In order to fully and effectively implement the guidelines of the National Cholesterol Education Program's Adult Treatment Guidelines, models for implementation within physicians office practices must be designed, tested, and evaluated for cost/effectiveness. This study has been designed to compare the efficacy of three implementation models in two phases: Model 1, Basic office based implementation (Phase 1); Model 2, Office assisted implementation and Model 3, Basic office based implementation plus an inclusive nutritional/ behavioral intervention offered through a community nutrition center. Practices will be randomized after Phase 1 into two conditions in order to test Models 2 and 3. Model 1 will serve as a control group for the other two models and will also provide information on patient eligibility, recruitment patterns and accrual rates. Cholesterol response after 3 months of intervention will be the primary end-point although patients will be followed in Phase 2 for up to two years in order to determine long-term cholesterol response, patterns of drug therapy as well as effectiveness of drug therapy, and drop out rates. The cost/effectiveness of each of the models will be calculated. Twenty physician practices will be recruited from a group of thirty practices already identified in the greater Pittsburgh area. Each practice will accrue at least 40 patients who will be treated according to the NCEP, ATP guidelines. The results of this study will provide important information as to the number of patients who will be willing to enter therapy, the number who will successfully lower their blood cholesterol levels by dietary approaches alone, and the number who will require drug therapy and the response to this therapy. Finally, we will be able to determine the cost/effectiveness of each approach.
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