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Strategies for Suspected Pulmonary Embolism in Emergency Departments

4 febbraio 2009 aggiornato da: University Hospital, Angers

Strategies for Suspected Pulmonary Embolism in Emergency Departments - SPEED Study

Aims: 1) To evaluate the effectiveness of two interventions aimed at improving the management of patients with suspected pulmonary embolism: Written guidelines and Computer-Assisted Decision Support (CADS). 2) To evaluate the impact of electronic reminders on the appropriateness of the treatment of patients with suspected PE

Design: Pragmatic, unblinded, cluster randomised controlled study.

Setting: 20 French Emergency Departments

Patients: Out patients suspected of having pulmonary embolism

Methods: Emergency physicians will prospectively complete a standardized electronic form on Personal Data Assistant (PDA), including patients' characteristics, the clinical probability if assessed, the diagnostic tests performed, the treatments initiated and the final diagnostic and therapeutic decisions. Patients will be interviewed at the end of a 3-month follow-up period using a standardized questionnaire.

The reference rate of appropriateness of the diagnostic management before intervention will be assessed in each centre. At the end of this preliminary period, the centres will be randomized in two fold two groups according to a factorial design with stratification on their reference level of appropriateness. Half of the centres will have written guidelines and half a Computer-Assisted Decision Support for the diagnosis of PE on the PDA. In each of these two main groups, half of the centres will have electronic reminders on their PDA concerning the treatment of PE.

Judgment criteria

Main : Rate of strategies considered as validated according to the results of the systematic review and meta-analysis.3

Secondary judgment criteria (diagnosis):

  • Rate of strategies considered as validated or acceptable according to the opinion of international advisors.
  • Rate of thromboembolic-events during a 3-month follow-up period in patients for whom pulmonary embolism will be ruled out
  • Costs of the diagnostic management

Secondary judgment criteria (treatment):

  • Delay between Emergency Department admission and the first dose of antithrombotic treatment in patients with high clinical probability of PE according to the Revised Geneva Score
  • Rate of inappropriate treatment according to international recommendations for patients with confirmed PE.

Number of patients: By estimating that the rate of appropriateness would be 55% in the "written guidelines" group, 1331 patients are necessary to highlight an absolute superiority of 15% in the "CADS" group (rate of conformity of 70%).

The number of patients will be adjusted at the end of the preliminary period according to the level of appropriateness before interventions considering that it will improve less than 5% in the "written guidelines" group.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background: The management of patients with suspected pulmonary embolism (PE) represents an important medical and economic issue. In French Emergency Departments, more than 100 000 suspicions of PE are dealt with per year. In a previous work, we found that the routine diagnostic practice differs to a large extent from international guidelines and that excluding PE on the basis of inappropriate criteria exposes patients to a six-fold increased risk of venous thromboembolism during 3-months follow-up.1 Passive interventions to improve quality are generally ineffective but Computer-Assisted Decision Support and reminders appear as promising.2

Interventions:

At the end of the preliminary period, we will perform for all the investigators, an interactive oral presentation of the strategies considered as validated on the basis of a systematic review and meta-analysis.3 A strategy end up to exclude PE is considered as validated if the probability of PE is below 5% and a strategy end up to confirm PE is considered as validated if the probability of PE is upper than 85%. The strategies that do not achieve these criteria but considered as acceptable by international advisors will be presented too as well as the recommendations for the treatment of PE.4 In the group "written guidelines", emergency physicians will be provided with cards presenting the list of the validated and acceptable strategies as well as the Geneva diagnostic algorithm.5 The algorithm will be mention as a way to follow appropriate diagnostic criteria.

In the "CADS" group, the recommendations will be integrated into the electronic form allowing calculation of the pre-test probability according to revised Geneva Score 6, calculation of the post-test probabilities according to the likelihood ratios of the tests 3 and contextualized reminders as which test perform or when stop investigations.

In the groups "treatment help", reminders concerning the treatment (indications and contraindications, dosage) will be integrated into the electronic form on the PDA.

  1. Roy PM, Meyer G, Vielle B, Legall C, Verschuren F, Furber A. Inappropriateness of Diagnostic Management in Patients with Suspected Pulmonary Embolism: Frequency, Predictors and Association with Outcome. J Thromb Haemost 2005; 3:OR 304.
  2. Grimshaw JM, Shirran L, Thomas R, et al. Changing provider behavior: an overview of systematic reviews of interventions. Med Care 2001; 39:II2-45.
  3. Roy PM, Colombet I, Durieux P, Chatellier G, Sors H, Meyer G. Systematic review and meta-analysis of strategies for the diagnosis of suspected pulmonary embolism. Bmj 2005; 331:259.
  4. Buller HR, Agnelli G, Hull RD, Hyers TM, Prins MH, Raskob GE. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126:401S-428S.
  5. Perrier A, Roy PM, Aujesky D, et al. Diagnosing pulmonary embolism in outpatients with clinical assessment, D-dimer measurement, venous ultrasound, and helical computed tomography: a multicenter management study. Am J Med 2004; 116:291-9.
  6. Le Gal G, Righini M, Roy PM, et al. Derivation and validation of a simple standardized clinical score to predict pulmonary embolism in emergency patients: the revised geneva score. Ann Intern Med 2005; In press.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

1331

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Argenteuil, Francia, 95107
        • H Argenteuil
      • Besançon, Francia, 25000
        • UH Besançon
      • Bethune, Francia, 62408
        • H Bethune
      • Boulogne Billancourt, Francia, 92100
        • UH Ambroise Pare
      • Caen, Francia, 14033
        • UH Caen
      • Chalons-en-Champagne, Francia, 51005
        • H Chalons en Champagne
      • Chateauroux, Francia, 36019
        • H Chateauroux
      • Compiegne, Francia, 60200
        • H Compiegne
      • Dijon, Francia, 21033
        • UH Dijon
      • Dreux, Francia, 28107
        • H Dreux
      • Grenoble, Francia, 38043
        • UH Grenoble
      • Langres, Francia, 52200
        • H Langres
      • Le Mans, Francia, 72037
        • H le Mans
      • Lons le Saunier, Francia, 39016
        • H Lons le Saunier
      • Nancy, Francia, 54035
        • UH Nancy
      • Paris, Francia, 75651
        • UH La Pitie Salpetriere
      • Roanne, Francia, 42328
        • H Roanne
      • Saint Nazaire, Francia, 44606
        • H Saint Nazaire
      • Thouars, Francia, 79100
        • H Thouars
      • Toulouse, Francia, 31059
        • Uh Toulouse

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • patient with suspected pulmonary embolism
  • prescription of a specific paraclinical diagnostic investigation or start of a specific treatment for pulmonary embolism

Exclusion Criteria:

  • confirmation or exclusion of pulmonary embolism before admission in emergency department
  • confirmation of deep venous thrombosis before admission in emergency department
  • suspicion of pulmonary embolism during hospitalization (in-patient)
  • suspicion of pulmonary embolism without investigation realization
  • patient already included in the study
  • patient refusing the utilization of his data for the study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
rate of agreement between the diagnostic criteria applied in daily practice and those validated in the scientific literature

Misure di risultato secondarie

Misura del risultato
-(diagnostic intervention) Rate of strategies considered as validated or acceptable according to the opinion of international advisors.
- (diagnostic intervention) Rate of thromboembolic-events during a 3-month follow-up period in patients for whom pulmonary embolism will be ruled out
- (diagnostic intervention) Costs of the diagnostic management
- (therapeutic reminders) Delay between Emergency Department admission and the first dose of antithrombotic treatment in patients with high clinical probability of PE according to the Revised Geneva Score
- (therapeutic reminders)Rate of inappropriate treatment according to international recommendations for patients with confirmed PE.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Angers

Collaboratori

Ministry of Health, France

Investigatori

  • Investigatore principale: Pierre-Marie Roy, MD, PhD, UH Angers

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2005

Completamento dello studio (Effettivo)

1 settembre 2006

Date di iscrizione allo studio

Primo inviato

12 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

12 settembre 2005

Primo Inserito (Stima)

16 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

5 febbraio 2009

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 febbraio 2009

Ultimo verificato

1 febbraio 2009

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PHRC-04-01

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 .

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