Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities

NCT ID: NCT05018351

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2025-09-01

Brief Summary

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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

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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.

Conditions

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Mental Disorder Physical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment as Usual-Integrated Care (TAU-IC)

Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-half of research participants will be randomized to integrated care alone.

Group Type ACTIVE_COMPARATOR

Integrated Care

Intervention Type BEHAVIORAL

Participants receive integrated physical and mental health care from their usual provider.

Peer Navigator Program (PNP)

Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:

* scheduling and attending healthcare appointments;
* partnering with participant on tasks that arise from appointments;
* health-related goal setting; and
* taking action-steps toward health-related goals.

Group Type EXPERIMENTAL

Peer Navigation

Intervention Type BEHAVIORAL

Peer navigators will meet individually and face-to-face with participants to address their health and weight goals (i.e. working on health-related goals, attending health care appointments. and facilitating follow-up activities related to healthcare appointments).

Interventions

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Integrated Care

Participants receive integrated physical and mental health care from their usual provider.

Intervention Type BEHAVIORAL

Peer Navigation

Peer navigators will meet individually and face-to-face with participants to address their health and weight goals (i.e. working on health-related goals, attending health care appointments. and facilitating follow-up activities related to healthcare appointments).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arizona State University

OTHER

Sponsor Role collaborator

Thresholds Inc.

INDUSTRY

Sponsor Role collaborator

Illinois Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick W Corrigan, PsyD

Role: PRINCIPAL_INVESTIGATOR

Illinois Institute of Technology

Locations

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Thresholds

Chicago, Illinois, United States

Site Status RECRUITING

Illinois Institute of Technology

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patrick W Corrigan, PsyD

Role: CONTACT

312-567-7983

Carla D Kundert, MS

Role: CONTACT

312-567-6982

Facility Contacts

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Lisa Razzano, PhD

Role: primary

773-432-6228

Patrick W Corrigan, PsyD

Role: primary

312-567-6751

Carla D Kundert, MS

Role: backup

312-567-6982

Other Identifiers

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90DPHF0008

Identifier Type: -

Identifier Source: org_study_id

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