Protocol for the 'e-Nudge trial' : a randomised controlled trial of electronic feedback to reduce the cardiovascular risk of individuals in general practice [ISRCTN64828380]

Background: Cardiovascular disease (including coronary heart disease and stroke) is a major cause of death and disability in the United Kingdom, and is to a large extent preventable, by lifestyle modification and drug therapy. The recent standardisation of electronic codes for cardiovascular risk variables through the United Kingdom's new General Practice contract provides an opportunity for the application of risk algorithms to identify high risk individuals. This randomised controlled trial will test the benefits of an automated system of alert messages and practice searches to identify those at highest risk of cardiovascular disease in primary care databases. Design: Patients over 50 years old in practice databases will be randomised to the intervention group that will receive the alert messages and searches, and a control group who will continue to receive usual care. In addition to those at high estimated risk, potentially high risk patients will be identified who have insufficient data to allow a risk estimate to be made. Further groups identified will be those with possible undiagnosed diabetes, based either on elevated past recorded blood glucose measurements, or an absence of recent blood glucose measurement in those with established cardiovascular disease. Outcome measures: The intervention will be applied for two years, and outcome data will be collected for a further year. The primary outcome measure will be the annual rate of cardiovascular events in the intervention and control arms of the study. Secondary measures include the proportion of patients at high estimated cardiovascular risk, the proportion of patients with missing data for a risk estimate, and the proportion with undefined diabetes status at the end of the trial

Randomized Controlled Trial of an Informatics-based Intervention to Increase Statin Prescription for Secondary Prevention of Coronary Disease

OBJECTIVE: Suboptimal treatment of hyperlipidemia in patients with coronary artery disease (CAD) is well documented. We report the impact of a computer-assisted physician-directed intervention to improve secondary prevention of hyperlipidemia. DESIGN AND SETTING: Two hundred thirty-five patients under the care of 14 primary care physicians in an academically affiliated practice with an electronic health record were enrolled in this proof-of-concept physician-blinded randomized, controlled trial. Each patient with CAD or risk equivalent above National Cholesterol Education Program-recommended low-density lipoprotein (LDL) treatment goal for greater than 6 months was randomized, stratified by physician and baseline LDL. Physicians received a single e-mail per intervention patient. E-mails were visit independent, provided decision support, and facilitated “one-click” order writing. MEASUREMENTS: The primary outcomes were changes in hyperlipidemia prescriptions, time to prescription change, and changes in LDL levels. The time spent using the system was assessed among intervention patients. RESULTS: A greater proportion of intervention patients had prescription changes at 1 month (15.3% vs 2%, P=.001) and 1 year (24.6% vs 17.1%, P=.14). The median interval to first medication adjustment occurred earlier among intervention patients (0 vs 7.1 months, P=.005). Among patients with baseline LDLs >130 mg/dL, the first postintervention LDLs were substantially lower in the intervention group (119.0 vs 138.0 mg/dL, P=.04). Physician processing time was under 60 seconds per e-mail. CONCLUSION: A visit-independent disease management tool resulted in significant improvement in secondary prevention of hyperlipidemia at 1-month postintervention and showed a trend toward improvement at 1 year