Adverse Drug EventADEsEDNCT03442010
Adverse Drug Events at Emergency Department
An observational study of Adverse Drug Event, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Drug Event
- What is being tested?
- Detection of adverse drug events
- How many people
- 13,453 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2011to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population was composed of patient admitted in emergency department of Montpellier University hospital.
Who may be able to join
- Patients aged above 18 years old, admitted to the department during the study period
Who cannot join
- Patient presenting acute psychological disturbance or they did not agree to participate at this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Risk Factor of Adverse Drug Events Detected at Emergency Department Visit
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.
- Conditions
- Adverse Drug Event
- Being tested
- Detection of adverse drug events
- Keywords
- Emergency department, Clinical Pharmacist, Adverse drug event
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of adverse drug eventsOther
Detection of adverse drug events
| Study group | Role | What they receive |
|---|---|---|
| People with adverse drug event | People with adverse drug event Receives: Other: Detection of adverse drug events | |
| People without adverse drug event | People without adverse drug event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse drug events
Number of adverse drug events identified in a emergency deparmtent
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Nov 2011
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13,453 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril BREUKER, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442010
- Sponsor's protocol ID
- RECHMPL18_0095
- Acronym
- ADEsED
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
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 33866662Laureau 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factor of Adverse Drug Events Detected at Emergency Department Visit
- ClinicalTrials.gov ID
- NCT03442010
- Acronym / sponsor ID
- ADEsED / RECHMPL18_0095
- Conditions
- Adverse Drug Event
- Keywords
- Emergency department, Clinical Pharmacist, Adverse drug event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,453 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with adverse drug event | – | Other: Detection of adverse drug eventsPeople with adverse drug event |
| People without adverse drug event | – | –People without adverse drug event |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population was composed of patient admitted in emergency department of Montpellier University hospital.
Key inclusion criteria (1 listed)
- Patients aged above 18 years old, admitted to the department during the study period
Key exclusion criteria (1 listed)
- Patient presenting acute psychological disturbance or they did not agree to participate at this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of adverse drug eventsDetection of adverse drug events | Other | People with adverse drug event |
Primary outcome
Number of adverse drug events
Time frame: 1 day
Number of adverse drug events identified in a emergency deparmtent
1 secondary outcome
number of variable associated with adverse drug events
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 33866662Lohan 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.
- Derived from this study: PubMed 32175969Laureau 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.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyril BREUKER principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Event, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse drug events (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03442010, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.