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Completed

NCT Number: NCT05426096

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Best Practice Advisory

Other

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 outcomes

  1. Hyperglycemia (glucose >180 mmol/dL)

    Time frame: PACU admission to discharge (1-3 hours post operatively)

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

Secondary outcomes

  1. Hypoglycemia (glucose <60 mmol/dL)

    Time frame: PACU admission to discharge (1-3 hours post operatively)

    Frequency of hypoglycemia (glucose <60 mmol/dL) at first PACU measurement

  2. Intraoperative glucose monitoring

    Time frame: Intraoperative

    Frequency of intraoperative glucose monitoring

  3. Adherence to Multicenter Perioperative Outcomes Group (MPOG) GLU-01

    Time frame: Intraoperative

    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.

  4. Adherence to MPOG GLU-05

    Time frame: Intraoperative

    Percentage of cases with administration of insulin within 90 minutes of blood glucose >200 mg/dL.

  5. Intraoperative Insulin

    Time frame: Intraoperative

    Total administered intraoperative insulin (Units)

  6. Magnitude of intraoperative hyperglycemia

    Time frame: Intraoperative

    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)

  7. Glucose at first PACU measurement

    Time frame: PACU admission to discharge (1-3 hours post operatively)

    Glucose at first PACU measurement

Other outcomes

  1. Incidence of intraoperative hypokalemia

    Time frame: intraoperative

    Incidence of intraoperative hypokalemia (mild: potassium <3.5 mEq/L- 3.0 mEq/L; severe <3.0 mEq/L)

  2. Incidence of first postoperative hypokalemia

    Time frame: 3 hours post operatively

    First postoperative hypokalemia (mild: potassium <3.5 mEq/L- 3.0 mEq/L; severe <3.0 mEq/L).

  3. Incidence of surgical site infection

    Time frame: 30 days after surgery

    Incidence of surgical site infection

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2022
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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