Team tests strategies to care for patients with multiple diseases
Clinical trial offers model for studying the effectiveness of guideline-directed therapies in a diverse population
DALLAS – June 11, 2024 – In a large clinical trial, UT Southwestern Medical Center researchers developed a robust model for testing strategies to prevent health problems in patients with multiple chronic conditions. The study, published in the New England Journal of Medicine, addressed a lack of research on the effectiveness of guideline-directed therapies and included patients from racial groups who are typically underrepresented in clinical trials.
Miguel Vazquez, M.D., Professor of Internal Medicine and Clinical Director of the Division of Nephrology at UT Southwestern, said the trial was notable for taking place under real-world conditions. “We proved that it was possible to conduct a rigorous trial where patients from multiple large health care clinics are receiving care to test interventions for overlapping diseases that can cause serious complications and death,” he said.
Dr. Vazquez led the study with Robert Toto, M.D., Professor of Internal Medicine, Director of the Center for Translational Medicine, Medical Director of UT Southwestern’s Multi-Specialty Clinic, and Associate Dean of the UT Southwestern Clinical and Translational Science Award (CTSA) Program.
The co-occurrence of chronic health conditions is increasingly common in the U.S. Therapies based on clinical guidelines are often used to decrease hospitalizations and death for these patients, but there are barriers to receiving guideline-directed therapies, including physicians who are overwhelmed by the many demands of their patients.
The researchers evaluated whether providing physicians with additional support would improve health for patients living with a kidney-dysfunction triad of chronic kidney disease, Type 2 diabetes, and hypertension, which together pose a high risk for major cardiovascular issues and kidney failure.
They enrolled 11,000 adults with the kidney-dysfunction triad who were being treated at 141 primary care practices, including through Parkland Health, Texas Health Resources, and the VA North Texas Health Care System, all in Dallas-Fort Worth.
All patients had access to guideline-directed therapies such as blood pressure targets, immunizations, and education as a typical part of their care. Half of the patients received these therapies with the addition of an electronic algorithm to identify patients and practice facilitators assigned to support primary care providers at participating clinics.
“The interventions we tested are treatments that patients should be receiving, but they may not be,” Dr. Vazquez explained. “It’s difficult to address multiple complex problems at primary care practices where patients are seen for a short amount of time with limited resources.”
The team predicted that having facilitators support physicians and patient care would reduce health problems in kidney-dysfunction triad patients. However, there was no significant difference in outcomes between the two groups. Hospitalizations were reported in 20.7% of the intervention group and 21.1% in the usual-care group. Rates of emergency room visits were 24.3% for the intervention group and 22.6% for the usual-care group. Other outcomes – cardiovascular events, dialysis, and death – occurred at similar rates for both groups.
The project addressed the lack of research on the practical effects of guideline-based interventions in health care settings. Partnering with a private nonprofit, a public safety-net health care system, a veterans health care system, and a private health care system made the findings in this study broadly relevant to patients from diverse socioeconomic groups and racial/ethnic groups.
“We performed this study to gain insight on testing interventions to prevent health outcomes that are meaningful for patients, their families, and caregivers,” Dr. Toto said. “We’ve learned a lot about overcoming barriers to conducting a large, high-fidelity trial in a real-world situation and developed a platform that others can use to conduct similar studies.”
Other UTSW researchers from the Department of Internal Medicine who contributed to this study are Perry Bickel, M.D., Associate Professor and Chief of the Division of Endocrinology; Samir M. Parikh, M.D., Professor and Chief of the Division of Nephrology; Richard T. “Tyler” Miller, M.D., Professor of Internal Medicine and Vice Chair of the VA North Texas Health Care System; Susan Hedayati, M.D., Professor and Associate Vice Chair for Research in Internal Medicine; Jeffrey Hastings, M.D., Associate Professor of Internal Medicine in the Division of Cardiology and Chief of Staff at the VA North Texas Health Care System; and Blake Barker, M.D., Associate Professor of Internal Medicine and Associate Dean of Student Affairs for UT Southwestern Medical School. Other UTSW contributors from the Peter O’Donnell Jr. School of Public Health are Chul Ahn, Ph.D., Professor and Director of Biostatistics Shared Resource at the Harold C. Simmons Comprehensive Cancer Center, and Song Zhang, Ph.D., Professor and Director of Biostatistics, Epidemiology, and Research Design for the CTSA Program.
Dr. Vazquez is also the Chief of Nephrology at Parkland Health. Dr. Toto is also Professor in the O’Donnell School of Public Health. Dr. Hedayati is Director of Nephrology Clinical and Population Health Research.
A Distinguished Teaching Professor, Dr. Toto holds the Mary M. Conroy Professorship in Kidney Disease. Dr. Bickel holds the Daniel W. Foster, M.D. Distinguished Chair in Internal Medicine. Dr. Miller, who is also a Professor in the Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, holds the Jacob Lemann, M.D. Professorship in Calcium Transport. Dr. Parikh holds the Robert Tucker Hayes Distinguished Chair in Nephrology, in Honor of Dr. Floyd C. Rector, Jr. and the Ruth W. and Milton P. Levy, Sr. Chair in Molecular Nephrology.
The trial was funded by the National Institutes of Health, which included a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NCT02587936).
About UT Southwestern Medical Center
UT Southwestern, one of the nation’s premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty members have received six Nobel Prizes and include 25 members of the National Academy of Sciences, 21 members of the National Academy of Medicine, and 13 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 3,100 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in more than 80 specialties to more than 120,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 5 million outpatient visits a year.
About Parkland Health
Parkland Health is one of the largest public hospital systems in the country. Premier services at the state-of-the-art Parkland Memorial Hospital include the Level I Rees-Jones Trauma Center, the only burn center in North Texas verified by the American Burn Association for adult and pediatric patients, and a Level III Neonatal Intensive Care Unit. The system also includes two on-campus outpatient clinics – the Ron J. Anderson, MD Clinic and the Moody Outpatient Center – as well as more than 30 community-based clinics and numerous outreach and education programs. By cultivating its diversity, inclusion, and health equity efforts, Parkland enriches the health and wellness of the communities it serves. For more information, visit parklandhealth.org.