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The goal of this prospective, unblinded, pragmatic and repeated crossover trial is to learn if clinical decision support alerts will impact postoperative nausea and vomiting (PONV) prophylaxis and reduce PONV rates in adult patients who have planned surgery with general anesthesia. The main aim is to improve PONV, establishing a scalable Clinical Decision Support (CDS) Tool for personalized PONV prevention.
The primary hypothesis is that, compared with standard care, the Anesthesia Workflow-Driven Clinical Decision Support Tool for Personalized PONV Prevention will be associated with a significant improvement in the rate of appropriate administration of PONV prophylaxis and a significant decrease in the incidence of PONV.
This study will evaluate a new clinical decision support (CDS) tool designed to improve how and when PONV prevention strategies are used. Unlike traditional tools that provide generic, one-time alerts, this new system is integrated into the electronic health record (EHR) and delivers timely, targeted reminders to anesthesia providers at key moments during a patient's surgical care-such as before surgery begins, after anesthesia is given, and before the patient wakes up. These alerts are based on each patient's individual risk for PONV and are intended to support, not replace, clinical judgment. The study will use a crossover design over 12 months, alternating between periods when the tool is active and when it is not. The goal is to determine whether this time-sensitive, workflow-integrated tool can lead to better adherence to best practices and improved patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No intervention will be delivered. | |
| Anesthesia Workflow-Driven Clinical Decision Support (AW-D CDS) Tool Intervention | Experimental | The AW-D CDS Tool will test the delivery of PONV prophylaxis with the use of the clinical decision support tool. When a patient meets the study study criteria, the AW-D CDS Tool will provide automated notification through the electronic health system. The automated notifications be triggered and linked to the point-of-care/desired time of PONV medication administration throughout the workflow of the anesthetic case to optimize the timing of PONV medication administration (pre-procedure evaluation, post-induction, pre-emergence). The provider is not forced to follow the recommendations, rather it serves as a reminder of best practices as defined by our department. The intervention will be assessed using a repeated cross-over design at the institutional level with periods of time for washout, control and study intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AW-D Clinical Decision Support Tool | Other | The AW-D Clinical Decision Support Tool will test the automatic delivery of best practice advisories for antiemetic medications at critical timepoints in the perioperative period. |
| Measure | Description | Time Frame |
|---|---|---|
| Adult patients: rate of appropriate administration of PONV prophylaxis | For adult patients (PONV-5), the rate of appropriate administration of PONV prophylaxis based consensus guidelines and standardized institutional protocols. For the definition of the primary outcome we will be using the definition set by the Michigan PeriOperative Group ASPIRE Program, as follows: adult patients with PONV-05, "are ≥18 years old who had a procedure requiring general anesthesia or cesarean delivery and administered appropriate prophylaxis for PONV" | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Adult Patients: incidence of PONV | Adult Patients: Incidence of PONV as defined by MPOG ASPIRE: Presence of i) PONV-03b, EHR documented nausea/vomiting in the immediate postoperative period, and/or ii) PONV-03, EHR documented PONV OR rescue antiemetic administration in the immediate postoperative period. | 3 hours postoperatively |
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Adult Inclusion Criteria
Adult Exclusion Criteria
ASA 6 including organ procurement,
Patients anticipated to be transferred directly to the intensive care unit intubated,
Procedure types:
Operating Room Anaesthesia Provider Inclusion Criteria
Any operating room anaesthesia provider of eligible patients will be included.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miklos Kertai, M.D., Ph.D. | Contact | 615-875-0378 | miklos.kertai@vumc.org | |
| Gail Mayo | Contact | 615-936-1705 | gail.mayo@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Miklos Kertai, M.D., Ph.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41667172 | Derived | Stallings EG, Wanderer JP, Balavage M, Henson CP, Fowler L, Eden S, Shotwell MS, Gruss C, Neuhafen KR, Gelfand BJ, Kertai MD; ASPIRE-PONV Investigators. Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) study: rationale and design for a sequential, repeated crossover trial. BMJ Open. 2026 Feb 10;16(2):e113842. doi: 10.1136/bmjopen-2025-113842. |
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This trial will use a repeated crossover design. The planned 12-month period of enrollment will be divided into four 12 -week blocks (10 weeks of control or intervention followed by a 2-week washout period).
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| Adult Patients: PACU length of stay |
Duration of time spent in PACU |
| PACU admission to discharge (usually 1-3 hours post operatively) |
| 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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