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Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02625181
Enrollment
27034
Registered
2015-12-09
Start date
2016-07-31
Completion date
2017-11-30
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

Decision support, Prediction models, PONV, prophylaxis, Decision Support Systems, Clinical, Decision Support Techniques

Brief summary

The purpose of this study is to determine how automated recommendations are best presented to optimize the adherence to guidelines on prophylaxis for nausea and vomiting after surgery.

Detailed description

Nausea and vomiting after surgery (PONV) is a common side effect of the surgical procedure, general anesthesia and opioid use occurring in about one third of patients. In addition to being very unpleasant for patients, it is associated with longer recovery room stays and increased costs. Much research has been done on prophylactic interventions that may be applied during the surgical procedure to prevent PONV. Current national guidelines recommend that a risk score is used to decide on the number of prophylactic interventions to administer to a patient. Based on specific characteristics of individual patients and the procedures that they are about to undergo, such a risk score predicts the risk of PONV for each individual. According to the national guidelines, patients with higher risks of PONV should receive more prophylactic interventions. However, in a busy operating room where the anesthesia provider performs multiple patient care tasks, closely following the recommendations to minimize the risk of PONV is often difficult. Computers may help anesthesia providers to adhere to best practices for PONV prevention by providing so-called decision support. A decision support system for PONV automatically calculates the risk of PONV for an individual patient and presents this predicted risk to the anesthesia provider on the computer screen that is being used by the anesthesia team for record keeping. In recent studies, such decision support systems have been demonstrated to improve adherence to PONV guidelines, especially when a recommendation on the number of interventions is added to the predicted risk. However, in these studies there was still quite some room for improvement of the adherence to PONV guidelines. In general, implementation science is only beginning to understand how such decision support systems are best used to improve medical decision making and minimize practice variations among providers. Further study of how the design of decision support systems impacts the decision making of healthcare providers is therefore warranted. In this proposed study, the investigators will implement several decision support elements for PONV that aim to help anesthesia providers to adhere to the departmental PONV guidelines during the anesthetic case. The study consists of three phases. The first phase is the preintervention phase - i.e. before the decision support has been implemented. The second phase is the first intervention phase with one CDSS feature added. The third phase is the second intervention phase with another CDSS feature added. The decision support elements will provide information about the patient's predicted risk of PONV and the number of prophylactic interventions that the departmental guidelines recommend based on that risk. We will start with preoperative email notifications, followed by an element within the anesthesia information management system (AIMS) that are displayed around the start and end of the procedure. All forms of decision support only provide recommendations. The anesthesia provider is free to act on the message or ignore the notifications. The investigators will compare the adherence to PONV guidelines and the actual occurrence of PONV (both nausea and emetic events: vomiting and retching) in the post-anesthesia care unit (PACU) between all study phases and between the different interventions. The goal of the comparison is to evaluate which decision support elements have an added value to optimize guideline adherence for PONV prophylaxis.

Interventions

PROCEDUREAutomated recommendation at the start of the case

The first notification is the main notification that informs the anesthesia providers at the start of anesthesia of the risk score for that individual patient and the recommended number of prophylactic interventions. The notification occurs within the anesthesia information management system (AIMS)

PROCEDUREAutomated notification at the start of surgery

The second notification within the AIMS will notify the anesthesia providers at the start of surgery when no prophylaxis has been given while three or more interventions were recommended.

PROCEDUREPreoperative recommendations: by email

A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.

PROCEDUREAutomated notification at the end of surgery

A notification will remind anesthesia providers at the closing of surgery how many prophylactic interventions are required to adhere to the recommended number of interventions.

The anesthesia electronic record keeping system

The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the preoperative emails.

PROCEDUREGeneral anesthesia

Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.

PROCEDUREElective surgery

Surgical procedures that are scheduled and not an emergency.

DRUGPropofol

Anesthetic drug used to maintain general anesthesia

DRUGSevoflurane

Anesthetic drug used to maintain general anesthesia

DRUGIsoflurane

Anesthetic drug used to maintain general anesthesia

DRUGDesflurane

Anesthetic drug used to maintain general anesthesia

DRUGScopolamine

Prophylactic antiemetic

Prophylactic antiemetic & rescue antiemetic

DRUGHaloperidol

Prophylactic antiemetic & rescue antiemetic

DRUGDexamethasone

Prophylactic antiemetic & rescue antiemetic

Prophylactic antiemetic & rescue antiemetic

Prophylactic antiemetic & rescue antiemetic

DRUGAprepitant

Prophylactic antiemetic & rescue antiemetic

DRUGMetoclopramide

Rescue antiemetic

DRUGFentanyl

Analgesic drug / Opioid

DRUGSufentanil

Analgesic drug / Opioid

DRUGAlfentanil

Analgesic drug / Opioid

DRUGRemifentanil

Analgesic drug / Opioid

DRUGMorphine

Analgesic drug / Opioid

DRUGMeperidine

Analgesic drug / Opioid

DRUGHydromorphone

Analgesic drug / Opioid

DRUGMethadone

Analgesic drug / Opioid

DRUGOxycodone

Analgesic drug / Opioid

Analgesic drug / Opioid

Analgesic drug / Opioid

DRUGKetamine

Analgetic / Analgesic drug

DRUGOndansetron

Prophylactic antiemetic & rescue antiemetic

DRUGGranisetron

Prophylactic antiemetic & rescue antiemetic

Prophylactic antiemetic & rescue antiemetic

DRUGPalonosetron

Prophylactic antiemetic & rescue antiemetic

Prophylactic antiemetic & rescue antiemetic

DRUGRamosetron

Prophylactic antiemetic & rescue antiemetic

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adult patients (18 years and older) that are scheduled for an elective surgical procedure under general anesthesia

Exclusion criteria

* Patients undergoing emergency surgery or organ transplantation * Patients that are transferred directly to the Intensive Care Unit after the end of the procedure * Patients that die intraoperatively * Procedures that only require a sedative level of anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Adherence to PONV GuidelinesA specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic casePONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support.

Secondary

MeasureTime frameDescription
PONV Incidence: Number of Participants With Postoperative Nausea and VomitingPACU recovery periodThe occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU.
The Number of Prophylactic Interventions for PONVA specific time frame on the day of surgery: from the start of admission at the holding room to the end of the anesthetic casethe absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU.
Time to Discharge From the Postanesthesia Care Unit (PACU)A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACUThis is the number of minutes from admission to the PACU until discharge, assessed up to 2 days

Countries

United States

Participant flow

Participants by arm

ArmCount
Baseline Measurement
No recommendations were provided for PONV prophylaxis.
1,518
CDS Email Recommendations
Automated recommendations on PONV prophylaxis provided by email only.
12,809
CDS Email + Real TIme Recommenations
Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
12,707
Total27,034

Baseline characteristics

CharacteristicTotalCDS Email + Real TIme RecommenationsBaseline MeasurementCDS Email Recommendations
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6727 Participants3104 Participants387 Participants3236 Participants
Age, Categorical
Between 18 and 65 years
20307 Participants9603 Participants1131 Participants9573 Participants
Age, Continuous52 years
STANDARD_DEVIATION 16.94
51 years
STANDARD_DEVIATION 17.15
53 years
STANDARD_DEVIATION 16.78
52 years
STANDARD_DEVIATION 16.73
History of PONV/Motion Sickness13257 Participants10728 Participants226 Participants2303 Participants
Race (NIH/OMB)
American Indian or Alaska Native
38 Participants23 Participants3 Participants12 Participants
Race (NIH/OMB)
Asian
221 Participants110 Participants11 Participants100 Participants
Race (NIH/OMB)
Black or African American
3086 Participants1595 Participants170 Participants1321 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1089 Participants481 Participants55 Participants553 Participants
Race (NIH/OMB)
White
22600 Participants10498 Participants1279 Participants10823 Participants
Region of Enrollment
United States
27034 participants12707 participants1518 participants12809 participants
Sex: Female, Male
Female
13575 Participants6212 Participants813 Participants6550 Participants
Sex: Female, Male
Male
13459 Participants6495 Participants705 Participants6259 Participants
Smoking Status is Current Non Smoker20258 Participants9352 Participants1183 Participants9723 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
90 / 27,034
other
Total, other adverse events
0 / 27,034
serious
Total, serious adverse events
90 / 27,034

Outcome results

Primary

Adherence to PONV Guidelines

PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support.

Time frame: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline MeasurementAdherence to PONV Guidelines666 Participants
CDS Email RecommendationsAdherence to PONV Guidelines5260 Participants
CDS Email + Real TIme RecommenationsAdherence to PONV Guidelines5863 Participants
Secondary

PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting

The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU.

Time frame: PACU recovery period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline MeasurementPONV Incidence: Number of Participants With Postoperative Nausea and Vomiting139 Participants
CDS Email RecommendationsPONV Incidence: Number of Participants With Postoperative Nausea and Vomiting1323 Participants
CDS Email + Real TIme RecommenationsPONV Incidence: Number of Participants With Postoperative Nausea and Vomiting1343 Participants
Secondary

The Number of Prophylactic Interventions for PONV

the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU.

Time frame: A specific time frame on the day of surgery: from the start of admission at the holding room to the end of the anesthetic case

ArmMeasureValue (MEAN)Dispersion
Baseline MeasurementThe Number of Prophylactic Interventions for PONV2.196 prophylactic antiemetics administeredStandard Deviation 0.932
CDS Email RecommendationsThe Number of Prophylactic Interventions for PONV2.176 prophylactic antiemetics administeredStandard Deviation 0.988
CDS Email + Real TIme RecommenationsThe Number of Prophylactic Interventions for PONV2.129 prophylactic antiemetics administeredStandard Deviation 0.977
Secondary

Time to Discharge From the Postanesthesia Care Unit (PACU)

This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days

Time frame: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU

ArmMeasureValue (MEAN)Dispersion
Baseline MeasurementTime to Discharge From the Postanesthesia Care Unit (PACU)266 minutesStandard Deviation 374
CDS Email RecommendationsTime to Discharge From the Postanesthesia Care Unit (PACU)264 minutesStandard Deviation 371
CDS Email + Real TIme RecommenationsTime to Discharge From the Postanesthesia Care Unit (PACU)266 minutesStandard Deviation 361

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026