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

Sponsor

European Georges Pompidou Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03101384

Collaborator

(none)

302

Enrollment

Location

23.7

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism Pulmonary Embolism and Thrombosis Diagnostic Errors Embolism Pulmonary Vascular Disorder	Other: Diagnostic error

Study Design

Study Type:

Observational

Anticipated Enrollment :

302 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

Actual Study Start Date :

Apr 11, 2017

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Severity of pulmonary embolism at the time of diagnosis [Day 1]
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

Secondary Outcome Measures

Complication of pulmonary embolism [Day 30 and 180]
Composite of death, shock and recurrence
Frequency of diagnostic errors [Day 1]
Frequency of diagnostic errors
Characteristic of patient with diagnosis errors [Day 30]
Characteristic of patient with diagnosis errors

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital européen Georges Pompidou	Paris	Ile de France	France	75015

Sponsors and Collaborators

European Georges Pompidou Hospital

Investigators

Principal Investigator: Guy Meyer, Pr, Hôpital Européen Georges Pompidou, AP-HP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guy Meyer, Professeur des Universités, European Georges Pompidou Hospital

ClinicalTrials.gov Identifier:

NCT03101384

Other Study ID Numbers:

N° ID RCB : 2017-A00433-50

First Posted:

Apr 5, 2017

Last Update Posted:

Jun 2, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Embolism

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Study Results

No Results Posted as of Jun 2, 2017