NCT02688504

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

October 18, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2018

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

2.2 years

First QC Date

December 30, 2015

Last Update Submit

May 12, 2020

Conditions

Car Accident

Keywords

labelled medicinesdrivers involved in serious and non-serious road accidentsrelevance and effectiveness of pictograms on medicines packaging

Outcome Measures

Primary Outcomes (1)

  • Drugs use reported by drivers involved in road accidents

    Drugs use is collected during a structured interview administered by a trained CRA. Measure title : percentage of drivers who take drugs, by ATC classification, by pictogram and by drug.

    inclusion date

Secondary Outcomes (3)

  • Responsibility of the driver for the accident

    inclusion date

  • Seriousness of the accident

    inclusion date

  • Knowledge of drivers about graded pictogram featured on drugs packaging

    inclusion date

Study Arms (2)

serious road accidents

Drivers involved in serious road accidents (hospitalization \> 24 hours)

non-serious road accidents

drivers involved in non-serious road accidents (hospitalization \< 24 hours).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Pellegrin

Bordeaux, 33000, France

Location

CH de Perigueux

Périgueux, France

Location

Study Officials

  • Nicholas MOORE, Pr

    Plateforme BPE

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 30, 2015

First Posted

February 23, 2016

Study Start

October 18, 2016

Primary Completion

December 26, 2018

Study Completion

December 26, 2018

Last Updated

May 14, 2020

Record last verified: 2020-05

Locations

FR(2)