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

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ClinicalTrials.gov Identifier: NCT02723019
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
San Diego State University
Information provided by (Responsible Party):
Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute

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, CA. 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Cardiometabolic Conditions Behavioral Health Concerns Behavioral: Volunteer Peer Mentor+Behavioral Hlth Nurse Not Applicable

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 SES (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, CA. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being
Actual Study Start Date : July 14, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Volunteer Peer Mentor + Behavioral Health Nurse
Behavioral: Volunteer Peer Mentor+Behavioral Hlth Nurse
Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse
Other Name: VPM + BHN

No Intervention: Control
Care as Usual



Primary Outcome Measures :
  1. Number of Hospitalizations [ Time Frame: 30- to 180-days after enrollment ]
  2. (PHQ-15) - patient-reported outcome [ Time Frame: 6 months ]
  3. Patient Reported Outcomes Measurement Information System (PROMIS) General Health Scale - patient-reported outcome [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Barriers to Care, Community Health Study/Study of Latinos (HCHS/SOL study) - patient-reported outcome [ Time Frame: 6 months ]
  2. Use of Outpatient Care [ Time Frame: 6 months ]
  3. Patient Activation Measure (PAM) - patient-reported outcome [ Time Frame: 6 months ]
  4. Resources for Chronic Disease Management, Chronic Illness Resources Survey (CIRS) - patient-reported outcome [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723019


Contacts
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Contact: Athena Philis-Tsimikas, MD (858) 678-7046 philis-tsimikas.athena@scrippshealth.org
Contact: Addie Fortmann, PhD 858-678-7097 fortmann.adelaide@scrippshealth.org

Locations
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United States, California
Scripps Mercy Chula Vista Recruiting
Chula Vista, California, United States, 91910
Contact: Athena Philis-Tsimikas, MD       philis-tsimikas.athena@scrippshealth.org   
Contact: Addie Fortmann, PhD       fortmann.addie@scrippshealth.org   
Sponsors and Collaborators
Scripps Whittier Diabetes Institute
San Diego State University

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Responsible Party: Athena Philis-Tsimikas, Principal Investigator, Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier: NCT02723019     History of Changes
Other Study ID Numbers: R01NR015754-01 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases