RTI DEcIDE Center Ongoing Projects
Comparative Effectiveness of Oral Hypoglycemics for Reducing Diabetic Nephropathy
This project follows from the systematic review on the comparative effectiveness and safety of oral diabetes medications for adults with type 2 diabetes (Bolen et al., 2007). We will evaluate the comparative effectiveness of sulfonylureas, metformin, thiazolidinediones (and combinations) on clinically significant renal outcomes as measured by the development of and progression through stages of chronic kidney disease (CKD). We will also examine use of these medications in elderly patients (≥65 years) and in patients with cardiac, psychiatric, or renal comorbidities. In particular, we will (1) examine the effects of these oral hypoglycemics on the prevalence of type 2 diabetes-related renal complications at several points in time following an initial diabetes mellitus diagnosis, incorporating National Kidney Foundation guidelines, and (2) target the dearth of information on physician prescribing and comparative effectiveness of frequently used oral diabetes medications in patients 65 years and older or with common comorbidities (CHF, CAD, psychiatric conditions, or CKD). To evaluate the influences of these oral hypoglycemics on renal complications and the influences of age or comorbidities on drug effectiveness, we will use data from the Baylor Health Care System (BHCS) in Dallas, Texas and the Christiana Care Health System (CCHS) in Delaware for newly diagnosed diabetes patients. BHCS and CCHS have implemented the same type of electronic medical records in all of their primary care clinics, the clinical information from which will be used for this analysis.
For additional information on this project, please contact Suzanne West, MPH, PhD.
Computer-based Clinical Decision Support Tools for Gene-based Tests Used in Breast Cancer
The project will develop and test four clinical decision support (CDS) tools regarding gene-based tests for breast cancer susceptibility, prognosis, and treatment.
The first pair of tools will assess a woman's suitability for testing for BRCA1 and BRCA2 gene mutations, which are associated with familial forms of breast cancer. One tool (Patient BRCA tool) will be designed for use by patients and the other tool (Integrated BRCA tool) will be designed for use by primary care providers.
- The Patient BRCA Tool will (1) assist in collection of family history of cancer to assess the risk of carrying the BRCA1 or BRCA2 gene mutations and (2) assist in making decisions for appropriate follow up. The tool will be completed by women in their homes prior to their office visit to a primary care provider.
- The Integrated BRCA Tool will use family history information to guide primary care providers through the process of discussing the woman's family history, cancer risk, and the recommendation for or against genetic counseling and BRCA testing.
The second pair of tools will (1) assist in determining which breast cancer patients are eligible for a Gene Expression Profiling (GEP) test and (2) assist in making appropriate treatment decisions based on GEP test results, risks, and benefits of adjuvant chemotherapy and patient preferences. One tool (Provider Only GEP Tool) will provide passive decision support to the clinician, and the other tool (Shared Decision-making Tool) will provide active decision support to the patient and the clinician.
- The Provider Only GEP Tool will synthesize patient-specific factors and facilitate oncologists' identification of general clinical guidelines about GEP testing and recommendations for adjuvant chemotherapy.
- The Shared Decision-making GEP Tool will (1) provide information customized for the individual patient and (2) guide the patient and oncologist through the testing and treatment decision-making process.
A focused literature search and input from experts will guide development of the tools. The accuracy and usability of each tool will also be assessed. In addition, we will assess the feasibility of integrating these tools into electronic medical records and their impact on clinical work flow. We will evaluate the impact of these tools on short-term outcomes using a cluster randomized control trial design.
For additional information on this project, please contact Linda Squiers, PhD.
Research Methods for Clinical Effectiveness Studies: Symposium and Journal Supplement Part II (2008-2010)
To further the methods agenda for the Agency for Healthcare Research and Quality (AHRQ), the RTI DEcIDE Center will organize and convene a symposium in spring 2009 that will focus on emerging methods in comparative and clinical effectiveness research. This is a direct follow-on to a similar effort on Emerging Methods in Comparative Effectiveness and Safety and papers published in Medical Care in 2007.
In Part II, we expect to focus on themes of clinically relevant heterogeneity for study populations (e.g., disease severity, some sociodemographic characteristics), data collection modalities including designs for prospective data collection, and incorporation of patient-reported outcomes as they relate to effectiveness studies done as a part of AHRQ's Effective Health Care (EHC) program, established in response to the Medicare Modernization Act. Exact topics for this symposium will be determined following stakeholder interviews and discussions with a planning committee. The symposium will provide opportunities for researchers, clinicians, providers, and policymakers to assess and discuss the latest methods, which will help increase the quality of research that is to be translated into policy.
Addressing heterogeneity (or lack of it) in effectiveness studies and measuring patient-reported outcomes involve issues that include, although are not limited to, study design, analysis and statistics, and reporting for clinical, research, policy, and perhaps lay audiences. They are generalizable to several areas of concern for AHRQ's EHC program; thus, they are broadly relevant and applicable to the DEcIDE network, AHRQ's Centers for Education and Research in Therapeutics (CERTs), the Evidence-based Practice Center program, and other audiences from both the public and private sectors. For example, distributed data network research (like that supported by AHRQ) faces challenges of accounting for differences and similarities in patient populations within the networks and of controlling for confounders. Similarly, "coverage with evidence development" activities on the part of payers raises questions, such as selection bias, pertinent to both trials and observational or quasi-experimental studies. Broad concerns arise with prospective data collection in general; narrow concerns can include use of newer analytic techniques of marginal structural modeling.
The DEcIDE Center together with AHRQ will announce a special call for abstracts in early winter 2009. As with the first symposium, presenters will then have an opportunity to submit their papers for publication in a peer-reviewed journal in late 2009 or early 2010.
For additional information on this project, please contact Kathleen Lohr, PhD.
Advancing Research Methodology for Measuring and Monitoring Patient-Centered Communication in Cancer Care (2007-2009)
This project, sponsored by the National Cancer Institute through the AHRQ DEcIDE program, will lay the groundwork for creating a measurement and monitoring system that will facilitate ongoing assessment, tracking, and improvement of the various functions of patient-centered communication (PCC) in cancer care. The specific objectives are threefold: (1) to develop a comprehensive inventory of the domains and subdomains that characterize the six PCC functions related to an NCI conceptual framework of PCC; (2) to develop an inventory of existing measures suitable for measuring these domains and subdomains and identify methods suitable for collecting reliable and valid longitudinal data on them; and (3) to conduct a scientific symposium on research methods for measuring and monitoring PCC in cancer care.
For additional information on this project, please contact Lauren McCormack, PhD.
Evaluation of a Medication Therapy Management Program on Patient Safety in Medicare Beneficiaries at High Risk of Adverse Drug Events (2007-2009)
The Medication Therapy Management (MTM) project is a prospective, multicenter randomized trial involving a pharmacist-based intervention to help older patients manage their drug therapies. The intervention comprises three main components: (1) reconciling medications (reviewing medications and dosages for patients' conditions and looking for possible interactions); (2) assessing drug-related problems (DRPs) that patients report; and (3) resolving DRPs through a pharmacist-based intervention. Patients are randomized to one of three arms: (1) a usual care (control) arm, (2) a basic MTM arm relying on patients' reporting information to the pharmacist, or (3) an enhanced MTM arm in which pharmacists receive summarized medical record information in addition to patient report.
This trial tests the hypothesis that patients enrolled in this MTM program will have fewer adverse drug events than patients in usual care. Adding access to patient-specific information, such as patient demographics, medical history, laboratory values, and medications, to an MTM program can further reduce adverse drug events and, by association, emergency department visits and hospitalizations. Patients receiving the MTM intervention will have more drug-related problems identified, fewer discrepancies in their medication lists, and a higher recommendation acceptance rate by their primary care physicians than those with usual care. Furthermore, patients in the two intervention arms are expected to have a higher degree of satisfaction with their medication regimen and greater overall satisfaction with their health care than patients receiving usual care.
The study is being conducted at three sites: the University of Illinois at Chicago, the Duke Primary Care Research Consortium, and the Baylor Geriatrics Center (BGC) of the Baylor Health Care System in Texas, which is a clinical partner of the RTI DEcIDE Center. The BGC is a convenient neighborhood medical facility with staff specializing in the care of older adults.
Enrollment of 400 subjects will begin in the 2007-2008 period. The project is expected to be completed in 2009. RTI staff include Linda Lux, M.P.A, the RTI Study Director, and Kathleen Lohr, Ph.D., RTI Distinguished Fellow. Andrew Masica, M.D., M.P.H., of BHCS, leads the clinical project for the RTI DEcIDE Center.
For further information on this project, please contact Linda Lux, MPA.
rti.org