Clinical trial NCT04864639: A Transition of Care Model From Hospital to Community for Hispanic/Latino Adult Patients With Diabetes.
Official title: A Transition of Care Model From Hospital to Community for Hispanic/Latino Adult Patients With Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Spanish
Transition of Care
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Albert Einstein College of Medicine
First posted: 2021-04-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Exclusion Criteria:

* There is no exclusion criteria based on comorbidities

Primary outcomes:
measure: Emergency Department (ED) Visits Within 30 Days Post Discharge
timeFrame: 30 days post-discharge
Secondary outcomes:
measure: Unplanned Readmissions to the Hospital Within 30 Days Post Discharge
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Leonor Corsino, MD
state: North Carolina
Study officials:
affiliation: Duke University
name: Leonor Corsino, MD
role: PRINCIPAL_INVESTIGATOR
References: