Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being
Phase: NA
Conditions: Type 2 Diabetes Mellitus, Cardiometabolic Conditions, Behavioral Health Concerns
Sponsor: Scripps Whittier Diabetes Institute

Cover Page for ClinicalTrials.gov 
 
Document: 
Protocol and Statistical Analysis Plan 
 
Official Study Title: 
Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being 
 
NCT# 
NCT02723019 
 
Document Date 
January 24, 2017 

Mi Puente Protocol 
The proposed randomized controlled trial will enroll 560 individuals according to the inclusion and 
exclusion criteria that follow and randomly assign them to a study group in order to test the 
effectiveness of Mi Puente, a nurse and volunteer peer team intervention (n=280) versus Usual Care, a 
best practices comparison (n=280) in Hispanics with multiple chronic physical and behavioral conditions. 
 
Inclusion criteria:  
1. Hispanic ethnicity (any race) 
2. Is currently inpatient at Scripps Mercy Hospital Chula Vista 
3. Age 18 years and older 
4. Two or more cardiometabolic conditions (e.g., obesity, diabetes, hypertension, ischemic heart 
disease, congestive heart failure, other chronic coronary conditions, dyslipidemia) 
5. One or more behavioral health concern(s) (e.g., broadly defined and related to mental health, 
medication adherence, life stressors, healthcare use, substance use 
6. Access to telephone (mobile or landline) 
 
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. Plans to discharge to location other than home (e.g., inpatient rehabilitation or nursing care) 
5. Does not speak Spanish or English 
 
Patients who are potentially eligible (based on demographics, diagnoses) will be identified through a 
daily review of electronic medical records (EMR) and asked by their bedside nurse if they are willing to 
discuss the study with research staff. Those who agree will be approached by a trained bilingual 
research assistant, who will obtain verbal informed consent and administer an evidence-based 
behavioral health screener. Patients with one or more behavioral health needs identified either via 
screening or EMR review (e.g. documented, pre-existing mental health diagnosis) will be deemed 
eligible, provided with a detailed description of the study and if interested will be asked to provide 
written informed consent. 
 
Behavioral Health Screener will comprise of the following parameters: 
1. Emotional Well-being, measured by the PROMIS Anxiety and Depression forms, 
2. Smoking, measured by number of cigarettes smoked per day 
3. Alcohol consumptions (AUDIT-C) 
4. Stress, measured by means of the Perceived Stress Scale, 4-item 
5. Medication Adherence, measured by how many days/weeks the recommended medications are 
taken, reported by the patient 
6. Healthcare access, patients’ report on where they normally seek medical care. 
 
After informed consent is obtained, assignment will be unveiled to the participant by the consenting 
research assistant and the participant will be assigned also with an ID number which will be used in all 

procedures using de-identified data. 
 
Participants assigned to the Usual Care (UC) group will be treated using best practice evidence-based 
discharge procedures, involving a team-based approach to enhance coordination of care for individuals 
at high risk for readmission. 
 
Participants assigned to the Mi Puente group will be receiving usual care along with the Mi Puente 
discharge procedure. The latter involves individualized support from a Behavioral Health Nurse while 
inpatient, a follow-up call from the Behavioral Health Nurse during post-discharge week 1 and weekly 
supportive phone calls from a Volunteer Peer Mentor during post-discharge weeks 1-4. The intervention 
will focus on building resources, skills, knowledge and on empowering patients and connecting them 
with appropriate outpatient services. 
 
EMR of all study subjects will be audited for specific information relevant to the trial (e.g. diagnoses, 
medication, complications, readmissions, length of stay) at baseline and for readmissions at 30-days and 
180-days after baseline. 
 
All study subjects will participate in three assessments of approximately 30-60 minutes duration at 
baseline and at 3 months and 6 months after baseline. Baseline assessment will be performed prior to 
hospital discharge in person and the month-3 and month-6 assessments will be conducted by 
telephone.  
 
Data collected during these assessments will involve the following patient-reported indicators: 
1. Demographic information (study-specific/standard item) 
2. Physical symptoms, measured via the PHQ-15 
3. Quality of life, measured by the PROMIS General Health Scale 
4. Healthcare access and barriers, measure adapted from the HCHS/SOL 
5. Patient activation, measured by the Patient Activation Measure 
6. Support resources for disease management, measured by means of the Chronic Illness Resources 
Survey. 
 
Guided by the RE-AIM framework, the program evaluation will examine the success of Mi Puente versus 
Usual Care in 1) Reaching a representative segment of the population (Reach); 2) Achieving meaningful 
outcomes through a well-implemented intervention (Efficacy/Implementation); and 3) Creating an 
intervention that can be adopted by and maintained in a real-world environment (Adoption/ 
Maintenance). As part of the evaluation, 20 participants will be invited to attend focus groups to share 
their experiences with the intervention (2-3 groups). The Behavioral Health Nurse and Volunteer Peer 
Mentors will also serve as “participants” via their involvement in evaluating the treatment fidelity of and 
their experiences with Mi Puente. 
 
Cost-effectiveness Analysis (CEA) of the Mi Puente intervention relative to Usual Care only will be 
conducted focusing on services delivered by the two care partners (Scripps/San Ysidro Health center) 
and Mi Puente coordination over the 6-month study period. Cost-effectiveness will be estimated using 
the Incremental Cost Effectiveness Ratio (ICER). The estimated ICER will be compared to CEA standards 

and similar interventions to provide context for the cost-effectiveness of Mi Puente. 
 
Timeline: The study will be conducted over 5 years, 07/01/15 – 06/30/20. The first 6 months will be 
devoted to start-up. Eligible patients will be enrolled between months 7 and 46 and the recruitment 
target is approximately 28 patients per month during this period, with post-discharge telephone 
intervention for Mi Puente group participants concluding in month 47. Follow-up telephone 
assessments of patient-reported outcomes will be completed between months 10 and 52. Focus groups 
will follow in months 53-54 and the last 6 months will be devoted to statistical analyses and report 
preparation. 
Study participants will be offered gift cards as an incentive to complete all assessments. Study 
participants will receive compensation after baseline ($20), month-3 ($20) and month-6 ($25) 
assessments in the form of gift cards. The total incentive for participants who will complete all 
assessments will be $65. Gift cards will be given after completion of each assessment; that is at baseline, 
3-months and 6 months. 
Patients interested in the study will be approached by a trained bilingual staff member while inpatient. 
The bilingual staff member will introduce the study to the participant and obtain verbal consent to 
administer evidence-based behavioral health screening. Patients who are deemed eligible to participate 
in the study will be provided with a copy of the consent form and will review all content together with 
the staff member both in Spanish and English. Adequate opportunity will be provided to the potential 
participant to consider all options and ask questions; care will be taken to ensure that all participants 
understand the information and that their participation is voluntary. Prior to each follow-up 
appointment, research staff will remind participants of the procedures and the voluntary nature of their 
participation. 
Statistical Analysis Plan 
Sample size 
Power and Sample Size 
The target study sample size is 560 participants allocated equally to the two groups (n = 280/group). 
Sample size estimates were calculated based on the primary outcome of hospital utilization at 30 and 
180 days, and the secondary outcome of changes in patient-reported outcomes. All estimates were 
generated using RMASS2 assuming a statistical significance level of .05 (two-tailed), and targeting at 
least 80% power. Sample size estimates were adjusted to up to 20% total attrition. Power analyses 
indicated that a sample size of 558 is needed at baseline to find a statistically significant incidence rate 
ratio of expected magnitude with 80% power. For patient-reported outcomes, we estimated an effect 
size of d = 0.50 as a clinically significant change. Using parameters defined above, 280 participants are 
needed to find a statistically significant difference between groups. 
Analytic Plan 
All analytic strategies will follow intent-to-treat principles.  Preliminary data screening and cleaning will 
be conducted, and statistical testing and effect size consultation will be used to determine if random 
assignment has resulted in statistical equivalence between groups. Significant covariates will be added 
to adjust for nonequivalence. Analyses of hospital utilization (primary outcome) and patient-reported 

outcomes will be conducted using multi-level modeling and the appropriate link function for a target 
outcome. Analyses will include “group” (Mi Puente or Usual ) as the between-subjects factor, “time” 
(assessment dates) as the within-subjects factor, and a cross-level, “group-by-time” interaction effect. 
Analyses will be conducted in IBM SPSS Statistics 22.0 (IBM, Inc., Armonk, NY, UK) and MPLUS (Muthen 
& Muthen, Los Angeles, CA, USA. Effect size indicators and confidence intervals will also be examined 
and reported.