Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Purpose
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 and pediatric 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.
Conditions
- Postoperative Nausea
- Postoperative Vomiting
Eligibility
- Eligible Ages
- Over 3 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 3 and ≤ 17 years old who have - Planned surgery with general anesthesia and - One or more risk factors for PONV; (history of motion sickness and/or postoperative nausea and vomiting, non-smoker, female gender) Pediatric
Exclusion Criteria
- Age < 3 or > 17 years old, - American Society of Anesthesiologist (ASA) classification of 5 or 6 including organ procurement, - Monitored Anesthesia Care cases, - Patients transferred directly to the ICU, - Procedure types: - labor epidurals, - radiation oncology, - MRI without additional procedures, - electroconvulsive therapy, - surgery duration < 30 minutes. Adult Inclusion Criteria - Age ≥ 18 years - Planned surgery with general anesthesia - Meet one or more risk factors for PONV (history of motion sickness and/or postoperative nausea and vomiting, non-smoker, female gender) Adult Exclusion Criteria - ASA 5 or 6 including organ procurement, - Patients transferred directly to the ICU, - Procedure types: - bronchoscopy only, - diagnostic imaging only, - electroconvulsive therapy, - endoscopy without another procedure, - intubation only cases, - labor epidurals, - transesophageal echocardiography (TEE)/cardioversion, - surgery duration < 30 minutes.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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).
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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No Intervention Control |
No intervention will be delivered. |
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Experimental Anesthesia Workflow-Driven Clinical Decision Support (AW-D CDS) Tool Intervention |
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. |
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Recruiting Locations
Nashville 4644585, Tennessee 4662168 37212
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt University Medical Center