Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Postoperative Nausea and Vomiting |
Device: Automatic Risk Presentation in the operating room Other: Education Other: Feedback |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | IMplementation of a Prediction Rule in Anesthesia Practice to Improve Cost-Effectiveness of Treatment of Postoperative Nausea and Vomiting |
- the incidence of PONV within the first 24 hours [ Time Frame: within 24 hours after surgery ] [ Designated as safety issue: No ]
- Behaviour of the anaesthesiologist regarding PONV-prophylaxis [ Time Frame: Perioperative ] [ Designated as safety issue: No ]
- Cost-effectiveness risk-based prophylaxis compared to standard care [ Time Frame: Within 24 hours after surgery ] [ Designated as safety issue: No ]
- Attitude of anesthesiologists to use risk estimations from a prediction rule [ Time Frame: At the start and end of the study ] [ Designated as safety issue: No ]
| Enrollment: | 11970 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively
|
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
|
|
Active Comparator: Usual Care
Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients
- Undergoing elective surgery
- General anesthesia
Exclusion Criteria:
- emergency surgery
- postoperative transfer to ICU
Contacts and Locations| Netherlands | |
| UMC Utrecht | |
| Utrecht, Netherlands, 3508 GA | |
| Study Chair: | Cor J Kalkman, M.D. PhD | UMC Utrecht |
| Principal Investigator: | Karel G Moons, PhD | UMC Utrecht |
More Information
No publications provided by UMC Utrecht
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | K.G.M.Moons, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00293618 History of Changes |
| Other Study ID Numbers: | 05/288, 945-16-202 |
| Study First Received: | February 16, 2006 |
| Last Updated: | January 15, 2009 |
| Health Authority: | Netherlands: Independent Ethics Committee |
Keywords provided by UMC Utrecht:
|
Implementation of prediction rules Decision Support Systems, Clinical PONV Emesis Nausea Vomiting |
Postoperative Implementation prediction rule impact study decision support clinical decision support |
Additional relevant MeSH terms:
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive |
Signs and Symptoms Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013