Open Access Study protocol

Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study): study protocol for a randomized controlled trial

Alex Dregan1*, Tjeerd van Staa2, Lisa Mcdermott3, Gerard McCann2, Mark Ashworth1, Judith Charlton1, Charles Wolfe1, Anthony Rudd1, Lucy Yardley3, Martin Gulliford1 and eCRT Research Team

Author Affiliations

1 King’s College London, Department of Primary Care and Public Health Sciences, Division of Health and Social Care Research, Capital House, 42 Weston St, London SE1 3QD, UK

2 Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK

3 School of Psychology, University of Southampton, Southampton, UK

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Trials 2012, 13:181  doi:10.1186/1745-6215-13-181

Published: 3 October 2012

Abstract

Background

The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously.

Methods/Design

The study aims to implement a cluster randomized trial (CRT) using the electronic patient records of the General Practice Research Database (GPRD) as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed.

Discussion

The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care.

Trial registration

Current Controlled Trials ISRCTN35701810

Keywords:
Clinical trials; Cluster analysis; Electronic health records; Feasibility studies; Stroke; Secondary prevention