Trial Outcomes & Findings for Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis (NCT NCT02625181)

NCT ID: NCT02625181

Last Updated: 2019-03-07

Results Overview

PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27034 participants
• Primary outcome timeframe: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case
• Results posted on: 2019-03-07

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Baseline Measurement n=1518 Participants No recommendations were provided for PONV prophylaxis.	CDS Email Recommendations n=12809 Participants Automated recommendations on PONV prophylaxis provided by email only.	CDS Email + Real TIme Recommenations n=12707 Participants Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.	Total n=27034 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1131 Participants n=5 Participants	9573 Participants n=7 Participants	9603 Participants n=5 Participants	20307 Participants n=4 Participants
Age, Categorical >=65 years	387 Participants n=5 Participants	3236 Participants n=7 Participants	3104 Participants n=5 Participants	6727 Participants n=4 Participants
Age, Continuous	53 years STANDARD_DEVIATION 16.78 • n=5 Participants	52 years STANDARD_DEVIATION 16.73 • n=7 Participants	51 years STANDARD_DEVIATION 17.15 • n=5 Participants	52 years STANDARD_DEVIATION 16.94 • n=4 Participants
Sex: Female, Male Female	813 Participants n=5 Participants	6550 Participants n=7 Participants	6212 Participants n=5 Participants	13575 Participants n=4 Participants
Sex: Female, Male Male	705 Participants n=5 Participants	6259 Participants n=7 Participants	6495 Participants n=5 Participants	13459 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	100 Participants n=7 Participants	110 Participants n=5 Participants	221 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	170 Participants n=5 Participants	1321 Participants n=7 Participants	1595 Participants n=5 Participants	3086 Participants n=4 Participants
Race (NIH/OMB) White	1279 Participants n=5 Participants	10823 Participants n=7 Participants	10498 Participants n=5 Participants	22600 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	55 Participants n=5 Participants	553 Participants n=7 Participants	481 Participants n=5 Participants	1089 Participants n=4 Participants
Region of Enrollment United States	1518 participants n=5 Participants	12809 participants n=7 Participants	12707 participants n=5 Participants	27034 participants n=4 Participants
History of PONV/Motion Sickness	226 Participants n=5 Participants	2303 Participants n=7 Participants	10728 Participants n=5 Participants	13257 Participants n=4 Participants
Smoking Status is Current Non Smoker	1183 Participants n=5 Participants	9723 Participants n=7 Participants	9352 Participants n=5 Participants	20258 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Measurement n=1518 Participants No recommendations were provided for PONV prophylaxis.	CDS Email Recommendations n=12809 Participants Automated recommendations on PONV prophylaxis provided by email only.	CDS Email + Real TIme Recommenations n=12707 Participants Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Adherence to PONV Guidelines	666 Participants	5260 Participants	5863 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Measurement n=1518 Participants No recommendations were provided for PONV prophylaxis.	CDS Email Recommendations n=12809 Participants Automated recommendations on PONV prophylaxis provided by email only.	CDS Email + Real TIme Recommenations n=12707 Participants Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting	139 Participants	1323 Participants	1343 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Measurement n=1518 Participants No recommendations were provided for PONV prophylaxis.	CDS Email Recommendations n=12809 Participants Automated recommendations on PONV prophylaxis provided by email only.	CDS Email + Real TIme Recommenations n=12707 Participants Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
The Number of Prophylactic Interventions for PONV	2.196 prophylactic antiemetics administered Standard Deviation 0.932	2.176 prophylactic antiemetics administered Standard Deviation 0.988	2.129 prophylactic antiemetics administered Standard Deviation 0.977

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Baseline Measurement n=1518 Participants No recommendations were provided for PONV prophylaxis.	CDS Email Recommendations n=12809 Participants Automated recommendations on PONV prophylaxis provided by email only.	CDS Email + Real TIme Recommenations n=12707 Participants Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Time to Discharge From the Postanesthesia Care Unit (PACU)	266 minutes Standard Deviation 374	264 minutes Standard Deviation 371	266 minutes Standard Deviation 361

Adverse Events

PONV Clinical Decision Support System

Serious events: 90 serious events

Other events: 0 other events

Deaths: 90 deaths

Serious adverse events

Measure	PONV Clinical Decision Support System n=27034 participants at risk 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.
Investigations Mortality - Baseline	0.46% 7/1518 • Number of events 7 • 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. 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.
Investigations Mortality - CDS Email Recommendations	0.34% 43/12809 • Number of events 43 • 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. 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.
Investigations Mortality - CDS Email + Real Time Recommendations	0.31% 40/12707 • Number of events 40 • 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. 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.

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Wanderer

Vanderbilt University Medical Center

Phone: 615-536-5194

Email: jon.wanderer@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place