Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
NCT ID: NCT02625181
Last Updated: 2019-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
27034 participants
INTERVENTIONAL
2016-07-31
2017-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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PONV clinical decision support system
Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
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)
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.
Preoperative recommendations: by email
A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.
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.
Anesthesia Information Management System (AIMS)
The anesthesia electronic record keeping system
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.
General anesthesia
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Elective surgery
Surgical procedures that are scheduled and not an emergency.
Propofol
Anesthetic drug used to maintain general anesthesia
Sevoflurane
Anesthetic drug used to maintain general anesthesia
Isoflurane
Anesthetic drug used to maintain general anesthesia
Desflurane
Anesthetic drug used to maintain general anesthesia
Scopolamine
Prophylactic antiemetic
Droperidol
Prophylactic antiemetic \& rescue antiemetic
Haloperidol
Prophylactic antiemetic \& rescue antiemetic
Dexamethasone
Prophylactic antiemetic \& rescue antiemetic
Promethazine
Prophylactic antiemetic \& rescue antiemetic
Meclizine
Prophylactic antiemetic \& rescue antiemetic
Aprepitant
Prophylactic antiemetic \& rescue antiemetic
Metoclopramide
Rescue antiemetic
Fentanyl
Analgesic drug / Opioid
Sufentanil
Analgesic drug / Opioid
Alfentanil
Analgesic drug / Opioid
Remifentanil
Analgesic drug / Opioid
Morphine
Analgesic drug / Opioid
Meperidine
Analgesic drug / Opioid
Hydromorphone
Analgesic drug / Opioid
Methadone
Analgesic drug / Opioid
Oxycodone
Analgesic drug / Opioid
Oxymorphone
Analgesic drug / Opioid
Hydrocodone
Analgesic drug / Opioid
Ketamine
Analgetic / Analgesic drug
Ondansetron
Prophylactic antiemetic \& rescue antiemetic
Granisetron
Prophylactic antiemetic \& rescue antiemetic
Dolasetron mesylate
Prophylactic antiemetic \& rescue antiemetic
Palonosetron
Prophylactic antiemetic \& rescue antiemetic
Tropisetron
Prophylactic antiemetic \& rescue antiemetic
Ramosetron
Prophylactic antiemetic \& rescue antiemetic
Interventions
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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)
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.
Preoperative recommendations: by email
A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.
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.
Anesthesia Information Management System (AIMS)
The anesthesia electronic record keeping system
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.
General anesthesia
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Elective surgery
Surgical procedures that are scheduled and not an emergency.
Propofol
Anesthetic drug used to maintain general anesthesia
Sevoflurane
Anesthetic drug used to maintain general anesthesia
Isoflurane
Anesthetic drug used to maintain general anesthesia
Desflurane
Anesthetic drug used to maintain general anesthesia
Scopolamine
Prophylactic antiemetic
Droperidol
Prophylactic antiemetic \& rescue antiemetic
Haloperidol
Prophylactic antiemetic \& rescue antiemetic
Dexamethasone
Prophylactic antiemetic \& rescue antiemetic
Promethazine
Prophylactic antiemetic \& rescue antiemetic
Meclizine
Prophylactic antiemetic \& rescue antiemetic
Aprepitant
Prophylactic antiemetic \& rescue antiemetic
Metoclopramide
Rescue antiemetic
Fentanyl
Analgesic drug / Opioid
Sufentanil
Analgesic drug / Opioid
Alfentanil
Analgesic drug / Opioid
Remifentanil
Analgesic drug / Opioid
Morphine
Analgesic drug / Opioid
Meperidine
Analgesic drug / Opioid
Hydromorphone
Analgesic drug / Opioid
Methadone
Analgesic drug / Opioid
Oxycodone
Analgesic drug / Opioid
Oxymorphone
Analgesic drug / Opioid
Hydrocodone
Analgesic drug / Opioid
Ketamine
Analgetic / Analgesic drug
Ondansetron
Prophylactic antiemetic \& rescue antiemetic
Granisetron
Prophylactic antiemetic \& rescue antiemetic
Dolasetron mesylate
Prophylactic antiemetic \& rescue antiemetic
Palonosetron
Prophylactic antiemetic \& rescue antiemetic
Tropisetron
Prophylactic antiemetic \& rescue antiemetic
Ramosetron
Prophylactic antiemetic \& rescue antiemetic
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vanderbilt University
OTHER
Responsible Party
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Jonathan Wanderer
Medical Director of Procedure Preparation Center
Principal Investigators
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Jonathan P Wanderer, MD, MPhil
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center, Division of Anesthesiology
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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151750
Identifier Type: -
Identifier Source: org_study_id
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