Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated recommendation at the start of the case
Automated notification at the start of surgery
Preoperative recommendations: by email
Automated notification at the end of surgery
Anesthesia Information Management System (AIMS)
Perioperative Data Warehouse (PDW)
General anesthesia
Elective surgery
Propofol
Sevoflurane
Isoflurane
Desflurane
Scopolamine
Droperidol
Haloperidol
Dexamethasone
Promethazine
Meclizine
Aprepitant
Metoclopramide
Fentanyl
Sufentanil
Alfentanil
Remifentanil
Morphine
Meperidine
Hydromorphone
Methadone
Oxycodone
Oxymorphone
Hydrocodone
Ketamine
Ondansetron
Granisetron
Dolasetron mesylate
Palonosetron
Tropisetron
Ramosetron
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Decision support, Prediction models, PONV, prophylaxis, Decision Support Systems, Clinical, Decision Support Techniques
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PONV clinical decision support system
Arm Description
Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02625181
Brief Title
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
Official Title
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
November 2, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Decision support, Prediction models, PONV, prophylaxis, Decision Support Systems, Clinical, Decision Support Techniques
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27034 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PONV clinical decision support system
Arm Type
Experimental
Arm Description
Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
Intervention Type
Procedure
Intervention Name(s)
Automated recommendation at the start of the case
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Automated notification at the start of surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Preoperative recommendations: by email
Intervention Description
A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.
Intervention Type
Procedure
Intervention Name(s)
Automated notification at the end of surgery
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Anesthesia Information Management System (AIMS)
Intervention Description
The anesthesia electronic record keeping system
Intervention Type
Device
Intervention Name(s)
Perioperative Data Warehouse (PDW)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Intervention Type
Procedure
Intervention Name(s)
Elective surgery
Intervention Description
Surgical procedures that are scheduled and not an emergency.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Anesthetic drug used to maintain general anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Anesthetic drug used to maintain general anesthesia
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Intervention Description
Anesthetic drug used to maintain general anesthesia
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Anesthetic drug used to maintain general anesthesia
Intervention Type
Drug
Intervention Name(s)
Scopolamine
Intervention Description
Prophylactic antiemetic
Intervention Type
Drug
Intervention Name(s)
Droperidol
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Promethazine
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Meclizine
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Intervention Description
Rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Alfentanil
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Meperidine
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Oxymorphone
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Hydrocodone
Intervention Description
Analgesic drug / Opioid
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Analgetic / Analgesic drug
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Granisetron
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Dolasetron mesylate
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Palonosetron
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Tropisetron
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Intervention Description
Prophylactic antiemetic & rescue antiemetic
Primary Outcome Measure Information:
Title
Adherence to PONV Guidelines
Description
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
Secondary Outcome Measure Information:
Title
PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
Description
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
Title
The Number of Prophylactic Interventions for PONV
Description
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
Title
Time to Discharge From the Postanesthesia Care Unit (PACU)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Wanderer, MD, MPhil
Organizational Affiliation
Vanderbilt University Medical Center, Division of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
We'll reach out to this number within 24 hrs