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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Device: Anesthesia Information Management System (AIMS); Procedure: General anesthesia; Drug: Propofol; Drug: Sevoflurane; Drug: Desflurane; Drug: Isoflurane; Procedure: Automated recommendation at the start of the case; Procedure: Automated notification at the start of surgery; Procedure: Preoperative recommendations: by email; Procedure: Automated notification at the end of surgery; Device: Perioperative Data Warehouse (PDW); Procedure: Elective surgery; 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

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.

• Study Type: Interventional
• Enrollment (Actual): 27034
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PONV clinical decision support system; Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.

Device: Anesthesia Information Management System (AIMS); The anesthesia electronic record keeping system; Procedure: General anesthesia; Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.; Drug: Propofol; Anesthetic drug used to maintain general anesthesia; Drug: Sevoflurane; Anesthetic drug used to maintain general anesthesia; Drug: Desflurane; Anesthetic drug used to maintain general anesthesia; Drug: Isoflurane; Anesthetic drug used to maintain general anesthesia; Procedure: Automated 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); Procedure: Automated 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.; Procedure: Preoperative recommendations: by email; A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.; Procedure: Automated 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.; Device: Perioperative Data Warehouse (PDW); 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.; Procedure: Elective surgery; Surgical procedures that are scheduled and not an emergency.; Drug: Scopolamine; Prophylactic antiemetic; Drug: Droperidol; Prophylactic antiemetic & rescue antiemetic; Drug: Haloperidol; Prophylactic antiemetic & rescue antiemetic; Drug: Dexamethasone; Prophylactic antiemetic & rescue antiemetic; Drug: Promethazine; Prophylactic antiemetic & rescue antiemetic; Drug: Meclizine; Prophylactic antiemetic & rescue antiemetic; Drug: Aprepitant; Prophylactic antiemetic & rescue antiemetic; Drug: Metoclopramide; Rescue antiemetic; Drug: Fentanyl; Analgesic drug / Opioid; Drug: Sufentanil; Analgesic drug / Opioid; Drug: Alfentanil; Analgesic drug / Opioid; Drug: Remifentanil; Analgesic drug / Opioid; Drug: Morphine; Analgesic drug / Opioid; Drug: Meperidine; Analgesic drug / Opioid; Drug: Hydromorphone; Analgesic drug / Opioid; Drug: Methadone; Analgesic drug / Opioid; Drug: Oxycodone; Analgesic drug / Opioid; Drug: Oxymorphone; Analgesic drug / Opioid; Drug: Hydrocodone; Analgesic drug / Opioid; Drug: Ketamine; Analgetic / Analgesic drug; Drug: Ondansetron; Prophylactic antiemetic & rescue antiemetic; Drug: Granisetron; Prophylactic antiemetic & rescue antiemetic; Drug: Dolasetron mesylate; Prophylactic antiemetic & rescue antiemetic; Drug: Palonosetron; Prophylactic antiemetic & rescue antiemetic; Drug: Tropisetron; Prophylactic antiemetic & rescue antiemetic; Drug: Ramosetron; Prophylactic antiemetic & rescue antiemetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	PACU recovery period
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.	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
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	A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Jonathan P Wanderer, MD, MPhil, Vanderbilt University Medical Center, Division of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): November 2, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: prophylaxis; PONV; Decision Support Techniques; Decision Support Systems, Clinical; Decision support; Prediction models
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents; Platelet Aggregation Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Analgesics, Opioid; Narcotics; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; Anesthetics, Local; Respiratory System Agents; Serotonin 5-HT3 Receptor Antagonists; Anesthetics, Inhalation; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Antitussive Agents; Anti-Dyskinesia Agents; Mydriatics; Neurokinin-1 Receptor Antagonists; Ketamine; Dexamethasone; Anesthetics; Remifentanil; Fentanyl; Propofol; Palonosetron; Desflurane; Diphenhydramine; Promethazine; Sevoflurane; Morphine; Granisetron; Haloperidol; Oxycodone; Ondansetron; Aprepitant; Meperidine; Isoflurane; Sufentanil; Hydromorphone; Meclizine; Methadone; Scopolamine; Hydrocodone; Butylscopolammonium Bromide; Metoclopramide; Alfentanil; Ramosetron; Droperidol; Oxymorphone; Tropisetron; Dolasetron
• Other Study ID Numbers: 151750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes