Evaluating possible intended and unintended consequences of the implementation of Minimum Unit Pricing of Alcohol in Scotland: a natural experiment
| ISRCTN | ISRCTN16039407 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16039407 |
| Secondary identifying numbers | 11/3005/40 |
- Submission date
- 24/04/2018
- Registration date
- 16/05/2018
- Last edited
- 31/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
MRC/CSO Social and Public Health Sciences Unit
University of Glasgow
Top floor
200 Renfield Street
Glasgow
G2 3QB
United Kingdom
Study information
| Study design | Observational cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluating possible intended and unintended consequences of the implementation of Minimum Unit Pricing of Alcohol in Scotland: a natural experiment |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2017 |
| Completion date | 30/09/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Sexual Health sites: 15000; A&E sites: 5640 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/11/2017 |
| Date of final enrolment | 28/03/2019 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
Hospital/treatment centre
Greater Glasgow Health Board
JB Russell House
Gartnaval Royal Hospital
1550 Great Western Road
Glasgow
G12 0XH
Scotland
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/06/2019 | 17/06/2020 | Yes | No |
| Results article | 01/10/2021 | 31/10/2022 | Yes | No |
Editorial Notes
31/10/2022: Publication reference added.
17/06/2020: Publication reference added.
