Clinical trial NCT05018351: Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities
Official title: Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorder
Physical Illness
Keywords: Mental Disorder
Physical Illness
Psychiatric Disability
Peer Navigator
Serious Mental Illness
Physical Health
Lead sponsor: Illinois Institute of Technology
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: Thresholds Inc.
First posted: 2021-08-24
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Persons are randomly assigned to receive either:

A) treatment as usual (TAU-IC), which is Integrated Care services with Thresholds, OR B) peer navigator program (PNP), which includes in-vivo support with managing physical health and wellness at least weekly
Primary purpose: TREATMENT

Brief summary: Adults with psychiatric disabilities get sick and die 20 to 30 years younger than same-age peers, with even greater disparities occurring when the person is from a low SES or of color. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices, and life consequences. These factors are worsened by service disparities which are often fragmented in the public health system.

Peer navigators are part of a program in which providers escort people with psychiatric disabilities around the fragmented system to meet their health and wellness goals, often a demanding task for the person who has needs addressed at clinics, labs, and pharmacies spread across an urban area. Navigators are peers because they have lived experience of recovery and are often from similar ethnic groups. A community-based participatory research program supported by NIMHD and PCORI developed a peer navigator program specific to the needs of people with psychiatric disabilities. Results of two small pilots funded by NIMHD and PCORI showed the Peer Navigator Program (PNP) led to significant improved service engagement which corresponded with better health, recovery, and quality of life. The studies included fidelity measurement which showed peer navigators conducting the intervention at high levels of fidelity.

The current research is an efficacy study with a more fully powered test of PNP versus treatment as usual, which is integrated care (TAU-IC). The investigators aim to recruit 300 adults with psychiatric disability who wish to improve physical health/wellness through peer health navigation randomized to TAU-IC or TAU-IC plus PNP. Individuals will participate in assigned interventions as part of 8-month cohorts with data being obtained at baseline, 4, 8, and 12 months. Data will include personal descriptors (demographics, diagnosis, life consequences report), outcomes (service engagement, physical symptoms, blood pressure, recovery, and quality of life), mediators (personal empowerment, self-determination, and perceived relationship for recovery), and process measures (fidelity, feasibility, and acceptability). Investigators hypothesize that those in PNP intervention will have improved outcomes over the integrated care as usual. A cost-benefit analysis will seek to model impact based on quality-adjusted life years. Larger effect sizes will permit post hoc identification of how PNP effects vary by participant characteristics such as ethnicity and gender.

Detailed description: Morbidity and mortality rates among people with psychiatric disabilities due to physical illness are very high such that people in this group die ten to thirty years younger than same age peers. This disparity is even worse among people with psychiatric disabilities from low SES groups. Factors explaining this difference are complex and include genetic comorbidity, iatrogenic effects of medication, life choices (e.g., modifiable health risks); and life consequences (e.g., harm related to poverty, homelessness, and poor diet).

Except for genetic comorbidities, these factors are worsened by service disparities which are often fragmented in the public health system. Community health work and personal navigation are methods that have shown benefits in fragmented systems. Peer navigators (PN) are an especially promising approach to helping people avail existing services. Peers are people with lived experience of recovery, often from similar ethnic groups. Peer navigators target service engagement that improves illness management and health. They do this with practical in-the-field services where they, among other things, accompany the person with health needs to their various appointments. This, in turn, seems to enhance personal report of recovery and quality of life as well as objective indicators such as hospitalization use, medication self-administration, and blood pressure. Peer navigator effects on targeted service engagement are mediated by personal empowerment and self-determination which is influenced by perceptions of the provider relationship promoting recovery. Two pilot studies have supported the feasibility and preliminary effect sizes of peer navigation. The current efficacy study will more completely examine feasibility and impact. In addition, data from this project will inform scaling up the intervention to other sites as well as assess training needs for wide-scale utilization.

People with psychiatric disabilities who wish to improve their physical health/wellness and prevent disease through peer health navigation will be recruited from Thresholds members and subsequently randomized to one of two conditions provided for eight months:

1. Treatment as usually in integrated care (TAU-IC) or
2. Peer navigator program (PNP) provided by providers who are peers (e.g., in recovery from psychiatric disabilities) plus TAU-IC

Investigators seek 150 participants per condition (N=300) to reach statistical power goals. Investigators will recruit 354 participants to account for expected loss-to-follow-up. The PNP intervention will last 8 months, with a 4-month maintenance phase. The PNP intervention includes in-vivo support with healthcare provider appointments, health-related goal-setting, and wellness activities.

This project is led by a community-based participatory research (CBPR) team comprised of people with lived experience partnering with the science team. The CBPR team will also be involved in dissemination and utilization activities. The PNP will be conducted by Thresholds, the largest provider of psychiatric rehabilitation in the Midwest. Scientists from the Chicago Health Disparities Center at Illinois Institute of Technology will implement research design and analyses.

Investigators will analyze fidelity, process, outcome and impact data, including the effect of PNP on blood pressure (when COVID-19 precautions allow for in-person data collection), made/accomplished healthcare contacts, perceived physical and mental health, medication adherence, depression, anxiety, satisfaction with health services, recovery, insurance status, hospital/ER use, medication compliance, and quality of life. Measures will be repeated at 4, 8, and 12 months. To understand the impact of peerness, self-determination, and personal empowerment as possible mediators, investigators will assess perceptions of peer disclosure, recovery promoting relationships, empowerment and perceived competence in managing health. Investigators' main hypothesis is that the PNP condition will lead to enhanced healthcare contacts, improved health, and increased engagement in health behaviors compared with the TAU-IC condition. Findings will advance knowledge and services to reduce disparities in comorbid health conditions for people with psychiatric disabilities.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Serious mental illness (as indicated by disability)
* A desire to improve their physical health/wellness and prevent disease through peer health navigation
* Willing to attend
* Active Thresholds member residing in the catchment area (Chicago South Side)

Exclusion Criteria:

* Currently receiving services from a peer support specialist to work on health-related goals
* Currently receiving Assertive Community Treatment services
* Not an active Thresholds member
* Does not reside in the catchment area (Chicago South Side)

Primary outcomes:
measure: Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in Texas Christian University Health Form (TCU-HLTHFORM) Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
Secondary outcomes:
measure: Change from Baseline in Quality of Life Scale (QLS) Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in Recovery Assessment Scale-Revised (RAS-R) Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in Systolic and Diastolic Blood Pressure at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in Center for Epidemiologic Studies Depression Scale-Depression 10-item version (CES-D 10) Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in Health Literacy Questionnaire (HLQ) Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in Medication Questionnaire (MQ) Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in COVID-19 Social Distancing and Hygiene Scale Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in Smoking Questionnaire Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Change from Baseline in Personal Satisfaction Interview Scores at Months 4, 8, and 12
timeFrame: Baseline, 4 months, 8 months, 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Thresholds
state: Illinois
city: Chicago
country: United States
facility: Illinois Institute of Technology
state: Illinois
Study officials:
affiliation: Illinois Institute of Technology
name: Patrick W Corrigan, PsyD
role: PRINCIPAL_INVESTIGATOR
References: