ISRCTN ISRCTN78924818
DOI https://doi.org/10.1186/ISRCTN78924818
Secondary identifying numbers NIHR PHR ref: 10/3010/21
Submission date
23/10/2012
Registration date
22/11/2012
Last edited
18/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 don't 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?
January 2013 to April 2014.

Who is funding the study?
National Institute for Health Research (NIHR) Public Health Research (PHR).

Who is the main contact?
Dr Simon Moore
mooresc2@cardiff.ac.uk

Contact information

Dr Simon Moore
Scientific

Violence & Society Research Group
School of Dentistry
College of Biomedical and Life Sciences
Cardiff University
Cardiff
CF14 4XY
United Kingdom

Phone +44 (0)29 20744246
Email mooresc2@cardiff.ac.uk

Study information

Study designRandomised controlled effectiveness trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised controlled trial of All-Wales Licensed Premises Intervention to reduce alcohol-related violence
Study acronymAWLPI
Study objectivesPrimary 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
Ethics approval(s)Dental School Research Ethics Committee, 07/09/2012, ref: 12/08
Health condition(s) or problem(s) studiedPublic Health Research
Intervention1. 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.
Intervention typeOther
Primary outcome measureDifference in police-recorded violence between intervention and control premises over a 12 month follow-up period
Secondary outcome measuresThe 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.
Overall study start date02/04/2012
Completion date08/09/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants600 premises (300 intervention; 300 control)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment02/04/2012
Date of final enrolment08/09/2014

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Cardiff University
Cardiff
CF14 4XY
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

Research and Commercial Division
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

Website http://www.cardiff.ac.uk/
ROR logo "ROR" https://ror.org/03kk7td41

Funders

Funder type

Government

National Institute for Health Research (NIHR) - Public Health Research Programme (UK) ref: 10/3010/21

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 10/01/2014 Yes No
Results article results 01/09/2015 Yes No