Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Device: Automatic Risk Presentation in the operating room; Other: Education; Other: Feedback

• Registration Number: NCT00293618
• Lead Sponsor: UMC Utrecht

Brief Summary

This study evaluates whether the implementation of a prediction rule for postoperative nausea and vomiting changes physician behaviour, improves patient outcome and improves cost-effectiveness of treatment of postoperative nausea and vomiting.

Detailed Description

Background and objectives. So-called prediction rules (risk scores) have become increasingly popular in all medical disciplines. This will only rise with the introduction of electronic patient records as these will enhance their use. However, effects of implementation of such rules in daily care has hardly been studied. Also not in anesthesiology. We developed and validated an accurate rule to preoperatively predict the risk of postoperative nausea and vomiting (PONV) in surgical inpatients. PONV causes extreme patient discomfort and occurs in even 30%-50% of all surgical inpatients. As routine administration of PONV prophylaxis is not cost-effective, a risk-tailored approach using an accurate prediction rule is widely advocated. Before large-scale implementation, we aim to study whether such implementation indeed changes physician behavior and improves patient outcome. Given the increase interest in prediction rules, another aim is to study general causes of successful/poor implementation of prediction rules in health care. Design. Cluster, randomized study in which 60 anesthesiologists and senior residents of the UMC Utrecht will be randomized to either the intervention or usual care group.

Study population. Adult,elective,non-ambulatory,surgical patients undergoing general anesthesia of UMC Utrecht.

Intervention. Implementation of risk-tailored PONV strategy (use of the PONV prediction rule with suggested anti-emetic strategies per risk group) in current care.

Outcomes. Primary:incidence of PONV in first 24 hours. Secondary:change in anesthesiologists' behavior in terms of administered anti-emetic management, cost-effectiveness of intervention, attitudes of physicians towards prediction rules in general.

Sample size. 11,000

Economic evaluation. Estimation of incremental costs per prevented PONV case.

Study Timeline

• Study First Submitted: 2006-02-16
• Study First Submitted QC: 2006-02-16
• Study First Posted: 2006-02-17
• Study Start: 2006-03
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-15
• Last Update Posted: 2009-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11970

Inclusion Criteria

• Adult patients
• Undergoing elective surgery
• General anesthesia

Exclusion Criteria

• emergency surgery
• postoperative transfer to ICU

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Automatic Risk Presentation in the operating room	Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively
Usual Care	Education	Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have
Intervention	Education	Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively
Intervention	Feedback	Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively

Primary Outcome Measures

Name	Time	Method
the incidence of PONV within the first 24 hours	within 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Behaviour of the anaesthesiologist regarding PONV-prophylaxis	Perioperative
Cost-effectiveness risk-based prophylaxis compared to standard care	Within 24 hours after surgery
Attitude of anesthesiologists to use risk estimations from a prediction rule	At the start and end of the study

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands