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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Transition of Care Model

• Registration Number: NCT04864639
• Lead Sponsor: Duke University

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-29
• Study Start: 2021-08-04
• Primary Completion: 2022-02-17
• Study Completion: 2022-02-17
• Results First Submitted: 2023-02-03
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-14
• Last Update Submitted: 2023-03-14
• Results First Posted: 2023-03-17
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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Exclusion Criteria

• There is no exclusion criteria based on comorbidities

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transition of Care	Transition of Care Model	Experimental: 32 participants will be discharged to a newly developed discharge/transition of care model.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Leonor Corsino, MD; 🇺🇸 Durham, North Carolina, United States