Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial

Vanderbilt University Medical Center19,480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

19,480

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Adult Inclusion Criteria * Age ≥ 18 years * Planned surgery with general anesthesia with endotracheal intubation or laryngeal mask airway * Meet zero or more risk factors for PONV ( history of motion sickness or postoperative nausea and vomiting, non-smoker, female sex, duration of inhalation anesthesia greater than 1 hour, undergoing high risk surgical procedure (cholecystectomy, laparoscopy, gynecologic), and perioperative opioid use) Adult Exclusion Criteria * ASA 6 including organ procurement, * Patients anticipated to be transferred directly to the intensive care unit intubated, * Procedure types: * Electroconvulsive therapy, * Intubation only cases, * labor epidurals, * transesophageal echocardiography (TEE)/cardioversion, * surgery duration \< 30 minutes. Operating Room Anaesthesia Provider Inclusion Criteria Any operating room anaesthesia provider of eligible patients will be included.

Outcomes

Primary Outcomes

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"

Time frame: Intraoperative

Secondary Outcomes

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.

Time frame: 3 hours postoperatively

Adult Patients: PACU length of stay

Duration of time spent in PACU

Time frame: PACU admission to discharge (usually 1-3 hours post operatively)