Incidence of Iatrogenic Diseases on Hospital's Emergency Consultations

Iatrogenic Disease Clinical Trial

— EIU  

Official title:

Incidence of Iatrogenic Diseases on Toulon-La Seyne Sur Mer Hospital Emergency Consultations During Summer 2018

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960398
• Other study ID #: 2019-CHITS-02
• Status: Completed
• Start date: June 28, 2019
• Est. completion date: September 9, 2019

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: September 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Iatrogenic Disease

Intervention

Drug:
• Iatrogenic disease impact on emergency consultations
Determination of the proportion of emergency consultations linked to iatrogenic diseases

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer	La Seyne-sur-Mer	Var
France	Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer	Toulon	Var

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average of patient age among the patients consulting because of an adverse drug reaction	Average and standard deviation of patient age among the patients consulting in emergency department because of an adverse drug reaction.	10 days
Secondary	Proportion of male and female patients consulting because of an adverse drug reaction	Number of male and female patients consulting in emergency department because of an adverse drug reaction divided by the total number of patients consulting in emergency department because of an adverse drug reaction.	10 days
Secondary	Number of treatments administered to patients who consult because of an adverse drug reaction	Number of treatments patients were taking when they arrived in emergency department for a consultation because of an adverse drug reaction	1 day
Secondary	Frequency of the drugs leading to a consultation in emergency department because of an adverse drug reaction	For each drug leading, during the 10 chosen days, to a consultation because of an adverse reaction, number of times when this drug was at the origin of a consultation	10 days