- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00293618
Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule
IMplementation of a Prediction Rule in Anesthesia Practice to Improve Cost-Effectiveness of Treatment of Postoperative Nausea and Vomiting
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Utrecht, Olanda, 3508 GA
- UMC Utrecht
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Adult patients
- Undergoing elective surgery
- General anesthesia
Exclusion Criteria:
- emergency surgery
- postoperative transfer to ICU
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Intervention
Arm of anesthesiologists and senior residents who receive a patient's individual predicted PONV risk intraoperatively
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Automatic calculation and presentation of a patient's individual predicted PONV risk by the anesthesia information management system during the entire procedure
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 about the physician's personal performance on prevention of PONV
|
|
Comparatore attivo: Usual Care
Anesthesiologists and senior residents who provide usual care: they provide PONV prophylaxis as they always have
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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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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the incidence of PONV within the first 24 hours
Lasso di tempo: within 24 hours after surgery
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within 24 hours after surgery
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Behaviour of the anaesthesiologist regarding PONV-prophylaxis
Lasso di tempo: Perioperative
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Perioperative
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Cost-effectiveness risk-based prophylaxis compared to standard care
Lasso di tempo: Within 24 hours after surgery
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Within 24 hours after surgery
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Attitude of anesthesiologists to use risk estimations from a prediction rule
Lasso di tempo: At the start and end of the study
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At the start and end of the study
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Cor J Kalkman, M.D. PhD, UMC Utrecht
- Investigatore principale: Karel G Moons, PhD, UMC Utrecht
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- van 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.
- van 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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Primo Inserito (Stima)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 05/288
- 945-16-202
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .