NCT00188032

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-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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,331

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

First QC Date

September 12, 2005

Last Update Submit

February 4, 2009

Conditions

Quality of Health CarePulmonary Embolism

Keywords

pulmonary embolismclinical practicequality of health carediagnostic criteriaComputer-Assisted Decision Supportreminders

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Computer-Assisted diagnostic Decision SupportPROCEDURE
written diagnostic guidelinesPROCEDURE
electronic therapeutic remindersPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

H Argenteuil

Argenteuil, 95107, France

Location

UH Besançon

Besançon, 25000, France

Location

H Bethune

Béthune, 62408, France

Location

UH Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

UH Caen

Caen, 14033, France

Location

H Chalons en Champagne

Châlons-en-Champagne, 51005, France

Location

H Chateauroux

Châteauroux, 36019, France

Location

H Compiegne

Compiègne, 60200, France

Location

UH Dijon

Dijon, 21033, France

Location

H Dreux

Dreux, 28107, France

Location

UH Grenoble

Grenoble, 38043, France

Location

H Langres

Langres, 52200, France

Location

H le Mans

Le Mans, 72037, France

Location

H Lons le Saunier

Lons-le-Saunier, 39016, France

Location

UH Nancy

Nancy, 54035, France

Location

UH La Pitie Salpetriere

Paris, 75651, France

Location

H Roanne

Roanne, 42328, France

Location

H Saint Nazaire

Saint-Nazaire, 44606, France

Location

H Thouars

Thouars, 79100, France

Location

UH Toulouse

Toulouse, 31059, France

Location

Related Publications (2)

  • 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.

    PMID: 16052017BACKGROUND

  • 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.

    PMID: 19920268DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Pierre-Marie Roy, MD, PhD

    UH Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

June 1, 2005

Study Completion

September 1, 2006

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations

FR(20)