Incidence of Iatrogenic Diseases on Hospital's Emergency Consultations (EIU)

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

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.

Study Overview

• Status: Completed
• Conditions: Iatrogenic Disease
• Intervention / Treatment: Drug: Iatrogenic disease impact on emergency consultations

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.

• Study Type: Observational
• Enrollment (Actual): 2500

Contacts and Locations

Study Locations

• France
  • Var
    • La Seyne-sur-Mer, Var, France, 83500
      • Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer
    • Toulon, Var, France, 83100
      • Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Determination of the proportion of emergency consultations linked to iatrogenic diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Investigators: Study Director: Tiziana PLATINO, MD, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Actual): September 9, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: emergency; incidence; iatrogenic; adverse drug reaction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Iatrogenic Disease
• Other Study ID Numbers: 2019-CHITS-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No