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

• Sponsor: Vanderbilt University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02625181
• Collaborator: (none)
• Enrollment: 27,034
• Location: 1
• Arm: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 1591.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	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: 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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 27034 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Nov 2, 2017
• Actual Study Completion Date: Nov 30, 2017

Arms and Interventions

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.

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: Anesthesia Information Management System (AIMS); The anesthesia electronic record keeping system; 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: General anesthesia; Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.; Procedure: Elective surgery; Surgical procedures that are scheduled and not an emergency.; Drug: Propofol; Anesthetic drug used to maintain general anesthesia; Drug: Sevoflurane; Anesthetic drug used to maintain general anesthesia; Drug: Isoflurane; Anesthetic drug used to maintain general anesthesia; Drug: Desflurane; Anesthetic drug used to maintain general anesthesia; 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212

Sponsors and Collaborators

• Vanderbilt University

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 28, 2018

More Information

Publications

None provided.

• Responsible Party: Jonathan Wanderer, Medical Director of Procedure Preparation Center, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT02625181
• Other Study ID Numbers: 151750
• First Posted: Dec 9, 2015
• Last Update Posted: Mar 7, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Jonathan Wanderer, Medical Director of Procedure Preparation Center, Vanderbilt University: Decision support; Prediction models; PONV; prophylaxis; Decision Support Systems, Clinical; Decision Support Techniques
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Promethazine; Diphenhydramine; Meclizine; Dexamethasone; Fentanyl; Sufentanil; Scopolamine; Oxymorphone; Meperidine; Droperidol; Ketamine; Morphine; Remifentanil; Oxycodone; Methadone; Hydromorphone; Hydrocodone; Alfentanil; Haloperidol; Ondansetron; Aprepitant; Palonosetron; Metoclopramide; Granisetron; Ramosetron; Tropisetron; Dolasetron; Anesthetics; Propofol; Sevoflurane; Desflurane; Isoflurane; Butylscopolammonium Bromide

Study Results

Participant Flow

Arm/Group Title	Baseline Measurement	CDS Email Recommendations	CDS Email + Real TIme Recommenations
Arm/Group Description	No recommendations were provided for PONV prophylaxis.	Automated recommendations on PONV prophylaxis provided by email only.	Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Period Title: Overall Study
STARTED	1518	12809	12707
COMPLETED	1518	12809	12707
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Baseline Measurement	CDS Email Recommendations	CDS Email + Real TIme Recommenations	Total
Arm/Group Description	No recommendations were provided for PONV prophylaxis.	Automated recommendations on PONV prophylaxis provided by email only.	Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.	Total of all reporting groups
Overall Participants	1518	12809	12707	27034
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1131 74.5%	9573 74.7%	9603 75.6%	20307 75.1%
>=65 years	387 25.5%	3236 25.3%	3104 24.4%	6727 24.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (16.78)	52 (16.73)	51 (17.15)	52 (16.94)
Sex: Female, Male (Count of Participants)
Female	813 53.6%	6550 51.1%	6212 48.9%	13575 50.2%
Male	705 46.4%	6259 48.9%	6495 51.1%	13459 49.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.2%	12 0.1%	23 0.2%	38 0.1%
Asian	11 0.7%	100 0.8%	110 0.9%	221 0.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	170 11.2%	1321 10.3%	1595 12.6%	3086 11.4%
White	1279 84.3%	10823 84.5%	10498 82.6%	22600 83.6%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	55 3.6%	553 4.3%	481 3.8%	1089 4%
Region of Enrollment (participants) [Number]
United States	1518 100%	12809 100%	12707 100%	27034 100%
History of PONV/Motion Sickness (Count of Participants)
Count of Participants [Participants]	226 14.9%	2303 18%	10728 84.4%	13257 49%
Smoking Status is Current Non Smoker (Count of Participants)
Count of Participants [Participants]	1183 77.9%	9723 75.9%	9352 73.6%	20258 74.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baseline Measurement	CDS Email Recommendations	CDS Email + Real TIme Recommenations
Arm/Group Description	No recommendations were provided for PONV prophylaxis.	Automated recommendations on PONV prophylaxis provided by email only.	Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Measure Participants	1518	12809	12707
Count of Participants [Participants]	666 43.9%	5260 41.1%	5863 46.1%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baseline Measurement	CDS Email Recommendations	CDS Email + Real TIme Recommenations
Arm/Group Description	No recommendations were provided for PONV prophylaxis.	Automated recommendations on PONV prophylaxis provided by email only.	Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Measure Participants	1518	12809	12707
Count of Participants [Participants]	139 9.2%	1323 10.3%	1343 10.6%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baseline Measurement	CDS Email Recommendations	CDS Email + Real TIme Recommenations
Arm/Group Description	No recommendations were provided for PONV prophylaxis.	Automated recommendations on PONV prophylaxis provided by email only.	Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Measure Participants	1518	12809	12707
Mean (Standard Deviation) [prophylactic antiemetics administered]	2.196 (0.932)	2.176 (0.988)	2.129 (0.977)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baseline Measurement	CDS Email Recommendations	CDS Email + Real TIme Recommenations
Arm/Group Description	No recommendations were provided for PONV prophylaxis.	Automated recommendations on PONV prophylaxis provided by email only.	Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Measure Participants	1518	12809	12707
Mean (Standard Deviation) [minutes]	266 (374)	264 (371)	266 (361)

Adverse Events

Time Frame	We analyzed adverse events in this patient population during their intraoperative course from entry into OR until exit from the OR (adverse events sourced from our adverse event reporting system), and during their hospitalization (source for mortality data), an average of 4.9 days.
Adverse Event Reporting Description	We utilized our perioperative information management system to determine the number of adverse events that occurred associated with the patients' intraoperative course. We used our hospital registration system to determine all cause mortality for this patient population.
Arm/Group Title	PONV Clinical Decision Support System
Arm/Group Description	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) Preoperative recommendations: by email: A recommendation on PONV prophylaxis to anesthesia providers through email.
All Cause Mortality
	PONV Clinical Decision Support System
	Affected / at Risk (%)	# Events
Total	90/27034 (0.3%)
Serious Adverse Events
	PONV Clinical Decision Support System
	Affected / at Risk (%)	# Events
Total	90/27034 (0.3%)
Investigations
Mortality - Baseline	7/1518 (0.5%)	7
Mortality - CDS Email Recommendations	43/12809 (0.3%)	43
Mortality - CDS Email + Real Time Recommendations	40/12707 (0.3%)	40
Other (Not Including Serious) Adverse Events
	PONV Clinical Decision Support System
	Affected / at Risk (%)	# Events
Total	0/27034 (0%)

Limitations/Caveats

We were unable to complete analysis of hyperlink data for PONV recommendations as planned because the data were not archived as intended. We were unable to include University of Washington as a collaborative site due to technical differences.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.