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

NCT ID: NCT06899191

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-30

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Type 2 Diabetes Mellitus (T2DM) Hyperglycemia Insulin Dependent Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

All ED providers exposed to electronic alerts

Group Type EXPERIMENTAL

Hemoglobin A1c

Intervention Type DIAGNOSTIC_TEST

Prompt to order A1c

Observation Unit

Intervention Type BEHAVIORAL

Electronic prompt nudging ED provider to consider admitting patient to the Observation Unit for care coordination and more aggressive glycemic control

Interventions

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Hemoglobin A1c

Prompt to order A1c

Intervention Type DIAGNOSTIC_TEST

Observation Unit

Electronic prompt nudging ED provider to consider admitting patient to the Observation Unit for care coordination and more aggressive glycemic control

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Paul Peng, MD PhD MSCR

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rutgers, Robert Wood Johnson Hospital

New Brunswick, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul Peng, MD PhD MS

Role: CONTACT

732-633-1402

Facility Contacts

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Paul Peng, MD PhD MS

Role: primary

732-633-1402

References

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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.

Reference Type BACKGROUND
PMID: 38635005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22226261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23610182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23949906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18657930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36528482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28993036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27353284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30316635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36151309 (View on PubMed)

Crawford AL, Laiteerapong N. Type 2 Diabetes. Ann Intern Med. 2024 Jun;177(6):ITC81-ITC96. doi: 10.7326/AITC202406180. Epub 2024 Jun 11.

Reference Type BACKGROUND
PMID: 38857502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19302369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25650899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38078589 (View on PubMed)

Other Identifiers

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Pro2024002629

Identifier Type: -

Identifier Source: org_study_id

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