ISRCTN - ISRCTN78924818: All Wales Licensed Premises Intervention

Plain English 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 dont 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Moore

ORCID ID

Contact details

Violence & Society Research Group
School of Dentistry
College of Biomedical and Life Sciences
Cardiff University
Cardiff
CF14 4XY
United Kingdom
+44 (0)29 20744246
mooresc2@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NIHR PHR ref: 10/3010/21

Study information

Scientific title

Randomised controlled trial of All-Wales Licensed Premises Intervention to reduce alcohol-related violence

Acronym

AWLPI

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

Ethics approval

Dental School Research Ethics Committee, 07 September 2012, ref: 12/08

Study design

Randomised controlled effectiveness trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Public Health Research

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Difference in police recorded violence between intervention and control premises over a 12 month follow-up period

Secondary outcome measures

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.

Overall trial start date

02/04/2012

Overall trial end date

08/09/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600 premises (300 intervention; 300 control)

Participant 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

Recruitment start date

02/04/2012

Recruitment end date

08/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Violence & Society Research Group
Cardiff
CF14 4XY
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data