- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06899191
Diabetes Electronic Prompt for Improved Care Coordination and Treatment in the ED (DEPICCT)
Diabetes Electronic Prompt for Improved Care Coordination and Treatment (DEPICCT) in the ED
The goal of this clinical trial is to improve the processes of Type 2 Diabetes (T2D) care coordination and treatment in the emergency department (ED) by utilizing clinical decision support mechanisms in the electronic health record (EHR). The main question is whether electronic prompts triggered by hyperglycemia and elevated A1c results in providers providing earlier treatments and faster time to subsequent primary care appointment and greater reduction in hemoglobin A1c (HA1c).
ED clinicians will receive alerts called Our Practice Advisories (OPA's) through the EPIC EHR. The 1st OPA triggers when a random point-of-care (POC) glucose is ≥250 mg/dL, prompting a suggested additional HA1c order. A 2nd OPA triggers if the resulting HA1c is ≥10%, prompting consideration of further care coordination in the Observation Unit. Investigators will compare the outcomes post-intervention compared to pre-intervention.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Rutgers, Robert Wood Johnson Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Moderate hyperglycemia, (glucose ≥250 mg/dL)
- Patients who arrive in the emergency department
- Not pregnant or peri-partum
- Not SARS-COV-2 PCR positive in past 7 days
Exclusion Criteria:
- Diabetic ketoacidosis (pH < 7.20, HCO3 < 15, AG > 25)
- Diabetic foot ulcer or skin complications
- Hyperglycemic hyperosmolar state with neurologic impairment
- Patients who leave against medical advice (AMA), elope from the ED, or are transferred to another facility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
All ED providers exposed to electronic alerts
|
Prompt to order A1c
Electronic prompt nudging ED provider to consider admitting patient to the Observation Unit for care coordination and more aggressive glycemic control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physiologic Response
Time Frame: From date of ED encounter to 4 months after
|
% Patients achieving: HbA1c 1% reduction in 3 months
|
From date of ED encounter to 4 months after
|
|
Care Coordination: Follow-Up Care
Time Frame: From date of ED encounter until 4 weeks after
|
% Patients achieving: A T2D-related appointment within 4 weeks
|
From date of ED encounter until 4 weeks after
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Care Coordination: Length of stay
Time Frame: 1 day
|
Length of stay (minutes) of subject ED encounter
|
1 day
|
|
Care Coordination: Insurance
Time Frame: Within 3 weeks of ED encounter
|
Inclusion: patients with NO insurance Measure % Patients achieving new insurance
|
Within 3 weeks of ED encounter
|
|
Care Coordination: Medication Prescription
Time Frame: 3 days
|
Inclusion: patients discharged from the ED or observation Unit % subjects prescribed a diabetes medication |
3 days
|
|
Care Coordination: Medication Change
Time Frame: 3 days
|
Inclusion: patients discharged from the ED or observation Unit % subjects with a change in diabetes medication regimen |
3 days
|
|
Care Coordination: Appointment
Time Frame: 3 months
|
Time (days) to next appointment related to T2D, calculated as [Appt date] - [ED encounter date]
|
3 months
|
|
Physiologic: A1c Orders
Time Frame: 1 day
|
Proportion of patients with hemoglobin A1c ordered in the ED
|
1 day
|
|
Physiologic: ED medications
Time Frame: 1 day
|
% subjects receiving (1) intravenous fluids, (2) insulin, (3) other diabetes medications while in the ED
|
1 day
|
|
Care Coordination: Disposition
Time Frame: Within 1 day of ED encounter date
|
number of patients discharged, number of patients admitted to observation unit, number of patients admitted to hospital
|
Within 1 day of ED encounter date
|
|
Physiologic: Serum Glucose
Time Frame: 1 day
|
Serum glucose concentration change from beginning to end of ED encounter
|
1 day
|
|
Physiologic: Hemoglobin A1c percentage
Time Frame: 6 months
|
Serum hemoglobin A1c (%)
|
6 months
|
|
Physiologic: Diagnosis
Time Frame: 1 day
|
Proportion of subjects with newly diagnosed Type 2 Diabetes, proportion of subjects with poorly controlled, established Type 2 Diabetes
|
1 day
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Magee MF, Nassar C. Hemoglobin A1c testing in an emergency department. J Diabetes Sci Technol. 2011 Nov 1;5(6):1437-43. doi: 10.1177/193229681100500615.
- Driver BE, Olives TD, Bischof JE, Salmen MR, Miner JR. Discharge Glucose Is Not Associated With Short-Term Adverse Outcomes in Emergency Department Patients With Moderate to Severe Hyperglycemia. Ann Emerg Med. 2016 Dec;68(6):697-705.e3. doi: 10.1016/j.annemergmed.2016.04.057. Epub 2016 Jun 25.
- Driver BE, Olives TD, Prekker ME, Miner JR, Klein LR. The Association of Emergency Department Treatments for Hyperglycemia with Glucose Reduction and Emergency Department Length of Stay. J Emerg Med. 2017 Dec;53(6):791-797. doi: 10.1016/j.jemermed.2017.08.068. Epub 2017 Oct 6.
- Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.
- American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S20-S42. doi: 10.2337/dc24-S002.
- Yan JW, Vujcic B, Le BN, Van Aarsen K, Chen T, Halane F, Clemens KK. Predictors of 30-day recurrent emergency department visits for hyperglycemia in patients with types 1 and 2 diabetes: a population-based cohort study. CJEM. 2024 Jun;26(6):424-430. doi: 10.1007/s43678-024-00686-4. Epub 2024 Apr 18.
- Magee MF, Nassar CM, Copeland J, Fokar A, Sharretts JM, Dubin JS, Smith MS. Synergy to reduce emergency department visits for uncontrolled hyperglycemia. Diabetes Educ. 2013 May-Jun;39(3):354-64. doi: 10.1177/0145721713484593. Epub 2013 Apr 22.
- King WM 4th, McDermott MT, Trujillo JM. Initial management of severe hyperglycemia in patients with type 2 diabetes: an observational study. Diabetes Ther. 2013 Dec;4(2):375-84. doi: 10.1007/s13300-013-0036-9. Epub 2013 Aug 16.
- Ginde AA, Delaney KE, Pallin DJ, Camargo CA Jr. Multicenter survey of emergency physician management and referral for hyperglycemia. J Emerg Med. 2010 Feb;38(2):264-70. doi: 10.1016/j.jemermed.2007.11.088. Epub 2008 Jul 26.
- Gale J, Varndell W, James S, Perry L. Unscheduled emergency department presentations with diabetes: Identifying high risk characteristics. Australas Emerg Care. 2023 Sep;26(3):205-210. doi: 10.1016/j.auec.2022.12.001. Epub 2022 Dec 15.
- Driver BE, Klein LR, Cole JB, Prekker ME, Fagerstrom ET, Miner JR. Comparison of two glycemic discharge goals in ED patients with hyperglycemia, a randomized trial. Am J Emerg Med. 2019 Jul;37(7):1295-1300. doi: 10.1016/j.ajem.2018.09.053. Epub 2018 Oct 5.
- Crawford AL, Laiteerapong N. Type 2 Diabetes. Ann Intern Med. 2024 Jun;177(6):ITC81-ITC96. doi: 10.7326/AITC202406180. Epub 2024 Jun 11.
- Charfen MA, Ipp E, Kaji AH, Saleh T, Qazi MF, Lewis RJ. Detection of undiagnosed diabetes and prediabetic states in high-risk emergency department patients. Acad Emerg Med. 2009 May;16(5):394-402. doi: 10.1111/j.1553-2712.2009.00374.x. Epub 2009 Mar 16.
- Bowen ME, Xuan L, Lingvay I, Halm EA. Random blood glucose: a robust risk factor for type 2 diabetes. J Clin Endocrinol Metab. 2015 Apr;100(4):1503-10. doi: 10.1210/jc.2014-4116. Epub 2015 Feb 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Autoimmune Diseases
- Immune System Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Diabetes Mellitus, Type 1
- Hyperglycemia
- Health Care Facilities Workforce and Services
- Health Facilities
- Hospital Units
- Clinical Observation Units
Other Study ID Numbers
- Pro2024002629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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