A Transition of Care Model From Hospital to Community for Hispanic/Latino Adult Patients With Diabetes. (TOC)

This pilot study was designed to address the existing gap in the transition of care of Hispanic/Latino Adults with diabetes from hospital to community. The over arching goal of this study is to develop, test, and determine the feasibility of a transition of care (ToC) model from the hospital to the community for adult Hispanic/Latino patients with diabetes.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Transition of Care Model

Detailed Description

This pilot study is designed to develop, test, and determine the feasibility of a transition of care model from the hospital to the community for adult Hispanic/Latino patients with diabetes. The proposed study originally designed was randomized pilot study with two arms: 1) the usual transition of care and (2) a transition of care model newly developed using information collected during our study aim 1. Given the multiple challenges brought on by the COVID-19 pandemic, we found it necessary to adapt and modify the original study design. The study designed with approval from our funding team was changed to utilize the Plan-Do-Act-Study (PDSA) as a framework. The PDSA is an iterative process that allows us to test on a small scale and document unexpected observations and determine what modifications should be made and prepare for next test. A transition of care (ToC) model will be developed based on the following data: 1) results from semi-structure interviews from our first cohort of Hispanic/Latino participants with diabetes recently discharged from the hospital and providers from the hospital and community ; 2) feedback from participants in the community during the Community Consultation Studio . Once developed, the ToC model will be tested with a total of 16 participants discharged from the hospital to the community. The model will incorporate the preference and perspective of providers and patients. Participants will complete a set of of questionnaires (demographic, sociocultural and medical history) prior to discharge and a follow up telephone call interview 30-days post discharge. A total of 5 participants for the first set of participants will be interview. These interviews will be analyzed for common patterns and themes for which the results will inform improvement of the ToC. A second cohort of participants (n=16) will be enrolled. And complete the same set of questionnaires along with the 30 day post discharge telephone call. Finally, after implementing and enrolling the second cohort, as small subset will be interview including providers (n=3) to obtain additional information that will inform further improvement of the ToC.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Leonor Corsino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years of age
• Diagnosis of Diabetes Mellitus
• Self-identified Hispanic/Latino
• Spanish or English speaking
• Currently hospitalized in the Duke University Health System
• Able to provide informed consent without a proxy

Exclusion Criteria:

• There is no exclusion criteria based on comorbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transition of Care; Experimental: 32 participants will be discharged to a newly developed discharge/transition of care model.	Other: Transition of Care Model; Participants with diabetes, Hispanic/Latinos, adults will receive newly developed discharge instructions.; Other Names: Patient discharge model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department (ED) Visits Within 30 Days Post Discharge	The number of times the participant has revisited the ED after their discharge from the hospital.	30 days post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned Readmissions to the Hospital Within 30 Days Post Discharge	The number of times the patient is readmitted to the hospital for unplanned admissions after discharge.	up to 30 days

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); New York Regional Center for Diabetes Translation Research, Albert Einstein College of Medicine
• Investigators: Principal Investigator: Leonor Corsino, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Spanish; Transition of Care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: Pro00103607; 5P30DK111022-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that results reported in manuscript after deidentification (text, tables, figures, appendices)
• IPD Sharing Time Frame: Sharing will end 5 years after manuscript publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No