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Completed

NCT Number: NCT02723019

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Mercy Chula Vista

Chula Vista, California, 91910, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volunteer Peer Mentor+Behavioral Health Nurse

Behavioral

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

Other names: Volunteer Peer Mentor (VPM) + Behavioral Health Nurse (BHN)

Primary outcomes

  1. Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment

    Time frame: 30 days from baseline

    Number of patients with at least one hospital readmission within 30 days after enrollment

  2. Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment

    Time frame: 180 days from baseline

    Number of patients with at least one hospital readmission within 180 days after enrollment

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome

    Time frame: 6 months from baseline

    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.

  2. Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome

    Time frame: 6 months from baseline

    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.

  3. Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - Short Version - Patient-reported Outcome

    Time frame: 6 months from baseline

    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.

  4. Number of Outpatient Visits Over the Past 6 Months - Patient-reported

    Time frame: 6 months from baseline

    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.

Sponsors and collaborators

Lead sponsor

Scripps Whittier Diabetes Institute

Other

Collaborators

  • San Diego State University

Registry information

Acronym: Mi Puente

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 30, 2016
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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