The Department of Family Medicine’s Chester Fox, MD, and Linda Kahn, PhD, are co-investigators on an NIH trial involving 7,000 patients with complex comorbid conditions.

Family Med Faculty Collaborate on $5.8M Study of Chronic Disease

Published January 29, 2015

Faculty in the University at Buffalo’s Department of Family Medicine are playing key roles in a $5.8 million clinical trial to improve care and outcomes for patients with coexisting diabetes, hypertension and chronic kidney disease.

Chester Fox and Linda Kahn are among the co-investigators on the high-impact trial — one of only a handful to receive funding through the NIH’s Health Care Systems Research Collaboratory.

Chester Fox, MD, clinical professor, and Linda Kahn, PhD, research professor, are among the co-investigators on the five-year National Institutes of Health study — one of only a handful to receive funding through the NIH’s Health Care Systems Research Collaboratory.

Trial to Enroll 7,000 Patients

The NIH Collaboratory supports large-scale, high-impact clinical studies that engage health care systems as research partners.

This study — titled “Improving Chronic Disease Management with PIECES” — will enroll 7,000 patients from 254 practices in four health care systems in Texas and Connecticut.

Participants will receive integrated care enhanced by novel software.

The software, named PIECES, extracts data from electronic medical records in real time, helping physicians better manage patients’ treatment.

CKD Expert to Design Work Flow, Analyze Data

As the study’s primary care subject matter expert on chronic kidney disease, Fox will help design its work flow, ensuring that the trial seamlessly integrates into physicans’ everyday medical practice.

At study’s end, he will help analyze data to learn whether patients in the intervention group had lower mortality rates and fewer hospitalizations, readmissions and cardiovascular events than patients receiving standard care.

“This study uses computer support to help physicians better control disease states,” Fox says. “It gives information on your patients’ current status so you can medically manage three diseases at once instead of using a disease-specific approach.”

Medical Anthropologist to Design, Evaluate PROs

As the national evaluator for patient-reported outcomes, Kahn will design and evaluate the questionnaires patients complete during the trial.

“Patient-reported outcomes — or PROs — are becoming increasingly important in both research and clinical practice,” she explains. “They’re defined in different ways but, in general, these are self-reports by patients without interpretation by a health care provider.”

The study’s PROs will address a range of topics, including patients’ satisfaction with their care, their quality of life and the burden that managing their condition creates.

“If patients can provide this feedback, doctors can help them self-manage their chronic conditions,” Kahn notes.

“The PROs can help patients share their experiences with their doctor and can help the doctor develop a therapeutic alliance with their patients by understanding the barriers and challenges their patients face.”

Kahn also will evaluate health care providers’ feedback from the study to learn, among other things, whether the protocol improved their their ability to care for patients with complex comorbid conditions.

In conjunction with the study, she serves on an NIH Collaboratory work group to develop best practices for collecting and measuring PROs.

Oversight by NIDDK, NHLBI

Overseeing the study are the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung and Blood Institute.

NIH program officers actively serve on the research steering committee, a unique feature of the NIH Collaboratory study.

Miguel Vazquez, MD, of the University of Texas Southwestern Medical Center, is lead investigator.