Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule

UMC Utrecht

Status: Completed

Conditions: Postoperative Nausea and Vomiting

Treatments: Other: Feedback; Device: Automatic Risk Presentation in the operating room; Other: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT00293618

05/288

945-16-202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,970 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients
• Undergoing elective surgery
• General anesthesia

Exclusion criteria

• emergency surgery
• postoperative transfer to ICU

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

11,970 participants in 2 patient groups

Intervention

Experimental group

Description:

Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively

Treatment:

Other: Education

Other: Feedback

Device: Automatic Risk Presentation in the operating room

Usual Care

Active Comparator group

Description:

Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have

Treatment:

Other: Education