Clinical trial NCT03960398: Incidence of Iatrogenic Diseases on Hospital's Emergency Consultations
Official title: Incidence of Iatrogenic Diseases on Toulon-La Seyne Sur Mer Hospital Emergency Consultations During Summer 2018
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iatrogenic Disease
Keywords: iatrogenic
emergency
incidence
adverse drug reaction
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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

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.

Detailed description: This will be a retrospective study.

The number of patients will be defined by the number of visits during a random draw of 10 emergency department consultation days between 21st June 2018 and 22nd September 2018 in Toulon - La Seyne sur Mer public hospital.

There are between 100 and 300 emergency department consultations per day in this hospital so the estimated number of patients will be between 1000 and 3000.

Every patient who came to hospital for a consultation in emergency department during this period of time will be included in the study except those who expressed their opposition to their data collection and treatment.

Each patient will be anonymized with a code defined as follows : N(ame) L(ast name) 001 (chronological inclusion number)

Information of the patients involved in adverse drug reactions will be extracted and a description of this patient sample will be made.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Dead patients
* Patient's opposition

Primary outcomes:
measure: Proportion of patients coming to emergency department because of an adverse drug reaction
timeFrame: 10 days (chosen at random between 21st June and 22nd September 2018)
Secondary outcomes:
measure: Average of patient age among the patients consulting because of an adverse drug reaction
timeFrame: 10 days
measure: Proportion of male and female patients consulting because of an adverse drug reaction
timeFrame: 10 days
measure: Number of treatments administered to patients who consult because of an adverse drug reaction
timeFrame: 1 day
measure: Frequency of the drugs leading to a consultation in emergency department because of an adverse drug reaction
timeFrame: 10 days
Other outcomes:
Locations:
city: La Seyne-sur-Mer
country: France
facility: Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer
state: Var
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
name: Tiziana PLATINO, MD
role: STUDY_DIRECTOR
References: