Diabetes Electronic Prompt for Improved Care Coordination and Treatment in the ED

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus (T2DM); Hyperglycemia; Insulin Dependent Diabetes

• Registration Number: NCT06899191
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

Detailed Description

Type 2 Diabetes (T2D) is a growing public health crisis with rates of diabetes steadily increasing over the last 10 years. The ED is commonly the first point of contact for individuals who present with symptoms of hyperglycemia, often with very severe (HbA1C \> 10%) underlying diabetes. However, there is currently no national guideline or clinical policy for the ED management of patients who are not in diabetic ketoacidosis (DKA) or in a hyperglycemia hyperosmolar state (HHS). The investigators hypothesize that there are two subgroups who may benefit from greater care coordination initiated from the ED: patients who are newly-diagnosed with severe T2D and patients whom T2D is poorly-controlled despite medication adherence. This study designs electronic prompt practice advisories that nudge ED providers towards more aggressive treatment pathways. It is currently unknown whether alert tools can improve the delivery and coordination of care of patients with severe T2D presenting to the ED.

Study Timeline

• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Study First Posted: 2025-03-27
• Study Start: 2025-03-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-12-30
• Study Completion: 2026-03

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Care Coordination: Follow-Up Care	From date of ED encounter until 4 weeks after	% Patients achieving: A T2D-related appointment within 4 weeks
Physiologic Response	From date of ED encounter to 4 months after	% Patients achieving: HbA1c 1% reduction in 3 months

Secondary Outcome Measures

Name	Time	Method
Care Coordination: Disposition	Within 1 day of ED encounter date	number of patients discharged, number of patients admitted to observation unit, number of patients admitted to hospital
Care Coordination: Length of stay	1 day	Length of stay (minutes) of subject ED encounter
Care Coordination: Insurance	Within 3 weeks of ED encounter	Inclusion: patients with NO insurance Measure % Patients achieving new insurance
Care Coordination: Medication Prescription	3 days	Inclusion: patients discharged from the ED or observation Unit; % subjects prescribed a diabetes medication
Physiologic: Serum Glucose	1 day	Serum glucose concentration change from beginning to end of ED encounter
Physiologic: Diagnosis	1 day	Proportion of subjects with newly diagnosed Type 2 Diabetes, proportion of subjects with poorly controlled, established Type 2 Diabetes
Care Coordination: Medication Change	3 days	Inclusion: patients discharged from the ED or observation Unit; % subjects with a change in diabetes medication regimen
Care Coordination: Appointment	3 months	Time (days) to next appointment related to T2D, calculated as \[Appt date\] - \[ED encounter date\]
Physiologic: A1c Orders	1 day	Proportion of patients with hemoglobin A1c ordered in the ED
Physiologic: Hemoglobin A1c percentage	6 months	Serum hemoglobin A1c (%)
Physiologic: ED medications	1 day	% subjects receiving (1) intravenous fluids, (2) insulin, (3) other diabetes medications while in the ED

Trial Locations

Locations (1)

Rutgers, Robert Wood Johnson Hospital; 🇺🇸 New Brunswick, New Jersey, United States