Title: All-Wales Licensed Premises Intervention (AWLPI): A Randomised Controlled Trial of an Intervention to Reduce Alcohol-Related Violence
Funder: Division for Social Care and Health Research (Wales)

Abstract: Design: A randomised controlled trial of an intervention designed to reduce alcohol-related violence in premises licensed for the on-site sale and consumption of alcohol with an embedded process evaluation. Setting: The study will be conducted across all 22 Local Authorities in Wales and therefore across areas of varying deprivation. Target population: Eligible licensed premises are those licensed for the on-sale and consumption of alcohol and have recorded one or more violent incidents in the preceding twelve months. Intervention being evaluated: Local Authority employed Environmental Health Officers (EHO) will host Safety and Awareness Days engaging premises staff regional managers and local partners. This is followed by an evidenced-based enhanced-audit that identifies premises risks that contribute to violence including risks that must be addressed under existing legislation. Results from the enhanced-audit specify how premises operation and policy could be changed to minimise risk. Based on findings from the audit EHOs will provide instructional materials including templates for premises logs for recording activity (e.g. incidents training etc.) and specimen policies. Further depending on the nature or severity of the risk EHOs will enforce change where legislation allows advise on change or refer premises to licensing authorities who are able to place conditions on premises licences. One month following the audit EHOs will revisit intervention premises to assess changes made in response to initial contact and further enforce change. Intervention materials will be designed with EHOs and other stakeholders in the initial six months of the project with the aim of integrating materials in EHO normal practice. Outcomes and follow-up period. Differences between control and intervention premises police recorded violence will test effectiveness. The follow-up period will be twelve months following intervention delivery. In addition and embedded process evaluation will consider fidelity and acceptability. We will further monitor intervention costs and determine the value of possible reductions in violence to assess the interventions economic benefit. Sample size: A previous exploratory trial of 32 premises (16 control 16 intervention considered intervention effectiveness over a 181 day (three months pre- and 3 months post-intervention). Analytic strategy was recurrent event analysis in which the intervention was included as a time varying covariate. Results suggest the intervention contributed a non-significant 10% reduction in PL failure rate. Simulations were used to assess the likely sample size and follow-up period required to deploy a full trial sufficiently powered detect a reduction in violence. A group size of 272 providing power of 0.9 to detect a 10% reduction in the failure rate at a significance level of 0.05 across a twelve month follow-up period. For expository ease we assume a total sample size of 600 is both realistic and sufficient. Planned analyses: In order to account for potential time varying covariates censoring multiple events and discontinuous risk intervals our preferred approach is to develop an Andersen-Gill model a derivation of the Cox proportional hazards model. This model can be used to assess hypothesised intervention wane over the twelve month follow-up period. Secondary analyses will further explore the volume of violence attriutable to licensed premises. Project timetables including recruitment rate: Estimated Project start: 2 April 2012Appoint Development Group: 2 April 2012Deliver database of Welsh premises for selection and randomisation: 2 November 2012Deliver refined intervention and EHO training: 18 December 2012EHO intervention period: 1 January 2013 to 25 March 2013 (Environmental Health Officers across all 22 Local Authorities in Wales). First EHO will deliver “Safety and Health Awareness Days” second audit premises then provide feedback and deliver materials third re-audit premises enforcing change as appropriate and noting distance travelled. Complete embedded process evaluation: 25 March 2013Deliver process evaluation write-up: 15 July 2013Complete follow-up period and deliver final data set for analysis: 16 June 2014Complete analysis and write-up: 8 September 2014Project close: 8 September 2014


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH