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
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
| OTHER | 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 |
| OTHER | Feedback | Feedback 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.