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Integrated Care & Patient Navigators for Latinos With Serious Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469714
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Trilogy
Information provided by (Responsible Party):
Patrick Corrigan, Illinois Institute of Technology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mental Disorders Behavioral: Peer Navigator Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integrated Care & Patient Navigators for Latinos With Serious Mental Illness
Study Start Date : August 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
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 Name: Peer Navigator

No Intervention: Controlled
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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 scores of each subscale range from 4 to 16.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469714


Locations
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United States, Illinois
Illinois Institute of Technology
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Illinois Institute of Technology
Patient-Centered Outcomes Research Institute
Trilogy
Investigators
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Principal Investigator: Patrick Corrigan, Psy.D Illinois Institute of Technology
Additional Information:
Publications:
Corrigan PW, Jakus MR. The reliability of severely mentally ill patients' report of treatment satisfaction. International Journal of Methods in Psychiatric Research 3: 215-219, 1993.
Corrigan PW, Michaels PJ. Perceived availability of services scale. Chicago: CASD. 2012.
Lehman AF. A quality of life interview for the chronically mentally ill. Evaluation and Program Planning 11(1): 51-62, 1988.

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Responsible Party: Patrick Corrigan, Distinguished Professor of Psychology, Illinois Institute of Technology
ClinicalTrials.gov Identifier: NCT02469714    
Other Study ID Numbers: PCORI-AD1306-01419
First Posted: June 11, 2015    Key Record Dates
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patrick Corrigan, Illinois Institute of Technology:
Patient Navigator
Integrated Care
Latino
Mental health and wellness
Physical health and wellness
Additional relevant MeSH terms:
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Mental Disorders