Condition category
Not Applicable
Date applied
24/04/2018
Date assigned
16/05/2018
Last edited
11/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Minimum unit pricing of alcohol is a new public health policy that aims to reduce alcohol-related harms and health inequalities. It sets a minimum price (based on alcohol content) below which alcohol cannot be sold and it is designed to impact those at greatest risk of experiencing alcohol-related harms. A comprehensive set of evaluations is being coordinated by NHS Health Scotland, which this study contributes to. This study aims to investigate the impact of the introduction of minimum unit pricing of alcohol in Scotland on alcohol-related attendances to Emergency Departments and sexual health clinics.

Who can participate?
Patients over 16 years of age who attend the participating Emergency Departments or sexual health clinics

What does the study involve?
Data is collected from four Emergency Departments in Scotland and North England to see if there is a difference in the rates of alcohol attendees before and after the legislation is in place. Data is also collected from six sexual health clinics in Scotland and North England. Questionnaires are provided to all attendees at the clinics for self-completion, seeking information on alcohol consumption, drug use and the source of any alcohol consumed. Differences in the outcomes between Scotland and North England are measured to see if there have been any potential negative effects caused by the introduction of the legislation.

What are the possible benefits and risks of participating?
Participants have the opportunity to contribute to the evaluation of a national health policy. Risks are negligible.

Where is the study run from?
1. Glasgow Royal Infirmary (UK)
2. Sheffield Teaching Hospital (UK)
3. Royal Liverpool University Hospital (UK)
4. Royal Infirmary of Edinburgh (UK)
5. Sandyford Clinic (UK)
6. Sexual Health Lothian (UK)
7. Sexual Health Manchester (UK)
8. The Centre for Sexual Health - Leeds (UK)
9. Royal Hallamshire Hospital (UK)
10. Sexual Health Tayside (UK)

When is the study starting and how long is it expected to run for?
September 2017 to September 2020

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

Who is the main contact?
Ross Forsyth

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ross Forsyth

ORCID ID

Contact details

MRC/CSO Social and Public Health Sciences Unit
University of Glasgow
Top floor
200 Renfield Street
Glasgow
G2 3QB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/3005/40

Study information

Scientific title

Evaluating possible intended and unintended consequences of the implementation of Minimum Unit Pricing of Alcohol in Scotland: a natural experiment

Acronym

Study hypothesis

This study aims to investigate the impact of the introduction of minimum unit pricing (MUP) of alcohol in Scotland on alcohol-related attendances to Emergency Departments and potentially unanticipated negative impacts of the introduction of minimum unit pricing (MUP) of alcohol in Scotland.

Ethics approval

Scotland A Research Ethics Committee, original approval 14/08/2012, latest ethical review 17/01/2018, REC ref: 12/SS/0120 for the Emergency Dept arm and 12/SS/0121 for the Sexual Health arm

Study design

Observational cross sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Alcohol-related A&E attendances, and Sexual Health Clinic attendances

Intervention

This research is a natural experiment study of the impact of introducing MUP in Scotland. The methods involve a repeated cross-sectional audit of all alcohol-related attendances at EDs in two Scottish hospitals and two North England geographical control hospitals at three timepoints. On each occasion, data collection will involve a face-to-face survey administered by research nurses to ED patients over selected times during a three week time period.

The sexual health arm of the study will compare self-completed questionnaires at three sexual health clinics in Scotland with three sexual health clinics in North England at three different time points.

Each wave of data collection for the main study will last three weeks. The first wave is planned for prior to the introduction of MUP in Scotland with two follow-up waves of data collection at approximately 6 months after and 12 months after.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The primary outcome for the ED arm:
Absolute numbers of alcohol-related attendances as defined by any one of:
1. Patient self-reports attendance is alcohol-related
2. Patient reports alcohol consumption in past 24 hours >=8 units in men, >=6 units in women
3. Patient not approached because too intoxicated with alcohol
Compared between intervention and control areas, adjusted for baseline attendances
Measured by questionnaire administered by research nurses at the Emergency Departments: Wave 1 – February 2018, Wave 2 - October 2018 and Wave 3 – February 2019

The primary outcome for the sexual health arm:
Rates of higher/lower risk drinking, as measured by FAST score, compared between intervention and control areas, adjusted for baseline attendances. Data will be collected at baseline (February 18), 6 month follow up (October 18) and 1 year follow up (February 19)

Secondary outcome measures

Secondary outcomes for the ED arm:
1. Changes in absolute number of alcohol-related attendances by age/sex/deprivation
2. Changes in problematic alcohol use, as defined by the Fast Alcohol Screening Test (FAST)
3. Changes in mean FAST score
4. Changes in prevalence of binge drinking in the past week
5. Changes in reason for attendance, coded by ICD-10
Measured by questionnaire administered by research nurses at the Emergency Departments: Wave 1 – February 2018, Wave 2 - October 2018 and Wave 3 – February 2019

The secondary outcome for the sexual health arm:
Self-reported binge-drinking with analyses for differential impact by age/sex/deprivation. Data will be collected at baseline (February 18), 6 month follow up (October 18) and 1 year follow up (February 19)

Overall trial start date

01/09/2017

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

For the Emergency Department arm of the study, the target population for the study is all patients over 16 years age who attend EDs to receive acute treatment for a health condition. For those who are approached, the inclusion criteria are:
1. >=age 16
2. able to speak English and no interpreter available
3. Is a new ED presentation
4. The patient is conscious
5. The patient is physically well enough
6. The patient is mentally well enough
7. The patient is sober enough (alcohol)
8. The patient is sober enough (drugs)
9. The patient is still in the department
10. The patient is safe for staff to approach

For the sexual health arm of the study the target population for the study is all patients of any age attending participating sexual health clinics during data collection periods. The inclusion criteria are:
1. People able to complete the questionnaire
2. People who are deemed by the clinical staff as appropriate to approach

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

Sexual Health sites: 15000; A&E sites: 5640

Participant exclusion criteria

For the ED sites:
1. Patient too unwell
2. Too distressed
3. Grossly intoxicated (alcohol)
4. Grossly intoxicated (drugs)
5. Cognitive impairment
6. Police in attendance
7. Clear language barrier, and no interpreter available
8. Patient already participating
9. Routine follow-up that has been instigated by ED staff
10. Patient left dept
11. Patient admitted
12. Staff safety issue
13. End of shift
14. Dead on arrival
15. Other

For the Sexual Health sites:
1. People unable to complete the questionnaire with assistance from the research assistant
2. People who leave the department before an approach can be made
3. People who are deemed by the clinical staff as inappropriate to approach

Recruitment start date

22/11/2017

Recruitment end date

28/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glasgow Royal Infirmary
G4 0SF

Trial participating centre

Sheffield Teaching Hospital
S10 2JF

Trial participating centre

Royal Liverpool University Hospital
L7 8XP

Trial participating centre

Royal Infirmary of Edinburgh
EH16 4SA

Trial participating centre

Sandyford Clinic
G3 7NB

Trial participating centre

Sexual Health Lothian
EH3 9HQ

Trial participating centre

Sexual Health Manchester
M13 9WU

Trial participating centre

The Centre for Sexual Health - Leeds
LS2 8NG

Trial participating centre

Royal Hallamshire Hospital
S10 2JF

Trial participating centre

Sexual Health Tayside
DD1 9SY

Sponsor information

Organisation

NHS Greater Glasgow & Clyde

Sponsor details

Greater Glasgow Health Board
JB Russell House
Gartnaval Royal Hospital
1550 Great Western Road
Glasgow
G12 0XH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Study protocol is available on the NIHR website: https://www.journalslibrary.nihr.ac.uk/programmes/phr/11300540/#/summary-of-research

Planned publication of the study results in a high-impact peer reviewed journal in 2020/21.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as although not personal data the data are potentially sensitive. Electronically entered data will be held on a secure computer drive at SPHSU and paper versions shelved in a locked storage room.

Intention to publish date

30/09/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes