Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05426096
Recruitment Status : Not yet recruiting
First Posted : June 21, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Matthew Zapf, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetes Hyperglycemia Other: Best Practice Advisory Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Comparison of Intraoperative Best Practice Advisory Reminders to Protocolize Insulin Administration Versus Standard Care in Patients at High Risk of Hyperglycemia
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
Drug Information available for: Insulin

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05426096


Contacts
Layout table for location contacts
Contact: Matthew Zapf, M.D. 615-343-9419 matthew.a.zapf@vumc.org
Contact: Gail Mayo 615-936-1705 gail.mayo@vumc.org

Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Matthew Zapf, M.D. Vanderbilt University Medical Center
Layout table for additonal information
Responsible Party: Matthew Zapf, Instructor, Anesthesiology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT05426096    
Other Study ID Numbers: 220991
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases