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ED Diabetes Screening and Outpatient Care

Primary Purpose

Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Bridge Visits
Standard of Care
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telehealth Bridge Visits

Control

Arm Description

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.

Patients in the control arm will receive standard of care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 6 Months of Diagnosis
Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 12 Months of Diagnosis
Percent of Patients who Start on Diabetes Medications within 6 Months of Diagnosis

Full Information

First Posted
June 2, 2023
Last Updated
August 23, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05899023
Brief Title
ED Diabetes Screening and Outpatient Care
Official Title
Identifying Risk Factors for Poor Glycemic Control Among Emergency Department Patients and Improving Linkage to Outpatient Care
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2024 (Anticipated)
Primary Completion Date
July 1, 2028 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telehealth Bridge Visits
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in the control arm will receive standard of care.
Intervention Type
Other
Intervention Name(s)
Telehealth Bridge Visits
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of Patients who Complete at least One In-Person Follow-up Outpatient Visit
Description
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.
Time Frame
Up to Month 6 Post-Diagnosis
Secondary Outcome Measure Information:
Title
Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 6 Months of Diagnosis
Time Frame
Up to Month 6 Post-Diagnosis
Title
Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 12 Months of Diagnosis
Time Frame
Up to Month 12 Post-Diagnosis
Title
Percent of Patients who Start on Diabetes Medications within 6 Months of Diagnosis
Time Frame
Up to Month 6 Post-Diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David C. Lee
Phone
212-562-6561
Email
David.Lee@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Lee
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared with researchers who provide a methodologically sound proposal upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.Lee@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal will be granted access upon reasonable request. Requests should be directed to David.Lee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

ED Diabetes Screening and Outpatient Care

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