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Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule

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ClinicalTrials.gov Identifier: NCT00293618
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : January 16, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Postoperative Nausea and Vomiting Device: Automatic Risk Presentation in the operating room Other: Education Other: Feedback

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11970 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2006
Primary Completion Date : December 2007
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. the incidence of PONV within the first 24 hours [ Time Frame: within 24 hours after surgery ]

Secondary Outcome Measures :
  1. Behaviour of the anaesthesiologist regarding PONV-prophylaxis [ Time Frame: Perioperative ]
  2. Cost-effectiveness risk-based prophylaxis compared to standard care [ Time Frame: Within 24 hours after surgery ]
  3. Attitude of anesthesiologists to use risk estimations from a prediction rule [ Time Frame: At the start and end of the study ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients
  • Undergoing elective surgery
  • General anesthesia

Exclusion Criteria:

  • emergency surgery
  • postoperative transfer to ICU
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293618

UMC Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Study Chair: Cor J Kalkman, M.D. PhD UMC Utrecht
Principal Investigator: Karel G Moons, PhD UMC Utrecht
More Information

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
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: January 16, 2009
Last Verified: January 2009

Keywords provided by UMC Utrecht:
Implementation of prediction rules
Decision Support Systems, Clinical
prediction rule
impact study
decision support
clinical decision support

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes