IMplementation of a Prediction Rule in Anesthesia Practice to Improve Cost-Effectiveness of Treatment of Postoperative Nausea and Vomiting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- UMC Utrecht
- Enrollment
- 11,970
- Locations
- 1
- Primary Endpoint
- the incidence of PONV within the first 24 hours
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients
- •Undergoing elective surgery
- •General anesthesia
Exclusion Criteria
- •emergency surgery
- •postoperative transfer to ICU
Arms & Interventions
Intervention
Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively
Intervention: Automatic Risk Presentation in the operating room (Device)
Intervention
Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively
Intervention: Education (Other)
Intervention
Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively
Intervention: Feedback (Other)
Usual Care
Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have
Intervention: Education (Other)
Outcomes
Primary Outcomes
the incidence of PONV within the first 24 hours
Time Frame: within 24 hours after surgery
Secondary Outcomes
- Behaviour of the anaesthesiologist regarding PONV-prophylaxis(Perioperative)
- Cost-effectiveness risk-based prophylaxis compared to standard care(Within 24 hours after surgery)
- Attitude of anesthesiologists to use risk estimations from a prediction rule(At the start and end of the study)