Clinical trial NCT00293618: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2006-02-17
Enrollment: 11970
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Undergoing elective surgery
* General anesthesia

Exclusion Criteria:

* emergency surgery
* postoperative transfer to ICU

Primary outcomes:
measure: the incidence of PONV within the first 24 hours
timeFrame: within 24 hours after surgery
Secondary outcomes:
measure: Behaviour of the anaesthesiologist regarding PONV-prophylaxis
timeFrame: Perioperative
measure: Cost-effectiveness risk-based prophylaxis compared to standard care
timeFrame: Within 24 hours after surgery
measure: Attitude of anesthesiologists to use risk estimations from a prediction rule
timeFrame: At the start and end of the study
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Cor J Kalkman, M.D. PhD
role: STUDY_CHAIR
affiliation: UMC Utrecht
name: Karel G Moons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.