The proposed project seeks to improve the medication adherence and clinical control of ambulatory patients' prescribed treatment for two clinical situations: (1) Chronic oral administration of 3-hydroxy-3-methylgiutaryl coenzyme A reductase inhibitors (statins) for reducing dyslipidemia and thereby cardiovascular morbidity and mortality, and (2) Chronic oral anticoagulation therapy with warfarin for dysrhythmias, prosthetic heart valves, congestive heart failure, and thromboembolism. These situations reflect high prevalence, considerable long-term risk, well defined and established therapies, demonstrable benefit exceeding risk from treatment, but disappointing overall impact in real world settings. Improving adherence for these situations should translate into better clinical outcomes and provide lessons useful for other conditions requiring long-term treatment with oral medications without prompts from symptoms. The project is a randomized controlled trial that (a) applies adherence-enhancing interventions at the levels of patient, physician, and medical care system for the two clinical situations; (b) demonstrates that improved levels of medication adherence occur in the INTERVENTION compared to the USUAL CARE groups; (c) evaluates the potential for dissemination by replicating into community-based practices the successful interventions from academic clinic settings; and (d) assesses the cost-effectiveness of the interventions compared to usual care in both academic and community practice environments. The primary hypothesis is that the integrated interventions will achieve significantly higher levels of days with correct dosages for these two treatment conditions compared to usual care. The interventions reflect both social cognitive and self-determination theory as well as continuous quality improvement strategies using clinical process guidelines. Patients' achievements by levels of adherence and clinical control provide a strategic matrix for feedback that guides actions by the prescribing physician and the project educator. Electronic medication monitoring allows dynamic and comprehensive assessment of medication adherence by day as well as by longer interval corresponding to times of clinical visits and evaluation. Feedback from such monitoring for both patient and physician as well as physicians' adherence to practice guidelines provides keys to improving overall adherence and outcomes.
