Behavioral Health Concerns, Cardiometabolic Conditions, Type 2 Diabetes Mellitus
Conditions
Keywords
Hispanic Americans, Mental Health, Multimorbidity, Patient Readmission, Transitional Care
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.
Interventions
BEHAVIORALVolunteer Peer Mentor+Behavioral Health Nurse
Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse
Sponsors
San Diego State University
Scripps Whittier Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment | 30 days from baseline | 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 | 180 days from baseline | Number of patients with at least one hospital readmission within 180 days after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome | 6 months from baseline | 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 | 6 months from baseline | 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 | 6 months from baseline | 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 | 6 months from baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 271 |
| Control Care as Usual | 265 |
| Total | 536 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 17 | 13 |
| Overall Study | Lost to Follow-up | 57 | 70 |
| Overall Study | Withdrawal by Subject | 11 | 7 |
Baseline characteristics
| Characteristic | Intervention Group | Control | Total |
|---|---|---|---|
| Age, Continuous | 61.94 years STANDARD_DEVIATION 14.1 | 62.66 years STANDARD_DEVIATION 12.21 | 62.30 years STANDARD_DEVIATION 13.19 |
| Behavioral Health Concerns | 2.93 behavioral health concerns STANDARD_DEVIATION 1.56 | 3.03 behavioral health concerns STANDARD_DEVIATION 1.66 | 2.98 behavioral health concerns STANDARD_DEVIATION 1.61 |
| Born in Mexico | 186 Participants | 204 Participants | 390 Participants |
| Cardiometabolic Conditions | 3.31 cardiometabolic conditions STANDARD_DEVIATION 1.33 | 3.35 cardiometabolic conditions STANDARD_DEVIATION 1.41 | 3.33 cardiometabolic conditions STANDARD_DEVIATION 1.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 271 Participants | 265 Participants | 536 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Has Some Type of Health Insurance | 248 Participants | 247 Participants | 495 Participants |
| Hospital Visit Length of Stay in Days | 4.87 days STANDARD_DEVIATION 4.95 | 4.45 days STANDARD_DEVIATION 5.52 | 4.66 days STANDARD_DEVIATION 5.24 |
| Income Less than 30,000 per year | 207 Participants | 207 Participants | 414 Participants |
| Inpatient Days Over the Past 3 Months | 4.47 inpatient days STANDARD_DEVIATION 9.17 | 2.87 inpatient days STANDARD_DEVIATION 5.33 | 3.67 inpatient days STANDARD_DEVIATION 7.25 |
| LACE Index -Length of Patient Stay in the Hospital, Acuity of Admission, Comorbidity, Emergency Vist | 7.26 LACE Index STANDARD_DEVIATION 2.41 | 7.47 LACE Index STANDARD_DEVIATION 4.45 | 7.36 LACE Index STANDARD_DEVIATION 2.33 |
| Less than High School Education | 113 Participants | 134 Participants | 247 Participants |
| Married or Cohabitating | 123 Participants | 137 Participants | 260 Participants |
| Not Employed | 207 Participants | 204 Participants | 411 Participants |
| Outpatient Visits Over the Past 3 Months | 4.82 outpatient visits STANDARD_DEVIATION 7.2 | 4.42 outpatient visits STANDARD_DEVIATION 6.83 | 4.62 outpatient visits STANDARD_DEVIATION 7.01 |
| Patient Activation Measure (PAM) - 13 Item | 60.14 units on a scale STANDARD_DEVIATION 11.4 | 61.85 units on a scale STANDARD_DEVIATION 12.33 | 60.99 units on a scale STANDARD_DEVIATION 11.86 |
| Patient-Reported Outcomes Measurement Information System Global-10 Health Scale | 26.91 units on a scale STANDARD_DEVIATION 6 | 26.63 units on a scale STANDARD_DEVIATION 6.23 | 26.8 units on a scale STANDARD_DEVIATION 6.12 |
| Primary Language is Spanish | 200 Participants | 212 Participants | 412 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 21 Participants | 35 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 166 Participants | 171 Participants | 337 Participants |
| Race (NIH/OMB) White | 83 Participants | 67 Participants | 150 Participants |
| Region of Enrollment United States | 271 participants | 265 participants | 536 participants |
| Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CRIS) | 2.80 units on a scale STANDARD_DEVIATION 0.68 | 2.78 units on a scale STANDARD_DEVIATION 0.63 | 2.79 units on a scale STANDARD_DEVIATION 0.65 |
| Sex: Female, Male Female | 133 Participants | 124 Participants | 257 Participants |
| Sex: Female, Male Male | 138 Participants | 141 Participants | 279 Participants |
| Urgent Care/Emergency Department Visits Over the Past 3 Months | 1.55 urgent care and ED visits STANDARD_DEVIATION 1.73 | 1.49 urgent care and ED visits STANDARD_DEVIATION 2.49 | 1.52 urgent care and ED visits STANDARD_DEVIATION 2.11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 271 | 13 / 265 |
| other Total, other adverse events | 0 / 271 | 0 / 265 |
| serious Total, serious adverse events | 0 / 271 | 0 / 265 |
Outcome results
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
Time frame: 180 days from baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment | 120 participants |
| Control | Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment | 98 participants |
p-value: 0.19Regression, Logistic
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
Time frame: 30 days from baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment | 43 participants |
| Control | Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment | 25 participants |
Comparison: Analyzed using logistic regression analysisp-value: 0.01Regression, Logistic
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.
Time frame: 6 months from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Number of Outpatient Visits Over the Past 6 Months - Patient-reported | 5.39 outpatient visits | Standard Deviation 7.79 |
| Control | Number of Outpatient Visits Over the Past 6 Months - Patient-reported | 4.39 outpatient visits | Standard Deviation 6.79 |
Comparison: negative binomial regression model analysisp-value: 0.42negative binomial regression model analy
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.
Time frame: 6 months from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome | 66.15 score on a scale | Standard Deviation 11.87 |
| Control | Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome | 66.81 score on a scale | Standard Deviation 14.45 |
Comparison: multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimationp-value: 0.28multilevel model analysis, random interc
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.
Time frame: 6 months from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome | 29.74 score on a scale | Standard Deviation 7.32 |
| Control | Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome | 29.57 score on a scale | Standard Deviation 7.13 |
Comparison: multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimationp-value: 0.73multilevel model analysis, random interc
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.
Time frame: 6 months from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - Short Version - Patient-reported Outcome | 3.14 score on a scale | Standard Deviation 0.69 |
| Control | Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - Short Version - Patient-reported Outcome | 3.14 score on a scale | Standard Deviation 0.68 |
Comparison: multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimationp-value: 0.71multilevel model analysis, random interc