This application is a competing continuation for the Centers for Education and Research on Therapeutics (CERTs) Research Center on cardiovascular disease. The quality of medical care has become a major focus of national health-policy discussions. Continuing improvement in survival and freedom from disability will depend on focusing on better systems for developing therapeutics; demonstrating which therapies are beneficial; and employing them in the right patients. Building on work completed in the first funding cycle of the CERTs, we are dedicated to approaching each element of this """"""""cycle of quality"""""""" -from basic concepts to clinical trials, clinical practice guidelines, quality indicators, performance measurement and finally, outcomes. We will continue to coordinate major clinical trials and outcome studies that translate basic findings into the phase of evaluation (Phase 2 studies) and that definitively demonstrate the efficacy and economic attractiveness of proposed therapies(Phase 3 and 4 studies). We will also embark on a major study of the structure and process of the quality cycle using the example of the ACC/AHA guidelines process, the interaction of NIH/FDA/academia and industry in the formulation of clinical trials and the development of quality indicators. The Duke Health system will be used as a model to study methods of improving adherence to standards of care, and collaborating systems will be used to validate these approaches. Initial trials will evaluate a community pharmacist intervention and the use of a novel internet/voice activated system to share critical data among doctors and patients. Our early work demonstrating the economics of treatment of heart failure will be extended to secondary prevention of coronary artery disease. We will work with the FDA on risk management programs for cardiovascular therapeutic products. Finally, we will continue to train a cadre of investigators, both at the academic site and the practice site, so that the cycle of quality will be improved measurably on a national level.
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