Strategies for Suspected Pulmonary Embolism in Emergency Departments
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.
調査の概要
状態
詳細な説明
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.
- 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.
- Grimshaw JM, Shirran L, Thomas R, et al. Changing provider behavior: an overview of systematic reviews of interventions. Med Care 2001; 39:II2-45.
- 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.
- 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.
- 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.
- 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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Argenteuil、フランス、95107
- H Argenteuil
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Besançon、フランス、25000
- UH Besançon
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Bethune、フランス、62408
- H Bethune
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Boulogne Billancourt、フランス、92100
- UH Ambroise Pare
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Caen、フランス、14033
- UH Caen
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Chalons-en-Champagne、フランス、51005
- H Chalons en Champagne
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Chateauroux、フランス、36019
- H Chateauroux
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Compiegne、フランス、60200
- H Compiegne
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Dijon、フランス、21033
- UH Dijon
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Dreux、フランス、28107
- H Dreux
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Grenoble、フランス、38043
- UH Grenoble
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Langres、フランス、52200
- H Langres
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Le Mans、フランス、72037
- H le Mans
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Lons le Saunier、フランス、39016
- H Lons le Saunier
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Nancy、フランス、54035
- UH Nancy
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Paris、フランス、75651
- UH La Pitie Salpetriere
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Roanne、フランス、42328
- H Roanne
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Saint Nazaire、フランス、44606
- H Saint Nazaire
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Thouars、フランス、79100
- H Thouars
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Toulouse、フランス、31059
- Uh Toulouse
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
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rate of agreement between the diagnostic criteria applied in daily practice and those validated in the scientific literature
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二次結果の測定
結果測定 |
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-(diagnostic intervention) Rate of strategies considered as validated or acceptable according to the opinion of international advisors.
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- (diagnostic intervention) Rate of thromboembolic-events during a 3-month follow-up period in patients for whom pulmonary embolism will be ruled out
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- (diagnostic intervention) Costs of the diagnostic management
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- (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
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- (therapeutic reminders)Rate of inappropriate treatment according to international recommendations for patients with confirmed PE.
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協力者と研究者
捜査官
- 主任研究者：Pierre-Marie Roy, MD, PhD、UH Angers
出版物と役立つリンク
一般刊行物
- 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 Jul 30;331(7511):259. doi: 10.1136/bmj.331.7511.259.
- Roy PM, Durieux P, Gillaizeau F, Legall C, Armand-Perroux A, Martino L, Hachelaf M, Dubart AE, Schmidt J, Cristiano M, Chretien JM, Perrier A, Meyer G. A computerized handheld decision-support system to improve pulmonary embolism diagnosis: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):677-86. doi: 10.7326/0003-4819-151-10-200911170-00003.
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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