Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule

Study Overview
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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.

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.

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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Device: Automatic Risk Presentation in the operating room
* Other: Education
* Other: Feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Undergoing elective surgery General anesthesia Exclusion Criteria: emergency surgery postoperative transfer to ICU

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively | Device: Automatic Risk Presentation in the operating room<br>* Automatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure<br>Other: Education<br>* 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<br>Other: Feedback<br>* Feedback about the physician's personal performance on prevention of PONV<br>|
| Active Comparator: Usual Care<br>Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have | Other: Education<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of PONV within the first 24 hours |  | within 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation of prediction rules, Decision Support Systems, Clinical, PONV, Emesis, Nausea, Vomiting, Postoperative, Implementation, prediction rule, impact study, decision support, clinical decision support