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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05426096
• Other study ID #: 220991
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: October 5, 2024

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8200
• Est. completion date: October 5, 2024
• Est. primary completion date: October 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of intraoperative hypokalemia	Incidence of intraoperative hypokalemia (mild: potassium <3.5 mEq/L- 3.0 mEq/L; severe <3.0 mEq/L)	intraoperative
Other	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
Other	Incidence of surgical site infection	Incidence of surgical site infection	30 days after surgery
Primary	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	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)
Secondary	Intraoperative glucose monitoring	Frequency of intraoperative glucose monitoring	Intraoperative
Secondary	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
Secondary	Adherence to MPOG GLU-05	Percentage of cases with administration of insulin within 90 minutes of blood glucose >200 mg/dL.	Intraoperative
Secondary	Intraoperative Insulin	Total administered intraoperative insulin (Units)	Intraoperative
Secondary	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
Secondary	Glucose at first PACU measurement	Glucose at first PACU measurement	PACU admission to discharge (1-3 hours post operatively)