CHAMP-1 Pilot Trial
Research type
Research Study
Full title
Community pharmacy: Highlighting Alcohol use in Medication aPpointments (CHAMP-1) Pilot Study
IRAS ID
262435
Contact name
Jim McCambridge
Contact email
Sponsor organisation
University of York
ISRCTN Number
ISRCTN57447996
Duration of Study in the UK
0 years, 6 months, 23 days
Research summary
Summary of Research
This application is for the pilot trial phase of a five year research programme, funded by the National Institute for Health Research. The researchers want to find a way of discussing alcohol consumption in local pharmacies, and specifically to see if this works for NHS patients who use existing medicine review services. This research will allow us to consider how this should be rolled out across the country if it works, and what should happen if it doesn’t. In the first phase of the programme, we co-produced the intervention with community pharmacists and patients. The pilot trial will examine the feasibility of implementing the intervention, called the Medicines and Alcohol Consultation (MAC), and recruiting patients to a trial. We have set criteria to judge whether we proceed with a full trial. This work will take 7 months to complete and be undertaken in community pharmacies in Yorkshire. Patients will be eligible if they receive medicine review services, are drinking more than is healthy, and are willing to take part.
Summary of Results
Background Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial.
Methods
This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management. Trial procedures were assessed by recruitment, attrition, and follow-up rates.Results
260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the intervention arm and confidence in medication management reduced slightly for both groups. Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption.Conclusions
The pilot trial demonstrates the feasibility of implementing the MAC in community pharmacy and trial recruitment and data collection procedures. However, decommissioning of MURs means that it is not possible to conduct a definitive trial of the intervention in this service.REC name
South West - Frenchay Research Ethics Committee
REC reference
19/SW/0082
Date of REC Opinion
13 Jun 2019
REC opinion
Further Information Favourable Opinion