This K08 Mentored Clinical Scientist Development Award application requests three years of support to pursue two related, broad objectives: (1) to prepare the candidate to become an independent researcher who will be competitive for R01 funding, and (2) to develop a program of clinical research examining the effects of informed consent on compliance with chronic preventive medical therapy in different populations. The candidate is a family physician who completed in 1982 a two-year Robert Wood Johnson Fellowship in Family Medicine and who has 20 years of experience in academic family medicine. He is now in the second year of a two-year Advanced Research Training Grant sponsored by the American Academy of Family Physicians. Additional coursework in quantitative and qualitative methods will bolster his ability to conduct mixed-methods research on a challenging clinical problem--poor compliance with long-term preventive therapy with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins). The proposed research program is grounded in the theory of emotion-based decision making to develop and test the utility of a practical model of informed consent. The main hypothesis is: Informed consent will improve compliance with statin therapy for moderate-risk and high-risk, hyperlipidemic patients. The candidate has already used information and feedback from individual interviews and focus groups with hyperlipidemic patients to develop an informed consent form and graphic decision aid for statin therapy. In addition, the effects of informed consent on one-year compliance with statin therapy are being tested in a pilot study with fully literate, middle-income, patients who have never been offered statin therapy. This award would support extension of this line of inquiry to a full-scale randomized clinical trial in the same population, with the specific aims of: (1) ascertaining the utility of informed consent for increasing compliance with statin therapy (compared to usual care), and (2) determining the effects of informed consent on patients' apprehension about experiencing adverse side effects from statin therapy. A substudy with a 10% subsample will use individual interviewing, review of audiotapes of the initial study visit with the patient's primary care provider, and qualitative data analysis techniques to probe patients' thoughts and feelings during the visit.
