Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study.
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2024-07
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Abstract
Background/objective
Slowing the progression of diabetic kidney disease (DKD) is critical. We conducted a randomized controlled trial to target risk factors for DKD progression.Methods
We evaluated the effect of a pharmacist-led intervention focused on supporting healthy behaviors, medication management, and self-monitoring on decline in estimated glomerular filtration rate (eGFR) for 36 months compared with an educational control.Results
We randomized 138 individuals to the intervention group and 143 to control. At baseline, mean (SD) eGFR was 80.7 (21.7) mL/min/1.73m2, 56% of participants had chronic kidney disease and a history of uncontrolled hypertension with a baseline SBP of 134.3 mm Hg. The mean (SD) decline in eGFR by cystatin C from baseline to 36 months was 5.0 (19.6) and 5.9 (18.6) mL/min/1.73m2 for the control and intervention groups, respectively, with no significant between-group difference (P=0.75).Conclusions
We did not observe a significant difference in clinical outcomes by study arm. However, we showed that individuals with DKD will engage in a pharmacist-led intervention. The potential explanations for a lack of change in DKD risk factors can be attributed to 5 broad issues, challenges: (1) associated with enrolling patients with low eGFR and poor BP control; (2) implementing the intervention; (3) limited duration during which to observe any clinical benefit from the intervention; (4) potential co-intervention or contamination; and (5) low statistical power.Type
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Bosworth, Hayden B, Uptal D Patel, Allison A Lewinski, Clemontina A Davenport, Jane Pendergast, Megan Oakes, Matthew J Crowley, Leah L Zullig, et al. (2024). Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study. Medical care. 10.1097/mlr.0000000000002043 Retrieved from https://hdl.handle.net/10161/31466.
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Scholars@Duke

Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy

Uptal Dinesh Patel
Uptal Patel, MD is an Adjunct Professor interested in population health with a broad range of clinical and research experience. As an adult and pediatric nephrologist with training in health services and epidemiology, his work seeks to improve population health for patients with kidney diseases through improvements in prevention, diagnosis and treatment.
Prior efforts focused on four inter-related areas that are essential to improving kidney health: i) reducing the progression of chronic kidney disease by improving its detection and management, particularly by leveraging technology to facilitate engagement and self-management; ii) elucidating the inter-relationships between kidney disease and cardiovascular disease, which together amplify the risk of death; iii) improving the evidence in nephrology through comparative effectiveness research, including clinical trials, observational studies, and meta-analyses; and iv) promoting more optimal clinical health policy for all patients with kidney disease. These inter-disciplinary projects have been funded by a variety of public and private sources including the Robert Wood Johnson Foundation, Veterans Affairs, National Institutes of Health, Agency for Healthcare Research & Quality, Food and Drug Administration, Centers for Medicare & Medicaid Services, Renal Physicians Association, and the American Society of Nephrology.
Current efforts seek to advance novel therapies for kidney diseases through early clinical development that he leads at AstraZeneca.

Allison A. Lewinski
As a nurse scientist and health services researcher, with a joint appointment between the Duke University School of Nursing (DUSON) and the Durham Veterans Affairs Health Care System (VHA), I have acquired expertise in the areas of diabetes distress, qualitative research methods, and virtual care (e.g., telehealth, digital health) as a method of care delivery. My research focuses on the current and potential ability of virtual care interventions to reduce distress, improve self-management, increase access to evidence-based care delivery, and improve patient and population health outcomes. My collaborative and interdisciplinary research focuses on how patient-, provider-, and system-level factors influence virtual care use and outcomes. As evidence of its growing significance and impact at DUSON and the VHA, my work has been well funded, published in high-impact journals, presented at select conferences, and used to guide health system decision-making. I am a sought-after teacher and mentor because I connect my research interests to teaching students and mentees rigorous and systematic research approaches. I am frequently asked by local and national colleagues to provide guidance on distress, qualitative research methods, and virtual care approaches used in grants, projects, and manuscripts.
My research contributions have focused on alleviating psychosocial distress, developing and implementing multi-level virtual care interventions, and enhancing qualitative methods. As a staff nurse, I witnessed the psychosocial distress of patients who experience challenges in obtaining care which led to my interest in diabetes distress. I aspire and work to improve health outcomes for individuals with chronic illness by developing equitable and sustainable multi-level virtual care interventions and assessing their implementation and adaptation. Virtual care describes any remote interaction between a patient and/or members of their care team. To achieve these goals, I use qualitative methods and implementation science approaches to enhance alignment between patient, modality, disease state, and social and environmental context; my collective assessments address for whom and what purposes, in what situations and contexts, when in a disease course or clinical activity, and in what specific ways such interventions are effective. My focus on the uptake and adoption of virtual care to address psychosocial distress considers interactions with patients, between patients and clinicians, and within health care systems and the larger population.

Jane Frances Pendergast
Dr. Pendergast is a senior faculty member in the Department of Biostatistics & Bioinformatics, with specialized expertise in multivariate and longitudinal data. Before coming to Duke, she was a Statistics/Biostatistics faculty member at the Universities of Florida and Iowa. Her primary collaborations at Duke are with members of the Division of General Internal Medicine and the Aging Center.

Matthew Janik Crowley
Diabetes, Hypertension, Health Services Research

Leah L Zullig
Leah L. Zullig, PhD, MPH is a health services researcher and an implementation scientist. She is a Professor in the Duke Department of Population Health Sciences and an investigator with the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham Veterans Affairs Health Care System. Dr. Zullig leads INTERACT, the Implementation Science Research Collaborative, and is co-leader of Duke Cancer Institute's cancer prevention and control program.
Dr. Zullig’s overarching research interests address three domains: improving cancer care delivery and quality; promoting cancer survivorship and chronic disease management; and improving medication adherence. Throughout these three area of foci Dr. Zullig uses an implementation science lens with the goal of providing equitable care for all by implementing evidence-based practices in a variety of health care environments. She has authored over 200 peer-reviewed publications.
Dr. Zullig completed her BS in Health Promotion, her MPH in Public Health Administration, and her PhD in Health Policy.
Areas of expertise: Implementation Science, Health Measurement, Health Policy, Health Behavior, Telehealth, and Health Services Research
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