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Completed

NCT Number: NCT04864639

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leonor Corsino, MD

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transition of Care Model

Other

Participants with diabetes, Hispanic/Latinos, adults will receive newly developed discharge instructions.

Other names: Patient discharge model

Primary outcomes

  1. Emergency Department (ED) Visits Within 30 Days Post Discharge

    Time frame: 30 days post-discharge

    The number of times the participant has revisited the ED after their discharge from the hospital.

Secondary outcomes

  1. Unplanned Readmissions to the Hospital Within 30 Days Post Discharge

    Time frame: up to 30 days

    The number of times the patient is readmitted to the hospital for unplanned admissions after discharge.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Albert Einstein College of Medicine
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: TOC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2021
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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