Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188032
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2005-09-12
Brief Title:
Strategies for Suspected Pulmonary Embolism in Emergency Departments
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Strategies for Suspected Pulmonary Embolism in Emergency Departments - SPEED Study
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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-analysis3
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
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-analysis3
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
Detailed Description:
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-up1 Passive interventions to improve quality are generally ineffective but Computer-Assisted Decision Support and reminders appear as promising2
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-analysis3 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 PE4 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 algorithm5 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 3OR 304
2 Grimshaw JM Shirran L Thomas R et al Changing provider behavior an overview of systematic reviews of interventions Med Care 2001 39II2-45
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 331259
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 126401S-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 116291-9
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
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-analysis3 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 PE4 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 algorithm5 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 3OR 304
2 Grimshaw JM Shirran L Thomas R et al Changing provider behavior an overview of systematic reviews of interventions Med Care 2001 39II2-45
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 331259
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 126401S-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 116291-9
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None