Comparison of Intraoperative Best Practice Advisory Reminders to Protocolize Insulin Administration Versus Standard Care in Patients at High Risk of Hyperglycemia
NCT ID: NCT05426096
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
7232 participants
INTERVENTIONAL
2022-10-05
2023-10-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 1
NCT00655460
Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control
NCT05136157
Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital
NCT02868606
Outcomes With Tight Control of Hyperglycemia in Cardiac Surgery Patients
NCT00282698
Comparing Efficacy Between Two Protocols of Intravenous Insulin Infusion for Diabetic Adults in ICU
NCT06810596
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
No interventions assigned to this group
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vanderbilt University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Miklos Kertai
Professor of Anesthesiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Miklos Kertai, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
220991
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.