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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00293618
Enrollment
11970
Registered
2006-02-17
Start date
2006-03-31
Completion date
2008-01-31
Last updated
2009-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

Implementation of prediction rules, Decision Support Systems, Clinical, PONV, Emesis, Nausea, Vomiting, Postoperative, Implementation, prediction rule, impact study, decision support, clinical decision support

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.

Interventions

DEVICEAutomatic Risk Presentation in the operating room

Automatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure

OTHEREducation

Specific 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

OTHERFeedback

Feedback about the physician's personal performance on prevention of PONV

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients * Undergoing elective surgery * General anesthesia

Exclusion criteria

* emergency surgery * postoperative transfer to ICU

Design outcomes

Primary

MeasureTime frame
the incidence of PONV within the first 24 hourswithin 24 hours after surgery

Secondary

MeasureTime frame
Behaviour of the anaesthesiologist regarding PONV-prophylaxisPerioperative
Cost-effectiveness risk-based prophylaxis compared to standard careWithin 24 hours after surgery
Attitude of anesthesiologists to use risk estimations from a prediction ruleAt the start and end of the study

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026