Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism (IDEA-PE)

Diagnostic errors have been reported frequently in patient with pulmonary embolism since symptoms are not specific. However, there is only scarce evidence that the delay associated with diagnostic errors may impact patient prognosis. The aim of this study is to determine the frequency of diagnostic errors and if they are associated with more severe pulmonary embolism in term of initial presentation and complications.

Study Overview

• Status: Unknown
• Conditions: Embolism; Pulmonary Embolism; Pulmonary Vascular Disorder; Pulmonary Embolism and Thrombosis; Diagnostic Errors
• Intervention / Treatment: Other: Diagnostic error

• Study Type: Observational
• Enrollment (Anticipated): 302

Contacts and Locations

• Study Contact: Name: Guy Meyer, Pr; Phone Number: 06 25 50 04 58; Email: guy.meyer@aphp.fr
• Study Contact Backup: Name: Benoit Côté, Md; Phone Number: 06 25 50 04 58; Email: benoit.cote.6@ulaval.ca

Study Locations

• France
  • Ile de France
    • Paris, Ile de France, France, 75015
      • Recruiting
      • Hopital Europeen Georges Pompidou
      • Contact: Guy Meyer, Pr.; Email: guy.meyer@aphp.fr
      • Contact: Benoit Côté, Dr.; Phone Number: 06 25 50 04 58; Email: benoit.cote.6@ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with an episode of first acute symptomatic pulmonary embolism

Description

Inclusion Criteria:

• 18 years and older
• Episode of symptomatic acute pulmonary embolism objectively proven

Exclusion Criteria:

• Below 18 years of age
• Patient chronically receiving therapeutic anticoagulation
• Pulmonary embolism complicating a current hospitalisation for another medical reason
• Asymptomatic pulmonary embolism

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with a diagnostic error; Defined by one of : Absence of prescribed test included in an accepted pulmonary diagnosis algorithm in the next 48h00 after the firts contact with a physician; Absence of prescribed test included in an accepted pulmonary diagnosis algorithm by the first contacted physician but the diagnostic is done before 48h00 because the patient went at the emergency room on his own initiative.; More than one doctor consulted before the diagnostic of pulmonary embolism (excluding the emergency physician if the patient was referred by the 1st contact doctor)	Other: Diagnostic error; There is no intervention in our study. Patient will be managed with usual care. We will divide patients in the 2 groups according to the presence of diagnostic error.
Patient without a diagnostic error; Any patient that did not meet the criteria to define the diagnostic error

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of pulmonary embolism at the time of diagnosis	According to the 2014 Europe Society of Cardiology classification that combine clinical characteristics, signs of right ventricular dysfunction on imaging test and cardiac laboratory biomarkers	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication of pulmonary embolism	Composite of death, shock and recurrence	Day 30 and 180
Frequency of diagnostic errors	Frequency of diagnostic errors	Day 1
Characteristic of patient with diagnosis errors	Characteristic of patient with diagnosis errors	Day 30

Collaborators and Investigators

• Sponsor: European Georges Pompidou Hospital
• Investigators: Principal Investigator: Guy Meyer, Pr, Hôpital Européen Georges Pompidou, AP-HP

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Vascular Diseases; Embolism; Thrombosis; Pulmonary Embolism; Embolism and Thrombosis
• Other Study ID Numbers: N° ID RCB : 2017-A00433-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No