Clinical trial NCT02688504: Health and Road Safety: Influence of Drugs Use and Health Status
Official title: CESIR-U2 : Influence of Drugs Use and Health Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Car Accident
Keywords: labelled medicines
drivers involved in serious and non-serious road accidents
relevance and effectiveness of pictograms on medicines packaging
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a multicentre observational study that will include 2 populations: drivers involved in serious road accidents (hospitalization \> 24 hours) and non-serious road accidents (hospitalization \< 24 hours). The drivers involved in road accidents and admitted in an emergency department will be identified during daily visits (except on week end) by Clinical Research Associates (CRA) of the different centres. As soon as possible, a structured validated interview will done by a trained CRA.

Brief summary: In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram.

When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization \> 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance.

This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility.

This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization \< 24 hours) that represent around 73% of accidents.


Eligibility criteria: Inclusion Criteria:

* Driver involved in a road accident and admitted in an emergency department
* Aged over 18 years
* Able to respond to a structured questionnaire
* Having agreed to participate in the study

Exclusion Criteria:

* Minors
* Passenger
* Pedestrian
* Discharge or transfer to another hospital/clinic before the interview

Primary outcomes:
measure: Drugs use reported by drivers involved in road accidents
timeFrame: inclusion date
Secondary outcomes:
measure: Responsibility of the driver for the accident
timeFrame: inclusion date
measure: Seriousness of the accident
timeFrame: inclusion date
measure: Knowledge of drivers about graded pictogram featured on drugs packaging
timeFrame: inclusion date
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Périgueux
country: France
facility: CH de Perigueux
Study officials:
affiliation: Plateforme BPE
name: Nicholas MOORE, Pr
role: STUDY_CHAIR
References: