Recruiting

Peer Navigator Program

Sponsor:

Illinois Institute of Technology

Code:

NCT05018351

Conditions

Mental Disorder

Physical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Integrated Care

Peer Navigation

Study Details

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.

Conditions

Mental Disorder

Physical Illness

Study ID

NCT05018351

Start date

May 17, 2021

Status verified date

Mar, 2022

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

354 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

Integrated Care

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

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).

Primary outcome measure

  • Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores at Months 4, 8, and 12 [ Time Frame: Baseline, 4 months, 8 months, 12 months ]
  • Change from Baseline in Texas Christian University Health Form (TCU-HLTHFORM) Scores at Months 4, 8, and 12 [ Time Frame: Baseline, 4 months, 8 months, 12 months ]

Central Contacts and Locations

Central contacts

Patrick W Corrigan, PsyD

312-567-7983corrigan@iit.edu

Locations

Thresholds

Recruiting

Chicago, Illinois, United States, 60613

Contacts

Illinois Institute of Technology

Recruiting

Chicago, Illinois, United States, 60616

Contacts

Patrick W Corrigan, PsyD

312-567-6751corrigan@iit.edu

Carla D Kundert, MS

312-567-6982

More Information

Sponsor

Illinois Institute of Technology

Last update posted

Apr 8, 2022

Last verified

Mar, 2022

Keywords

  • Mental Disorder
  • Physical Illness
  • Psychiatric Disability
  • Peer Navigator
  • Serious Mental Illness
  • Physical Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Illinois Institute of Technology on 2022-04-08.