Comparison of Intraoperative Best Practice Advisory Reminders to Protocolize Insulin Administration Versus Standard Care in Patients at High Risk of Hyperglycemia

This study will assess the implementation of a glucose management clinical decision support tool. The specific objective is to determine if supplementing the existing glucose check reminder with a best practice advisory (BPA), an actionable insulin dosing calculator, providers will be influenced to improve the control of hyperglycemia.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Diabetes
• Intervention / Treatment: Other: Best Practice Advisory

Detailed Description

Poor intraoperative glucose control has been linked to multiple types of infections including surgical site infections and urinary tract infections. Several studies suggest maintaining glucose at less than 180 mg/dL effectively prevents infections, and minimizes risks of hypoglycemia as compared to stricter blood glucose targets.

The insulin dosing protocol that will be used in the study is available for use throughout the Vanderbilt University Medical Center (VUMC) Department of Anesthesiology. The insulin calculator (BPA) automates the protocol guidelines. When a patient meets the study criteria, the BPA will provide an automated notification through the electronic health record system. These automated notifications will pop up intraoperatively after the glucose check reminder in cases where the patient meets the study criteria. The provider is not forced to follow the recommendations of the insulin dosing calculator, rather it just serves as a reminder of best practices as defined by our department.

The specific objective is to determine if supplementing the existing glucose check reminder with a BPA, an actionable insulin dosing calculator, will influence providers to improve the control of hyperglycemia. Study results will guide the future integration of the BPA at VUMC.

• Study Type: Interventional
• Enrollment (Actual): 7232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient Participants

Inclusion Criteria:

• All patients having surgery at Vanderbilt University Medical Center Main Operating Rooms (ORs), Vanderbilt Medical Center Children's Hospital, Medical Center East or Gynecological (4S) ORs, who qualify for the glucose check best practice advisory (BPA). To qualify for the glucose BPA, the patient must meet the following criteria: 1) a documented diagnosis of diabetes, without a recorded measurement of glucose within the last 2 hours, or 2) the patient had an insulin administration within the last twelve hours and did not have a recorded measurement of blood glucose within the last hour.

Exclusion Criteria:

• Patients having surgery at other locations
• Patients not qualifying for the VUMC glucose check BPA

Provider participants:

Any provider of eligible patients may receive the BPA while providing care for these patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: BPA Intervention; The BPA intervention will test the delivery of the insulin calculator (BPA) which automates the standard insulin dosing protocol guidelines. When a patient meets the study criteria, the BPA will provide an automated notification through the electronic health record system. These automated notifications will pop up intraoperatively after the glucose check reminder in cases where the patient meets the study criteria. The provider is not forced to follow the recommendations of the insulin dosing calculator, rather it just serves as a reminder of best practices as defined by our department. The intervention will be assessed using a sequential and repeated cross-over design at the institutional level with periods of time for wash in, wash out, control and study intervention.	Other: Best Practice Advisory; The BPA intervention will test the delivery of the insulin calculator (BPA) which automates the standard insulin dosing protocol guidelines through the electronic health record system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperglycemia (glucose >180 mmol/dL)	Frequency of hyperglycemia (glucose >180 mg/dL) at first Post Anesthesia Care Unit (PACU) measurement.	PACU admission to discharge (1-3 hours post operatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycemia (glucose <60 mmol/dL)	Frequency of hypoglycemia (glucose <60 mmol/dL) at first PACU measurement	PACU admission to discharge (1-3 hours post operatively)
Intraoperative glucose monitoring	Frequency of intraoperative glucose monitoring	Intraoperative
Adherence to Multicenter Perioperative Outcomes Group (MPOG) GLU-01	MPOG GLU-01 is a quality measure defined as the percentage of cases with perioperative glucose >200 mg/DL with >200 mg/dL with administration of insulin or glucose recheck within 90 minutes of original glucose measurement.	Intraoperative
Adherence to MPOG GLU-05	Percentage of cases with administration of insulin within 90 minutes of blood glucose >200 mg/dL.	Intraoperative
Intraoperative Insulin	Total administered intraoperative insulin (Units)	Intraoperative
Magnitude of intraoperative hyperglycemia	Magnitude of intraoperative hyperglycemia defined as the product of time and glucose level when glucose is greater than 180 mmol/dL (the area outside of normoglycemia)	Intraoperative
Glucose at first PACU measurement	Glucose at first PACU measurement	PACU admission to discharge (1-3 hours post operatively)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypokalemia	Incidence of intraoperative hypokalemia (mild: potassium <3.5 mEq/L- 3.0 mEq/L; severe <3.0 mEq/L)	intraoperative
Incidence of surgical site infection	Incidence of surgical site infection	30 days after surgery
Incidence of first postoperative hypokalemia	First postoperative hypokalemia (mild: potassium <3.5 mEq/L- 3.0 mEq/L; severe <3.0 mEq/L).	3 hours post operatively

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Miklos Kertai, M.D., Ph.D., Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): October 5, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia
• Other Study ID Numbers: 220991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No