EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial.
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2024-08
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Abstract
Background
Approximately 10-15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use.Methods
Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs.Results
Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %.Conclusion
The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.Type
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German, Jashalynn, Qing Yang, Daniel Hatch, Allison Lewinski, Hayden B Bosworth, Brystana G Kaufman, Ranee Chatterjee, Gina Pennington, et al. (2024). EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial. Contemporary clinical trials. p. 107673. 10.1016/j.cct.2024.107673 Retrieved from https://hdl.handle.net/10161/31460.
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Scholars@Duke
Qing Yang
Dr. Qing Yang is Associate Professor and Biostatistician at Duke School of Nursing. She received her PhD in Biostatistics from University of California, Los Angeles. Dr. Yang’s statistical expertise is longitudinal data analysis and time-to-event data analysis. As a biostatistician, she has extensive experience collaborating with researchers in different therapeutic areas, including diabetes, cancer, cardiovascular disease and mental health. Her current research interests are advanced latent variable models that are widely used in symptom cluster research and intensive longitudinal data analysis that arise from mobile health research.
See my personal Github website.
Allison A. Lewinski
I am a health services researcher and implementation scientist with a joint appointment at the Duke University School of Nursing (DUSON) and the Durham Veterans Affairs Health Care System (VHA). My expertise spans diabetes distress, qualitative research methods, and virtual care delivery (including telehealth and digital health).
My research examines how virtual care interventions can reduce distress, improve self-management, expand access to evidence-based care, and enhance patient and population health outcomes. I focus on patient-, provider-, and system-level factors that influence the use and effectiveness of virtual care. This work has been funded by competitive grants, published in high-impact journals, presented at national conferences, and used to inform health system decision-making. I am frequently sought by colleagues locally and nationally for expertise in diabetes distress, qualitative methods, and virtual care strategies for grants, projects, and manuscripts.
I strive to improve outcomes for individuals with chronic illness by developing equitable, sustainable virtual care solutions and evaluating their implementation. To optimize these interventions, I apply qualitative and implementation science approaches to ensure alignment among patient needs, care modalities, disease states, and social contexts. My work addresses critical questions: for whom and for what purposes are these interventions effective, in which contexts, and at what points in the care continuum. Ultimately, my research advances the implementation and adoption of virtual care to reduce psychosocial distress and improve health outcomes through patient-clinician interactions and system-level innovations.
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
Brystana G. Kaufman
Areas of Expertise: Health Economics, Health Policy, and Health Services Research
Dr. Kaufman is a health services researcher focused on improving the value of care for older adults with complex care needs, such as serious illness or developmental disability. She brings expertise in causal inference as well as Medicaid and Medicare value-based payment models to inform evidence-based program design. Her work prioritizes the evaluation of health disparities for underserved communities and seeks to inform whole-person models of care that integrate traditional clinical services with behavioral health, socioeconomic and social supports to address older adults’ diverse needs and reflect their preferences for care. She worked with the CMS Innovation Center as a 2022-2023 Health and Aging Policy fellow, and she is core faculty with the Duke-Margolis Institute for Health Policy.
Dr. Kaufman received her Master of Science in Public Health and PhD in Health Policy and Management from the Gillings School of Global Public Health at the University of North Carolina-Chapel Hill.
Ranee Chatterjee
Ryan Shaw
Ryan Shaw serves as the Chief Nurse Innovation Officer for Duke University Health System. By leveraging technology and evidence-based practices, he identifies opportunities to empower nurses to thrive as changemakers, addressing healthcare delivery challenges, improving patient outcomes, and enhancing efficiency.
In his faculty role at the Duke University School of Nursing, he leads research teams driving digital transformation in healthcare. His work has been supported by organizations such as the U.S. National Institutes of Health (NIH) and the National Science Foundation (NSF), among others. He is passionate about mentoring students to become the next generation of health scientists and clinicians.
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