Integrated Care & Patient Navigators for Latinos With Serious Mental Illness
Primary Purpose
Mental Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Navigator Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Mental Disorders focused on measuring Patient Navigator, Integrated Care, Latino, Mental health and wellness, Physical health and wellness
Eligibility 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
Sites / Locations
- Illinois Institute of Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Peer Navigator Intervention
Controlled
Arm Description
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months.
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Outcomes
Primary Outcome Measures
Weekly Health Appointment Measure
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
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)
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.
Empowerment Scale (EMP)
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.
Recovery Assessment Scale (RAS)
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.
Medical Outcome Study (SF-36)
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.
Quality of Life Scale (QLS)
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.
Availability Health Service Scale (AHSS)
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.
Texas Christian University Health Form- Physical Health Subscale
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.
Full Information
NCT ID
NCT02469714
First Posted
June 5, 2015
Last Updated
August 23, 2019
Sponsor
Illinois Institute of Technology
Collaborators
Patient-Centered Outcomes Research Institute, Trilogy
1. Study Identification
Unique Protocol Identification Number
NCT02469714
Brief Title
Integrated Care & Patient Navigators for Latinos With Serious Mental Illness
Official Title
Integrated Care & Patient Navigators for Latinos With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Illinois Institute of Technology
Collaborators
Patient-Centered Outcomes Research Institute, Trilogy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Patient Navigator, Integrated Care, Latino, Mental health and wellness, Physical health and wellness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer Navigator Intervention
Arm Type
Experimental
Arm Description
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months.
Arm Title
Controlled
Arm Type
No Intervention
Arm Description
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Intervention Type
Behavioral
Intervention Name(s)
Peer Navigator Intervention
Other Intervention Name(s)
Peer Navigator
Intervention Description
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
Primary Outcome Measure Information:
Title
Weekly Health Appointment Measure
Description
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).
Time Frame
Every week for up to 52 weeks
Secondary Outcome Measure Information:
Title
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)
Description
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.
Time Frame
Baseline (0), 4, 8, and 12 months
Title
Empowerment Scale (EMP)
Description
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.
Time Frame
Baseline (0), 4, 8, and 12 months
Title
Recovery Assessment Scale (RAS)
Description
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.
Time Frame
Baseline (0), 4, 8, and 12 months
Title
Medical Outcome Study (SF-36)
Description
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.
Time Frame
Baseline (0), 4, 8, and 12 months
Title
Quality of Life Scale (QLS)
Description
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.
Time Frame
Baseline (0), 4, 8, and 12 months
Title
Availability Health Service Scale (AHSS)
Description
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.
Time Frame
Baseline (0), 4, 8, and 12 months
Title
Texas Christian University Health Form- Physical Health Subscale
Description
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.
Time Frame
Baseline (0), 4, 8, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Corrigan, Psy.D
Organizational Affiliation
Illinois Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Illinois Institute of Technology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2191833
Citation
Corrigan PW. Consumer satisfaction with institutional and community care. Community Ment Health J. 1990 Apr;26(2):151-65. doi: 10.1007/BF00752392.
Results Reference
background
PubMed Identifier
8488222
Citation
Corrigan PW, Jakus MR. The Patient Satisfaction Interview for partial hospitalization programs. Psychol Rep. 1993 Apr;72(2):387-90. doi: 10.2466/pr0.1993.72.2.387.
Results Reference
background
PubMed Identifier
5487612
Citation
Fischer EH, Turner JL. Orientations to seeking professional help: development and research utility of an attitude scale. J Consult Clin Psychol. 1970 Aug;35(1):79-90. doi: 10.1037/h0029636. No abstract available.
Results Reference
background
PubMed Identifier
21346488
Citation
Johansen R, Hestad K, Iversen VC, Agartz I, Sundet K, Andreassen OA, Melle I. Cognitive and clinical factors are associated with service engagement in early-phase schizophrenia spectrum disorders. J Nerv Ment Dis. 2011 Mar;199(3):176-82. doi: 10.1097/NMD.0b013e31820bc2f9.
Results Reference
background
PubMed Identifier
9255837
Citation
Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.
Results Reference
background
PubMed Identifier
20810594
Citation
Rogers ES, Ralph RO, Salzer MS. Validating the empowerment scale with a multisite sample of consumers of mental health services. Psychiatr Serv. 2010 Sep;61(9):933-6. doi: 10.1176/ps.2010.61.9.933.
Results Reference
background
PubMed Identifier
10427613
Citation
Corrigan PW, Faber D, Rashid F, Leary M. The construct validity of empowerment among consumers of mental health services. Schizophr Res. 1999 Jul 27;38(1):77-84. doi: 10.1016/s0920-9964(98)00180-7.
Results Reference
background
PubMed Identifier
10401893
Citation
Corrigan PW, Giffort D, Rashid F, Leary M, Okeke I. Recovery as a psychological construct. Community Ment Health J. 1999 Jun;35(3):231-9. doi: 10.1023/a:1018741302682.
Results Reference
background
PubMed Identifier
15957202
Citation
Corrigan PW, Salzer M, Ralph RO, Sangster Y, Keck L. Examining the factor structure of the recovery assessment scale. Schizophr Bull. 2004;30(4):1035-41. doi: 10.1093/oxfordjournals.schbul.a007118.
Results Reference
background
PubMed Identifier
1593914
Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Results Reference
background
PubMed Identifier
16047498
Citation
de Vet HC, Ader HJ, Terwee CB, Pouwer F. Are factor analytical techniques used appropriately in the validation of health status questionnaires? A systematic review on the quality of factor analysis of the SF-36. Qual Life Res. 2005 Jun;14(5):1203-18; dicussion 1219-21, 1223-4. doi: 10.1007/s11136-004-5742-3.
Results Reference
background
PubMed Identifier
6838316
Citation
Lehman AF. The well-being of chronic mental patients. Arch Gen Psychiatry. 1983 Apr;40(4):369-73. doi: 10.1001/archpsyc.1983.01790040023003.
Results Reference
background
PubMed Identifier
10265063
Citation
Lehman AF. The effects of psychiatric symptoms on quality of life assessments among the chronic mentally ill. Eval Program Plann. 1983;6(2):143-51. doi: 10.1016/0149-7189(83)90028-9.
Results Reference
background
PubMed Identifier
7627679
Citation
Corrigan PW, Buican B, McCraken S. The needs and resources assessment interview for severely mentally ill adults. Psychiatr Serv. 1995 May;46(5):504-5. doi: 10.1176/ps.46.5.504.
Results Reference
background
PubMed Identifier
19139138
Citation
Contopoulos-Ioannidis DG, Karvouni A, Kouri I, Ioannidis JP. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ. 2009 Jan 12;338:a3006. doi: 10.1136/bmj.a3006.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Corrigan PW, Michaels PJ. Perceived availability of services scale. Chicago: CASD. 2012.
Results Reference
background
Citation
Lehman AF. A quality of life interview for the chronically mentally ill. Evaluation and Program Planning 11(1): 51-62, 1988.
Results Reference
background
Links:
URL
http://www.chicagohealthdisparities.org
Description
Projects led by Dr. Patrick Corrigan that address health disparities
Learn more about this trial
Integrated Care & Patient Navigators for Latinos With Serious Mental Illness
We'll reach out to this number within 24 hrs