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

Health Services Research Institute, Warwick Medical School, Gibbet Hill Rd, Coventry CV4 7AL, UK.
Trials (Impact Factor: 2.12). 02/2006; 7:11. DOI: 10.1186/1745-6215-7-11
Source: PubMed

ABSTRACT 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.

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.


Available from: Tim A Holt, May 29, 2015
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    ABSTRACT: An estimated 750,000 people in the UK have diabetes that is either undiagnosed or unrecorded on diabetes registers. Opportunities are missed to prevent or delay complications and reduce cardiovascular risk. This `missing population' problem has been addressed at various levels: raising awareness among the public; targeted case finding in at-risk groups; and lowering the threshold for investigation of suggestive symptoms among clinicians. Cardiovascular risk assessments are recommended in the UK for the over 40-year-old population and include blood glucose measurements. To further support these measures, this article discusses a recently reported technique for identifying possible cases of undiagnosed diabetes using simple searches on primary care databases, and its implications for practice and future research.Br J Diabetes Vasc Dis 2008; 8: 291—294
    The British Journal of Diabetes & Vascular Disease 11/2008; 8:291-294. DOI:10.1177/1474651408098455
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    ABSTRACT: Primary care databases contain cardiovascular disease risk factor data, but practical tools are required to improve identification of at-risk patients. To test the effects of a system of electronic reminders (the 'e-Nudge') on cardiovascular events and the adequacy of data for cardiovascular risk estimation. Randomised controlled trial. Nineteen general practices in the West Midlands, UK. The e-Nudge identifies four groups of patients aged over 50 years on the basis of estimated cardiovascular risk and adequacy of risk factor data in general practice computers. Screen messages highlight individuals at raised risk and prompt users to complete risk profiles where necessary. The proportion of the study population in the four groups was measured, as well as the rate of cardiovascular events in each arm after 2 years. Over 38 000 patients' electronic records were randomised. The intervention led to an increase in the proportion of patients with sufficient data who were identifiably at risk, with a difference of 1.94% compared to the control group (95% confidence interval [CI] = 1.38 to 2.50, P<0.001). A corresponding reduction occurred in the proportion potentially at risk but requiring further data for a risk estimation (difference = -3.68%, 95% CI = -4.53 to -2.84, P<0.001). No significant difference was observed in the incidence of cardiovascular events (rate ratio = 0.96, 95% CI = 0.85 to 1.10, P = 0.59). Automated electronic reminders using routinely collected primary care data can improve the adequacy of cardiovascular risk factor information during everyday practice and increase the visibility of the at-risk population.
    British Journal of General Practice 04/2010; 60(573):e137-43. DOI:10.3399/bjgp10X483904 · 2.36 Impact Factor
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    ABSTRACT: The aim of this research was to explore the potential of routinely collected primary care data to support the identification of individuals for cardiovascular risk reduction. The work involved a systematic literature review of reminder interventions operating at the point of care; a randomised controlled trial of a novel software tool to facilitate the targeting of individuals at risk of cardiovascular disease; and an exploration of qualitative issues relevant to the challenge of cardiovascular risk reduction in current practice. The Systematic review resulted in a narrative synthesis and a meta-analysis. It concluded that reminder interventions are generally effective at changing practitioner behaviour, but the effect is inconsistent, probably dependent on organisational context, and difficult to predict. The e-Nudge trial involved 19 practices in Coventry and Warwickshire, who used the e-Nudge software tool for two years. This tool was programmed for the project by the clinical software company EMIS. Whilst the primary outcome (cardiovascular event rate) was not significantly reduced in this timescale, a beneficial effect was demonstrated on the adequacy of data to support risk estimation and on the visibility of the at risk population. A new means of addressing the problem of undiagnosed and late-diagnosed diabetes was also discovered. Qualitative aspects of this area of care are presented through a discussion of ethical issues, a limited series of interviews with members of the public included in the appendix, and extensive field notes taken throughout the research. These provide some context in support of the e-Nudge trial. Routinely collected data of UK general practice provide a potentially rich resource to support primary cardiovascular disease prevention, but practical, ethical and conceptual issues must all be addressed to optimise their impact. This conclusion forms the thesis to be explored and justified through this dissertation.