Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Spanish, Transition of Care
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.
Interventions
OTHERTransition of Care Model
Participants with diabetes, Hispanic/Latinos, adults will receive newly developed discharge instructions.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Albert Einstein College of Medicine
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department (ED) Visits Within 30 Days Post Discharge | 30 days post-discharge | The number of times the participant has revisited the ED after their discharge from the hospital. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned Readmissions to the Hospital Within 30 Days Post Discharge | up to 30 days | The number of times the patient is readmitted to the hospital for unplanned admissions after discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Transition of Care |
|---|---|
| Age, Continuous | 47.5 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 30 days post-discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transition of Care | Emergency Department (ED) Visits Within 30 Days Post Discharge | 0 emergency department visits | Standard Deviation 0 |
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.
Time frame: up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transition of Care | Unplanned Readmissions to the Hospital Within 30 Days Post Discharge | 0 hospital readmissions | Standard Deviation 0 |