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DiabetesNCT05426096

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

A study testing Best Practice Advisory in people with Diabetes and Hyperglycemia, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes, Hyperglycemia
What is being tested?
Best Practice Advisory
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,232 participants
Where
1 siteUnited States
Study dates
5 Oct 2022to 5 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

Other trials in United States

About this study

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.

Read the 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.

Being tested
Best Practice Advisory
Medical subject headings
Diabetes Mellitus, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best Practice AdvisoryOther

    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.

Study groups in NCT05426096
Study groupRoleWhat they receive
ControlNo interventionNot described
BPA InterventionExperimentalThe 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.
Receives: Other: Best Practice Advisory

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hyperglycemia (glucose >180 mmol/dL)

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

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

Secondary outcomes (7)

  1. Hypoglycemia (glucose <60 mmol/dL)

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

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

  2. Intraoperative glucose monitoring

    Frequency of intraoperative glucose monitoring

    Measured: Intraoperative

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

    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.

    Measured: Intraoperative

  4. Adherence to MPOG GLU-05

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

    Measured: Intraoperative

  5. Intraoperative Insulin

    Total administered intraoperative insulin (Units)

    Measured: Intraoperative

  6. Magnitude of intraoperative hyperglycemia

    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)

    Measured: Intraoperative

  7. Glucose at first PACU measurement

    Glucose at first PACU measurement

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start5 Oct 2022
  3. Primary completion5 Oct 2023
  4. Study completion5 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
7,232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05426096
Sponsor's protocol ID
220991
Status last verified
Nov 2024
First submitted
15 Jun 2022
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37620270

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice Advisory in people with Diabetes and Hyperglycemia, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hyperglycemia (glucose >180 mmol/dL) (time frame: PACU admission to discharge (1-3 hours post operatively)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05426096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

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