A Transition of Care Model From Hospital to Community for Hispanic/Latino Adult Patients With Diabetes.
Phase: NA
Conditions: Diabetes Mellitus
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
 
A Transition of Care Model from Hospital to Community for Hispanic/Latino Adult Patients with Diabetes 
 
Document Date: November 9, 2021 
 
NCT04864639 
 

 
Purpose of the Study 
  
The prevalence of diabetes in adults over the age of 20 is significantly higher in the Hispanic/Latino  
population compared to non-Hispanic whites. Admitted patients with diabetes are at higher risk for 
readmission and Emergency Department (ED) visits than those without diabetes especially those in 
lower socioeconomic status and racial/ethnic minority groups. The goals of this proposed study are to 
explore patients and providers perceptions (n=15, 6 providers and 4 patients) of the current discharge 
process which will inform the development of a patient-centered transition of care model for Hispanic 
/Latino adults (≥18 years of age) with diabetes from hospital to the community. It is hypothesized that a 
culturally tailored transition of care model tailored for Hispanic/Latinos adults with diabetes will result in 
fewer ED visits, hospital admissions, and re-admissions. 
 
The objective remains the same for Aim2. Our hypothesis is that participants enrolled in the newly 
developed transition of care model will have less Emergency Room visits post discharge, lower rates of 
unplanned readmission at 30 days post discharge and will report more follow up visits with a health care 
provider within 30 days of discharge than those individuals discharged on the usual transition of care 
plan.  In addition, patient experience will be better in those in the new transition of care model. 
  
 
Background & Significance 
 
The prevalence of diabetes in adults over the age of 20 is significantly higher in the Hispanic/Latino 
population compared to non- Hispanic whites.  Diabetes imposes a large economic burden partially due 
to the significantly higher rates of hospital admission compared to those individuals without diabetes.  
In 2014, a total of 7.2 million hospital discharges were reported with diabetes as any listed diagnosis 
among U.S. adults aged 18 years or older.  Admitted patients with diabetes are at higher risk for 
readmission and Emergency Department (ED) visits than those without diabetes especially those in 
lower socioeconomic status, racial/ethnic minority groups, history of prior admission, diabetes 
associated comorbidities, public insurance, and emergent or urgent admission.   
  
Diabetes is one of the most common conditions managed in the hospital, yet how to transition a patient 
with diabetes to the outpatient setting is understudied and outcomes of patients with diabetes after 
discharge is unknown. The importance of the transition of care from hospital to the community for 
patients with diabetes has been identified as a major area of improvement in diabetes care. Despite the 
economic burden and growing interest in factors leading to readmission, a paucity of research exists 
focusing on the transition of care among patients with diabetes.  The American Diabetes Association 
(ADA) recommends a well-structured, patient-centered, transitions of the care, which includes a 
discharge plan and follow up within 30 days from discharge to help reduce the rates of readmission as 
well as a hospital stay.  Unfortunately, this transition is significantly challenging for patients with fewer 
resources, language barriers, cultural differences, and low health literacy which collectively can lead to 
an increase risk of readmissions and emergency department visits. Further, the limited available data 
looking at outcomes post-discharge in patients with diabetes shows that being Hispanic/Latino is 
associated with a higher risk for multiple hospitalizations and re-hospitalization. Despite the increasing 

advances in diabetes care, Hispanic/Latino patients remain a leading subgroup of patients not reaching 
diabetes goals. Therefore, developing a transition of care model that is patient/culturally centered for 
Hispanic/Latino adults with diabetes from the hospital to the community/home will reduce the existent 
gap in diabetes care. 
 
 
Design & Procedures 
 
Aim 1:  To develop the transition of care model for Hispanic/Latino adults, patients and providers will be 
selected from Duke Regional Hospital (DRH) and Duke University Health System (DUHS), the local 
Hispanic/Latino community, and local clinics in Durham delivering care to Hispanic/Latino patients with 
diabetes. Drs. Corsino and Padilla will collect the data. It is anticipated that a total of 15 participants (4 
patients) and (6 providers - physicians [MD, DO], nurse practitioners (NPs), and physician assistants 
(PAs)) will be obtained. We seek to explore patients' and providers' perspectives on the transition of 
care from hospital to community. All participants will complete a brief questionnaire. The information 
collected will be instrumental in developing a transition of care model that is culturally/patient 
centered. 
 
Aim 2:  Overall common themes have been collected from the 4 patient participants and 6 provider 
participants interviews and questionnaires thus far. Providers and patients uniformly expressed a need 
for a simple discharge summary that is more visual and in Spanish, language barriers and financial 
constraints. 
 
Duke CTSI will conduct a Community Consultation Studio with community Engaged Research Initiative 
Core as a part of Pro00103450. They will interview 6-8 participants from Hispanic/Latino communities 
with diabetes. The common themes from this interview along with the common themes from the first 
10 participants in this protocol will be combined to develop a transition of care model. 
 
The first set of 16 participants will be discharged on the newly developed model based on interviews 
and data collected already and CTSI CCS protocol Pro00103450. The participants will be asked to 
complete a set of questionnaires and a 30-day post discharge telephone interview. 
 
This interactive approach will use the Plan-Do-Study-Act (PDSA) framework. Changes can be reassessed 
and modified swiftly as a part of the continuous improvement cycle to allow for adjustments that 
facilitate the desired outcomes. 
 
The second set of 16 participants will be discharged on a model based on the first 16 participants 
experience and feedback. Five participants enrolled in the first set will be re-interviewed to assess their 
feedback regarding the process. Based on this information the TOC model will be revised. 
 
The second set of participants will complete a set of questionnaires and a 30-day post discharge phone 
interview similar to the first set of participants. 
 

Key personnel will administer informed consent, eConsent or verbal consent depending on the 
participants access to resources at the time of enrollment. Covid-19 face to face interactions has limited 
the ability of face to face contact strictly for research purposes. We would like to keep the face to face 
option available for consent and questionnaires because some participants may be recruited by the key 
personnel rounding on the patient. 
 
The Hispanic/Latino population has limited access to e-mail and smart phones. In the event that 
participants do not have access to email and cellphone we will obtain verbal consent. The informed 
consent, questionnaires and 30 day follow up phone call may all be done verbally in these cases. The 30 
day follow telephone call will be recorded with an encrypted recorder. The recording will be used for 
review purposes only. 
 
The 30-day follow up telephone survey will also collect data from participants receiving care outside of 
the Duke University Health System and systems not sharing the same electronic medical record. 
 
3 additional providers will be reconsented and repeat the original interview. 
 
 
Selection of Subjects 
  
Aim 1 inclusion criteria: 
Patients: 
1. 18 years or older 
2. Self-Identified as Hispanic/Latino 
3. Previous diagnosis with Diabetes Mellitus 
4. Ability to provide informed consent without a proxy 
5.  An admitted patient at a Duke University Hospital or Duke Regional Hospital facility.   
6.  English or Spanish speaking 
  
Providers: 
1.  See patients at Duke Regional Hospital or Duke University Hospital 
2.  Working in the local clinics proving care for the local Hispanic/Latino patients. 
 
For Aim 2 the patient inclusion criteria will only include patients that are currently hospitalized. 
There is not exclusion criteria based on comorbidities. 
  
  
Subject Recruitment and Compensation 
 
Subjects will be introduced to the study by Dr. Corsino, Dr. Padilla or other key personnel. They are both 
bilingual. Approximately 4 patients will be recruited from Durham, NC. Inclusion criteria include age ≥18 
years, self-identified as Hispanic/Latino, previous diagnosis of diabetes, Spanish and/or English speaker, 
ability to provide informed consent without a proxy, with a recent (within 3 months) hospitalization at 
Duke Regional Hospital (DRH) or Duke University Hospital. Maestro care/Epic slicer dicer will be used to 

identify participants with a recent hospitalization. Patient word of mouth may also be used from local 
Hispanic organizations. Both methods have been previously implemented by Co-PI (Corsino) while 
enrolling Hispanic/Latino participants in research studies. Approximately 6 health care providers will be 
recruited from the DRH and Duke University Hospital. We aim to enroll a diverse group of providers 
including MDs, DOs, NPs and PAs. Providers will be approached for recruitment by the Co-PIs or 
designated trained research staff. Both inpatient and outpatient providers will be targeted. 
Compensation will be $10 per person. If the participant is not interested in sharing their social security 
number with the research team they will receive a gift of similar monetary value. 
 
Aim 2:  Participants will be recruited using Slicer Dicer or the inpatient diabetes admission list.  Trained 
key personnel on the study will introduce the potential subjects to the study. A total of 32 subjects will 
be recruited and enrolled. The subjects will be compensated $25 dollars from petty cash for their 
participation. For the re-interviews (providers) will receive $10 dollars. 
 
 
Risk/Benefit Assessment 
 
This is a minimal risk study.  We will not include vulnerable populations. 
  
This study should result in better understanding of factors that impact the transition of care of 
Hispanics/Latinos patients with diabetes. Identifying and understanding internal and external barriers to 
the transition of care should be determined when considering designing a culturally sensitive transition 
of care model. A better method to transition from inpatient setting to home for Hispanic/Latinos with 
regard to factors such as lower socioeconomic status, language, and health literacy along with a 
fragmented delivery system may result in better outcomes during the transition phase from acute to the 
outpatient setting.  
 
The benefits to the subject are that the participant may require fewer visits to the ED and less 
admissions to the hospital in the 30 days following their hospitalization. 
 
The importance of this study is to optimize the transition of care of Hispanic/Latino patients with 
diabetes because it is poorly understood. This study will inform a more aligned discharge and follow-up 
process for Hispanic/Latino patients discharge in future and will also inform future larger randomized 
trials. 
  
 
Data Analysis & Statistical Considerations 
 
General Data Analytics. The recording will be reviewed by the Co-PI, each independently, they will 
identify themes and will color code them. Subsequently themes will be combined into common themes. 
 
Analysis. For all outcomes and demographic information collected, descriptive analysis (means 
and standard deviations for continuous variables and frequencies and percentages for categorical 
variables) overall and by randomization arms. The non-feasibility outcomes will be compared 

between the usual care and intervention group. Chi-squared or Fisher’s Exact tests will be 
conducted to assess the differences of each outcome between groups. Logistic regression models 
will be conducted to access the adjusted differences of each outcome between usual care and 
intervention groups. The models will be adjusted for a limited number of variables that are theoretically 
thought to explain some variation in the value of the outcomes. 
 
For Aim 2 we would like to ensure that we are able to at minimum detect a difference in the primary 
outcomes in the number of Emergency Department visits and hospital re-admissions.