A cluster randomised controlled trial of pharmacist led statin outreach support (SOS) in primary care: design and baseline characteristics.

Abstract

BACKGROUND:

Statins 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.

DESIGN:

The 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 5months minimum post SOS intervention delivery.

RESULTS:

Thirty 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.

CONCLUSIONS:

Compared 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.

• Authors: Richard Lowrie, Jill Morrison, Alex McConnachie
• Journal: Contemporary clinical trials (Contemp Clin Trials) Vol. 31 Issue 4 Pg. 303-11 (Jul 2010) ISSN: 1559-2030 [Electronic] United States
• PMID: 20348032 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hydroxymethylglutaryl-CoA Reductase Inhibitors

Topics

• Aged
• Aged, 80 and over
• Cardiovascular Diseases (drug therapy)
• Cerebrovascular Disorders (drug therapy)
• Drug Prescriptions (standards)
• Female
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)
• Hypercholesterolemia (drug therapy)
• Male
• Middle Aged
• Peripheral Vascular Diseases (drug therapy)
• Pharmacists
• Physicians, Primary Care (education)
• Practice Patterns, Physicians' (standards)
• Prospective Studies
• Quality Assurance, Health Care
• Regression Analysis
• Single-Blind Method
• Statistics, Nonparametric
• United Kingdom