Postoperative Nausea and Vomiting
Conditions
Keywords
Decision support, Prediction models, PONV, prophylaxis, Decision Support Systems, Clinical, Decision Support Techniques
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.
Interventions
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)
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.
A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.
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.
The anesthesia electronic record keeping system
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.
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Surgical procedures that are scheduled and not an emergency.
Anesthetic drug used to maintain general anesthesia
Anesthetic drug used to maintain general anesthesia
Anesthetic drug used to maintain general anesthesia
Anesthetic drug used to maintain general anesthesia
Prophylactic antiemetic
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Rescue antiemetic
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgesic drug / Opioid
Analgetic / Analgesic drug
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Prophylactic antiemetic & rescue antiemetic
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Measurement No recommendations were provided for PONV prophylaxis. | 1,518 |
| CDS Email Recommendations Automated recommendations on PONV prophylaxis provided by email only. | 12,809 |
| CDS Email + Real TIme Recommenations Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email. | 12,707 |
| Total | 27,034 |
Baseline characteristics
| Characteristic | Total | CDS Email + Real TIme Recommenations | Baseline Measurement | CDS Email Recommendations |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6727 Participants | 3104 Participants | 387 Participants | 3236 Participants |
| Age, Categorical Between 18 and 65 years | 20307 Participants | 9603 Participants | 1131 Participants | 9573 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 16.94 | 51 years STANDARD_DEVIATION 17.15 | 53 years STANDARD_DEVIATION 16.78 | 52 years STANDARD_DEVIATION 16.73 |
| History of PONV/Motion Sickness | 13257 Participants | 10728 Participants | 226 Participants | 2303 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 38 Participants | 23 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) Asian | 221 Participants | 110 Participants | 11 Participants | 100 Participants |
| Race (NIH/OMB) Black or African American | 3086 Participants | 1595 Participants | 170 Participants | 1321 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1089 Participants | 481 Participants | 55 Participants | 553 Participants |
| Race (NIH/OMB) White | 22600 Participants | 10498 Participants | 1279 Participants | 10823 Participants |
| Region of Enrollment United States | 27034 participants | 12707 participants | 1518 participants | 12809 participants |
| Sex: Female, Male Female | 13575 Participants | 6212 Participants | 813 Participants | 6550 Participants |
| Sex: Female, Male Male | 13459 Participants | 6495 Participants | 705 Participants | 6259 Participants |
| Smoking Status is Current Non Smoker | 20258 Participants | 9352 Participants | 1183 Participants | 9723 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 90 / 27,034 |
| other Total, other adverse events | 0 / 27,034 |
| serious Total, serious adverse events | 90 / 27,034 |
Outcome results
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.
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Measurement | Adherence to PONV Guidelines | 666 Participants |
| CDS Email Recommendations | Adherence to PONV Guidelines | 5260 Participants |
| CDS Email + Real TIme Recommenations | Adherence to PONV Guidelines | 5863 Participants |
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.
Time frame: PACU recovery period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Measurement | PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting | 139 Participants |
| CDS Email Recommendations | PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting | 1323 Participants |
| CDS Email + Real TIme Recommenations | PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting | 1343 Participants |
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.
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Measurement | The Number of Prophylactic Interventions for PONV | 2.196 prophylactic antiemetics administered | Standard Deviation 0.932 |
| CDS Email Recommendations | The Number of Prophylactic Interventions for PONV | 2.176 prophylactic antiemetics administered | Standard Deviation 0.988 |
| CDS Email + Real TIme Recommenations | The Number of Prophylactic Interventions for PONV | 2.129 prophylactic antiemetics administered | Standard Deviation 0.977 |
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
Time frame: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Measurement | Time to Discharge From the Postanesthesia Care Unit (PACU) | 266 minutes | Standard Deviation 374 |
| CDS Email Recommendations | Time to Discharge From the Postanesthesia Care Unit (PACU) | 264 minutes | Standard Deviation 371 |
| CDS Email + Real TIme Recommenations | Time to Discharge From the Postanesthesia Care Unit (PACU) | 266 minutes | Standard Deviation 361 |