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

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ClinicalTrials.gov Identifier: NCT04864639
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : December 14, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Transition of Care Model Not Applicable

Detailed Description:
This pilot study is designed to develop, test, and determine the feasibility of a transition of care model from hospital to the community for adult Hispanic/Latino patients with diabetes. The proposed study utilized 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 culturally centered ToC model will be develop 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 (n=4) and providers from the hospital and community (n=6); 2) feedback from participants in the community during the Community Consultation Studio think tank. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Transition of Care Model From Hospital to Community for Hispanic/Latino Adult Patients With Diabetes.
Actual Study Start Date : August 4, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Arm Intervention/treatment
Experimental: Transition of Care
Experimental: 32 participants will be discharged to a culturally relevant newly developed discharge/transition of care model.
Other: Transition of Care Model
Participants with diabetes, Hispanic/Latinos, adults will receive newly developed discharge instructions.
Other Name: Patient discharge model




Primary Outcome Measures :
  1. Emergency department 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 Outcome Measures :
  1. Re-admissions to the hospital within 30 days post discharge [ Time Frame: up to 30 days ]
    The number of times the participant has be admitted to the hospital after their discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Patients:

    1. At least 18 years of age
    2. Diagnosis of Diabetes Mellitus
    3. Self-identified Hispanic/Latino
    4. Spanish or English speaking
    5. Currently hospitalized in the Duke University Health System
    6. Able to provide informed consent without a proxy
  • Providers:

    1. See patients at Duke Regional Hospital or Duke University Hospital
    2. Works in the local clinics proving care for the local Hispanic/Latino patients.

Exclusion Criteria:

  • There is no exclusion criteria based on comorbidities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864639


Contacts
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Contact: Leonor Corsino, MD (919) 684-4005 leonor.corsinonunez@duke.edu
Contact: Iris padilla, PhD 919-613-9771 iris.padilla@duke.edu

Locations
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United States, North Carolina
Leonor Corsino, MD Recruiting
Durham, North Carolina, United States, 27710
Contact: Iris Padilla, PhD, MSN, APRN, FNP-BC, FAANP       iris.padilla@duke.edu   
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Leonor Corsino, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04864639    
Other Study ID Numbers: Pro00103607
5P30DK111022-05 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: December 14, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that results reported in manuscript after deidentification (text, tables, figures, appendices)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Sharing will end 5 years after manuscript publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Diabetes Mellitus
Spanish
Transition of Care
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases