Community pharmacy: Highlighting Alcohol use in Medication aPpointments (CHAMP-1) research programme

Aims and Objectives This research programme aims to co-produce with the pharmacy profession and with patients, and evaluate in a definitive RCT, an intervention discussing alcohol within medication appointments. We will engage with policy makers to support implementation and contribute to decision-making on extending the health improvement role of community pharmacies. The study objectives are to undertake: Intervention development, feasibility and acceptability studies to prepare the intervention and trial design for a definitive evaluation study; A pilot trial in advance of the main trial; A definitive randomised controlled trial evaluating the clinical and economic effects of the intervention; Four participant-centred qualitative process studies which explore the complexities of medication appointments and their effects on patients and pharmacists; A long term health economics modelling study to estimate future costs and outcomes; Policy engagement throughout the duration of the programme in order to assist post-trial decision-making regardless of the result. Background and rationale The Department of Health have recommended that community pharmacy based alcohol interventions should be developed. We have completed the only previous RCT of an alcohol intervention within the community pharmacy setting in the international literature. The RCT found no differences in outcomes amongst those who received a dedicated brief intervention delivered by pharmacists. A recently completed systematic review on community pharmacy public health interventions that included our study recommended that further alcohol interventions should be developed. Research plan The programme will be delivered in three phases, with a total of six workstreams corresponding to the study objectives. We iteratively develop the intervention, before preliminary evaluation in a pilot RCT, and refine the proposed trial procedures in so doing. The pre-trial phase comprises a qualitative patient interview study; a systematic review; focus group discussions and workshops with key stakeholders; a study of implementation in practice; and finalisation of intervention manual content. The pilot trial undertaken in 8 community pharmacies with approximately 80 participants will be external to the definitive trial in order to ensure that all intervention and research processes are ready. The main trial is pragmatic, with a parallel group comparison of the novel intervention with usual care in a 1: 1 allocation ratio. We will recruit 820 participants in 41 pharmacies, with cluster randomisation by pharmacy. The primary hypothesis tested is that highlighting alcohol use in medication appointments reduces alcohol consumption after 6 months. Secondary hypotheses concern the potential for this intervention to confer other health and economic benefits in addition to reduced drinking, after 6 and 12 months. Patients will be consecutively invited to take part in a study to improve the health benefits of medication appointments. They will be blinded to the alcohol study focus in order to safeguard against contamination and bias, and outcome data will be collected by phone after 6 and 12 months. Sample size estimation is based on a meta-analytic estimate of effect, and an ICC of 0.02 and 20% attrition from the previous pharmacy trial. The health economics study components will consist of a within trial cost-effectiveness analysis and the long term modelling of health outcomes and costs using an existing model to assess the potential impact on health related quality of life and health care costs beyond the time horizon of the trial. The four participant-centred qualitative studies within the main trial are as follows: a) Medication appointments process study will audio-record approximately 10-15 appointments from each group (20-30 in total) with the data analysed using an adapted form of conversation analysis; b) Post-intervention patient interview study with approximat