Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being

Study Overview
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Brief Summary
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Mi Puente (or My Bridge) is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente utilizes a sustainable nurse + volunteer peer team-based model, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). Participants will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes.

Detailed Description
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This study targets disparities in cardiometabolic disease prevalence and outcomes, and the unmet behavioral health needs in the US Hispanic population. Differences in the quantity and quality of health care targeted to and received by members of the Hispanic population contribute to these disparities. Inequities in health care access and use are likely the result of an interaction of several multi-level factors, such as those related to low Socio-Economic Status (e.g., lack of transportation or health coverage, time constraints, unsafe environments, knowledge barriers), cultural factors, language or communication-style differences, and others. Mi Puente (or My Bridge) is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente builds upon a sustainable nurse + volunteer peer team-based model and a strong collaborative, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). The program is guided by the Social Ecological Model,34 Resources and Support for Self-Management Model,35,36 and Transtheoretical Model of behavior change,37,38 and will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes. Ultimately the investigators seek to evaluate an effective, culturally appropriate, sustainable, and scalable program that addresses integrated health needs and reduces health disparities in Hispanics and other at-risk populations.

Official Title
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Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being

Conditions
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Type 2 Diabetes Mellitus, Cardiometabolic Conditions, Behavioral Health Concerns

Intervention / Treatment
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* Behavioral: Volunteer Peer Mentor+Behavioral Health Nurse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be Hispanic Must be ≥18 years Must have ≥2 cardiometabolic conditions (e.g., obesity, diabetes, hypertension, dyslipidemia ischemic heart diseases, congestive heart failure, other chronic coronary conditions) Must have ≥1 behavioral health concern(s) (i.e., related to mental health, life stressors, medication adherence, healthcare use) Must have telephone access Exclusion Criteria: Pregnancy Serious life-threatening condition with life expectancy < 6 months Psychiatric morbidity or neurological/cognitive impairment of sufficient severity to preclude participation in the intervention Discharging to location other than home (e.g., nursing care) Does not speak Spanish or English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Volunteer Peer Mentor + Behavioral Health Nurse | Behavioral: Volunteer Peer Mentor+Behavioral Health Nurse<br>* Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse<br>* Other names: Volunteer Peer Mentor (VPM) + Behavioral Health Nurse (BHN);|
| No Intervention: Control<br>Care as Usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment | Number of patients with at least one hospital readmission within 30 days after enrollment | 30 days from baseline | 
| Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment | Number of patients with at least one hospital readmission within 180 days after enrollment | 180 days from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome The minimum score on this scale is 10 and the maximum score on this scale is 50. A higher score on this scale means a better outcome. This measure provides an overall score of self-reported physical and mental health. | 6 months from baseline | 
| Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome | Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome The minimum score for this scale is 0 and the maximum score for this scale is 100. A higher score on this scale is more patient activation and is a better outcome. This measure provides an overall score of patient activation. | 6 months from baseline | 
| Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - Short Version - Patient-reported Outcome | Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - short version - patient-reported outcome The minimum score is 1 and the maximum score is 5. A higher score is a better outcome. This measure provides an overall score of support for healthful lifestyle behaviors and self-management from multiple sources. | 6 months from baseline | 
| Number of Outpatient Visits Over the Past 6 Months - Patient-reported | Number of Outpatient Visits Over the Past 6 Months - Patient-reported - Outpatient Healthcare Utilization This measure assesses outpatient healthcare utilization by capturing the number of self-reported outpatient visits completed in the past 6 months. The minimum number of outpatient visits is 0. There is not set maximum. A higher score is a better outcome. | 6 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hispanic Americans, Mental Health, Multimorbidity, Patient Readmission, Transitional Care