Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Automatic Risk Presentation in the operating room
Education
Feedback
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Implementation of prediction rules, Decision Support Systems, Clinical, PONV, Emesis, Nausea, Vomiting, Postoperative, Implementation, prediction rule, impact study, decision support, clinical decision support
Eligibility Criteria
Inclusion Criteria: Adult patients Undergoing elective surgery General anesthesia Exclusion Criteria: emergency surgery postoperative transfer to ICU
Sites / Locations
- UMC Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Usual Care
Arm Description
Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively
Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have
Outcomes
Primary Outcome Measures
the incidence of PONV within the first 24 hours
Secondary Outcome Measures
Behaviour of the anaesthesiologist regarding PONV-prophylaxis
Cost-effectiveness risk-based prophylaxis compared to standard care
Attitude of anesthesiologists to use risk estimations from a prediction rule
Full Information
NCT ID
NCT00293618
First Posted
February 16, 2006
Last Updated
January 15, 2009
Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00293618
Brief Title
Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule
Official Title
IMplementation of a Prediction Rule in Anesthesia Practice to Improve Cost-Effectiveness of Treatment of Postoperative Nausea and Vomiting
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Implementation of prediction rules, Decision Support Systems, Clinical, PONV, Emesis, Nausea, Vomiting, Postoperative, Implementation, prediction rule, impact study, decision support, clinical decision support
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11970 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have
Intervention Type
Device
Intervention Name(s)
Automatic Risk Presentation in the operating room
Intervention Description
Automatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Feedback
Intervention Description
Feedback about the physician's personal performance on prevention of PONV
Primary Outcome Measure Information:
Title
the incidence of PONV within the first 24 hours
Time Frame
within 24 hours after surgery
Secondary Outcome Measure Information:
Title
Behaviour of the anaesthesiologist regarding PONV-prophylaxis
Time Frame
Perioperative
Title
Cost-effectiveness risk-based prophylaxis compared to standard care
Time Frame
Within 24 hours after surgery
Title
Attitude of anesthesiologists to use risk estimations from a prediction rule
Time Frame
At the start and end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients
Undergoing elective surgery
General anesthesia
Exclusion Criteria:
emergency surgery
postoperative transfer to ICU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cor J Kalkman, M.D. PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karel G Moons, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
24105403
Citation
Kappen TH, Moons KG, van Wolfswinkel L, Kalkman CJ, Vergouwe Y, van Klei WA. Impact of risk assessments on prophylactic antiemetic prescription and the incidence of postoperative nausea and vomiting: a cluster-randomized trial. Anesthesiology. 2014 Feb;120(2):343-54. doi: 10.1097/ALN.0000000000000009.
Results Reference
derived
PubMed Identifier
23083383
Citation
van Dijk JF, Kappen TH, van Wijck AJ, Kalkman CJ, Schuurmans MJ. The diagnostic value of the numeric pain rating scale in older postoperative patients. J Clin Nurs. 2012 Nov;21(21-22):3018-24. doi: 10.1111/j.1365-2702.2012.04288.x.
Results Reference
derived
PubMed Identifier
21840522
Citation
van Dijk JF, van Wijck AJ, Kappen TH, Peelen LM, Kalkman CJ, Schuurmans MJ. Postoperative pain assessment based on numeric ratings is not the same for patients and professionals: a cross-sectional study. Int J Nurs Stud. 2012 Jan;49(1):65-71. doi: 10.1016/j.ijnurstu.2011.07.009. Epub 2011 Aug 15.
Results Reference
derived
Learn more about this trial
Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule
We'll reach out to this number within 24 hrs