Title: Community pharmacy: Highlighting Alcohol use in Medication aPpointments (CHAMP-1) research programme
Funder: Department of Health and Social Care

Abstract: 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 approximately 15-20 purposively selected patients will explore the experience of discussing alcohol during medication appointments; c) Follow-up patient interview study will examine alcohol, medication use and health over the 6 month study period; d) Pharmacist cohort study with 7-8 pharmacists to study in-depth practice development. A constructionist, inductive thematic analysis will be applied to the interview data in studies b-d. Projected outputs & dissemination plans The final phase of the programme comprises dissemination of findings based on ongoing policy engagement to achieve rapid translation into NHS policy and practice. The research team will work closely with advisory groups of patients, pharmacists and policy makers from the outset, to shape the conduct of the research and the resulting outputs. Conventional scientific forms of dissemination will be complemented by a website-based hub to support wider engagement. Benefits to patients and the NHS In the North East and Yorkshire and Humber we work closely with Community Pharmacy Research champions, and local and regional networks and forums. Our host NHS trust, North of England Commissioning Support Unit (NECS), along with the key organizations supporting this research including Royal Pharmaceutical Society (RPS) and Centre for Pharmacy Postgraduate Education (CPPE), are also well placed to promote research translation for NHS patient benefit at national level.

Lay abstract: Aims Working with pharmacists and patients, the researchers want to find a way of discussing alcohol consumption in local pharmacies, and to see if this works for patients. This will allow us to speak to relevant organisations about how this should be rolled out across the country if it works, and what should happen if it doesn t. Background There has been very little research done in this area. The most important study has been carried out by this research team. We previously used an approach that had worked in general practice but found that it did not work in local pharmacies. This was because pharmacists were doing something quite different from their usual role. To overcome this problem, we now plan to include alcohol when discussing medication. If this works well, people with health problems who drink more than is healthy may cut down, drinking may affect their medication less, and improve their health as a result. Design and methods We will do this work over five years. To begin with, we will develop the methods for the main study, and work with patients and pharmacists to plan exactly how and when the subject of alcohol should be discussed during medication appointments. The main study will compare two groups of patients: those who will have the alcohol and medication discussion as we plan, and those who will have appointments as they are now. A computer will decide which group a patient goes in to. We will do a mini-version of the study first to make sure everything will work as we intend. The main study will largely take place in years three and four. We will recruit 41 pharmacies and 820 patients. After six and twelve months, we will compare the drinking and health of both groups, and because of the way the study is done, any differences should be due to the alcohol discussion. With permission, we will audio-record some discussions and speak to some patients and pharmacists to help us better understand how these discussions take place, and how we can make them as useful as possible. In year 5 we will estimate how much of a difference this discussion can make to patients and the NHS. We will discuss study findings with health planners to help them decide what should be done in order to improve the health of the population. Patient, professional and public involvement The research team will work closely with advisory groups of patients, pharmacists and policy makers from the beginning of this research to make sure that what we do meets their needs. We will share study findings widely with patients, pharmacists, policy makers and the public in different presentation and report formats.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CARDIOVASCULAR;CANCER AND NEOPLASMS;ORAL AND GASTROINTESTINAL;STROKE