Quality of Health CareNCT00188032
Strategies for Suspected Pulmonary Embolism in Emergency Departments
A study testing Computer-Assisted diagnostic Decision Support, written diagnostic guidelines and electronic therapeutic reminders in people with Quality of Health Care and Pulmonary Embolism, run by University Hospital, Angers at 20 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Health Care, Pulmonary Embolism
- What is being tested?
- Computer-Assisted diagnostic Decision Support, written diagnostic guidelines and electronic therapeutic reminders
- Type of treatment
- Surgery or procedure
- How many people
- 1,331 participants
- Where
- 20 sitesFrance
- Study dates
- Jun 2005to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with suspected pulmonary embolism
- prescription of a specific paraclinical diagnostic investigation or start of a specific treatment for pulmonary embolism
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
H Argenteuil
Argenteuil, 95107
UH Besançon
Besançon, 25000
H Bethune
Béthune, 62408
UH Ambroise Pare
Boulogne-Billancourt, 92100
UH Caen
Caen, 14033
H Chalons en Champagne
Châlons-en-Champagne, 51005
H Chateauroux
Châteauroux, 36019
H Compiegne
Compiègne, 60200
UH Dijon
Dijon, 21033
H Dreux
Dreux, 28107
UH Grenoble
Grenoble, 38043
H Langres
Langres, 52200
H le Mans
Le Mans, 72037
H Lons le Saunier
Lons-le-Saunier, 39016
UH Nancy
Nancy, 54035
UH La Pitie Salpetriere
Paris, 75651
H Roanne
Roanne, 42328
H Saint Nazaire
Saint-Nazaire, 44606
H Thouars
Thouars, 79100
UH Toulouse
Toulouse, 31059
About this study
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.
Read more
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.
Read the 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-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.
- Conditions
- Quality of Health Care, Pulmonary Embolism
- Being tested
- Computer-Assisted diagnostic Decision Support, written diagnostic guidelines, electronic therapeutic reminders
- Keywords
- pulmonary embolism, clinical practice, quality of health care, diagnostic criteria, Computer-Assisted Decision Support, reminders
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted diagnostic Decision SupportProcedure or surgery
written diagnostic guidelinesProcedure or surgery
electronic therapeutic remindersProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of agreement between the diagnostic criteria applied in daily practice and those validated in the scientific literature
Secondary outcomes (5)
-(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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of Health CareStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,331 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, France
- Investigators
- Pierre-Marie Roy, MD, PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188032
- Sponsor's protocol ID
- PHRC-04-01
- Status last verified
- Feb 2009
- First submitted
- 12 Sep 2005
- Last updated
- 5 Feb 2009
- Results posted
- No
Publications
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.
PubMed 16052017Roy 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.
PubMed 19920268
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Suspected Pulmonary Embolism in Emergency Departments - SPEED Study
- ClinicalTrials.gov ID
- NCT00188032
- Acronym / sponsor ID
- PHRC-04-01
- Conditions
- Quality of Health Care, Pulmonary Embolism
- Keywords
- pulmonary embolism, clinical practice, quality of health care, diagnostic criteria, Computer-Assisted Decision Support, reminders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,331 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Ministry of Health, France
- Study start
- Jun 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient with suspected pulmonary embolism
- prescription of a specific paraclinical diagnostic investigation or start of a specific treatment for pulmonary embolism
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-Assisted diagnostic Decision Support | Procedure or surgery | – |
| written diagnostic guidelines | Procedure or surgery | – |
| electronic therapeutic reminders | Procedure or surgery | – |
Primary outcome
rate of agreement between the diagnostic criteria applied in daily practice and those validated in the scientific literature
5 secondary outcomes
-(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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
- Background: PubMed 16052017Roy 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.
- Derived from this study: PubMed 19920268Roy 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.
Related trials for Quality of Health Care
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Active, not recruitingObservational study
A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy
Multifocal Motor Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Marie Roy, MD, PhD principal investigator
UH Angers
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Assisted diagnostic Decision Support, written diagnostic guidelines and electronic therapeutic reminders in people with Quality of Health Care and Pulmonary Embolism, run by University Hospital, Angers at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of agreement between the diagnostic criteria applied in daily practice and those validated in the scientific literature. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00188032, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.