Clinical Trials Directory

Trials / Completed

CompletedNCT00293618

Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule

IMplementation of a Prediction Rule in Anesthesia Practice to Improve Cost-Effectiveness of Treatment of Postoperative Nausea and Vomiting

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
11,970 (actual)
Sponsor
UMC Utrecht · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEAutomatic Risk Presentation in the operating roomAutomatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure
OTHEREducationSpecific information is provided to the intervention group: about PONV, about the prediction model. While the Usual Care group only receives information about the study purposes
OTHERFeedbackFeedback about the physician's personal performance on prevention of PONV

Timeline

Start date
2006-03-01
Primary completion
2007-12-01
Completion
2008-01-01
First posted
2006-02-17
Last updated
2009-01-16

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT00293618. Inclusion in this directory is not an endorsement.