Candidate: After training as a clinical nephrologist in Milan, Italy, I moved to the United States to pursue a career in outcomes research. Working as the Assistant Medical Director of the Quality Management Department of Dialysis Clinic Inc. (DCI), a large dialysis organization, I developed a keen interest in the delivery of high-quality care as a means to improve outcomes of hemodialysis (HD) patients. In 2007 I joined Arbor Research Collaborative for Health (Arbor Research) as a research scientist and have played an increasingly valuable role as a core member of the research team for the international Dialysis Outcomes and Practice Patterns Study (DOPPS), a 12-country prospective cohort study of HD practices. I also contribute to the newly launched DOPPS Practice Monitor and to the CMS End Stage Renal Disease (ESRD) Quality Measures Project. In my professional roles I have collaborated with leaders in clinical epidemiology in chronic kidney disease (CKD) and ESRD. My research efforts so far have led to 19 peer-reviewed articles (6 as first author) in major journals, 11 invited publications and presentations at professional meetings, including the American Society of Nephrology. Career goals: My long-term professional goal is to become an independently funded investigator and to make important contributions in outcomes research in kidney failure by identifying modifiable clinical practices that may improve the quality of care in HD. My previous experiences have set the foundation for my current research interest. The K01 Award will serve as a spring-board towards this long-term goal by providing me support and protected time to achieve the following immediate goals during the award period: (a) obtain guidance and learn a specific set of skills from each of my outstanding mentors; (b) receive formal graduate- level training in clinical research, especially epidemiology and biostatistics; (c) complete the proposed research project and publish results in major biomedical journals; (d) apply for and secure independent funding. Career development plan: My career development plan will allow me to leverage the strengths of two leading research institutions: Arbor Research in Ann Arbor MI, and Vanderbilt University Medical Center (VUMC) in Nashville TN. Arbor Research will provide me with the opportunity to be mentored by highly-qualified investigators with whom I have an established relationship (Drs. Bruce Robinson, Robert Merion and Brenda Gillespie), a unique research infrastructure, and the ready accessibility of DOPPS data. These resources will be complemented by those at VUMC, including close mentorship by Dr. T. Alp Ikizler, interactions with other patient-oriented researchers and clinicians, and a vibrant scientific environment. I will spend one week per month in Ann Arbor and the rest of the time in Nashville, where I live for family reasons. I have designed a detailed communication strategy that will ensure productive mentorship and collaborations at both institutions. Each member of my outstanding mentorship committee will provide complementary expertise. As the didactic component of my plan, I will obtain a Master of Science in Clinical Investigation by attending the VUMC program, a highly successful training platform which is directed by Dr. Ikizler. Environment: Arbor Research is a not-for-profit organization that leads health outcomes studies in chronic disease and end-stage organ failure, including the DOPPS, the Scientific Registry of Transplant Recipients (SRTR), and numerous studies for the U.S. Department of Health and Human Services. Arbor Research's multidisciplinary, team-based approach is ideally suited to this mentorship program. VUMC is a major university-based research center with a strong track record in supporting the career of junior investigators. The resources at VUMC provide an environment robust in patient-oriented research and a wide range of career development and didactic opportunities. Research plan: In an effort to improve dialysis patient outcomes, increasing attention is paid to the delivery of high-quality care by acting on modifiable factors. Dialysis providers often use the facility proportion of patients meeting practice guidelines (CPG) targets as an indicator of quality of care delivered. Mortality risk of patients treated in dialysis units with greater achievement of quality indicators is lower, and certain quality indicators will soon affect the dialysis reimbursement rate in the US. However, facility achievement of multiple quality indicators is generally rare, and the combination of quality indicators that is associated with the best patient outcomes remains to be identified. Quality DOPPS is an ancillary study to the DOPPS that is designed to identify practices associated with achievement of facility quality indicators and the impact of these indicators on patient outcomes. Using data from a contemporary HD cohort and current CPGs, the combination of key facility quality indicators associated with best patient survival will be identified and incorporated in an aggregate quality index (Aim 1), which could serve as a powerful continuous quality improvement (CQI) tool. Quality DOPPS will also identify clinic practices and services that are associated with greater achievement of key quality indicators (Aim 2). Findings from Quality DOPPS will inform the design of an interventional study to test the efficacy of specific CQI tools and practices on facility quality indicators and patient outcomes, which will be the focus of future applications for independent research funding.
Patients on hemodialysis have high mortality and hospitalization rates, and generally poor quality of life. Delivery of high-quality care may help to improve patient outcomes, but caregivers lack complete information about which practices to focus on to ensure the best quality of care. The Quality Dialysis Outcomes and Practice Patterns Study ('Quality DOPPS') will fill this knowledge gap by identifying the combination of key clinical indicators associated with the lowest mortality risk, and modifiable practices that are able to impact these indicators.
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