跳至主要内容
临床试验/NCT00293618
NCT00293618已完成不适用

IMplementation of a Prediction Rule in Anesthesia Practice to Improve Cost-Effectiveness of Treatment of Postoperative Nausea and Vomiting

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 11,970 人开始时间: 2006年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
UMC Utrecht
入组人数
11,970
试验地点
1
主要终点
the incidence of PONV within the first 24 hours

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients
  • •Undergoing elective surgery
  • •General anesthesia

排除标准

  • •emergency surgery
  • •postoperative transfer to ICU

研究组 & 干预措施

Intervention

Experimental

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

干预措施: Automatic Risk Presentation in the operating room (Device)

Intervention

Experimental

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

干预措施: Education (Other)

Intervention

Experimental

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

干预措施: Feedback (Other)

Usual Care

Active Comparator

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

干预措施: Education (Other)

结局指标

主要结局

the incidence of PONV within the first 24 hours

时间窗: within 24 hours after surgery

次要结局

  • 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)

研究者

发起方
UMC Utrecht
申办方类型
Other

研究点 (1)

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