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

NCT ID: NCT04864639

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2022-02-17

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Transition of Care

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

Group Type: EXPERIMENTAL

Transition of Care Model

Intervention Type: OTHER

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

Interventions

Transition of Care Model

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

Intervention Type: OTHER

Other Intervention Names

Patient discharge model

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonor Corsino, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Leonor Corsino, MD

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36471392 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P30DK111022-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00103607

Identifier Type: -

Identifier Source: org_study_id