Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11970 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively

Group Type EXPERIMENTAL

Automatic Risk Presentation in the operating room

Intervention Type DEVICE

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

Education

Intervention Type OTHER

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

Feedback

Intervention Type OTHER

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

Usual Care

Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

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

Interventions

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Automatic 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

Intervention Type DEVICE

Education

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

Intervention Type OTHER