Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Vanderbilt University Medical Center
- Study ID
- NCT07152249
- Status
- Recruiting
Conditions
- Postoperative Nausea
- Postoperative Vomiting
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AW-D Clinical Decision Support Tool — OTHERThe 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.
Study Details
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.
Key Dates
- Start date
- Sep 3, 2025
- Status verified
- Jan 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 19,480 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- No Intervention: ControlNo intervention will be delivered.
- Experimental: Anesthesia Workflow-Driven Clinical Decision Support (AW-D CDS) Tool InterventionThe 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.
Primary Outcome Measure
Adult patients: rate of appropriate administration of PONV prophylaxis [ Time Frame: Intraoperative ]
Central Contacts
- Miklos Kertai, M.D., Ph.D.615-875-0378
- Gail Mayo615-936-1705
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | Miklos Kertai, MD Ellen Stallings Ellen Stallings, MD (SUB_INVESTIGATOR) |