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CompletedNCT03442010ADEsEDUpdated Mar 10, 2020

Adverse Drug Events at Emergency Department

An observational study in Adverse Drug Event, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13,453
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Adverse Drug Event

Keywords

  • Emergency department
  • Clinical Pharmacist
  • Adverse drug event
03

In context

Drug-Related Side Effects and Adverse Reactions

449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.

This study's enrollment of 13,453 is above the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • Patient presenting acute psychological disturbance or they did not agree to participate at this study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
13,453 participants (actual)
Patient registry
No

Groups and cohorts

  • People with adverse drug event

    People with adverse drug event

    Other: Detection of adverse drug events

  • People without adverse drug event

    People without adverse drug event

Interventions

  • OtherDetection of adverse drug events

    Detection of adverse drug events

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What researchers measure

Primary outcomes

  1. Number of adverse drug events

    Number of adverse drug events identified in a emergency deparmtent

    Time frame: 1 day

Secondary outcomes

  1. number of variable associated with adverse drug events

    number of variable associated with adverse drug events in ermergency department patients

    Time frame: 1 day

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Publications

  • Lohan L, Marin G, Faucanie M, Laureau M, Macioce V, Perier D, Pinzani V, Giraud I, Castet-Nicolas A, Jalabert A, Villiet M, Sebbane M, Breuker C. Impact of medication characteristics and adverse drug events on hospital admission after an emergency department visit: Prospective cohort study. Int J Clin Pract. 2021 Jul;75(7):e14224. doi: 10.1111/ijcp.14224. Epub 2021 Apr 23. PubMed 33866662 ↗
  • Laureau M, Vuillot O, Gourhant V, Perier D, Pinzani V, Lohan L, Faucanie M, Macioce V, Marin G, Giraud I, Jalabert A, Villiet M, Castet-Nicolas A, Sebbane M, Breuker C. Adverse Drug Events Detected by Clinical Pharmacists in an Emergency Department: A Prospective Monocentric Observational Study. J Patient Saf. 2021 Dec 1;17(8):e1040-e1049. doi: 10.1097/PTS.0000000000000679. PubMed 32175969 ↗

Individual participant data

Plan to share: Undecided — NC

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2011 to primary completion in Dec 2019, 97 months.

Of 65 non-industry observational studies under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24. This study's 97 months is above that.

Counting every sponsor, half of 69 studies reached it within 45 months; a quarter within 24 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2018
First posted
Feb 22, 2018
StartActual
Nov 1, 2011
Primary completionActual
Dec 1, 2019
CompletionActual
Dec 1, 2019
Last update
Mar 10, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03442010
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Nov 1, 2011
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Last update
Mar 10, 2020

Study contacts

Cyril BREUKER
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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