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

NCT05426096 | Completed

• 1 other identifier: 220991
• Study Type: interventional
• Target: 7,232
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Hypoglycemia (glucose <60 mmol/dL)

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

• Intraoperative glucose monitoring

  Intraoperative

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

  Intraoperative

• Adherence to MPOG GLU-05

  Intraoperative

• Intraoperative Insulin

  Intraoperative

Other Outcomes (3)

• Incidence of intraoperative hypokalemia

  intraoperative

• Incidence of first postoperative hypokalemia

  3 hours post operatively

• Incidence of surgical site infection

  30 days after surgery

Study Arms (2)

Control

NO INTERVENTION

BPA Intervention

EXPERIMENTAL

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

Interventions

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.

BPA Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Zapf M, Patel D, Henson P, McEvoy MD, Huang E, Wanderer JP, Fowler L, Mccarthy K, Freundlich RE, Eden S, Shotwell MS, Kertai MD; PROGRAM Investigators. PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia. BMJ Open. 2023 Aug 24;13(8):e072745. doi: 10.1136/bmjopen-2023-072745.

  PMID: 37620270 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Miklos Kertai, M.D., Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: October 5, 2022
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)