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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30DK111022-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Albert Einstein College of Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transition of Care | Experimental | Experimental: 32 participants will be discharged to a newly developed discharge/transition of care model. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transition of Care Model | Other | Participants with diabetes, Hispanic/Latinos, adults will receive newly developed discharge instructions. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned Readmissions to the Hospital Within 30 Days Post Discharge | The number of times the patient is readmitted to the hospital for unplanned admissions after discharge. | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonor Corsino, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leonor Corsino, MD | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36471392 | Derived | 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. |
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Individual participant data that results reported in manuscript after deidentification (text, tables, figures, appendices)
Sharing will end 5 years after manuscript publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Transition of Care | Experimental: Participants will be discharged to a newly developed discharge/transition of care model. Transition of Care Model: Participants with diabetes, self-identified Hispanic/Latinos, adults will receive newly developed discharge instructions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transition of Care | Experimental: Participants will be discharged to a newly developed discharge/transition of care model. Transition of Care Model: Participants with diabetes, self-identified Hispanic/Latinos, adults will receive newly developed discharge instructions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | emergency department visits | 30 days post-discharge |
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Approximately 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transition of Care | Experimental: Participants will be discharged to a newly developed discharge/transition of care model. Transition of Care Model: Participants with diabetes, Hispanic/Latinos, adults will receive newly developed discharge instructions. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leonor Corsino, MD, MHS | Duke University | 919-684-4005 | leonor.corsinonunez@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2021 | Feb 2, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2022 | Apr 4, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Unplanned Readmissions to the Hospital Within 30 Days Post Discharge | The number of times the patient is readmitted to the hospital for unplanned admissions after discharge. | Posted | Mean | Standard Deviation | hospital readmissions | up to 30 days |
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| 1 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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