A pilot cluster randomised trial of the Medicinesand Alcohol Consultation (MAC): an intervention to discuss alcohol use in community pharmacy medicine review services

Abstract

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. Trial registration ISRCTN57447996

Optimising retention success: a research team’s experience of following-up participants recruited to a pilot trial through community pharmacies in England

“…The long alcohol measure was completed best by telephone (89% fully completed by telephone, 33% fully completed by post (95% CI: 13.7% to 80.8%; P=0.0064)); however the PROMIS measure 10 had fewer items missing when completed by post (100% fully completed by post, 79% fully completed by telephone (95% CI: -10.5% to 36.3%; P=0.1355)). Comparison data regarding the short and long alcohol recall measures are presented in the pilot trial paper 8 .…”

“…The trial involved participants with a range of ages and therefore is broadly representative of the type of patients that use community pharmacies. We were unable to meet our recruitment target due to various factors, some of which were beyond our control, and these have been described previously 8 . As the study was conducted in only one geographical location, this presents a limitation that may hinder generalisability.…”

“…The pilot trial’s primary clinical outcomes were the 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. Details of the trial’s methodology are reported elsewhere 8 .…”

“…Full results of the pilot trial and the experiences of the community pharmacists involved are reported elsewhere 8 , 9 . This paper focuses specifically on our experiences of contacting participants and the techniques used in an attempt to maximise our follow-up rate.…”

Introducing alcohol as a drug in medicine reviews with pharmacists: Findings from a co‐design workshop with patients

“…Findings from this co‐design workshop and further workshops held with pharmacists were used to review and produce a second version of the MAC intervention with a clearer grounding in what person‐centred consultation practice meant from the point of view of people receiving medicines reviews. Findings were discussed with the program PPI and pharmacist advisory groups and used to develop the next iteration of the MAC used in a feasibility study and later tested in a pilot trial [46]. Framing alcohol as a drug has been consolidated as a core feature of the MAC, for which further intervention development work is ongoing.…”