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All Wales Licensed Premises Intervention
ISRCTN ISRCTN78924818
DOI 10.1186/ISRCTN78924818
ClinicalTrials.gov identifier
EudraCT number
Public title All Wales Licensed Premises Intervention
Scientific title Randomised controlled trial of All-Wales Licensed Premises Intervention to reduce alcohol-related violence
Acronym AWLPI
Serial number at source NIHR PHR ref: 10/3010/21
Study hypothesis Primary objective
To determine the impact of Safety Management in Licensed Premises (SMILE) on police recorded violence

Secondary objectives
1. To assess whether intervention impacts change over time
2. To identify the costs associated with SMILE and the extent to which it can be regarded as an efficient use of public funds
3. To assess whether the integrity of SMILE is maintained across LAs
4. To determine the optimal format of the risk-led PL intervention for delivery by EHOs
5. To develop a revised logic model of the intervention
6. To consider the relationship between outcomes and intervention reach, dose and receipt
Lay summary Background and study aims
About 7 in 10 of A&E admissions are alcohol related at peak times. Urban centres typically produce a substantial share of all alcohol-related violence, and are particularly associated with severe intoxication and violent injury. Recent studies have shown that environment-specific risk factors and recognition that premises-level (PL) programs (interventions) that address such risks can lead to a reduction in alcohol-related violence. Interventions that address these risk factors are therefore urgently required to reduce the burden of harm to health services. By reducing known risk factors within premises and their immediate environment, the aim is to directly or indirectly reduce alcohol misuse and/or injury.

Who can participate?
Premises are eligible for the trial if they are on-licence premises that are: based within the 22 local authorities (LAs) in Wales, are a public house, night club, or hotel, and have recorded one or more violent incidents (including Section 18/20, Section 47, common assault, affray, assault of a police officer) in the previous twelve months.

What does the study involve?
The study is being delivered by Environmental Health Officers (EHOs) in Wales. The intervention itself is made up of three components. First, EHOs will audit premises to identify areas where premises operation might increase the risk of violence (e.g. inappropriate alcohol promotions, which are associated with violence). Second, based on the outcome of the audit, EHOs will take one of four possible steps: 1) take no further action if there are no risks; 2) advise premises to make changes; 3) formally require premises to make changes; 4) refer premises to police and Local Authority (LA) licensing officers (who are able to place conditions on premises licenses). Finally, EHOs will conduct a second audit in premises where further action is required to assess whether the required changes have been made (they will enforce as required). Depending upon the severity of the risk identified in the initial audit, the second audit will take place either one month or three months later.
The control group premises will receive the usual contact that premises receive from EHOs, which does not routinely involve interventions for violence. Following the audit, we will provide premises staff with training and instructional materials designed to engage them in harm reduction practice, and will be tailored to the areas of risk identified on a per-premises basis.

What are the possible benefits and risks of participating?
If this intervention succeeds in reducing violence then there will be substantial benefits such as reducing fear of crime and the psychological impact of victimisation.
Due to the nature of the trial we donít foresee any risks over and above those usually associated with licensed premises.

Where is the study run from?
The trial is being run from Cardiff University Dental School

When is the study starting and how long is it expected to run for?
The intervention phase of the trial is will begin in January 2013 and will continue until April 2013. The follow-up period will continue until April 2014.

Who is funding the study?
The trial is funded by a National Institute for Health Research (NIHR) Public Health Research (PHR) programme grant (ref: 10/3010/21)

Who is the main contact?
Dr Simon Moore
mooresc2@cardiff.ac.uk
Ethics approval Dental School Research Ethics Committee, 07 September 2012, ref: 12/08
Study design Randomised controlled effectiveness trial
Countries of recruitment United Kingdom
Disease/condition/study domain Public Health Research
Participants - inclusion criteria 1. On-licence premises that are based within the 22 LAs in Wales
2. On-license premises that are a public house, night club, or hotel
3. On-license premises that have had recorded one or more violent incidents (including Section 18/20, Section 47, common assault, affray, assault of a police officer) in the preceding twelve months
Participants - exclusion criteria 1. On-license premises that are cafes, restaurants and entertainment venues such as sports facilities and concert halls
2. Premises that have recorded other offences such as criminal damage, drug use and theft
Anticipated start date 02/04/2012
Anticipated end date 08/09/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 600 premises (300 intervention; 300 control)
Interventions 1. An evaluation of the Safety Management in Licensed Premises (SMILE) intervention

2. The control group premises will receive the usual contact that premises receive from EHOs, which does not routinely involve interventions for violence.
Primary outcome measure(s) Difference in police recorded violence between intervention and control premises over a 12 month follow-up period
Secondary outcome measure(s) The trial will incorporate an embedded Process Evaluation (PE) to examine how the trial is implemented and to facilitate interpretation of outcome effects.

The PE will examine the following issues:
1. Trial arm implementation and context
2. Trial arm fidelity
3. Participation, reach and dose delivered
4. Reception and responsiveness

The trial will also include an embedded economic evaluation to determine the cost of delivering the intervention.
Sources of funding National Institute for Health Research (NIHR) - Public Health Research Programme (UK) ref: 10/3010/21
Trial website
Publications 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24405575
Contact name Dr  Simon  Moore
  Address Violence & Society Research Group
School of Dentistry
College of Biomedical and Life Sciences
Cardiff University
  City/town Cardiff
  Zip/Postcode CF14 4XY
  Country United Kingdom
  Tel +44 (0)29 20744246
  Email mooresc2@cardiff.ac.uk
Sponsor Cardiff University (UK)
  Address Research and Commercial Division
7th Floor
30-36 Newport Road
  City/town Cardiff
  Zip/Postcode CF24 0DE
  Country United Kingdom
  Sponsor website: http://www.cardiff.ac.uk/
Date applied 23/10/2012
Last edited 13/01/2014
Date ISRCTN assigned 22/11/2012
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