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
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
United Kingdom
Trial participating centre
Sheffield Teaching Hospital
S10 2JF
United Kingdom
Trial participating centre
Royal Liverpool University Hospital
L7 8XP
United Kingdom
Trial participating centre
Royal Infirmary of Edinburgh
EH16 4SA
United Kingdom
Trial participating centre
Sandyford Clinic
G3 7NB
United Kingdom
Trial participating centre
Sexual Health Lothian
EH3 9HQ
United Kingdom
Trial participating centre
Sexual Health Manchester
M13 9WU
United Kingdom
Trial participating centre
The Centre for Sexual Health - Leeds
LS2 8NG
United Kingdom
Trial participating centre
Royal Hallamshire Hospital
S10 2JF
United Kingdom
Trial participating centre
Sexual Health Tayside
DD1 9SY
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
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
2019 protocol in https://pubmed.ncbi.nlm.nih.gov/31221890/ (added 17/06/2020)