NCT02723019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 14, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 28, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

4.4 years

First QC Date

December 1, 2015

Results QC Date

December 21, 2022

Last Update Submit

February 6, 2023

Conditions

Type 2 Diabetes MellitusCardiometabolic ConditionsBehavioral Health Concerns

Keywords

Hispanic AmericansMental HealthMultimorbidityPatient ReadmissionTransitional Care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

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

    6 months from baseline

  • Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome

    6 months from baseline

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

    6 months from baseline

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

    6 months from baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

Volunteer Peer Mentor + Behavioral Health Nurse

Behavioral: Volunteer Peer Mentor+Behavioral Health Nurse

Control

NO INTERVENTION

Care as Usual

Interventions

Volunteer Peer Mentor+Behavioral Health NurseBEHAVIORAL

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

Also known as: Volunteer Peer Mentor (VPM) + Behavioral Health Nurse (BHN)
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Mercy Chula Vista

Chula Vista, California, 91910, United States

Location

Related Publications (2)

  • 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.

    PMID: 36697929DERIVED

  • 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.

    PMID: 32051005DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Psychological Well-Being

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPersonal SatisfactionBehavior

Limitations and Caveats

The study may not have captured all readmissions since there are many regional hospitals. Other evolving approaches, such as the use of statewide health information exchanges, may improve ascertainment in future research. We did not delineate preventable from nonpreventable readmissions and did not have information on readmission acuity. Although some hospitalizations may have occurred due to COVID-19, it is likely that this affected both groups equally.

Results Point of Contact

Title
Athena Philis-Tsimikas, MD, Co-Principal Investigator
Organization
Scripps Health
philis-tsimikas.athena@scrippshealth.org
858-678-7045

Study Officials

  • Athena Philis-Tsimikas, MD

    Scripps Whittier Diabetes Institute

    PRINCIPAL INVESTIGATOR

  • Linda Gallo, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2015

First Posted

March 30, 2016

Study Start

July 14, 2016

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

February 28, 2023

Results First Posted

February 28, 2023

Record last verified: 2023-02

Locations

US(1)