Duke Cardiovascular CERTs

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DESCRIPTION: (Provided by the Applicant): Cardiovascular (CV) disease remains the nation's #1 deadliest medical condition while CV care remains far from ideal and CV care costs are among the most expensive. The safety and effectiveness of many CV drugs and devices are uncertain in certain patient populations and in community settings, and there is ample evidence of under-, over- and mis-use of such agents. To address these issues, the Duke Clinical Research Institute (DCRI) has established a broad set of alliances with all of the major CV professional societies. These collaborations provide us with an unprecedented opportunity to evaluate 'real world' safety, effectiveness and efficiency of CV therapeutics, but also the means to translate knowledge gained into practice; with an ultimate goal of improving patient outcomes on a national scale. Our proposal also addresses CV therapeutics across the continuum; from in-patient settings to issues of long-term patient adherence; and for five major CV emphasis areas including: acute coronary syndromes; heart failure; stroke; sudden cardiac death; and coronary revascularization. This proposal is dedicated to advancing the state of the science of post-market CV drug and device evaluation and quality improvement, but also to generating practical and actionable information and products for clinicians, policy makers, and the public. Our Duke CERTs Specific Aims are to: 1. Promote the optimization of professional society-led CV registries as national surveillance systems for evaluating and assuring the safety and effectiveness of CV therapeutics and devices in community based settings; and meeting the informational needs of FDA, CMS, NIH, and AHRQ. 2. Identify specific barriers to both the translation of CV therapeutic and device evidence into routine clinical practice and long-term patient adherence to effective CV therapeutics. 3. Develop and rigorously evaluate patient- and provider-based interventions designed to improve the safe, effective, and efficient use of CV therapies and to improve long-term treatment adherence. 4. Widely disseminate those interventions found to be effective. 5. Train the next generation of CV outcomes researchers.