An exploratory randomised controlled trial of a premises-level intervention to reduce alcohol-related harm including violence in the United Kingdom.

BACKGROUND: To assess the feasibility of a randomised controlled trial of a licensed premises intervention to reduce severe intoxication and disorder; to establish effect sizes and identify appropriate approaches to the development and maintenance of a rigorous research design and intervention implementation. METHODS: An exploratory two-armed parallel randomised controlled trial with a nested process evaluation. An audit of risk factors and a tailored action plan for high risk premises, with three month follow up audit and feedback. Thirty-two premises that had experienced at least one assault in the year prior to the intervention were recruited, match paired and randomly allocated to control or intervention group. Police violence data and data from a street survey of study premises' customers, including measures of breath alcohol concentration and surveyor rated customer intoxication, were used to assess effect sizes for a future definitive trial. A nested process evaluation explored implementation barriers and the fidelity of the intervention with key stakeholders and senior staff in intervention premises using semi-structured interviews. RESULTS: The process evaluation indicated implementation barriers and low fidelity, with a reluctance to implement the intervention and to submit to a formal risk audit. Power calculations suggest the intervention effect on violence and subjective intoxication would be raised to significance with a study size of 517 premises. CONCLUSIONS: It is methodologically feasible to conduct randomised controlled trials where licensed premises are the unit of allocation. However, lack of enthusiasm in senior premises staff indicates the need for intervention enforcement, rather than voluntary agreements, and on-going strategies to promote sustainability. TRIAL REGISTRATION: UKCRN 7090; ISRCTN: 80875696.

Interventions for disorder and severe intoxication in and around licensed premises, 1989-2009.

AIMS: To systematically review rigorous evaluation studies into the effectiveness of interventions in and around licensed premises that aimed to reduce severe intoxication and disorder. METHODS: A systematic search was conducted. Papers that rigorously evaluated interventions based in and around licensed premises to reduce disorder or intoxication were included. RESULTS: Fifteen studies were identified, three randomized controlled trials and 12 non-randomized quasi-experimental evaluations. Outcome measures were intoxication (n = 6), disorder (n = 6) and intoxication and disorder (n = 3). Interventions included responsible beverage service training (n = 5), server violence prevention training (n = 1), enhanced enforcement of licensing regulations (n = 1), multi-level interventions (n = 5), licensee accords (n = 2) and a risk-focused consultation (n = 1). Intervention effects varied, even across studies using similar interventions. CONCLUSIONS: Server training courses that are designed to reduce disorder have some potential, although there is a lack of evidence to support their use to reduce intoxication and the evidence base is weak.

The reduction of intoxication and disorder in premises licensed to serve alcohol: an exploratory randomised controlled trial.

BACKGROUND: Licensed premises offer a valuable point of intervention to reduce alcohol-related harm. OBJECTIVE: To describe the research design for an exploratory trial examining the feasibility and acceptability of a premises-level intervention designed to reduce severe intoxication and related disorder. The study also aims to assess the feasibility of a potential future large scale effectiveness trial and provide information on key trial design parameters including inclusion criteria, premises recruitment methods, strategies to implement the intervention and trial design, outcome measures, data collection methods and intra-cluster correlations. DESIGN: A randomised controlled trial in licensed premises that had experienced at least one assault in the year preceding the intervention, documented in police or hospital Emergency Department (ED) records. Premises were recruited from four study areas by piloting four recruitment strategies of varying intensity. Thirty two licensed premises were grouped into matched pairs to reduce potential bias and randomly allocated to the control or intervention condition. The study included a nested process evaluation to provide information on intervention acceptability and implementation. Outcome measures included police-recorded violent incidents, assault-related attendances at each premises' local ED and patron Breath Alcohol Concentration assessed on exiting and entering study premises. RESULTS: The most successful recruitment method involved local police licensing officers and yielded a 100% success rate. Police-records of violence provided the most appropriate source of data about disorder at the premises level. CONCLUSION: The methodology of an exploratory trial is presented and despite challenges presented by the study environment it is argued an exploratory trial is warranted. Initial investigations in recruitment methods suggest that study premises should be recruited with the assistance of police officers. Police data were of sufficient quality to identify disorder and street surveys are a feasible method for measuring intoxication at the individual level. TRIAL REGISTRATION: UKCRN 7090; ISRCTN: 80875696. FUNDING: Medical Research Council (G0701758) to Simon Moore, Simon Murphy, Laurence Moore and Jonathan Shepherd.