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| Name | Class |
|---|---|
| San Diego State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Volunteer Peer Mentor + Behavioral Health Nurse |
|
| Control | No Intervention | Care as Usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volunteer Peer Mentor+Behavioral Health Nurse | Behavioral | Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athena Philis-Tsimikas, MD | Scripps Whittier Diabetes Institute | Principal Investigator |
| Linda Gallo, PhD | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Mercy Chula Vista | Chula Vista | California | 91910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36697929 | Derived | 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. | |
| 32051005 | Derived | 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. |
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The target sample size based on power analysis was N=560. Enrollment was paused in March 2020, and then concluded early due to the COVID-19 pandemic. Because the design accommodated a 20% attrition rate, sample size was adequate for analysis of all outcomes.
Between July 2016 and March 2020, the study enrolled 536 inpatients of a hospital in South San Diego County that serves a mostly Hispanic/Latino, low socio-economic status patient population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Volunteer Peer Mentor + Behavioral Health Nurse Volunteer Peer Mentor+Behavioral Hlth Nurse: Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse |
| FG001 | Control | Care as Usual |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Volunteer Peer Mentor + Behavioral Health Nurse Volunteer Peer Mentor+Behavioral Hlth Nurse: Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | 30 days from baseline |
|
180 days
All cause mortality
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Volunteer Peer Mentor + Behavioral Health Nurse Volunteer Peer Mentor+Behavioral Hlth Nurse: Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Athena Philis-Tsimikas, MD, Co-Principal Investigator | Scripps Health | 858-678-7045 | philis-tsimikas.athena@scrippshealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2017 | Feb 3, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2019 | Dec 12, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 6 months from baseline |
| 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 |
| 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 |
| 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 |
| Lost to Follow-up |
|
Care as Usual |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Less than High School Education | Count of Participants | Participants |
|
| Income Less than 30,000 per year | Count of Participants | Participants |
|
| Not Employed | Count of Participants | Participants |
|
| Married or Cohabitating | Count of Participants | Participants |
|
| Born in Mexico | Count of Participants | Participants |
|
| Primary Language is Spanish | Count of Participants | Participants |
|
| Has Some Type of Health Insurance | Count of Participants | Participants |
|
| Cardiometabolic Conditions | Mean | Standard Deviation | cardiometabolic conditions |
|
| Behavioral Health Concerns | Mean | Standard Deviation | behavioral health concerns |
|
| LACE Index -Length of Patient Stay in the Hospital, Acuity of Admission, Comorbidity, Emergency Vist | LACE index [a predictor of readmission and mortality risk that considers length of stay, admission acuity, comorbidities, and emergency department use, and ranges from 1 (lowest risk) to 19 (highest risk)]. | Mean | Standard Deviation | LACE Index |
|
| Hospital Visit Length of Stay in Days | Mean | Standard Deviation | days |
|
| Patient-Reported Outcomes Measurement Information System Global-10 Health Scale | This measure provides an overall score of self-reported physical and mental health. | Mean | Standard Deviation | units on a scale |
|
| Patient Activation Measure (PAM) - 13 Item | Mean | Standard Deviation | units on a scale |
|
| Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CRIS) | Mean | Standard Deviation | units on a scale |
|
| Outpatient Visits Over the Past 3 Months | Mean | Standard Deviation | outpatient visits |
|
| Urgent Care/Emergency Department Visits Over the Past 3 Months | Mean | Standard Deviation | urgent care and ED visits |
|
| Inpatient Days Over the Past 3 Months | Mean | Standard Deviation | inpatient days |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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 | Posted | Number | participants | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | outpatient visits | 6 months from baseline |
|
|
|
|
| 17 |
| 271 |
| 0 |
| 271 |
| 0 |
| 271 |
| EG001 | Control | Care as Usual | 13 | 265 | 0 | 265 | 0 | 265 |
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| D004700 | Endocrine System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |