AW-D Tool for Postoperative Nausea and Vomiting

(ASPIRE-PONV Trial)

Overseen By Gail Mayo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: ICU transfer, ASA 5 or 6, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

13120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool to help doctors prevent nausea and vomiting after surgery. The AW-D Clinical Decision Support Tool provides timely reminders to doctors, using information from patients' electronic health records, to ensure optimal timing and use of nausea prevention strategies. It targets patients undergoing surgery with general anesthesia who have a history of motion sickness or past surgery-related nausea, are non-smokers, or are female. The trial will compare periods when the tool is used to when it's not, to determine if it improves care and reduces nausea. As an unphased trial, this study allows patients to contribute to innovative research that may enhance surgical care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this clinical decision support tool is safe for postoperative nausea and vomiting prevention?

Research has shown that tools like the AW-D Clinical Decision Support Tool are generally safe and helpful. These tools assist healthcare providers in making better decisions without harming patients. For instance, one study tested a similar tool for managing nausea and vomiting after surgery and found no negative effects from the tool itself. The tool reminds providers when to give preventive treatment based on a patient's risk factors. As it is part of the electronic health record and only sends alerts, it doesn't directly interact with patients or medications. Therefore, the tool is considered safe for use in healthcare settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AW-D Clinical Decision Support Tool because it aims to enhance the management of postoperative nausea and vomiting (PONV) by using real-time automated notifications. Unlike standard treatments that typically rely on fixed protocols and manual decision-making, this tool integrates with the electronic health system to remind healthcare providers about the optimal timing for administering PONV medication. This approach could lead to more personalized and timely prophylaxis, potentially improving patient outcomes and streamlining the anesthesia workflow. By serving as a helpful reminder of best practices, the tool supports providers in making informed decisions without mandating changes in practice.

What evidence suggests that the AW-D Clinical Decision Support Tool is effective for reducing postoperative nausea and vomiting?

Studies have shown that clinical decision support (CDS) tools can reduce postoperative nausea and vomiting (PONV) by improving the timing and application of prevention strategies. This trial tests the AW-D CDS Tool as an intervention to deliver automated reminders. Research indicates that such reminders can enhance adherence to best practices for PONV medication. The tool provides timely alerts based on each patient's risk, aiding healthcare providers in making informed decisions. Previous patients benefited from similar tools, which improved the administration of PONV prevention measures. This suggests that the AW-D CDS Tool might effectively reduce PONV rates by optimizing medication timing. ^{1 3 4 6 7}

Who Is on the Research Team?

Miklos Kertai, M.D., Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

The ASPIRE-PONV trial is for adult and pediatric patients scheduled for surgery with general anesthesia. It aims to test if a new tool can help prevent postoperative nausea and vomiting by providing personalized alerts to doctors.

Inclusion Criteria

Pediatric: 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)

Adult: 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)

Exclusion Criteria

I am either under 3 or over 17 years old and fit specific medical or procedure criteria.

I am an adult patient undergoing minor procedures or specific treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the Anesthesia Workflow-Driven Clinical Decision Support Tool to optimize PONV prophylaxis

12 months

Follow-up

Participants are monitored for PONV incidence and prophylaxis adherence postoperatively

3 hours postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• AW-D Clinical Decision Support Tool

Trial Overview This study tests the AW-D Clinical Decision Support Tool, which gives real-time reminders about preventing PONV based on each patient's risk. The goal is to see if this leads to better use of prevention strategies and fewer cases of PONV.

How Is the Trial Designed?

Group I: Anesthesia Workflow-Driven Clinical Decision Support (AW-D CDS) Tool Intervention Experimental Treatment 1 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.

Group II: Control Active Control 1 Intervention

No intervention will be delivered.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. withpower.com withpower.com/trial/phase-postoperative-nausea-and-vomiting-8-2025-d750b

AW-D Tool for Postoperative Nausea and Vomiting The main aim is to improve PONV, establishing a scalable Clinical Decision Support (CDS) Tool for personalized PONV prevention.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10148234/

Automated feedback modestly improves perioperative ... This study aimed to evaluate the use of clinical decision support (CDS) in conjunction with feedback (post-hoc reporting) to improve PONV medication ...

3. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07152249

AW-D Clinical Decision Support Tool in Postoperative Nausea ... The main aim is to improve PONV, establishing a scalable Clinical Decision Support (CDS) Tool for personalized PONV prevention. The primary ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02625181

Real-time Decision Support for Postoperative Nausea and ... 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7390620/

An Electronic Medical Record-Derived Individualized ... We tested MIP by investigating the adherence with prophylactic bundles to reduce the risk of postoperative nausea and vomiting (PONV), retrieving PONV risk ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11297814/

Knowledge-based, computerized, patient clinical decision ... A knowledge-based CDSS aiming at optimizing the management of perioperative pain, postoperative nausea and vomiting (PONV), and laxative medications.

7. sciencedirect.com sciencedirect.com/science/article/pii/S000709121753946X

Simplified algorithm for the prevention of postoperative ... Secondary outcomes included, 1) the incidence of postoperative nausea (PON) and the incidence of postoperative vomiting (POV) within 1 and 24 h after surgery; 2 ...