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

Diabetes Mellitus Clinical Trial

— TOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864639
• Other study ID #: Pro00103607
• Secondary ID: 5P30DK111022-05
• Status: Completed
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: February 17, 2022

Study information

• Verified date: March 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Transition of Care Model
Participants with diabetes, Hispanic/Latinos, adults will receive newly developed discharge instructions.

Locations

Country	Name	City	State
United States	Leonor Corsino, MD	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), New York Regional Center for Diabetes Translation Research, Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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