Clinical trial NCT05426096: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hyperglycemia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 7232
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Hyperglycemia (glucose >180 mmol/dL)
timeFrame: PACU admission to discharge (1-3 hours post operatively)
Secondary outcomes:
measure: Hypoglycemia (glucose <60 mmol/dL)
timeFrame: PACU admission to discharge (1-3 hours post operatively)
measure: Intraoperative glucose monitoring
timeFrame: Intraoperative
measure: Adherence to Multicenter Perioperative Outcomes Group (MPOG) GLU-01
timeFrame: Intraoperative
measure: Adherence to MPOG GLU-05
timeFrame: Intraoperative
measure: Intraoperative Insulin
timeFrame: Intraoperative
measure: Magnitude of intraoperative hyperglycemia
timeFrame: Intraoperative
measure: Glucose at first PACU measurement
timeFrame: PACU admission to discharge (1-3 hours post operatively)
Other outcomes:
measure: Incidence of intraoperative hypokalemia
timeFrame: intraoperative
measure: Incidence of first postoperative hypokalemia
timeFrame: 3 hours post operatively
measure: Incidence of surgical site infection
timeFrame: 30 days after surgery
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Miklos Kertai, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: