Clinical trial NCT02723019: Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being
Official title: Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Cardiometabolic Conditions
Behavioral Health Concerns
Keywords: Hispanic Americans
Mental Health
Multimorbidity
Patient Readmission
Transitional Care
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2016-03-30
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Must be Hispanic
2. Must be ≥18 years
3. Must have ≥2 cardiometabolic conditions (e.g., obesity, diabetes, hypertension, dyslipidemia ischemic heart diseases, congestive heart failure, other chronic coronary conditions)
4. Must have ≥1 behavioral health concern(s) (i.e., related to mental health, life stressors, medication adherence, healthcare use)
5. Must have telephone access

Exclusion Criteria:

1. Pregnancy
2. Serious life-threatening condition with life expectancy \< 6 months
3. Psychiatric morbidity or neurological/cognitive impairment of sufficient severity to preclude participation in the intervention
4. Discharging to location other than home (e.g., nursing care)
5. Does not speak Spanish or English

Primary outcomes:
measure: Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment
timeFrame: 30 days from baseline
measure: Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment
timeFrame: 180 days from baseline
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome
timeFrame: 6 months from baseline
measure: Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome
timeFrame: 6 months from baseline
measure: Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - Short Version - Patient-reported Outcome
timeFrame: 6 months from baseline
measure: Number of Outpatient Visits Over the Past 6 Months - Patient-reported
timeFrame: 6 months from baseline
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Scripps Mercy Chula Vista
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Linda Gallo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallo LC, Fortmann AL, Bravin JI, Clark TL, Savin KL, Ledesma DL, Euyoque J, Sandoval H, Roesch SC, Gilmer T, Talavera GA, Philis-Tsimikas A. My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial. Trials. 2020 Feb 12;21(1):174. doi: 10.1186/s13063-019-3722-8.