Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities
DRRRP-PHN
1 other identifier
interventional
354
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2021
CompletedFirst Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
August 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedApril 8, 2022
March 1, 2022
4.3 years
June 1, 2021
March 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Scores at Months 4, 8, and 12
Assesses change in participants' health status and health-related quality of life over the 12 months of the study along 9 domains (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health). Each of the aforementioned scales have a range of scores from 0 (minimum) - 100 (maximum), with higher scores indicating better outcomes (e.g., a score of 100 on the physical functioning scale indicates no problems with physical functioning). The investigators will evaluate change along all 9 domains. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
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
This 24-item measure will assess respondents' experience with physical health problems (e.g., stomach problems or ulcers, bladder infections) and mental health problems (e.g., tired for no good reason, nervous) over the 12 months of the study. The TCU-HLTHFORM assesses health along two domains: psychological distress and physical health. The psychological distress scale scores range from 10 (minimum) to 5 (maximum), with scores of 25-29 indicating high levels of distress, and scores of 30-50 indicating very high levels of distress, thus worse outcomes. The physical health items range from 11 (minimum) to 55 (maximum). Higher scores on these items indicate higher levels of physical health problems, thus worse outcomes. Change = (Month 4 Score - Baseline), (Month 8 Score - Baseline), (Month 12 Score - Baseline)
Baseline, 4 months, 8 months, 12 months
Secondary Outcomes (10)
Change from Baseline in Quality of Life Scale (QLS) Scores at Months 4, 8, and 12
Baseline, 4 months, 8 months, 12 months
Change from Baseline in Recovery Assessment Scale-Revised (RAS-R) Scores at Months 4, 8, and 12
Baseline, 4 months, 8 months, 12 months
Change from Baseline in Systolic and Diastolic Blood Pressure at Months 4, 8, and 12
Baseline, 4 months, 8 months, 12 months
Change from Baseline in Center for Epidemiologic Studies Depression Scale-Depression 10-item version (CES-D 10) Scores at Months 4, 8, and 12
Baseline, 4 months, 8 months, 12 months
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scores at Months 4, 8, and 12
Baseline, 4 months, 8 months, 12 months
- +5 more secondary outcomes
Study Arms (2)
Treatment as Usual-Integrated Care (TAU-IC)
ACTIVE COMPARATORParticipants 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.
Peer Navigator Program (PNP)
EXPERIMENTALPeer 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
Participants receive integrated physical and mental health care from their usual provider.
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Illinois Institute of Technologylead
- Arizona State Universitycollaborator
- Thresholds Inc.collaborator
Study Sites (2)
Thresholds
Chicago, Illinois, 60613, United States
Illinois Institute of Technology
Chicago, Illinois, 60616, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick W Corrigan, PsyD
Illinois Institute of Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
August 24, 2021
Study Start
May 17, 2021
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
April 8, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available on 08-31-2025.
- Access Criteria
- To ensure the protection of the human subjects involved in our research, investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Results will be available to researchers and service agencies, with quantitative data available from an expected 300 participants with psychiatric disabilities who report a desire to improve physical health/wellness and prevent disease through peer navigation. No identifying information will be connected to the data and investigators do not believe that there is a possibility of deductive disclosure of subjects with unusual characteristics. Regardless, to ensure the protection of the human subjects involved in this research, investigators will make the data and associated documentation available to users only under a data-sharing agreement. Notice of available data will be posted in appropriate arenas including websites for the project: www.chicagohealthdisparities.org and www.ncse1.org.