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

Primary Purpose

Type 2 Diabetes Mellitus, Cardiometabolic Conditions, Behavioral Health Concerns

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Volunteer Peer Mentor+Behavioral Health Nurse
Sponsored by
Scripps Whittier Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Hispanic Americans, Mental Health, Multimorbidity, Patient Readmission, Transitional Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Mercy Chula Vista

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control

Arm Description

Volunteer Peer Mentor + Behavioral Health Nurse

Care as Usual

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 1, 2015
Last Updated
February 6, 2023
Sponsor
Scripps Whittier Diabetes Institute
Collaborators
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT02723019
Brief Title
Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being
Acronym
Mi Puente
Official Title
Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 14, 2016 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Whittier Diabetes Institute
Collaborators
San Diego State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Cardiometabolic Conditions, Behavioral Health Concerns
Keywords
Hispanic Americans, Mental Health, Multimorbidity, Patient Readmission, Transitional Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
536 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Volunteer Peer Mentor + Behavioral Health Nurse
Arm Title
Control
Arm Type
No Intervention
Arm Description
Care as Usual
Intervention Type
Behavioral
Intervention Name(s)
Volunteer Peer Mentor+Behavioral Health Nurse
Other Intervention Name(s)
Volunteer Peer Mentor (VPM) + Behavioral Health Nurse (BHN)
Intervention Description
Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse
Primary Outcome Measure Information:
Title
Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment
Description
Number of patients with at least one hospital readmission within 30 days after enrollment
Time Frame
30 days from baseline
Title
Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment
Description
Number of patients with at least one hospital readmission within 180 days after enrollment
Time Frame
180 days from baseline
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome
Description
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.
Time Frame
6 months from baseline
Title
Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome
Description
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.
Time Frame
6 months from baseline
Title
Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - Short Version - Patient-reported Outcome
Description
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.
Time Frame
6 months from baseline
Title
Number of Outpatient Visits Over the Past 6 Months - Patient-reported
Description
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.
Time Frame
6 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athena Philis-Tsimikas, MD
Organizational Affiliation
Scripps Whittier Diabetes Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Gallo, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Mercy Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32051005
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.
Results Reference
derived

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

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