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

Type 2 Diabetes Mellitus Clinical Trial

— Mi Puente  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723019
• Other study ID #: R01NR015754-01
• Status: Completed
• Phase: N/A
• Start date: July 14, 2016
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2023
• Source: Scripps Whittier Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Scripps Mercy Chula Vista	Chula Vista	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute	San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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