Condition category
Not Applicable
Date applied
02/05/2017
Date assigned
27/06/2017
Last edited
05/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Since 5th December 2014, drivers and riders of vehicles in Scotland have been subject to a stricter drink-drive policy (0.05 g/dL blood alcohol concentration limit) than the rest of Great Britain where the limit has remained unchanged (0.08 g/dL). The fact that a change in drink driving policy has happened in Scotland but not in other parts of Great Britain provides a perfect opportunity to conduct a “natural experiment” to assess whether the change resulted in health gains for Scotland as a whole, and helped reduce differences in health outcomes between the least and most deprived groups in society. The aim of our project is to formally evaluate the change in drink driving legislation.

Who can participate?
The entire population of Scotland, England and Wales.

What does the study involve?
The research team review the number of road traffic accidents by reviewing police data of road accidents recorded in a database every week for the four year study period. Information about the amount of alcohol sold is also observed using market research every four weeks for the four year study period.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating

Where is the study run from?
University of Glasgow (UK)

When is the study starting and how long is it expected to run for?
December 2014 to December 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Jim Lewsey
jim.lewsey@glasgow.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jim Lewsey

ORCID ID

Contact details

University of Glasgow
1 Lilybank Gardens
Glasgow
G12 8RZ
United Kingdom
+44 141 3303260
jim.lewsey@glasgow.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NIHR PHR 14/186/58

Study information

Scientific title

Evaluation of legislation to reduce the drink drive limit in Scotland: a natural experiment

Acronym

Study hypothesis

Research questions:
1. Has the change in drink driving legislation in Scotland been effective (reduction in RTAs)?
2. Has the change in drink driving legislation in Scotland led to changes in relative and absolute RTA rates that differ by levels of socio-economic deprivation?
3. Has the change in drink driving legislation in Scotland led to a reduction in population alcohol consumption?
4. Has the change in drink driving legislation in Scotland provided good value for money (been cost-effective)?

Ethics approval

Submission to MVLS College Ethics Committee, University of Glasgow. The committee reviewed the application and agreed that there is no objection on ethical grounds to the proposed study (letter dated 22/06/16).

Study design

Observational natural experiment design

Primary study design

Observational

Secondary study design

Natural experiment

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Road traffic accidents and per capita alcohol consumption.

Intervention

In Scotland, the drink drive policy was updated and came into effect on 5th December 2014, lowering to 50mg per 100ml of blood from 80mg. In the rest of Great Britain, the limit has remained at 0.08 g/dL.

Road traffic accidents and alcohol consumption by reviewing databases (STATS19 and Nielsen market research). There observations will take place a weekly basis over the 4-year study period for road traffic accidents and 4-weekly over the 4-year study period for alcohol sales data.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Road traffic accident counts will be measured by STATS19 police data of road accidents in Great Britain on a weekly basis over the 4-year study period.

Secondary outcome measures

1. Off-trade per capita alcohol sales will be measured by alcohol retail sales data from Nielsen market research company on a 4-weekly basis over the 4-year study period
2. On-trade per capita alcohol sales will be measured be alcohol retail sales data from Nielsen market research company on a 4-weekly basis over the 4-year study period

Overall trial start date

01/12/2014

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

The entire population of Scotland (intervention) and England and Wales (control).

Participant type

All

Age group

All

Gender

Both

Target number of participants

The entire population of Scotland, England and Wales

Participant exclusion criteria

No exclusion criteria

Recruitment start date

05/12/2012

Recruitment end date

05/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow
Institute of Health and Wellbeing 1 Lilybank Gardens
Glasgow
G12 8RZ
United Kingdom

Sponsor information

Organisation

University of Glasgow

Sponsor details

University Avenue
Glasgow
G12 8QQ
United Kingdom

Sponsor type

University/education

Website

http://www.gla.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of findings as academic papers in high-ranking, open access public health and health economic journals. After publication, a press release will be created that is accessible to all with assistance from the University of Glasgow external communications team. Results will also be presented at national and international public health conferences.

IPD Sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/04/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/01/2018: Internal review.