Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.
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2020-11
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Abstract
Background
Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure.Methods
Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months.Results
Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m2.Conclusions
Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.Type
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Kobe, Elizabeth A, David Edelman, Phillip E Tarkington, Hayden B Bosworth, Matthew L Maciejewski, Karen Steinhauser, Amy S Jeffreys, Cynthia J Coffman, et al. (2020). Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial. Contemporary clinical trials, 98. p. 106157. 10.1016/j.cct.2020.106157 Retrieved from https://hdl.handle.net/10161/29647.
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Scholars@Duke
David Edward Edelman
My general interests are in the improve quality of care for chronic illness, using diabetes as a model. While I have performed research on screening for, diagnosis of, and clinical severity of unrecognized diabetes in patient care settings, my current line of work is in using health systems interventions to prevent cardiovascular disease, and to improve outcomes from comorbid diabetes and hypertension.
Matthew Leonard Maciejewski
Matt Maciejewski, PhD is a Professor in the Department of Population Health Sciences. He is also a Senior Research Career Scientist in the Center of Innovation to Accelerate Discovery and Practice Transformation at the Durham VA Medical Center. Matt also holds Adjunct Professor appointments in the Schools of Public Health and Pharmacy at the University of North Carolina at Chapel Hill.
He has received funding from NIDDK, NIDA, CMS, AHRQ, VA HSR&D, and the RWJ Foundation to conduct evaluation of long-term clinical and economic outcomes of surgical interventions, behavioral interventions and Medicare program/policy changes on patients with obesity or cardiometabolic conditions. He is also interested in methods for addressing unobserved confounding in observational studies. Matt evaluated the first-ever population-based implementation of value-based insurance design and led the first-ever linkage of lab results and Medicare FFS claims. He has published over 300 papers in peer-reviewed journals such as JAMA, JAMA Internal Medicine, JAMA Surgery, Annals of Internal Medicine, Health Economics, Medical Care, and Health Services Research.
Areas of expertise: Health Services Research, Health Economics, Health Policy, Multimorbidity
Karen E. Steinhauser
Dr. Steinhauser's primary interests are end-of-life care, medical sociology and patient-provider relationships. Specifically, she investigates the composition and measurement of the quality of life for patients and their families at the end of life. Dr. Steinhauser is a Health Scientist with the Center for Health Services Research in Primary Care, VA Medical Center, Durham; Professor, Department of Population Health Science and Medicine; Senior Fellow with the Duke University Center for Aging; Associate Chief for Research, Duke Palliative Care, and Director, Duke Residency Professional Development Coaching Program.
Karen E. Steinhauser, PhD is a social scientist dedicated to improving quality of life of patients, families, and providers during serious illness. She is a Health Scientist with the Center for Health Services Research in Primary Care, VA Medical Center, Durham and Professor, Department of Medicine, Duke University Medical Center, Senior Fellow with the Duke University Center for Aging, and a former VA Career Development Awardee.
Karen Steinhauser, PhD, is Professor, Departments of Population Health Sciences and Medicine, Duke University Medical Center and Senior Fellow with the Duke University Center for Aging and Health Scientist with the Center for Health Services Research in Primary Care, VA Medical Center, Durham. Her research is dedicated to improving patient and family psychosocial and spiritual care, in serious illness. She has developed measurement tools to assess patient and family quality of life as well as psychosocial interventions to improve the experience of serious illness for patients and those who care for them. Dr. Steinhauser's research has used qualitative and qualitative methods, observational, trial and implementation research. Her latest work includes: developing a measure to assess the spiritual needs in palliative care, and addressing clinician resilience in palliative care. She serves as Associate Chief of Research for Duke Palliative Care, and Director of the Duke Residency Professional Development Coaching program. She has been a long-term member of AAHPM, having served on the research committee and being the 2015 Awardee for Excellence in Scientific Research in Palliative Care. She is the Director of Duke’s Residency Professional Development Coaching Program.
Area of expertise: Palliative Care, Qualitative Research
Cynthia Jan Coffman
Valerie A. Smith
Valerie A. Smith, DrPH, is an Associate Professor in the Duke University Department of Population Health Sciences and Senior Research Director of the Biostatistics Core at the Durham Veterans Affairs Medical Center's Center of Innovation. Her methodological research interests include methods for semicontinuous and zero-inflated data, cost and utilization modeling, causal inference methods, observational study design, and longitudinal data analysis.
Dr. Smith works largely in collaboration with a multidisciplinary team of researchers, with a focus on health policy interventions, health care utilization and expenditure patterns, program and policy evaluation, bariatric surgery and obesity treatment evaluation, aging, and caregiving.
Areas of expertise: Biostatistics, Health Services Research, Health Economics, and Health Policy
Matthew Janik Crowley
Diabetes, Hypertension, Health Services Research
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