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Adverse Drug Events at Emergency Department (ADEsED)

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ClinicalTrials.gov Identifier: NCT03442010
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Emergency departments (EDs) are a crucial element of the health care systems at interface between hospital and communities. The goals of the ED are to make an initial diagnosis and deliver urgent and critical care 24 hour per day and 365 days a year. Also, many Adverse Drug Events (ADEs) are not identified by emergency physicians. ADEs are injuries resulting from a drug related medical intervention. Their detection, documentation and reporting are essential for adequate medical care and knowledge of risk/benefit profiles of medication throughout their lifecycle. However, a number of studies indicate that in clinical practice the under-reporting of ADEs is a pervasive and widespread problem. The main reasons for under-reporting were difficulty in determining the cause of the ADE, lack of time, poor integration of ADE-reporting systems and uncertainty about reporting procedures. Successful treatment of ADEs depends on the ability of physicians to attribute ADEs to a medication. Some studies have reported that pharmacists but also student pharmacists were one of the best health care providers to establish medication history. Consequently, the aims of our study were to assess prevalence and characteristics of ADEs identified in an emergency department and to identify factors associated with ADEs in ED patients.

This prospective observational study is conducted at the ED of a tertiary care hospital (University hospital of Montpellier). This department supports 80 000 patients every years. Patient were not included if they were less than 18 years old, present acute psychological disturbance or they did not agree to participate at this study.

For each patient included, a pharmaceutical team conducted: medication reconciliation process to establish medication history and a structured interviews to determine self-reported adherence and self-medication. ADEs were attributed to a medication by the treating senior emergency physician: directly during patient consultation or after being alerted by the pharmaceutical team.


Condition or disease Intervention/treatment
Adverse Drug Event Other: Detection of adverse drug events

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Study Type : Observational
Estimated Enrollment : 13453 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence and Risk Factor of Adverse Drug Events Detected at Emergency Department Visit
Actual Study Start Date : November 1, 2011
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Group/Cohort Intervention/treatment
People with adverse drug event
People with adverse drug event
Other: Detection of adverse drug events
Detection of adverse drug events

People without adverse drug event
People without adverse drug event



Primary Outcome Measures :
  1. Number of adverse drug events [ Time Frame: 1 day ]
    Number of adverse drug events identified in a emergency deparmtent


Secondary Outcome Measures :
  1. number of variable associated with adverse drug events [ Time Frame: 1 day ]
    number of variable associated with adverse drug events in ermergency department patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population was composed of patient admitted in emergency department of Montpellier University hospital.
Criteria

Inclusion criteria:

- Patients aged above 18 years old, admitted to the department during the study period

Exclusion criteria:

- Patient presenting acute psychological disturbance or they did not agree to participate at this study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442010


Contacts
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Contact: Cyril BREUKER, PharmD,Phd 467337121 ext 33 c-breuker@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: cyril BREUKER       c-breuker@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Cyril BREUKER University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03442010     History of Changes
Other Study ID Numbers: RECHMPL18_0095
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Emergency department
Clinical Pharmacist
Adverse drug event

Additional relevant MeSH terms:
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Emergencies
Drug-Related Side Effects and Adverse Reactions
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders