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Completed

NCT Number: NCT02688504

Health and Road Safety: Influence of Drugs Use and Health Status

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pellegrin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Drugs use reported by drivers involved in road accidents

    Time frame: inclusion date

    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.

Secondary outcomes

  1. Responsibility of the driver for the accident

    Time frame: inclusion date

    The responsibility of the driver (responsible or not responsible) is a data extracted from the BAAC sheet (a sheet fulfilled by the police in case of traffic crashes)

  2. Seriousness of the accident

    Time frame: inclusion date

    The seriousness of the accident is assessed according the duration of hospital stay. If the duration is less than 24 hours, accidents are considered as non serious. If not, accidents are considered as serious.

  3. Knowledge of drivers about graded pictogram featured on drugs packaging

    Time frame: inclusion date

    Knowledge about graded pictogram is collected during a structured interview administered by a trained CRA. Measure title : percentage of drivers who know if a pictogram is featured on their drugs packagings.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

CESIR-U2 : Influence of Drugs Use and Health Status

Acronym: CESIR-U2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2016
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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