ED Diabetes Screening and Outpatient Care

Not Applicable

Not yet recruiting

• Conditions: Non Insulin Dependent Diabetes Mellitus; Diabetes Mellitus
• Interventions: Other: Standard of Care; Other: Telehealth Bridge Visits

• Registration Number: NCT05899023
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Study Start: 2025-11-30
• Primary Completion: 2028-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard of Care	Patients in the control arm will receive standard of care.
Telehealth Bridge Visits	Telehealth Bridge Visits	Patients in the experimental arm will receive post-emergency department telehealth bridge visits to connect ED patients with newly diagnosed diabetes to outpatient primary care.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percent of Patients who Start on Diabetes Medications within 6 Months of Diagnosis	Up to Month 6 Post-Diagnosis
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
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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States