Integrated Care & Patient Navigators for Latinos With Serious Mental Illness

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02469714

Enrollment

110

Registered

2015-06-11

Start date

2015-08-31

Completion date

2016-11-30

Last updated

2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders

Keywords

Patient Navigator, Integrated Care, Latino, Mental health and wellness, Physical health and wellness

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.

Interventions

BEHAVIORALPeer 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Weekly Health Appointment Measure	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

Measure	Time frame	Description
Empowerment Scale (EMP)	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.
Recovery Assessment Scale (RAS)	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.
Medical Outcome Study (SF-36)	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.
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)	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.
Availability Health Service Scale (AHSS)	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.
Texas Christian University Health Form- Physical Health Subscale	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.
Quality of Life Scale (QLS)	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.

Countries

United States

Participant flow

Recruitment details

Recruitment began 8/24/2015 to 11/20/2015. Locations for recruitment included: Trilogy, National Alliance on Mental Illness Chicago, social service providers, community coalitions, religious organizations, health fairs, and health centers that provided free or sliding scale access to care.

Pre-assignment details

No enrolled participants (from Baseline) were excluded from the study before or after assignment to groups

Participants by arm

Arm	Count
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. 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	55
Controlled Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months	55
Total	110

Baseline characteristics

Characteristic	Controlled	Total	Peer Navigator Intervention
Age, Continuous	42.67 years STANDARD_DEVIATION 11.918	45.62 years STANDARD_DEVIATION 11.311	48.56 years STANDARD_DEVIATION 9.927
Diagnosis Adult ADD	1 participants	1 participants	0 participants
Diagnosis Anxiety Disorder	6 participants	23 participants	17 participants
Diagnosis Bipolar Disorder	6 participants	8 participants	2 participants
Diagnosis Major Depression	40 participants	72 participants	32 participants
Diagnosis Post Traumatic Stress	1 participants	2 participants	1 participants
Diagnosis Schizoaffective	1 participants	1 participants	0 participants
Diagnosis Schizophrenia	0 participants	3 participants	3 participants
Education Associate's Degree	3 participants	6 participants	3 participants
Education Bachelor's Degree	3 participants	8 participants	5 participants
Education High School or GED	15 participants	28 participants	13 participants
Education Less than High School or GED	16 participants	39 participants	23 participants
Education More than a Bachelor's Degree	3 participants	5 participants	2 participants
Education Some College	15 participants	24 participants	9 participants
Employment No	36 participants	75 participants	39 participants
Employment Yes	19 participants	35 participants	16 participants
Ethnicity (NIH/OMB) Hispanic or Latino	55 Participants	110 Participants	55 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Language Preferred English	25 participants	41 participants	16 participants
Language Preferred Spanish	30 participants	69 participants	39 participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) More than one race	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	35 Participants	69 Participants	34 Participants
Race (NIH/OMB) White	16 Participants	33 Participants	17 Participants
Sex/Gender, Customized Female	36 participants	64 participants	28 participants
Sex/Gender, Customized Male	18 participants	44 participants	26 participants
Sex/Gender, Customized Transgender	1 participants	2 participants	1 participants
Sexual Orientation Bisexual	3 participants	7 participants	4 participants
Sexual Orientation Heterosexual	46 participants	92 participants	46 participants
Sexual Orientation Homosexual	2 participants	4 participants	2 participants
Sexual Orientation Other	0 participants	1 participants	1 participants
Sexual Orientation Queer	3 participants	5 participants	2 participants
Sexual Orientation Refuse to answer	1 participants	1 participants	0 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 55	0 / 55
serious Total, serious adverse events	0 / 55	0 / 55

Outcome results

Primary

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).

Time frame: Every week for up to 52 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 1	4.55 appointments	Standard Deviation 3.07
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 2	8.64 appointments	Standard Deviation 5.59
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 2	4.33 appointments	Standard Deviation 3.42
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 8	8.58 appointments	Standard Deviation 7.07
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 3	4.05 appointments	Standard Deviation 4.21
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 5	6.31 appointments	Standard Deviation 6.36
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 4	3.93 appointments	Standard Deviation 2.69
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 9	7.72 appointments	Standard Deviation 7.04
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 5	4.13 appointments	Standard Deviation 4.32
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 3	8.09 appointments	Standard Deviation 6.26
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 6	5.16 appointments	Standard Deviation 5.38
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 10	8.27 appointments	Standard Deviation 7.36
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 7	4.67 appointments	Standard Deviation 5.39
Peer Navigator Intervention	Weekly Health Appointment Measure	Total scheduled Month 6	8.04 appointments	Standard Deviation 7.35
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 8	5.07 appointments	Standard Deviation 5.36
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month11	7.05 appointments	Standard Deviation 7.49
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 9	4.8 appointments	Standard Deviation 5.09
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 12	6.95 appointments	Standard Deviation 7.36
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 10	4.53 appointments	Standard Deviation 4.7
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month4	7.65 appointments	Standard Deviation 5.69
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 11	3.81 appointments	Standard Deviation 4.56
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 13	7.53 appointments	Standard Deviation 7.22
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 12	3.55 appointments	Standard Deviation 4.22
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 7	7.8 appointments	Standard Deviation 7.4
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Achieved Month 13	4.09 appointments	Standard Deviation 4.47
Peer Navigator Intervention	Weekly Health Appointment Measure	Total Scheduled Month 1	6.33 appointments	Standard Deviation 4.25
Controlled	Weekly Health Appointment Measure	Total Achieved Month 13	2.91 appointments	Standard Deviation 6.05
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 1	3.42 appointments	Standard Deviation 4.31
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 2	4.65 appointments	Standard Deviation 5.62
Controlled	Weekly Health Appointment Measure	Total Scheduled Month11	5.22 appointments	Standard Deviation 7.01
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 3	4.67 appointments	Standard Deviation 5.32
Controlled	Weekly Health Appointment Measure	Total Scheduled Month4	5.6 appointments	Standard Deviation 6.12
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 5	4.33 appointments	Standard Deviation 5.56
Controlled	Weekly Health Appointment Measure	Total scheduled Month 6	5.11 appointments	Standard Deviation 6.88
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 7	5.85 appointments	Standard Deviation 7.31
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 8	5.8 appointments	Standard Deviation 7.79
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 9	4.69 appointments	Standard Deviation 7.41
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 10	5.15 appointments	Standard Deviation 7.14
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 12	5.6 appointments	Standard Deviation 7.44
Controlled	Weekly Health Appointment Measure	Total Scheduled Month 13	5.42 appointments	Standard Deviation 8.09
Controlled	Weekly Health Appointment Measure	Total Achieved Month 1	2.14 appointments	Standard Deviation 3.02
Controlled	Weekly Health Appointment Measure	Total Achieved Month 2	2.29 appointments	Standard Deviation 2.74
Controlled	Weekly Health Appointment Measure	Total Achieved Month 3	2 appointments	Standard Deviation 2.39
Controlled	Weekly Health Appointment Measure	Total Achieved Month 4	2.31 appointments	Standard Deviation 2.73
Controlled	Weekly Health Appointment Measure	Total Achieved Month 5	2.38 appointments	Standard Deviation 3.16
Controlled	Weekly Health Appointment Measure	Total Achieved Month 6	2.95 appointments	Standard Deviation 4.66
Controlled	Weekly Health Appointment Measure	Total Achieved Month 7	3 appointments	Standard Deviation 4.82
Controlled	Weekly Health Appointment Measure	Total Achieved Month 8	3.09 appointments	Standard Deviation 5.47
Controlled	Weekly Health Appointment Measure	Total Achieved Month 9	2.91 appointments	Standard Deviation 5.64
Controlled	Weekly Health Appointment Measure	Total Achieved Month 10	2.84 appointments	Standard Deviation 5.54
Controlled	Weekly Health Appointment Measure	Total Achieved Month 11	2.84 appointments	Standard Deviation 4.68
Controlled	Weekly Health Appointment Measure	Total Achieved Month 12	3.13 appointments	Standard Deviation 5.55

Comparison: Between group comparison of total scheduled appointments from 1-13 monthsp-value: 0.04ANCOVA

Comparison: Between group comparison of total achieved appointments from 1-13 monthsp-value: 0.008ANCOVA

Secondary

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.