Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus
Conditions
Brief summary
This goal of this NIH funded R01 study is to identify risk factors for not being able to follow-up for a new diagnosis of diabetes in the emergency department and improve linkage of these newly diagnosed patients to appropriate outpatient care. Its three aims will be accomplished through 1) a retrospective chart review of emergency department (ED) patients screened for diabetes, 2) a series of prospective qualitative interviews among ED patients with newly diagnosed diabetes who fail to follow-up for outpatient care, and 3) a simple randomized controlled trial to test the efficacy of telehealth bridge visits to connect ED patients with newly diagnosed diabetes to outpatient primary care.
Interventions
OTHERTelehealth Bridge Visits
Patients will be scheduled for a telemedicine visit staffed by a family or internal medicine trained physician who will assess their understanding and answer any questions about the new diagnosis of diabetes, start initial conversations about how to improve their habits around diet and exercise, and discuss medication options for diabetes and, if appropriate, initiate treatment. At the end of the telemedicine visit, providers will attempt to address any difficulties that patients are experiencing in accessing primary care by providing an alternative contact for care or reaching out to a primary care doctor as necessary. If the patient experiences difficulties accessing a primary care provider based on their first telemedicine visit, then an additional telemedicine visit can be scheduled for the patient.
OTHERStandard of Care
Standard of care currently includes calls from the site's follow-up center to see if patients received their HbA1c result, understood what their result meant, had any problems accessing medications prescribed or any difficulty scheduling an outpatient follow-up visit.
Sponsors
NYU Langone Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Emergency patient receiving lab tests with an initial HbA1c test result of ≥ 6.5% * Residential address in New York City or Long Island * Primary language is English or Spanish * Able to provide informed consent
Exclusion criteria
* No prior history of diabetes * No medical condition that would result in a spurious HbA1c test (e.g., sickle cell, recent blood loss)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients who Complete at least One In-Person Follow-up Outpatient Visit | Up to Month 6 Post-Diagnosis | A follow-up outpatient visit excludes the telehealth visits assigned to the experimental group. This outcome will be tracked using phone calls and data from Healthix, a regional health information exchange. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 6 Months of Diagnosis | Up to Month 6 Post-Diagnosis | Using phone follow-up and Healthix data, investigators will assess whether ED patients with newly diagnosed diabetes have a follow-up HbA1c test within 6 months of their initial diagnosis. Trend between initial and follow-up HbA1c test will be analyzed. |
| Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 12 Months of Diagnosis | Up to Month 12 Post-Diagnosis | Using phone follow-up and Healthix data, investigators will assess whether ED patients with newly diagnosed diabetes have a follow-up HbA1c test within 12 months of their initial diagnosis. Trend between initial and follow-up HbA1c test will be analyzed. |
| Percent of Patients who Start on Diabetes Medications within 6 Months of Diagnosis | Up to Month 6 Post-Diagnosis | Using phone follow-up and Healthix data, investigators will assess whether ED patients with newly diagnosed diabetes are started on any type of diabetes medication within 6 months of their initial diagn |
Countries
United States
Contacts
CONTACTDavid C. Lee
PRINCIPAL_INVESTIGATORDavid C. Lee
NYU Langone Health
Outcome results
None listed