Integrated Care & Patient Navigators for Latinos With Serious Mental Illness

March 12, 2024 updated by: Patrick Corrigan, Illinois Institute of Technology
The health care needs of people with serious mental illness are exacerbated by ethnic health disparities. Latinos with serious mental illness show significant health problems compared to other ethnic groups. Therefore, this project is to develop a meaningful peer-navigator program for Latinos with serious mental illness using community-based participatory research (CBPR). Investigators are currently working with seven Hispanic/Latinos with a mental illness that have formed a Consumer Research Team (CRT) that will guide this project. This project will identify and define the problem by conducting a mixed methods research thru qualitative interviews with various stakeholders defined by the investigator's CRT group. The qualitative findings will then be cross-validated in a quantitative survey by 100 Hispanic/Latinos with mental illness. This information will then be used to design an intervention using an integrated care model for Peer-Navigators. Feasibility, accessibility , acceptability and impact of the peer-navigator program will be then evaluated in a randomized control trial (RCT) with 100 Latinos with serious mental illness who will complete measures of physical health, mental health, service use and engagement at baseline, 4, 8, and 12 months. Investigators expect to show physical health improvement with the greater engagement observed in the peer navigator group. Investigators expect a similar improvement in mental health and quality of life as physical health concerns are diminished.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Latinos with serious mental illnesses have an inordinately high rate of physical illness leading to a significantly shortened life. One reason is the difficulty in engaging this disenfranchised group in primary care. Integrated services through community-based outreach and care coordination are an innovative and evidence-based practice that improves physical health. Unfortunately, social determinants of health for Latinos are often a barrier to participation in integrated care. Peer navigators offer a strategy that might help members of this group. Peer navigators, in this study, are Latinos with past history of serious mental illness specially trained to help patients meet their health needs. The program will be developed through community-based participatory research (CBPR) representing a hands-on partnership between investigators and a community advisory board made up of patient partners. Given this, investigators aim to do the following. (1) Develop a peer navigator program meant to enhance the impact of already existing integrated services for Latinos with serious mental illness. (2) Using an experimental design, test the impact of peer navigators, compared to existing integrated services alone, on engagement of Latinos with serious mental illness in primary care services. This includes indices of care seeking, appointments, and satisfaction with engagement. Investigators expect these indices to be higher in the group with peer navigators. (3) Determine the comparative impact of peer navigators versus integrated-care-as-usual on subsequent health. Investigators expect to show physical health improvement with the greater engagement observed in the peer navigator group. Investigators expect a similar improvement in mental health and quality of life as physical health concerns are diminished. This proposal represents the partnership between researchers from the Center on Adherence and Self-Determination (a National Institute of Mental Health-funded Center dedicated to understanding service engagement among people with serious mental illness and their health care system) and Trilogy. Consistent with other projects, investigators will develop a Community Advisory Board to conduct CBPR and complete a mixed-methods research project to inform the peer navigator program. Based on a power-analysis, investigators will recruit 100 Latinos with serious mental illness who will complete baseline measures of physical health, mental health, service use and engagement in the previous year, quality of life, and current housing/employment status. Patients will then be randomized to an existing integrated care program for Hispanic/Latinos with mental illness with or without peer navigators for one year. Measures will be repeated at 4, 8, and 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Illinois Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Identify ethnicity as Hispanic/Latino
  • Identify with experience with a mental illness

Exclusion Criteria:

  • Must be 18 years or older
  • Have case manager they met on a regular basis (every week for the past 4 months) for physical health

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peer Navigator Intervention
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months.
Behavioral: Peer Navigator Intervention
Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Other Names:
  • Peer Navigator
No Intervention: Controlled
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weekly Health Appointment Measure
Time Frame: Every week for up to 52 weeks
This scale represents the total achieved appointments and total scheduled appointments. Data was collected weekly and added up per month.The minimum is 0 ( no appointments ) with no maximum (participants were not limited to the number of appointments per week).
Every week for up to 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)
Time Frame: Baseline (0), 4, 8, and 12 months
ATSPPH is a 29 item scale that has been used in more than 150 studies. The scale ranges from 1 (disagreement) to 4 (agreement). Higher overall scores reflect more positive attitudes towards help seeking. Subscales were summed to get the total of each scale. Total scores range from 29-116.
Baseline (0), 4, 8, and 12 months
Recovery Assessment Scale (RAS)
Time Frame: Baseline (0), 4, 8, and 12 months
The RAS assesses five factors related to recovery from mental illness including hope and goals. The scale ranges from 1 (strongly disagree) to 5 (strongly agree). A higher score reflects greater attitudes towards recovery. The total score range is 22-110.
Baseline (0), 4, 8, and 12 months
Medical Outcome Study (SF-36)
Time Frame: Baseline (0), 4, 8, and 12 months
This a 36 item short form that is widely adopted measure of medical health outcomes in mental health services research. Each item is scored on a 0 to 100 range. Items in same scale are averaged together to create the 8 scale scores. Higher scores indicate better health. In the current study, the total score it the sum of all scales scores. The total score can range from 0 to 800.
Baseline (0), 4, 8, and 12 months
Quality of Life Scale (QLS)
Time Frame: Baseline (0), 4, 8, and 12 months
The QLS is highly used in services research and comprises 6 items of various domains of independent living. The scale ranges from 1 (terrible) to 7 (delighted). The lower the score the less quality of life. The total scores range 6-42.
Baseline (0), 4, 8, and 12 months
Availability Health Service Scale (AHSS)
Time Frame: Baseline (0), 4, 8, and 12 months
The scale measures the availability of health services. The scale ranges from 1 (Not at all) to 9 (Very much). The lower the score the less availability of a service. Items were summed to get the total of each scale. Score totals range from 26-234.
Baseline (0), 4, 8, and 12 months
Texas Christian University Health Form- Physical Health Subscale
Time Frame: Baseline (0), 4, 8, and 12 months
Assesses physical health in the last 4 months and Emotional/Mental Health in the last 30 days.The scale ranges from 1 (None of the time) to 5 (All of the time). The higher the score, the more health problems. Score totals on the physical health scale range 14-70.
Baseline (0), 4, 8, and 12 months
Empowerment Scale (EMP)
Time Frame: Baseline (0), 4, 8, and 12 months
This widely used scale examines multiple dimensions of perceived personal empowerment in people with serious mental illness. The scale ranges from 1 (strongly agree) to 4 (strongly disagree). The lower the score, the higher level of empowerment. The total scores range from a minimum value of 4 to a maximum value of 16.
Baseline (0), 4, 8, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Illinois Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
Trilogy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Corrigan, Psy.D, Illinois Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCORI-AD1306-01419

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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