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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PONV clinical decision support system | Experimental | Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated recommendation at the start of the case | Procedure | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan P Wanderer, MD, MPhil | Vanderbilt University Medical Center, Division of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline Measurement | No recommendations were provided for PONV prophylaxis. |
| FG001 | CDS Email Recommendations | Automated recommendations on PONV prophylaxis provided by email only. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2018 |
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|
| Automated notification at the start of surgery | Procedure | 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 | Procedure | A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center. |
|
| Automated notification at the end of surgery | Procedure | 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) | Device | The anesthesia electronic record keeping system |
|
| Perioperative Data Warehouse (PDW) | Device | 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 | Procedure | Any anesthetic drugs that are used to induce general anesthesia above the level of sedation. |
|
| Elective surgery | Procedure | Surgical procedures that are scheduled and not an emergency. |
|
| Propofol | Drug | Anesthetic drug used to maintain general anesthesia |
|
| Sevoflurane | Drug | Anesthetic drug used to maintain general anesthesia |
|
| Isoflurane | Drug | Anesthetic drug used to maintain general anesthesia |
|
| Desflurane | Drug | Anesthetic drug used to maintain general anesthesia |
|
| Scopolamine | Drug | Prophylactic antiemetic |
|
| Droperidol | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Haloperidol | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Dexamethasone | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Promethazine | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Meclizine | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Aprepitant | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Metoclopramide | Drug | Rescue antiemetic |
|
| Fentanyl | Drug | Analgesic drug / Opioid |
|
| Sufentanil | Drug | Analgesic drug / Opioid |
|
| Alfentanil | Drug | Analgesic drug / Opioid |
|
| Remifentanil | Drug | Analgesic drug / Opioid |
|
| Morphine | Drug | Analgesic drug / Opioid |
|
| Meperidine | Drug | Analgesic drug / Opioid |
|
| Hydromorphone | Drug | Analgesic drug / Opioid |
|
| Methadone | Drug | Analgesic drug / Opioid |
|
| Oxycodone | Drug | Analgesic drug / Opioid |
|
| Oxymorphone | Drug | Analgesic drug / Opioid |
|
| Hydrocodone | Drug | Analgesic drug / Opioid |
|
| Ketamine | Drug | Analgetic / Analgesic drug |
|
| Ondansetron | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Granisetron | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Dolasetron mesylate | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Palonosetron | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Tropisetron | Drug | Prophylactic antiemetic & rescue antiemetic |
|
| Ramosetron | Drug | Prophylactic antiemetic & rescue antiemetic |
|
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 |
| FG002 | CDS Email + Real TIme Recommenations | Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email. |
|
| COMPLETED |
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| NOT COMPLETED |
|
This population was analyzed prior to the institution of CDS for PONV prophylaxis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Measurement | No recommendations were provided for PONV prophylaxis. |
| BG001 | CDS Email Recommendations | Automated recommendations on PONV prophylaxis provided by email only. |
| BG002 | CDS Email + Real TIme Recommenations | Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| History of PONV/Motion Sickness | Count of Participants | Participants |
| ||||||||||||||||
| Smoking Status is Current Non Smoker | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 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 | 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. | Posted | Count of Participants | Participants | PACU recovery period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | prophylactic antiemetics administered | 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 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Mean | Standard Deviation | minutes | A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) Preoperative recommendations: by email: A recommendation on PONV prophylaxis to anesthesia providers through email. | 90 | 27,034 | 90 | 27,034 | 0 | 27,034 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality - Baseline | Investigations | Systematic Assessment |
| ||
| Mortality - CDS Email Recommendations | Investigations | Systematic Assessment |
| ||
| Mortality - CDS Email + Real Time Recommendations | Investigations | Systematic Assessment |
|
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Wanderer | Vanderbilt University Medical Center | 615-536-5194 | jon.wanderer@vanderbilt.edu |
| Feb 8, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D017558 | Elective Surgical Procedures |
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| D007530 | Isoflurane |
| D000077335 | Desflurane |
| D012601 | Scopolamine |
| D004329 | Droperidol |
| D006220 | Haloperidol |
| D003907 | Dexamethasone |
| D011398 | Promethazine |
| D008468 | Meclizine |
| D000077608 | Aprepitant |
| D008787 | Metoclopramide |
| D005283 | Fentanyl |
| D017409 | Sufentanil |
| D015760 | Alfentanil |
| D000077208 | Remifentanil |
| D009020 | Morphine |
| D008614 | Meperidine |
| D004091 | Hydromorphone |
| D008691 | Methadone |
| D010098 | Oxycodone |
| D010111 | Oxymorphone |
| D006853 | Hydrocodone |
| D007649 | Ketamine |
| D017294 | Ondansetron |
| D017829 | Granisetron |
| C060344 | dolasetron |
| D000077924 | Palonosetron |
| D000077526 | Tropisetron |
| C071315 | ramosetron |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D013514 | Surgical Procedures, Operative |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D005019 | Ethyl Ethers |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011437 | Propylamines |
| D000588 | Amines |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001559 | Benzhydryl Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D010647 | Phenyl Ethers |
| D010880 | Piperidines |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D003061 | Codeine |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D011812 | Quinuclidines |
| D007546 | Isoquinolines |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|