ED Diabetes Screening and Outpatient Care

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05899023
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
200
1
2
60
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Telehealth Bridge Visits
  • Other: Standard of Care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Identifying Risk Factors for Poor Glycemic Control Among Emergency Department Patients and Improving Linkage to Outpatient Care
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2028
Anticipated Study Completion Date :
Jul 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Active Comparator: Control

Patients in the control arm will receive standard of care.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

  2. 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]

  3. Percent of Patients who Start on Diabetes Medications within 6 Months of Diagnosis [Up to Month 6 Post-Diagnosis]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: David C. Lee, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05899023
Other Study ID Numbers:
  • 23-00571
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2023