Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05018351
Status:
RECRUITING
Last Update Posted:
2022-04-08
First Post:
2021-06-01
Brief Title:
Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities
Sponsor:
Illinois Institute of Technology
Organization:
Illinois Institute of Technology
Study Overview
Official Title:
Peer Navigators for the Health and Wellness of People With Psychiatric Disabilities
Status:
RECRUITING
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRRRP-PHN
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 healthwellness 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
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 healthwellness 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 eg modifiable health risks and life consequences eg 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 healthwellness 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 eg in recovery from psychiatric disabilities plus TAU-IC
Investigators seek 150 participants per condition N300 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 madeaccomplished healthcare contacts perceived physical and mental health medication adherence depression anxiety satisfaction with health services recovery insurance status hospitalER 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
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 healthwellness 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 eg in recovery from psychiatric disabilities plus TAU-IC
Investigators seek 150 participants per condition N300 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 madeaccomplished healthcare contacts perceived physical and mental health medication adherence depression anxiety satisfaction with health services recovery insurance status hospitalER 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None