This K23 Mentored Patient-Oriented Research Career Development Award will enable the candidate to develop the skills and experience necessary to become an independent investigator and scholar in interventions research for schizophrenia. The candidate is making a transition from health services to interventions research in order to address directly problems he has confronted as a clinician. The primary focus of work will be medication adherence. The overarching hypothesis is that medication non-adherence is a multifactorial barrier to good outcomes that is surmountable with specific interventions, or combinations of interventions, that address the underlying causes. An additional focus is on the decision-making capacity of persons with schizophrenia, which has important implications for medication adherence and for human subjects protections. The career objectives are to: 1) Improve understanding of the theory, concepts, and methodology related to design and analysis methods for clinical trials, 2) Gain additional exposure to issues and theoretical underpinnings of human subjects protections in vulnerable populations, with an emphasis on decision-making capacity, 3) Establish credibility as an investigator in the area of medication adherence and decision-making capacity, 4) Design and pilot test a novel clinical effectiveness trial addressing medication adherence and outcomes in a group of schizophrenic patients at high risk of non-adherence. Supervised research with experienced mentors is the main component of the career development plan. Coursework, tutorials, and workshops will be the mechanism to further develop methodologic skills and to develop expertise in treatment adherence and decision-making capacity. Two research projects will be pursued. Project 1 will use data collected in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial to conduct a novel longitudinal evaluation of medication adherence, awareness of illness, and decision-making capacity. Project 2 will establish the feasibility of a longitudinal effectiveness trial examining an intervention to improve medication adherence and outcomes in schizophrenia. This pilot study will build upon what is learned in Project 1 and will guide the design and provide preliminary data for a subsequent R01 application. At the end of the career development period, the applicant will have the skills and experience needed to lead studies of interventions designed to improve treatment adherence. The applicant's career will focus on designing and testing interventions to improve outcomes of persons who are severely affected by schizophrenia.
