Integrated Care & Patient Navigators for Latinos With Serious Mental Illness

• Sponsor: Illinois Institute of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT02469714
• Collaborator: Patient-Centered Outcomes Research Institute (Other), Trilogy (Other)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 7.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Disorders	Behavioral: Peer Navigator Intervention	N/A

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 Design

• Study Type: Interventional
• 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: Aug 1, 2015
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

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

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Illinois Institute of Technology	Chicago	Illinois	United States	60616

Sponsors and Collaborators

• Illinois Institute of Technology
• Patient-Centered Outcomes Research Institute
• Trilogy

Investigators

• Principal Investigator: Patrick Corrigan, Psy.D, Illinois Institute of Technology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Projects led by Dr. Patrick Corrigan that address health disparities

Publications

• 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. Review.
• 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.
• 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.
• 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.
• Corrigan PW, Jakus MR. The Patient Satisfaction Interview for partial hospitalization programs. Psychol Rep. 1993 Apr;72(2):387-90.
• 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.
• 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.
• Corrigan PW. Consumer satisfaction with institutional and community care. Community Ment Health J. 1990 Apr;26(2):151-65. Review.
• de Vet HC, Adèr 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. Review.
• 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.
• 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.
• 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.
• Lehman AF. The well-being of chronic mental patients. Arch Gen Psychiatry. 1983 Apr;40(4):369-73.
• Modrcin M, Rapp CA, Poertner J. The evaluation of case management services with the chronically mentally ill. Eval Program Plann. 1988;11(4):307-14.
• 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.
• 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.
• 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.

• 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: Jun 11, 2015
• Last Update Posted: Sep 23, 2019
• Last Verified: Aug 1, 2019

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

Study Results

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

Arm/Group Title	Peer Navigator Intervention	Controlled
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Period Title: Overall Study
STARTED	55	55
4 Month Follow-Up	50	51
8 Month Follow-Up	49	50
COMPLETED	47	50
NOT COMPLETED	8	5

Baseline Characteristics

Arm/Group Title	Peer Navigator Intervention	Controlled	Total
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months	Total of all reporting groups
Overall Participants	55	55	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.56 (9.927)	42.67 (11.918)	45.62 (11.311)
Sex/Gender, Customized (participants) [Number]
Female	28 50.9%	36 65.5%	64 58.2%
Male	26 47.3%	18 32.7%	44 40%
Transgender	1 1.8%	1 1.8%	2 1.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	55 100%	55 100%	110 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.8%	1 1.8%	2 1.8%
Asian	0 0%	1 1.8%	1 0.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 1.8%	0 0%	1 0.9%
White	17 30.9%	16 29.1%	33 30%
More than one race	2 3.6%	2 3.6%	4 3.6%
Unknown or Not Reported	34 61.8%	35 63.6%	69 62.7%
Language (participants) [Number]
Preferred English	16 29.1%	25 45.5%	41 37.3%
Preferred Spanish	39 70.9%	30 54.5%	69 62.7%
Education (participants) [Number]
Less than High School or GED	23 41.8%	16 29.1%	39 35.5%
High School or GED	13 23.6%	15 27.3%	28 25.5%
Some College	9 16.4%	15 27.3%	24 21.8%
Associate's Degree	3 5.5%	3 5.5%	6 5.5%
Bachelor's Degree	5 9.1%	3 5.5%	8 7.3%
More than a Bachelor's Degree	2 3.6%	3 5.5%	5 4.5%
Employment (participants) [Number]
Yes	16 29.1%	19 34.5%	35 31.8%
No	39 70.9%	36 65.5%	75 68.2%
Diagnosis (participants) [Number]
Major Depression	32 58.2%	40 72.7%	72 65.5%
Bipolar Disorder	2 3.6%	6 10.9%	8 7.3%
Anxiety Disorder	17 30.9%	6 10.9%	23 20.9%
Post Traumatic Stress	1 1.8%	1 1.8%	2 1.8%
Schizophrenia	3 5.5%	0 0%	3 2.7%
Schizoaffective	0 0%	1 1.8%	1 0.9%
Adult ADD	0 0%	1 1.8%	1 0.9%
Sexual Orientation (participants) [Number]
Heterosexual	46 83.6%	46 83.6%	92 83.6%
Homosexual	2 3.6%	2 3.6%	4 3.6%
Bisexual	4 7.3%	3 5.5%	7 6.4%
Queer	2 3.6%	3 5.5%	5 4.5%
Other	1 1.8%	0 0%	1 0.9%
Refuse to answer	0 0%	1 1.8%	1 0.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer Navigator Intervention	Controlled
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Measure Participants	55	55
Total Scheduled Month 1	6.33 (4.25)	3.42 (4.31)
Total Scheduled Month 2	8.64 (5.59)	4.65 (5.62)
Total Scheduled Month 3	8.09 (6.26)	4.67 (5.32)
Total Scheduled Month4	7.65 (5.69)	5.6 (6.12)
Total Scheduled Month 5	6.31 (6.36)	4.33 (5.56)
Total scheduled Month 6	8.04 (7.35)	5.11 (6.88)
Total Scheduled Month 7	7.8 (7.40)	5.85 (7.31)
Total Scheduled Month 8	8.58 (7.07)	5.8 (7.79)
Total Scheduled Month 9	7.72 (7.04)	4.69 (7.41)
Total Scheduled Month 10	8.27 (7.36)	5.15 (7.14)
Total Scheduled Month11	7.05 (7.49)	5.22 (7.01)
Total Scheduled Month 12	6.95 (7.36)	5.6 (7.44)
Total Scheduled Month 13	7.53 (7.22)	5.42 (8.09)
Total Achieved Month 1	4.55 (3.07)	2.14 (3.02)
Total Achieved Month 2	4.33 (3.42)	2.29 (2.74)
Total Achieved Month 3	4.05 (4.21)	2 (2.39)
Total Achieved Month 4	3.93 (2.69)	2.31 (2.73)
Total Achieved Month 5	4.13 (4.32)	2.38 (3.16)
Total Achieved Month 6	5.16 (5.38)	2.95 (4.66)
Total Achieved Month 7	4.67 (5.39)	3 (4.82)
Total Achieved Month 8	5.07 (5.36)	3.09 (5.47)
Total Achieved Month 9	4.8 (5.09)	2.91 (5.64)
Total Achieved Month 10	4.53 (4.70)	2.84 (5.54)
Total Achieved Month 11	3.81 (4.56)	2.84 (4.68)
Total Achieved Month 12	3.55 (4.22)	3.13 (5.55)
Total Achieved Month 13	4.09 (4.47)	2.91 (6.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Navigator Intervention, Controlled
	Comments	Between group comparison of total scheduled appointments from 1-13 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.04
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.66
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Peer Navigator Intervention, Controlled
	Comments	Between group comparison of total achieved appointments from 1-13 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.008
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.61
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer Navigator Intervention	Controlled
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Measure Participants	55	55
Baseline	90.18 (13.42)	91.15 (12.31)
4 Month	89.77 (10.36)	89.7682 (11.65)
8 Month	89.62 (10.80)	88.74 (11.67)
12 Month	91.04 (10.39)	87.85 (13.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Navigator Intervention, Controlled
	Comments	This statistical analysis applies from baseline to 12 month.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.135
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer Navigator Intervention	Controlled
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Measure Participants	55	55
Baseline	11.66 (1.29)	11.12 (1.22)
4 Month	11.12 (1.53)	10.79 (1.39)
8 Month	10.82 (1.31)	10.96 (1.39)
12 Month	10.91 (1.19)	10.99 (1.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Navigator Intervention, Controlled
	Comments	This statistical analysis applies from baseline to 12 month.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.077
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer Navigator Intervention	Controlled
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Measure Participants	55	55
Baseline	78.87 (10.62)	85.33 (10.85)
4 Month	85.97 (10.23)	85.79 (10.47)
8 Month	87.37 (9.91)	85.52 (10.54)
12 Month	88.27 (9.80)	85.28 (11.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Navigator Intervention, Controlled
	Comments	This statistical analysis applies from baseline to 12 month.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.0005
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer Navigator Intervention	Controlled
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Measure Participants	54	55
Baseline	319.84 (149.41)	379.97 (165.37)
4 Month	420.23 (143.29)	432.43 (171.31)
8 Month	427.52 (140.36)	422.91 (176.97)
12 Month	444.91 (163.58)	454.81 (168.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Navigator Intervention, Controlled
	Comments	This statistical analysis applies from baseline to 12 month.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.060
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer Navigator Intervention	Controlled
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Measure Participants	55	55
Baseline	23.5 (6.92)	26.01 (6.23)
4 Month	25.93 (5.19)	27.12 (6.47)
8 Month	26.35 (5.56)	26.39 (7.46)
12 Month	27.39 (5.81)	26.37 (7.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Navigator Intervention, Controlled
	Comments	This statistical analysis applies from baseline to 12 month.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.073
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.03
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer Navigator Intervention	Controlled
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Measure Participants	49	53
Baseline	159.85 (42.41)	157.46 (50.27369)
4 Month	185.72 (44.02)	166.24 (49.62)
8 Month	189.18 (39.52)	171.34 (46.29)
12 Month	195.23 (33.64)	183.85 (45.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Navigator Intervention, Controlled
	Comments	This statistical analysis applies from baseline to 12 month.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.34
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer Navigator Intervention	Controlled
Arm/Group 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. 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	Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Measure Participants	55	55
Baseline	48.40 (11.37)	43.15 (11.92)
4 Month	41.67 (10.94)	40.47 (10.58)
8 Month	42.62 (11.96)	41.31 (11.74)
12 Month	40.59 (11.47)	40.49 (12.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Peer Navigator Intervention, Controlled
	Comments	This statistical analysis applies from baseline to 12 month.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.21
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Peer Navigator Intervention		Controlled
Arm/Group 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. 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		Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
All Cause Mortality
	Peer Navigator Intervention		Controlled
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Peer Navigator Intervention		Controlled
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Peer Navigator Intervention		Controlled
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)

Limitations/Caveats

Concerns to US Immigration and Customs Enforcement for those with undocumented residency status make some Latinos suspicious of institutions.Heterogeneity may influence solutions to health care concerns of these Latinos with serious mental illness.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.