Clinical research programs in the division of general internal medicine are focused in a number of areas and units within the Division as noted below.
Extramural funding by full-time faculty is derived from the National Institutes of Health, foundations such as the Foundation for Informed Medical Decision Making, U.S. Department of Veterans Affairs and industry.
Center for Clinical Effectiveness
Research and clinical practice activities of the Center bring together staff and faculty as well as investigators from a broad range of disciplines and departments. The primary focus areas for the Center are:
Decision Analysis, Patient-Centered Decision Making, and development of Decision Support Tools
A major strategic goal of the Center is the development of a suite of decision analytically driven decision support tools. These will take a variety of forms, including interactive web pages, and ultimately integration into the electronic health record and computerized physician order entry. The tools will be designed to help clinicians as well as patients and their families grapple with complicated therapeutic and diagnostic decisions.
Decision analytic models can synthesize comparative effectiveness data from multiple clinical studies, as clinical trials seldom perform head-to-head comparisons of all of the treatment alternatives clinicians have for any particular disorder. In addition, these tools can incorporate patient preferences and values for health outcomes, which are of particular importance for preference sensitive decisions in which patients are trading off significant treatment side effects and adverse outcomes in the hopes of preventing further disease progression.
One example of such a decision support tool (DST) is an interactive Web page-based DST providing recommendations for anticoagulation therapy for patients with non-valvular atrial fibrillation. In a related project, investigators in the Center have active funding to develop adjuncts to atrial fibrillation practice guidelines that allow the incorporation of patient values for health outcomes in the decision regarding antithrombotic therapy.
Another actively funded area of investigation is the development of decision support tools to aid obese patients in making decisions regarding bariatric surgery. This work has also focused specifically on patients with diabetes. Projects are also investigating psychosocial, clinical, and socio-demographic determinants of decision-making and satisfaction with decisions about bariatric surgery.
Faculty in the Center teach courses in the University of Cincinnati’s Master’s degree program in Clinical and Translational Sciences on Decision Analysis and Cost-Effectiveness Analysis.
The Center also hosts a weekly Decision Modeling Seminar in which a multi-disciplinary group of faculty, fellows, and residents interested in performing decision analyses meet to work on their modeling projects. Dr. Eckman is also faculty in the Master of Public Health program at L’Ecole des Hautes Etudes en Santé Publique in Paris, where he teaches a week-long course each year on Decision and Cost-Effectiveness Analysis in Public Health.
Health-related Quality of Life Research
The Center is actively engaged in health-related quality of life research both locally and nationally. Recent studies have focused on health status and health values in patients with HIV/AIDS, patients co-infected with HIV and hepatitis C, adolescents transitioning into adulthood with chronic diseases such as inflammatory bowel disease, hepatitis C infection, and end-stage liver disease.
A recently completed NIH-funded multi-site study focused on spirituality and health values of patients co-infected with HIV and hepatitis C.
VA-funded studies have examined spirituality and the will to live in Veterans with HIV/AIDS, and non-health related mediators of adherence and health values of Veterans with HIV/AIDS. Currently funded work includes the evaluations of impact of complementary and alternative medicine approaches on health-related quality of life in adolescents with chronic diseases such as asthma and sickle cell anemia.
At the policy level, the Center conducts cost-effectiveness analyses of diagnostic, treatment and screening strategies for both adults and children. Areas of particular interest include the management of anticoagulation therapy in atrial fibrillation and venous thromboembolic disease, public health screening strategies for hepatitis B and C infections, neonatal infections, and HIV/AIDS. In addition, through collaboration with the College of Pharmacy, Center staff and Fellows investigate pharmacoeconomic issues such as the impact of obesity on costs and outcomes of kidney transplantation.
Outcomes Research and Comparative Effectiveness
The Center is active in outcomes and effectiveness research in many areas, both locally and nationally. Local projects involve the Veterans Affairs Medical Center and the Children’s Hospital Medical Center. In conjunction with the Section of Outcomes Research in the Division of General Internal Medicine, the Center holds a regular multidisciplinary Outcomes Research Conference, which is a seminar for persons interested in conducting outcomes research.
Examples of recent projects include the examination of racial disparities in the use of inhaled steroid therapy for children with asthma and the impact of these disparities on health outcomes, racial disparities in exposure and metabolism of environmental tobacco smoke, and racial differences in the prescribing of warfarin for patients with non-valvular atrial fibrillation in Ohio Medicaid patients.
Quality of Care and Patient Safety
The Cincinnati VA Medical Center is one of only four VA hospitals with a Patient Safety Center. This program has spearheaded local and national efforts to improve quality of care and reduce medical errors. In collaboration with colleagues at the Veterans Affairs Medical Center, Center faculty have conducted studies of severity of illness in intensive care including a severity of illness model for ICU patients throughout the VA system.
Outside of the VA setting Center faculty have explored the impact of a computerized Atrial Fibrillation Decision Support Tool on clinical outcomes; predictors of warfarin use in a cohort of 11,000 Ohio Medicaid patients with non-valvular atrial fibrillation; psychosocial and clinical predictors of adverse events (bleeding or thrombosis) in Ohio Medicaid patients receiving anticoagulant therapy; and the impact of Computerized Physician Order Entry (CPOE) at University and Christ Hospitals on various process measures and the rate of medication errors.
Mentoring & Teaching
Senior faculty of the Center have been training fellows and mentoring faculty and residents for more than 20 years. Drs. Tsevat and Eckman have been one-on-one mentors repeatedly for members of both the Society of General Internal Medicine and the Society for Medical Decision Making.
Dr. Tsevat has taught courses and presented invited workshops on mentoring at both societies. Dr. Tsevat also co-directs the Clinical Epidemiology and Clinical Effectiveness track in the University of Cincinnati’s Masters in Clinical and Translational Sciences program and teaches a course in that program entitled “Clinical Research Scholars Seminar.”
Dr. Tsevat also is co-PI on the University of Cincinnati’s Clinical and Translational Science Award (CTSA).
Dr. Eckman co-directs the Research Informatics track in the Master’s degree program, and under the auspices of the National Center for Research Resources of the NIH, has been working on developing a distance learning curriculum for the Research Informatics track.
Dr. Schauer was recently appointed Director of Resident Research for the College of Medicine’s Department of Internal Medicine.
Center for Health Informatics
The UC Center for Health Informatics (CHI) was established in 2006 with the support of the Dean of the College of Medicine and the Director of the Department of Public Health Sciences.
CHI is currently funded by the CCTST, the Dean’s office, and charge back for services.
CHI provides informatics support to CCTST. As an example, the Research Record system has been developed by CHI and CCTST. This application provides for CCTST membership enrollment as well as tracking of services from CCTST to investigators. The Research Record has gained national attention and shared with other CTSA sites.
The major projects underway with CCTST are developing the next enhanced version of the Research Record, major revision of the CCTST website, and development of tracking assisted investigator outcomes. The latter is development of the strategy and foundations for tracking AHC researcher successes as measured publications, grants, grant submissions, IRB studies, and collaborations with other investigators.
The core mission of CHI is to assist in providing data to researchers from the adult patient care systems. This service has grown dramatically in 2011, providing more than 75 data sets to various individuals for both research and quality improvement efforts.
CHI has become the first choice for many requests, as evidence by the continued increase in requests of both returning and new investigators. CHI works closely with UC Health IT, UH research support, and other operational groups to satisfy the data needs in the most efficient and highest quality manner.
CHI is positioned to be the Informatics group supporting Epic for research and advanced analytics. CHI is implementing SAP Business Objects as a Business Intelligence (BI) platform using the Centricity EMR data set. This capability will be expanded to Epic in the next twelve months. This functionality will expand the information available from Epic and is line with Epic’s recommended strategy for large organizations wishing to mine data.
We provide additional services to researchers on study design, data management, data set coding, data set transformations, and general consultation on data access and mining from the clinical systems.
Other areas focused on clinical and implementation research include:
Sickle Cell Disease
Medicine-Pediatrics faculty in the Division have received HRSA funding to establish a medical home for patients with sickle cell disease who are transitioning from pediatric to adult care. Infrastructure is being developed to coordinate care between the medical home, pediatric and adult sickle cell centers at Cincinnati Children's Hospital Medical Center and The University Hospital, and between community primary care sites, and address patients' educational needs about sickle cell disease and its complications.
Faculty in our division have made pioneering advances in investigating the impact of hormonal fluctuations in the pathogenesis of migraine headaches. This has resulted in numerous clinical trials investigating among other topics, hormonal manipulation therapy in the control and prevention of migraine headache.
Medical Education Research
Faculty in the Division of General Internal Medicine have conducted a number of studies examining the impact of various educational and operational innovations in the residency program, particularly related to the EIP (Educational Innovations Program) award granted by the ACGME. Other research foci have included predicting performance of housestaff on standardized certifying examinations, and medical student self-assessment using matrix evaluation, and the effect of changes in duty hours on resident education and patient care.
Fernald Project - Data and Specimen Sharing
Individuals and groups interested in using the FMMP database and samples for health-related research may apply for Access to Data and/or Frozen Biologic Specimens. If approved by the Fernald Trustee, with the advice of the FMMP Citizen's Advisory Committee, data files from the FMMP database or archived samples (frozen whole blood, serum, plasma and urine) may be distributed to qualified researchers.
Any individual or group desiring access to the FMMP database or archived samples for purposes of analysis must first submit an application to the FMMP Project Director, Dr. Robert Wones, who, in turn, will first obtain input from the Fernald Citizens' Advisory Committee, and then will present the application to the Fernald Trustee with the recommendation of the Fernald Citizens' Advisory Committee and his recommendation.
Continuing Participation is Important for Future Research
Future research studies (epidemiological studies) will track changes in health status over time and 2) explore the relationship between exposure to materials released from the Fernald Feed Materials Production Center (FMPC) and health effects. To achieve these research objectives, it is important for us to continuously update information on the health status of program participants.
We obtain this information by three different means: 1) medical examinations provided by the program; 2) yearly questionnaires mailed to program participants; and 3) when necessary, from outside medical records obtained with permission of the participant. When a participant dies, we record the medical cause of death as noted on the death certificate. We either obtain a copy of the death certificate from the family or access the information through the National Death Index.
A very important function of the yearly questionnaire is to update changes in health status, which occur between examinations. This yearly contact helps us to be better prepared for the next examination. If the participant elects not to have an examination, the information from the yearly questionnaire gives us information on new medical problems, and allows us to follow-up on important diagnoses such as new cases of cancer.
The yearly questionnaire also helps us keep current on our contact information for each participant (name, address, phone number and last name changes).
As we become aware of changes in the health status of the program participants, we may request their permission to obtain appropriate medical records (such as biopsy reports, hospital discharge summaries or reports of CT scans). All of the data described above will form the basis for subsequent epidemiological studies as envisioned in the Fernald Settlement Agreement.