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NCT Number: NCT00293618

Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, 3508 GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients
  • Undergoing elective surgery
  • General anesthesia

Exclusion criteria

  • emergency surgery
  • postoperative transfer to ICU

Treatment and study plan

Automatic Risk Presentation in the operating room

Device

Automatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure

Education

Other

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

feedback

Other

Feedback about the physician's personal performance on prevention of PONV

Primary outcomes

  1. the incidence of PONV within the first 24 hours

    Time frame: within 24 hours after surgery

Secondary outcomes

  1. Behaviour of the anaesthesiologist regarding PONV-prophylaxis

    Time frame: Perioperative

  2. Cost-effectiveness risk-based prophylaxis compared to standard care

    Time frame: Within 24 hours after surgery

  3. Attitude of anesthesiologists to use risk estimations from a prediction rule

    Time frame: At the start and end of the study

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Feb 17, 2006
Registry last updated
Jan 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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