A cluster randomised controlled trial of pharmacist led Statin Outreach Support (SOS) in primary care: Design and baseline characteristics

BackgroundStatins reduce the risk of vascular events, however statin prescribing is often sub optimal and better evidence is needed to inform quality improvements. The Statin Outreach Support (SOS) trial was designed to test the efficacy of pharmacist led educational outreach directed at General Practices, aiming to improve statin prescribing for community dwelling patients with vascular disease. This paper describes the study rationale, design, methods and baseline characteristics of participants.DesignThe SOS trial was designed to investigate whether practices receiving SOS improve their statin prescribing and patients achieve reduced cholesterol levels. It was a prospective, single blind, cluster randomised controlled trial with a follow-up period of 5 months minimum post SOS intervention delivery.ResultsThirty one practices were recruited from the UK's largest Health Board area. At randomisation, 16 practices were allocated to SOS and 15 to usual care with 4040 patients included at baseline. Participating practices showed few differences compared with non-participating practices; practices and patients randomised to each arm of the study had similar distributions with respect to age, complications, cholesterol levels and statin prescribing. Baseline data compared favourably with landmark, placebo-controlled statin trials.ConclusionsCompared with existing implementation research, SOS trial has more participants, a detailed description of baseline characteristics and over 90% power (at 5% significance) to detect a difference of 12% in the proportion of patients with controlled cholesterol after SOS.