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

NCT04864639 | Completed Results

• 2 other identifiers: Pro001036075P30DK111022-05
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Spanish; Transition of Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Unplanned Readmissions to the Hospital Within 30 Days Post Discharge

  up to 30 days

Study Arms (1)

Transition of Care

EXPERIMENTAL

Experimental: 32 participants will be discharged to a newly developed discharge/transition of care model.

Other: Transition of Care Model

Interventions

Transition of Care Model OTHER

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

Also known as: Patient discharge model

Transition of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Albert Einstein College of Medicine: collaborator

Study Sites (1)

Leonor Corsino, MD

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Corsino L, Padilla BI. A transition of care model from hospital to community for Hispanic/Latino adult patients with diabetes: design and rationale for a pilot study. Pilot Feasibility Stud. 2022 Dec 5;8(1):246. doi: 10.1186/s40814-022-01203-z.

  PMID: 36471392 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Given the multiple challenges brought on by the COVID-19 pandemic, the PIs found it necessary to modify the original study design. Under the guidance of the study sponsors/mentors, the study design was changed to a Plan-Do-Study-Act (PDSA) cycle framework. The rationale for this modified approach was informed by the fact that "the usual transition of care" was significantly altered during the pandemic. The recruitment goal was not reached before running out of funding for the study.

Results Point of Contact

• Title: Leonor Corsino, MD, MHS
• Organization: Duke University

leonor.corsinonunez@duke.edu

919-684-4005

Study Officials

• Leonor Corsino, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: August 4, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 17, 2023
• Results First Posted: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Sharing will end 5 years after manuscript publication

Locations

US (1)