Dallas, Texas - UT Southwestern Medical Center - in collaboration with Parkland Health & Hospital System, Texas Health Resources, VA North Texas Health Care System, and ProHealth Physicians, Inc. of Connecticut - will lead the first National Institutes of Health-funded, multicenter, clinical trial to address interventions for patients with multiple chronic conditions centered around kidney disease.
The five-year study will look at individuals with three commonly associated diseases – chronic kidney disease (CKD), diabetes, and hypertension – across a variety of healthcare settings, to determine which practices are most effective in reducing hospitalizations, readmissions, cardiovascular events, and mortality. About 14 percent of the adult population in the U.S. have chronic kidney disease, about 10 percent have diabetes, and about 33 percent has hypertension. Moreover, about half of those with CKD have diabetes, and a large proportion have hypertension.
“Most of the prior studies have focused on each disease in isolation, which is not the real world for clinicians. Many people have kidney disease plus diabetes plus high blood pressure or other issues. We want to study what are the most effective treatments for patients with multiple coexistent diseases,” said Dr. Miguel Vazquez, principal investigator for the national trial, Professor of Internal Medicine, Clinical Director of Nephrology, and Medical Director of Kidney Transplantation at UT Southwestern. “The idea is to make findings from this study applicable to as many patients as possible. We want to identify the patients that could benefit from these interventions, then implement a model of integrated health care delivery based on best clinical practices.”
Key to this model is delivery of evidence-based interventions in collaboration with primary care practitioners in the community setting where patients receive most of their care.
“Dr. Vazquez’s project puts UT Southwestern on the playing field with the most prestigious academic health centers conducting clinical and translational research anywhere in the world. This innovative research project to improve outcomes in these three crippling chronic diseases using cutting edge information technology is real “meaningful use” of the electronic health record,“ said co-principal investigator Dr. Robert Toto, Associate Dean for Clinical and Translational Science, and Professor of Internal Medicine and Clinical Sciences, who holds the Mary M. Conroy Professorship in Kidney Disease.
The project, called Improving Chronic Disease Management with PIECES (ICD Pieces), will be primarily overseen by the National Institute of Diabetes and Digestive and Kidney Diseases and secondarily by the National Heart, Lung, and Blood Institute. It is one of three recent research awards totaling up to $19.4 million over five years and supported by the NIH Health Care Research Collaboratory to address the growing proportion of the U.S. population that has multiple chronic medical conditions.
The study relies on a novel information technology platform called PIECES, developed by Dr. Ruben Amarasingham, President and Chief Executive Officer of the Parkland Center for Clinical Innovation (PCCI) and a co-investigator on the study. The PIECES platform will utilize electronic health record data for data collection, early disease detection and monitoring and care coordination for patients with chronic medical conditions. PIECES extracts data from electronic health records to identify and sort in real time patients at high risk for adverse clinical events. This process helps providers improve patient safety and care quality by allocating resources to the right patients at the right time.
“We are thrilled to be collaborating with such high-caliber health care systems,” said Dr. Amarasingham, Associate Professor of Internal Medicine and Clinical Science at UT Southwestern. “The unique opportunity to work in partnership to use research and technology to improve the health of patients is humbling.”
The four participating systems — Parkland Health & Hospital System, Texas Health and Resources System, VA North Texas Health Care System, and ProHealth Physicians, Inc. — were selected to make the results broadly applicable across various patient populations and various types of health care systems, including safety net hospitals, facilities caring for veterans, accountable care organizations, and private hospital systems.
“Texas Health Resources continues to benefit from our collaboration with PCCI and UT Southwestern,” said Dr. Ferdinand Velasco, Chief Health Information Officer for Texas Health Resources. “We believe this project, which leverages our investment in health information technology, will help us enhance care for patients with chronic diseases. The study aligns well with Texas Health’s focus on physician-directed population health that helps our patients live healthy and productive lives.”
ProHealth Physicians of Connecticut cares for an outpatient population of approximately 350,000, including 90,000 with hypertension, 26,000 with diabetes, and 25,000 with kidney disease, said John Lynch, Vice President of Research and Government Affairs at ProHealth.
“In order for us to provide optimal patient-centered care, it is essential to identify disease at its earliest stages, segment our population by predictable risk, identify the optimal interventions by risk category, and adjust care plans for patient-specific circumstances, especially accounting for interactions for those with multiple chronic conditions, and achieve the triple aim – appropriate access, highest quality, at lowest possible cost,” said Mr. Lynch.
Currently 8,404,602 veterans are enrolled in the VA system nationally. The prevalences of CKD, diabetes and hypertension are 20 percent, 34 percent, and 68 percent, respectively, which are all higher than corresponding percentages of patients enrolled in Medicare.
“We are so excited that the VA North Texas Health Care System is included as a site as the VA is the largest integrated health care delivery system in the U.S. that provides care to CKD patients,” said Dr. Susan Hedayati, Associate Professor of Internal Medicine at UT Southwestern Associate Director of the Nephrology Fellowship Training Program, nephrologist at the VA North Texas Health Care Center, and co-investigator on the study at the VA. “Although effective treatments for these three conditions have been established, the challenge remains in widely translating such treatments to clinical practice and affecting clinical outcomes. Effective treatment of these three comorbid conditions by primary care physicians in turn may lessen the rate of progression to end-stage renal disease and use of specialized health care resources, such as nephrology, interventional radiology, and vascular surgery, and lead to not only decreased morbidity and mortality, but also overall decreased health care costs.”
The grants are funded through the National Institutes of Health’s (NIH) Health Care Systems (HCS) Research Collaboratory, which engages health care systems as research partners in conducting large-scale clinical studies. The HCS Research Collaboratory, created by NIH in 2012, currently supports five large-scale clinical trials with partnering health care systems across the United States and a Collaboratory Coordinating Center at Duke University. The funds are managed through the NIH Common Fund, which encourages collaboration and supports a series of exceptionally high-impact, trans-NIH programs.