ED Diabetes Screening and Outpatient Care

Diabetes Mellitus Clinical Trial

Official title:

Identifying Risk Factors for Poor Glycemic Control Among Emergency Department Patients and Improving Linkage to Outpatient Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05899023
• Other study ID #: 23-00571
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2025
• Est. completion date: May 31, 2028

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: David C. Lee
• Phone: 212-562-6561
• Email: David.Lee[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Non Insulin Dependent Diabetes Mellitus

Intervention

Other:
• Telehealth 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.
• Standard 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Patients who Complete at least One In-Person Follow-up Outpatient Visit	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.	Up to Month 6 Post-Diagnosis
Secondary	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
Secondary	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
Secondary	Percent of Patients who Start on Diabetes Medications within 6 Months of Diagnosis		Up to Month 6 Post-Diagnosis