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

Not Applicable

Completed

Conditions: Postoperative Nausea and Vomiting

Interventions: Procedure: Automated recommendation at the start of the case
Procedure: Automated notification at the start of surgery
Procedure: Automated notification at the end of surgery
Device: Anesthesia Information Management System (AIMS)
Device: Perioperative Data Warehouse (PDW)
Procedure: General anesthesia
Procedure: Elective surgery
Drug: Propofol
Drug: Sevoflurane
Drug: Isoflurane
Drug: Desflurane
Drug: Scopolamine
Drug: Droperidol
Drug: Haloperidol
Drug: Dexamethasone
Drug: Promethazine
Drug: Meclizine
Drug: Aprepitant
Drug: Metoclopramide
Drug: Fentanyl
Drug: Sufentanil
Drug: Alfentanil
Drug: Remifentanil
Drug: Morphine
Drug: Meperidine
Drug: Hydromorphone
Drug: Methadone
Drug: Oxycodone
Drug: Oxymorphone
Drug: Hydrocodone
Drug: Ketamine
Drug: Ondansetron
Drug: Granisetron
Drug: Dolasetron mesylate
Drug: Palonosetron
Drug: Tropisetron
Drug: Ramosetron

Registration Number: NCT02625181

Lead Sponsor: Vanderbilt University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27034

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PONV clinical decision support system	Automated recommendation at the start of the case	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Anesthesia Information Management System (AIMS)	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	General anesthesia	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Sevoflurane	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Automated notification at the start of surgery	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Automated notification at the end of surgery	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Perioperative Data Warehouse (PDW)	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Propofol	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Elective surgery	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Dolasetron mesylate	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Ondansetron	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Desflurane	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Meperidine	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Promethazine	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Isoflurane	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Scopolamine	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Droperidol	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Haloperidol	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Dexamethasone	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Meclizine	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Aprepitant	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Alfentanil	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Metoclopramide	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Fentanyl	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Sufentanil	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Remifentanil	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Hydromorphone	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Morphine	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Methadone	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Oxycodone	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Hydrocodone	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Tropisetron	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Ketamine	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Granisetron	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Palonosetron	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Ramosetron	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
PONV clinical decision support system	Oxymorphone	Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.

Primary Outcome Measures

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

Name	Time	Method
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 PACU	This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days
PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting	PACU recovery period	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	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	the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU.