might have occurred. If clients have an outstanding referral to health care providers, the peer navigator will go with the client (whenever requested) or facilitate their trip to a provider by helping them get bus tickets or identify other reliable means of transportation. Peer navigators will meet with their clients depending on their need and jointly established treatment plan. Their services will involve 1) providing instrumental support for treatment engagement and recovery by focusing on strengths, being a role model and sharing personal experience, show genuine concern, identify stressors and roadblock and link to self-help [18] 2) sharing information about treatment engagement, creating service linkages after involvement with the justice system, health and lifestyle changes required to promote recovery, and information about access to free treatment options[19, 20]. 3) fostering emotional support for treatment engagement by showing empathy, promoting empowerment/ hope, and facilitating trust in treatment providers[18, 21]. In addition to the weekly meetings with their clients, peer navigators will do a monthly progress evaluation and refine treatment plans accordingly.
2.2.5. Peer navigator training and supervision. We will recruit 4 peer navigators (3 male, 1 female) and train them to fidelity to deliver the intervention. The 4 half-day long, didactic in-person initial trainings will consist of reviewing the peer navigation intervention rationale, materials, and strategies; audio-taped demonstrations; and live practice sessions with feedback. Weekly group supervision meetings will be held with peer navigators via phone or in-person to assist with any outstanding concerns. All peer navigation sessions will be audiotaped. Supervision will involve review of peer navigators’ audiotaped sessions (with fidelity rating as appropriate), group supervision and case discussion, and individual phone consultation as needed.
We will employ several approaches that we have found helpful in achieving low attrition rates (0-20%) in previous intervention studies with individuals re-entering the community after incarceration[22-25] (including those who were homeless) and other high-risk samples.[26, 27] These include study staff’s strong relationships with participants and efforts to value and appreciate their study participation. The study research assistant will call participants and mail them letters to remind them of their appointments and maintain a list of 2 other people who will always know where participants reside. Locator information will be updated at each study contact. Telephone follow-up assessment (removing the need for transportation), and study team flexibility in scheduling follow-up assessments (i.e., on evenings or weekends) will also facilitate participant retention. Finally, participants will be remunerated $50 for each follow-up assessment, facilitating retention.
2.2.6. Assessments. 2.2.6.1.Primary outcomes: Feasibility and acceptability. The primary outcomes of this study will be to evaluate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, of delivering the enhanced peer-navigator and control interventions. We will use the End of Treatment Questionnaire[14] to assess client experience with the intervention. To measure the feasibility, acceptability and satisfaction with the intervention, we will use the Client Satisfaction Questionnaire (CSQ-8)[28]. We will also evaluate the recruitment, refusal, retention, attendance rates.
2.2.6.2. Secondary outcomes. Clinical outcomes. The presence and severity of manic symptoms will be measured by using the Altman Self-Rating Mania Scale (ASRM) [29]. This 5-item scale has been reported to be consistent with standard DSM 5 diagnosis of presence and severity of manic symptoms [29]. We will use the 16 item version of Prodromal Questionnaire (PQ-16) to assess psychotic symptoms[30], and the Quick Inventory of Depressive Symptoms (QIDS-SR; [31] to assess depressive symptoms. The 12-item WHO-Disability Assessment Schedule (WHO-DAS-II) [32] will be used to measure functioning in the domains of cognition, mobility, self-care, getting along/interaction with other people, life activities and participation in community activities. The 4 items Brief Adherence Rating Scale (BARS) [33] will be used to assess adherence to psychiatric medications. BARS items evaluate past month adherence in terms of the number of prescribed doses per day; number of days the patient did not take the prescribed doses; and number of days the client took less than the prescribed doses. We will use Treatment History Interview (THI)[34] to measure number of hospitalizations after release. Numbers of suicide attempts will be measured by using the Columbia Suicide Severity Rating Scale (C-SSRS)[35]. Substance use will be measured using the Alcohol Use Disorders Identification Test (AUDIT) [36]; and Drug Use Disorders Identification Test (DUDIT) [37]; brief measures of alcohol and drug use severity. The AUDIT has been recommended as part of the NIH PhenX Toolkit of assessments.
Life context outcomes. We will use a calendar-based interview method [38-44] to measure number of nights unstably housed and days until rearrest.
Target mechanisms. Measuring the target mechanisms for this peer navigation intervention may contribute towards refining the intervention, clarifying the peer navigator roles and improving client outcomes. Instrumental support and informational support for treatment engagement will be measured using an adapted version of the Social Wellbeing-Social Support (SWB-SS) scale, originally developed for people with chronic illness [45]. We will adapt the informational support (10 items) and instrumental support (5 items) sub-sections of the scale to assess the frequency and ease of obtaining these supports when needed. Emotional support for treatment engagement will be assessed using items from the Important People and Activities Scale[46]. The Self Stigma of Mental Illness Short Form (SSMI-SF) will be used to assess social norms around treatment engagement and recovery [47].
Table 2: Secondary Outcomes of MAPS study
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Health service outcomes
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Utilization of community mental health (primary), medical, and substance use services; fewer days between release from jail and first contact with any health care provider.
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Clinical outcomes
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Reduced psychiatric symptoms, increased functioning, adherence to psychiatric medications, fewer substance using days, fewer hospitalizations and suicide attempts.
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Life context outcomes
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Nights unstably housed, and time until re-arrest.
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Potential target mechanisms
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Instrumental (primary), informational, and emotional support for treatment engagement and social norms about treatment engagement and recovery.
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2.2.6.3. Demographic/screening measures will include age, educational level, marital status, occupation, employment (status, # hours per week), income, race, type of offense for which currently incarcerated, number of prior arrests, number of prior convictions, and length of sentence. These data will be compared to jail records. At follow ups, occupation, employment (status, # hours per week), and income will be repeated. We will use the Structured Clinical Interview for DSM-5 (SCID) [15] to ensure that all study participants have DSM-5 diagnosis of SMI, as operationalized in our inclusion criteria. The SCID is a semi-structured interview guide used for diagnosis of SMI. The 90 item Symptom Checklist 90 (SCL-90)[48] will be used to establish the eligibility criterion of “currently symptomatic” (using the SCL-90 score clinical cutoff of ³ 25) [49].
2.2.7. Data Analysis. The purpose of the R34 Exploratory Research Award is to collect preliminary data to assess feasibility and acceptability of an intervention and to inform a subsequent fully-powered randomized clinical trial. With data from 40 participants in intent to treat analyses (about 20 per condition), we would only have statistical power adequate (.80) to detect large effects (d = .91) with alpha of .05. Randomized trials of SMI interventions rarely produce effect sizes this large, therefore, our primary emphasis will be on examining the direction of effects and the range of effect sizes for differences between conditions. This pilot data can be used to demonstrate whether the effects of treatment look promising across a set of outcome variables, to begin to examine distribution of outcome variables to inform future analytic strategies.
Primary analyses will be intent-to-treat (using data from all treatment enrolees). We will also conduct secondary dose-response analyses. Analysis strategies used (hierarchical linear modelling [HLM]) can accommodate missing data, and can be used in a sample of 40 with a highly constrained covariance structure.
2.2.7.1. Study feasibility and treatment feasibility/acceptability. We will assess the feasibility of the research procedures by examining study recruitment and refusal rates, participants’ willingness to be randomized, follow-up rates, reliability and range of responses to study questionnaires, and success of the peer navigator training program. We will assess the feasibility and acceptability of peer navigation program by examining rates of treatment attendance, rates of treatment completion (based on the jointly established treatment plan) and drop-out, and scores on the End of Treatment Questionnaire. We will also examine reasons for termination for consistent patterns. We will examine the acceptability of peer navigation intervention by using data from CSQ-8 treatment satisfaction questionnaire and detailed exit interviews. Peers’ experiences with the peer navigators, the quality of their working relationship and their level of satisfaction with the service will evaluated using the Working Alliance Inventory-Short Revised (WAI-SR).
Secondary Outcomes. We will: (1) Calculate the effect size and 95% CI for number of outpatient mental health appointments. Exploratory tests for differences between conditions will use HLM, with number of outpatient mental health appointments in the 90 days prior to incarceration and baseline committed partnership status as a covariate. (2) Calculate the effect size and 95% CI separately for number of outpatient substance use appointments and number of outpatient medical appointments. (3) Conduct an exploratory comparison of the number of days between jail release and the first outpatient mental health appointment using Cox regression.
We will separately calculate the effect size and 95% CI for secondary outcomes, including mental health symptoms (ASRM, PQ-16, and QIDS-SR scores), functioning (WHODAS-12 score), psychiatric medication adherence (BARS score), number of post-release hospitalizations (from the THI), substance use (AUDIT and DUDIT scores), and nights unstably housed. Separate exploratory tests for differences between conditions will use HLM, with baseline scores as covariates. We will conduct an exploratory comparison of time until rearrest using Cox regression.
Target mechanisms.We will separately calculate the effect size and 95% CI for the effect of the intervention on proposed target mechanisms including instrumental (primary), informational, and emotional support for treatment (measured using the SWB-SS subscales and IPA respectively) and social norms supporting treatment engagement and recovery (measured using the SSMI-SF). Separate exploratory tests for differences between conditions will use HLM, with baseline scores as covariates. We will then explore the association of each of these target mechanisms with changes in our primary outcome (number of outpatient mental health visits) from baseline through 6 months post-release. These exploratory analyses will inform full tests of mediation (i.e., tests of the hypothesis that the effects of MAPS on outpatient mental health appointments is mediated through instrumental, information, and emotional support for treatment and social norms supporting treatment engagement/recovery) in a subsequent fully powered trial. Although we expect the MAPS intervention to be effective, should the intervention show no or limited evidence of effectiveness, exploratory tests of target mechanisms will also provide some initial information about whether MAPS’ limited effectiveness was due to failure to engage target mechanisms or to the target mechanisms not being associated with the final outcome.
Personalization and processes.We will explore gender, race/ethnicity, barriers to access to mental health care (assessed using the Barriers to Access to Care Evaluation Scale- Expanded; BACE-E[50]), substance use severity, number of past-year emergency room visits, and number of lifetime arrests as predictors and moderators of treatment outcome. We expect that MAPS will be appropriate for a full range of justice-involved individuals with SMI. We will also conduct preliminary analyses of dose-response effects.
Treatment Integrity. We will compute scale reliabilities of adherence and competence ratings using both individual item correlations and total intraclass correlations. We will calculate scale validity by correlating adherence and competence ratings to intervention outcomes, to each other, and to expert ratings. Adherence and competence ratings of trained raters will be compared to expert global ratings to determine cut-off scores with sufficient sensitivity and specificity.
2.2.8. Ethics and dissemination. The Mentoring And Peer Support (MAPS) study was approved by Michigan State University Biomedical IRB (#17-772). All study staff also completed the Michigan State University Human Subject training certificate and good clinical practice (GCP) trainings. The study is also registered in www.clinicaltrials.gov under identifier #NCT04256954, date of registration 05 February 2020, https://clinicaltrials.gov/ct2/show/NCT04256954.
The study will take several steps to protect the confidentiality of research data. The assessment survey and electronic data are linked using a subject ID number that is assigned upon enrollment into the project. Baseline data will be collected using standardized paper forms and will only be identified with the study ID of the participant. The codes that link the name of the participant and the study ID will be kept confidential in secured cabinets at the university. Collected forms will be transported to the PI’s data entry center at the university. Data collected from participants will be coded using that number rather than a name. Peer navigation sessions will be recorded using encrypted, password-enabled credit-card sized digital audio recorders that can also be brought to jail. Peer navigators then will upload the recordings to our secure research audio server from their (remote) computers for study supervision.
Results of this study will be shared with our local partners, including the Genesee County Jail, the Genesee Health System, and the Flint community. We will work with Office of the Genesee County Sheriff and our other community partners to share results of the study with their state and national networks, through presentation at their conferences and meetings, newsletters, flyers, and other strategies that they deem to be appropriate. We will also work with the university media representatives to disseminate results.