NCT03960398

Brief Summary

French population grows older year after year: 24.3% people were over 60 years old in 2006 against 20.6% in 2000 and the expected number might be over 33% in 2050. The elderly suffer from lots of illnesses, so they usually take lots of drugs. Therefore, this drug use is most likely to have adverse drug reactions. Finally, according to Health Ministry, the number of emergency department consultations doubled from 1996 to 2016. Consequently, it is interesting to study the impact of drug iatrogenic effects on emergency consultations. It would help to prevent these adverse drug reactions as we prescribe those drugs : First, do not harm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 28, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

May 21, 2019

Last Update Submit

November 27, 2019

Conditions

Keywords

iatrogenicemergencyincidenceadverse drug reaction

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients coming to emergency department because of an adverse drug reaction

    We will study each case and determine whether the consultation in the emergency department is due to adverse drug reaction or not.Number of patients having an emergency department consultation because of an adverse drug reaction divided by the total number of patients having an emergency department consultation during the same period of time.

    10 days (chosen at random between 21st June and 22nd September 2018)

Secondary Outcomes (4)

  • Average of patient age among the patients consulting because of an adverse drug reaction

    10 days

  • Proportion of male and female patients consulting because of an adverse drug reaction

    10 days

  • Number of treatments administered to patients who consult because of an adverse drug reaction

    1 day

  • Frequency of the drugs leading to a consultation in emergency department because of an adverse drug reaction

    10 days

Study Arms (1)

Patients concerned by iatrogenic diseases

Patients living in the South-East of France and consulting in the emergency department of Toulon La Seyne sur Mer hospital for iatrogenic diseases

Drug: Iatrogenic disease impact on emergency consultations

Interventions

Determination of the proportion of emergency consultations linked to iatrogenic diseases

Patients concerned by iatrogenic diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be adults living in the south-east of France and consulting the emergency department of Toulon - La Seyne sur Mer public hospital

You may qualify if:

  • Man or woman over 18 years old
  • Consultation in emergency department of Sainte Musse or La Seyne-sur-Mer hospital between 21st june 2018 and 22nd september 2018 included
  • Consultation of the patient in emergency department during the 10 day random draw of the research (from 00h01 to 23h59)
  • Consultation in emergency department because of a iatrogenic reason

You may not qualify if:

  • Dead patients
  • Patient's opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer

La Seyne-sur-Mer, Var, 83500, France

Location

Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer

Toulon, Var, 83100, France

Location

MeSH Terms

Conditions

Iatrogenic DiseaseEmergenciesDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced Disorders

Study Officials

  • Tiziana PLATINO, MD

    Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

June 28, 2019

Primary Completion

September 9, 2019

Study Completion

September 9, 2019

Last Updated

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations