Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial.
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2022-07-25
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Abstract
Importance
Persistently poorly controlled type 2 diabetes (PPDM) is common and causes poor outcomes. Comprehensive telehealth interventions could help address PPDM, but effectiveness is uncertain, and barriers impede use in clinical practice.Objective
To address evidence gaps preventing use of comprehensive telehealth for PPDM by comparing a practical, comprehensive telehealth intervention to a simpler telehealth approach.Design, setting, and participants
This active-comparator, parallel-arm, randomized clinical trial was conducted in 2 Veterans Affairs health care systems. From December 2018 to January 2020, 1128 outpatients with PPDM were assessed for eligibility and 200 were randomized; PPDM was defined as maintenance of hemoglobin A1c (HbA1c) level of 8.5% or higher for 1 year or longer despite engagement with clinic-based primary care and/or diabetes specialty care. Data analyses were preformed between March 2021 and May 2022.Interventions
Each 12-month intervention was nurse-delivered and used only clinical staffing/resources. The comprehensive telehealth group (n = 101) received telemonitoring, self-management support, diet/activity support, medication management, and depression support. Patients assigned to the simpler intervention (n = 99) received telemonitoring and care coordination.Main outcomes and measures
Primary (HbA1c) and secondary outcomes (diabetes distress, diabetes self-care, self-efficacy, body mass index, depression symptoms) were analyzed over 12 months using intent-to-treat linear mixed longitudinal models. Sensitivity analyses with multiple imputation and inclusion of clinical data examined the impact of missing HbA1c measurements. Adverse events and intervention costs were examined.Results
The population (n = 200) had a mean (SD) age of 57.8 (8.2) years; 45 (22.5%) were women, 144 (72.0%) were of Black race, and 11 (5.5%) were of Hispanic/Latinx ethnicity. From baseline to 12 months, HbA1c change was -1.59% (10.17% to 8.58%) in the comprehensive telehealth group and -0.98% (10.17% to 9.19%) in the telemonitoring/care coordination group, for an estimated mean difference of -0.61% (95% CI, -1.12% to -0.11%; P = .02). Sensitivity analyses showed similar results. At 12 months, patients receiving comprehensive telehealth had significantly greater improvements in diabetes distress, diabetes self-care, and self-efficacy; no differences in body mass index or depression were seen. Adverse events were similar between groups. Comprehensive telehealth cost an additional $1519 per patient per year to deliver.Conclusions and relevance
This randomized clinical trial found that compared with telemonitoring/care coordination, comprehensive telehealth improved multiple outcomes in patients with PPDM at a reasonable additional cost. This study supports consideration of comprehensive telehealth implementation for PPDM in systems with appropriate infrastructure and may enhance the value of telehealth during the COVID-19 pandemic and beyond.Trial registration
ClinicalTrials.gov Identifier: NCT03520413.Type
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Publication Info
Crowley, Matthew J, Phillip E Tarkington, Hayden B Bosworth, Amy S Jeffreys, Cynthia J Coffman, Matthew L Maciejewski, Karen Steinhauser, Valerie A Smith, et al. (2022). Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial. JAMA internal medicine. 10.1001/jamainternmed.2022.2947 Retrieved from https://hdl.handle.net/10161/25549.
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Scholars@Duke
Matthew Janik Crowley
Diabetes, Hypertension, Health Services Research
Cynthia Jan Coffman
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
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
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.
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