NIH Funds 1st Multicenter Clinical Trial

About 14 percent of the adult population in the U.S. have chronic kidney disease, 10 percent are diabetic, and 33 percent have hypertension.  Also, about half of people with chronic kidney disease are diabetic and a large proportion have high blood pressure.

The University of Texas Southwestern Medical Center www.utsouthwestern.edu in collaboration with the Parkland Health & Hospital System www.parklandhospital.com, Texas Health Resources www.texashealth.org, VA North Texas Health Care System www.northtexas.va.gov, and ProHealth Physicians, Inc. of Connecticut www.prohealthmd.com are going to lead the first NIH-funded multicenter clinical trial.

The five year study will look at the long term complications associated with chronic kidney disease, diabetes, and hypertension across healthcare settings and determine which practices are most effective in reducing hospitalizations, readmissions, cardiovascular events, and mortality.

Most prior studies have focused on each disease in isolation, which is not the real world for clinicians. “We want to study the most effective treatments for patients with multiple coexistent diseases,” said Dr. Miguel Vazquez, Principal Investigator for the National Trial, Clinical Director of Nephrology, and Medical Director of Kidney Transplantation at UT Southwestern.

The project, called “Improving Chronic Disease Management with PIECES” or (ICD Pieces) is going to be overseen by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) www.niddk.nih.gov and secondarily by the National Heart, Lung, and Blood Institute www.nhlbi.nih.gov.

The study uses a novel information technology platform called PIECES, developed by Dr. Ruben Amarasingham, President and CEO of the Parkland Center for Clinical Innovation and a Co-Investigator on the study. The PIECES platform uses EHR data to collect data and uses the EHR to detect people at high risk for adverse clinical events.

This project is one of three recent research awards totaling up to $19.4 million over five years funded by the NIH Health Care Systems Research Collaboratory www.nihcollaboraory.org to address the U.S population with multiple chronic medical conditions.

The NIH Health Care Systems (HCS) Research Collaboratory works with research partners at healthcare systems to conduct large-scale clinical studies. The Research Collaboratory currently supports five large scale clinical trials with partnering healthcare systems across the U.S plus a Collaboratory Coordinating Center at Duke University.

The goal is to identify disease at its earliest stages, segment the population by predictable risk, identify the optimal interventions by risk category, and adjust care plans for patient-specific circumstances especially for individuals with chronic diseases.