Postoperative Nausea and VomitingNCT00293618
Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule
A study testing Automatic Risk Presentation in the operating room, Education and Feedback in people with Postoperative Nausea and Vomiting, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Automatic Risk Presentation in the operating room, Education and Feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,970 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Undergoing elective surgery
- General anesthesia
Who cannot join
- emergency surgery
- postoperative transfer to ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMplementation of a Prediction Rule in Anesthesia Practice to Improve Cost-Effectiveness of Treatment of Postoperative Nausea and Vomiting
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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Automatic Risk Presentation in the operating room, Education, Feedback
- Keywords
- Implementation of prediction rules, Decision Support Systems, Clinical, PONV, Emesis, Nausea, Vomiting, Postoperative, Implementation, prediction rule, impact study, decision support, clinical decision support
- Medical subject headings
- Postoperative Nausea and Vomiting, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Risk Presentation in the operating roomDevice
Automatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure
EducationOther
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
FeedbackOther
Feedback about the physician's personal performance on prevention of PONV
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively Receives: Device: Automatic Risk Presentation in the operating room; Other: Education; Other: Feedback |
| Usual Care | Active comparator | Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of PONV within the first 24 hours
Measured: within 24 hours after surgery
Secondary outcomes (3)
Behaviour of the anaesthesiologist regarding PONV-prophylaxis
Measured: Perioperative
Cost-effectiveness risk-based prophylaxis compared to standard care
Measured: Within 24 hours after surgery
Attitude of anesthesiologists to use risk estimations from a prediction rule
Measured: At the start and end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11,970 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Cor J Kalkman, M.D. PhD, Study chair, UMC UtrechtKarel G Moons, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293618
- Sponsor's protocol ID
- 05/288
- Other IDs
- 945-16-202
- Status last verified
- Jan 2009
- First submitted
- 16 Feb 2006
- Last updated
- 16 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24105403van 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.
PubMed 23083383van 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.
PubMed 21840522
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMplementation of a Prediction Rule in Anesthesia Practice to Improve Cost-Effectiveness of Treatment of Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT00293618
- Acronym / sponsor ID
- 05/288
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Implementation of prediction rules, Decision Support Systems, Clinical, PONV, Emesis, Nausea, Vomiting, Postoperative, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,970 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Automatic Risk Presentation in the operating room, Other: Education, Other: FeedbackArm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively |
| Usual Care | Active comparator | Other: EducationAnesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Undergoing elective surgery
- General anesthesia
Key exclusion criteria (2 listed)
- emergency surgery
- postoperative transfer to ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic Risk Presentation in the operating roomAutomatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure | Device | Intervention |
| EducationSpecific 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 | Other | Intervention, Usual Care |
| FeedbackFeedback about the physician's personal performance on prevention of PONV | Other | Intervention |
Primary outcome
the incidence of PONV within the first 24 hours
Time frame: within 24 hours after surgery
3 secondary outcomes
Behaviour of the anaesthesiologist regarding PONV-prophylaxis
Time frame: Perioperative
Cost-effectiveness risk-based prophylaxis compared to standard care
Time frame: Within 24 hours after surgery
Attitude of anesthesiologists to use risk estimations from a prediction rule
Time frame: At the start and end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2009.
- Derived from this study: PubMed 24105403Kappen 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.
- Derived from this study: PubMed 23083383van 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.
- Derived from this study: PubMed 21840522van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cor J Kalkman, M.D. PhD study chair
UMC Utrecht
Karel G Moons, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Risk Presentation in the operating room, Education and Feedback in people with Postoperative Nausea and Vomiting, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of PONV within the first 24 hours (time frame: within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00293618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2009.