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

CHAMP-1 is a National Institute for Health Research funded five year research programme to design and evaluate in a definitive RCT, an intervention that helps incorporate discussion of alcohol within medication consultations.

The overarching aims of this research programme are to:

• To co-produce with the pharmacy profession and with patients, and evaluate in a definitive RCT, an intervention that develops the health and wellbeing role of community pharmacies, specifically within the context of established pharmaceutical services.
• To engage with policy makers to help implement this intervention if shown to be effective, and/or to contribute to decision-making about the wider systemic and workforce development needs involved in extending the health improvement role of community pharmacies.

The study objectives are to undertake:

1. Intervention development, feasibility and acceptability studies to prepare the intervention and trial design for a definitive evaluation study;
2. A pilot trial in advance of the main trial;
3. A definitive randomised controlled trial evaluating the clinical and economic effects of the intervention;
4. A series of participant-centred qualitative process studies which explore the complexities of medication appointments and their effects on both patients and pharmacists;
5. A long term health economics modelling study to estimate future costs and outcomes;
6. Policy engagement throughout the duration of the programme in order to assist post-trial decision-making regardless of the result.

The programme is organised into three phases:

Phase 1

The intervention will be developed from a preliminary version informed by qualitative interviews with patients and existing pharmacist consultation practice, and also based on theoretical, modelling and literature review work. It will then be refined through feasibility and acceptability studies including co-design workshop discussions with patients and pharmacists, and a study of implementation in practice.

Phase 2

A preliminary evaluation of the intervention in a pilot RCT will be undertaken in 8 community pharmacies with approximately 80 participants. This will be followed by the main trial where we plan to recruit 820 participants in 41 pharmacies, with cluster randomisation by pharmacy, and collect outcome data after 6 and 12 months. Four participant-centred qualitative studies will be undertaken as an integrated process evaluation within the main trial.

Phase 3

Dissemination of findings is based on ongoing policy engagement initiated early in the programme to support translation of study findings into NHS policy and practice. The research team will work closely with advisory groups of patients, pharmacists and policy makers to shape the conduct of the research and the resulting outputs.