Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00293618
First received: February 16, 2006
Last updated: January 15, 2009
Last verified: January 2009
  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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • the incidence of PONV within the first 24 hours [ Time Frame: within 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Adult patients
  • Undergoing elective surgery
  • General anesthesia

Exclusion Criteria:

  • emergency surgery
  • postoperative transfer to ICU
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00293618

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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 July 29, 2014