Pulmonary Embolism Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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