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

NCT ID: NCT02723019

Last Updated: 2023-02-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-14

Study Completion Date

2020-11-30

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.

Conditions

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Type 2 Diabetes Mellitus Cardiometabolic Conditions Behavioral Health Concerns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Volunteer Peer Mentor + Behavioral Health Nurse

Group Type EXPERIMENTAL

Volunteer Peer Mentor+Behavioral Health Nurse

Intervention Type BEHAVIORAL

Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse

Control

Care as Usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Volunteer Peer Mentor+Behavioral Health Nurse

Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse

Intervention Type BEHAVIORAL

Other Intervention Names

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Volunteer Peer Mentor (VPM) + Behavioral Health Nurse (BHN)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

Scripps Whittier Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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Athena Philis-Tsimikas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Athena Philis-Tsimikas, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Whittier Diabetes Institute

Linda Gallo, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

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Scripps Mercy Chula Vista

Chula Vista, California, United States

Site Status

Countries

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United States

References

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Gallo LC, Fortmann AL, Clark TL, Roesch SC, Bravin JI, Spierling Bagsic SR, Sandoval H, Savin KL, Gilmer T, Talavera GA, Philis-Tsimikas A. Mi Puente (My Bridge) Care Transitions Program for Hispanic/Latino Adults with Multimorbidity: Results of a Randomized Controlled Trial. J Gen Intern Med. 2023 Jul;38(9):2098-2106. doi: 10.1007/s11606-022-08006-1. Epub 2023 Jan 25.

Reference Type DERIVED
PMID: 36697929 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32051005 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01NR015754-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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