University of Texas Southwestern Medical Center has announced that it will lead the first of its kind multi-center clinical trial dedicated to address the needs of patients suffering from a series of chronic kidney conditions. The trial will be funded by the National Institutes of Health (NIH) and will be conducted in partnership with Parkland Health and Hospital System, Texas Health Resources, VA North Texas Health Care System, and ProHealth Physicians, Inc. of Connecticut.
Over the course of five years, the research team will analyze data on patients with chronic kidney disease (CKD), diabetes, and hypertension through several healthcare settings in order to understand the most effective practices able to decrease hospitalizations, readmissions, cardiovascular events, and mortality. The main purpose of the study is to reduce the burden of chronic kidney diseases, since 14 percent of U.S. adults are diagnosed with chronic kidney disease, while about 10 percent are diabetic, and 33 percent suffer from hypertension. For those with CKD, half have diabetes, and a high percentage are also diagnosed with hypertension.
“Most of the prior studies have focused on each disease in isolation, which is not the real world for clinicians,” explained the principal investigator for the national trial, Miguel Vazquez, who serves as professor of Internal Medicine, Clinical Director of Nephrology, and medical director of Kidney Transplantation at UT Southwestern. “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. 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,” Vazquez added.
The research project, which is entitled Improving Chronic Disease Management with PIECES (ICD Pieces), will be based on the interventions evidence model, as well as on the primary care practitioners in the community setting, which is where patients receive most of their care. In addition, it 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.
PIECES is the novel information technology platform that the study will be based on, which collects electronic health record data for early disease detection and monitoring, as well as provides chronic medical condition patients with coordinated care. In addition, the platform extracts information from electronic health records to determine high risk patients and adverse clinical events in real time, which is thought to improve both safety and quality of care, as it allocates resources to the right patient at the right time.
PIECES was developed by the president and chief executive officer of the Parkland Center for Clinical Innovation (PCCI), associate professor of Internal Medicine and Clinical Science at UT Southwestern and a co-investigator on the study, Ruben Amarasingham. “We are thrilled to be collaborating with such high-caliber health care systems. The unique opportunity to work in partnership to use research and technology to improve the health of patients is humbling,” he said.
Parkland Health and Hospital System, Texas Health and Resources System, VA North Texas Health Care System, and ProHealth Physicians, Inc. were the four systems chosen to participate in the trial in order to enlarge in applicability to more patient populations and more types of health care systems, such as 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,” stated Ferdinand Velasco, the 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.”
In addition, ProHealth Physicians of Connecticut provides healthcare to a population of about 350,000 people, including 90,000 patients suffering from hypertension, 26,000 from diabetes, and 25,000 from kidney disease, according to the vice president of Research and Government Affairs at ProHealth, John Lynch.
“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,” Lynch said.
The VA North Texas Health Care System, on the other hand, enrolls currently 8,404,602 veterans, 20% of them with CKD, 34% with diabetes and 68% with hypertension, a much higher prevalence than the one registered in Medicare patients. “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 the associate director of the Nephrology Fellowship Training Program, nephrologist at the VA North Texas Health Care Center, associate professor of Internal Medicine at UT Southwestern, and co-investigator on the study, Susan Hedayati.
“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,” she added.
This major trial is being made possible by the five-year NIH Health Care Systems Research Collaboratory grants awarded, on a total of $19.4 million, with the purpose of supporting research for multiple chronic medical conditions affecting the U.S. population.