search
Back to results

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

Primary Purpose

Diabetes, Hyperglycemia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice Advisory
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

BPA Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Hyperglycemia (glucose >180 mmol/dL)
Frequency of hyperglycemia (glucose >180 mg/dL) at first Post Anesthesia Care Unit (PACU) measurement.

Secondary Outcome Measures

Hypoglycemia (glucose <60 mmol/dL)
Frequency of hypoglycemia (glucose <60 mmol/dL) at first PACU measurement
Intraoperative glucose monitoring
Frequency of intraoperative glucose monitoring
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.
Adherence to MPOG GLU-05
Percentage of cases with administration of insulin within 90 minutes of blood glucose >200 mg/dL.
Intraoperative Insulin
Total administered intraoperative insulin (Units)
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)
Glucose at first PACU measurement
Glucose at first PACU measurement

Full Information

First Posted
June 15, 2022
Last Updated
August 9, 2023
Sponsor
Vanderbilt University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05426096
Brief Title
Comparison of Intraoperative Best Practice Advisory Reminders to Protocolize Insulin Administration Versus Standard Care in Patients at High Risk of Hyperglycemia
Official Title
Comparison of Intraoperative Best Practice Advisory Reminders to Protocolize Insulin Administration Versus Standard Care in Patients at High Risk of Hyperglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
October 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hyperglycemia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will assess this intervention 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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
BPA Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice Advisory
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hyperglycemia (glucose >180 mmol/dL)
Description
Frequency of hyperglycemia (glucose >180 mg/dL) at first Post Anesthesia Care Unit (PACU) measurement.
Time Frame
PACU admission to discharge (1-3 hours post operatively)
Secondary Outcome Measure Information:
Title
Hypoglycemia (glucose <60 mmol/dL)
Description
Frequency of hypoglycemia (glucose <60 mmol/dL) at first PACU measurement
Time Frame
PACU admission to discharge (1-3 hours post operatively)
Title
Intraoperative glucose monitoring
Description
Frequency of intraoperative glucose monitoring
Time Frame
Intraoperative
Title
Adherence to Multicenter Perioperative Outcomes Group (MPOG) GLU-01
Description
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.
Time Frame
Intraoperative
Title
Adherence to MPOG GLU-05
Description
Percentage of cases with administration of insulin within 90 minutes of blood glucose >200 mg/dL.
Time Frame
Intraoperative
Title
Intraoperative Insulin
Description
Total administered intraoperative insulin (Units)
Time Frame
Intraoperative
Title
Magnitude of intraoperative hyperglycemia
Description
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)
Time Frame
Intraoperative
Title
Glucose at first PACU measurement
Description
Glucose at first PACU measurement
Time Frame
PACU admission to discharge (1-3 hours post operatively)
Other Pre-specified Outcome Measures:
Title
Incidence of intraoperative hypokalemia
Description
Incidence of intraoperative hypokalemia (mild: potassium <3.5 mEq/L- 3.0 mEq/L; severe <3.0 mEq/L)
Time Frame
intraoperative
Title
Incidence of first postoperative hypokalemia
Description
First postoperative hypokalemia (mild: potassium <3.5 mEq/L- 3.0 mEq/L; severe <3.0 mEq/L).
Time Frame
3 hours post operatively
Title
Incidence of surgical site infection
Description
Incidence of surgical site infection
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Zapf, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miklos Kertai, M.D., Ph.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs