Trial Outcomes & Findings for Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being (NCT NCT02723019)

NCT ID: NCT02723019

Last Updated: 2023-02-28

Results Overview

Number of patients with at least one hospital readmission within 30 days after enrollment

Recruitment status

COMPLETED

Study phase

Target enrollment

536 participants

Primary outcome timeframe

30 days from baseline

Results posted on

2023-02-28

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	Control Care as Usual
Overall Study STARTED	271	265
Overall Study COMPLETED	186	175
Overall Study NOT COMPLETED	85	90

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Control Care as Usual
Overall Study Death	17	13
Overall Study Withdrawal by Subject	11	7
Overall Study Lost to Follow-up	57	70

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=271 Participants 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	Control n=265 Participants Care as Usual	Total n=536 Participants Total of all reporting groups
Age, Continuous	61.94 years STANDARD_DEVIATION 14.10 • n=5 Participants	62.66 years STANDARD_DEVIATION 12.21 • n=7 Participants	62.30 years STANDARD_DEVIATION 13.19 • n=5 Participants
Sex: Female, Male Female	133 Participants n=5 Participants	124 Participants n=7 Participants	257 Participants n=5 Participants
Sex: Female, Male Male	138 Participants n=5 Participants	141 Participants n=7 Participants	279 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	271 Participants n=5 Participants	265 Participants n=7 Participants	536 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	67 Participants n=7 Participants	150 Participants n=5 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	166 Participants n=5 Participants	171 Participants n=7 Participants	337 Participants n=5 Participants
Region of Enrollment United States	271 participants n=5 Participants	265 participants n=7 Participants	536 participants n=5 Participants
Less than High School Education	113 Participants n=5 Participants	134 Participants n=7 Participants	247 Participants n=5 Participants
Income Less than 30,000 per year	207 Participants n=5 Participants	207 Participants n=7 Participants	414 Participants n=5 Participants
Not Employed	207 Participants n=5 Participants	204 Participants n=7 Participants	411 Participants n=5 Participants
Married or Cohabitating	123 Participants n=5 Participants	137 Participants n=7 Participants	260 Participants n=5 Participants
Born in Mexico	186 Participants n=5 Participants	204 Participants n=7 Participants	390 Participants n=5 Participants
Primary Language is Spanish	200 Participants n=5 Participants	212 Participants n=7 Participants	412 Participants n=5 Participants
Has Some Type of Health Insurance	248 Participants n=5 Participants	247 Participants n=7 Participants	495 Participants n=5 Participants
Cardiometabolic Conditions	3.31 cardiometabolic conditions STANDARD_DEVIATION 1.33 • n=5 Participants	3.35 cardiometabolic conditions STANDARD_DEVIATION 1.41 • n=7 Participants	3.33 cardiometabolic conditions STANDARD_DEVIATION 1.37 • n=5 Participants
Behavioral Health Concerns	2.93 behavioral health concerns STANDARD_DEVIATION 1.56 • n=5 Participants	3.03 behavioral health concerns STANDARD_DEVIATION 1.66 • n=7 Participants	2.98 behavioral health concerns STANDARD_DEVIATION 1.61 • n=5 Participants
LACE Index -Length of Patient Stay in the Hospital, Acuity of Admission, Comorbidity, Emergency Vist	7.26 LACE Index STANDARD_DEVIATION 2.41 • n=5 Participants	7.47 LACE Index STANDARD_DEVIATION 4.45 • n=7 Participants	7.36 LACE Index STANDARD_DEVIATION 2.33 • n=5 Participants
Hospital Visit Length of Stay in Days	4.87 days STANDARD_DEVIATION 4.95 • n=5 Participants	4.45 days STANDARD_DEVIATION 5.52 • n=7 Participants	4.66 days STANDARD_DEVIATION 5.24 • n=5 Participants
Patient-Reported Outcomes Measurement Information System Global-10 Health Scale	26.91 units on a scale STANDARD_DEVIATION 6.00 • n=5 Participants	26.63 units on a scale STANDARD_DEVIATION 6.23 • n=7 Participants	26.8 units on a scale STANDARD_DEVIATION 6.12 • n=5 Participants
Patient Activation Measure (PAM) - 13 Item	60.14 units on a scale STANDARD_DEVIATION 11.40 • n=5 Participants	61.85 units on a scale STANDARD_DEVIATION 12.33 • n=7 Participants	60.99 units on a scale STANDARD_DEVIATION 11.86 • n=5 Participants
Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CRIS)	2.80 units on a scale STANDARD_DEVIATION 0.68 • n=5 Participants	2.78 units on a scale STANDARD_DEVIATION 0.63 • n=7 Participants	2.79 units on a scale STANDARD_DEVIATION 0.65 • n=5 Participants
Outpatient Visits Over the Past 3 Months	4.82 outpatient visits STANDARD_DEVIATION 7.20 • n=5 Participants	4.42 outpatient visits STANDARD_DEVIATION 6.83 • n=7 Participants	4.62 outpatient visits STANDARD_DEVIATION 7.01 • n=5 Participants
Urgent Care/Emergency Department Visits Over the Past 3 Months	1.55 urgent care and ED visits STANDARD_DEVIATION 1.73 • n=5 Participants	1.49 urgent care and ED visits STANDARD_DEVIATION 2.49 • n=7 Participants	1.52 urgent care and ED visits STANDARD_DEVIATION 2.11 • n=5 Participants
Inpatient Days Over the Past 3 Months	4.47 inpatient days STANDARD_DEVIATION 9.17 • n=5 Participants	2.87 inpatient days STANDARD_DEVIATION 5.33 • n=7 Participants	3.67 inpatient days STANDARD_DEVIATION 7.25 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days from baseline

Number of patients with at least one hospital readmission within 30 days after enrollment

Outcome measures

Outcome measures
Measure	Intervention Group n=271 Participants 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	Control n=265 Participants Care as Usual
Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment	43 participants	25 participants

PRIMARY outcome

Timeframe: 180 days from baseline

Number of patients with at least one hospital readmission within 180 days after enrollment

Outcome measures

Outcome measures
Measure	Intervention Group n=271 Participants 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	Control n=265 Participants Care as Usual
Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment	120 participants	98 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=271 Participants 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	Control n=265 Participants Care as Usual
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome	29.74 score on a scale Standard Deviation 7.32	29.57 score on a scale Standard Deviation 7.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=271 Participants 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	Control n=265 Participants Care as Usual
Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome	66.15 score on a scale Standard Deviation 11.87	66.81 score on a scale Standard Deviation 14.45

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=271 Participants 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	Control n=265 Participants Care as Usual
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	3.14 score on a scale Standard Deviation 0.68

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=271 Participants 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	Control n=265 Participants Care as Usual
Number of Outpatient Visits Over the Past 6 Months - Patient-reported	5.39 outpatient visits Standard Deviation 7.79	4.39 outpatient visits Standard Deviation 6.79

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 17 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Athena Philis-Tsimikas, MD, Co-Principal Investigator

Scripps Health

Phone: 858-678-7045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place