ED Diabetes Screening and Outpatient Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus

Intervention / Treatment
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* Other: Telehealth Bridge Visits
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth Bridge Visits<br>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. | Other: Telehealth Bridge Visits<br>* 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.<br>|
| Active Comparator: Control<br>Patients in the control arm will receive standard of care. | Other: Standard of Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percent of Patients who Start on Diabetes Medications within 6 Months of Diagnosis |  | Up to Month 6 Post-Diagnosis |