BACKGROUND/RATIONALE:
This study will evaluate a comprehensive telemedicine intervention for Veterans with persistently poor diabetes control despite clinic-based Veterans Health Administration (VHA) care. Because this approach is designed for delivery via existing Home Telehealth (HT) services, which are ubiquitous throughout VHA, it may represent an effective, practical alternative for Veterans whose diabetes is refractory to clinic-based care.

Although efforts by clinicians and researchers have improved diabetes control across VHA, Veterans with persistent poorly-controlled diabetes mellitus (PPDM) have not benefitted from these advances. We define PPDM as maintenance of a hemoglobin A1c (HbA1c) 8.5% for >1 year, despite receiving clinic-based diabetes care during this period. Veterans meeting this definition - approximately 12% of all Veterans with type 2 diabetes - contribute disproportionately to VHA's burden of diabetes complications and costs.

While clinic-based care is insufficiently effective in PPDM, telemedicine-based management that comprehensively addresses factors underlying poor diabetes control could improve outcomes for these high-risk Veterans. Unfortunately, healthcare systems have rarely integrated comprehensive telemedicine-based care into real-world practice, even for clinic-refractory conditions like PPDM. This gap stems from the fact that comprehensive telemedicine-based diabetes care has not previously been designed for practical delivery under real-world conditions. In order for telemedicine to fulfill its potential as a means to reduce the burden of PPDM, interventions must be developed with an emphasis on feasible delivery through existing workforce, infrastructure, and technical resources, such that effective implementation is eventually achievable. Until then, Veterans with PPDM will be left without alternatives when clinic-based care proves inadequate.

OBJECTIVE(S):
The proposed trial will evaluate Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM), a novel, comprehensive telemedicine intervention for PPDM that is designed for practical delivery within VHA. The Specific Aims of this study are to: 1) determine PRACTICE-DM's effectiveness; 2) evaluate PRACTICE-DM's acceptability and mechanisms of effect using a mixed method process evaluation; and 3) understand costs associated with PRACTICE-DM.

METHODS:
Two hundred Veterans with PPDM from two sites (Durham, NC and Richmond, VA) will be randomized to receive one of two HT-delivered interventions: 1) PRACTICE-DM, a comprehensive intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression support; or 2) an active control, standard HT care coordination and telemonitoring. Both interventions will be delivered over a 12-month period and all participants will continue to receive usual VHA care.

The primary study outcome will be change in HbA1c from study baseline to 12 months. The secondary outcomes are guided by a theoretical framework, and will include diabetes self-care, diabetes burden, self-efficacy, and depressive symptoms. Qualitative interviews will be conducted with 20 intervention-group Veterans, the HT nurses delivering the intervention, and administrators at each site. Intervention costs will be comprehensively assessed and compared to standard HT care coordination and telemonitoring.

FINDINGS/RESULTS:
None to date.

IMPACT:
Although VHA is a leader in telemedicine, its telemedicine capabilities are currently underutilized for Veterans with PPDM. These Veterans are refractory to clinic-based care, so contribute disproportionately to diabetes complications and costs. This study will leverage VHA's unique telemedicine infrastructure to deliver comprehensive management designed for PPDM, with the goal of improving outcomes in this high-risk, high cost population. Because the proposed intervention is designed for delivery using existing HT services, it may represent an effective, practical approach to reducing the burden of poor diabetes control across VHA.

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External Links for this Project

NIH Reporter

Grant Number: I01HX002339-01A2
Link: https://reporter.nih.gov/project-details/9502597

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PUBLICATIONS:

Journal Articles

1. Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Medical care. 2021 Jun 1; 59(Suppl 3):S242-S251. [view]
2. Crowley MJ, Tarkington PE, Bosworth HB, Jeffreys AS, Coffman CJ, Maciejewski ML, Steinhauser K, Smith VA, Dar MS, Fredrickson SK, Mundy AC, Strawbridge EM, Marcano TJ, Overby DL, Majette Elliott NT, Danus S, Edelman D. 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. 2022 Sep 1; 182(9):943-952. [view]
3. German J, Kobe EA, Lewinski AA, Jeffreys AS, Coffman C, Edelman D, Batch BC, Crowley MJ. Factors Associated With Diabetes Distress Among Patients With Poorly Controlled Type 2 Diabetes. Journal of the Endocrine Society. 2023 Mar 6; 7(5):bvad031. [view]
4. Alexopoulos AS, Crowley MJ, Wang Y, Moylan CA, Guy CD, Henao R, Piercy DL, Seymour KA, Sudan R, Portenier DD, Diehl AM, Coviello AD, Abdelmalek MF. Glycemic Control Predicts Severity of Hepatocyte Ballooning and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease. Hepatology (Baltimore, Md.). 2021 Sep 1; 74(3):1220-1233. [view]
5. Kobe EA, Lewinski AA, Jeffreys AS, Smith VA, Coffman CJ, Danus SM, Sidoli E, Greck BD, Horne L, Saxon DR, Shook S, Aguirre LE, Esquibel MG, Evenson C, Elizagaray C, Nelson V, Zeek A, Weppner WG, Scodellaro S, Perdew CJ, Jackson GL, Steinhauser K, Bosworth HB, Edelman D, Crowley MJ. Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes. Journal of general internal medicine. 2022 Sep 1; 37(12):3080-3088. [view]
6. Kobe EA, Edelman D, Tarkington PE, Bosworth HB, Maciejewski ML, Steinhauser K, Jeffreys AS, Coffman CJ, Smith VA, Strawbridge EM, Szabo ST, Desai S, Garrett MP, Wilmot TC, Marcano TJ, Overby DL, Tisdale GA, Durkee M, Bullard S, Dar MS, Mundy AC, Hiner J, Fredrickson SK, Majette Elliott NT, Howard T, Jeter DH, Danus S, Crowley MJ. 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. 2020 Nov 1; 98:106157. [view]
7. Alexopoulos AS, Duffy R, Kobe EA, German J, Moylan CA, Soliman D, Jeffreys AS, Coffman CJ, Crowley MJ. Underrecognition of Nonalcoholic Fatty Liver Disease in Poorly Controlled Diabetes: A Call to Action in Diabetes Care. Journal of the Endocrine Society. 2021 Dec 1; 5(12):bvab155. [view]

DRA: Health Systems, Diabetes and Other Endocrine Disorders
DRE: Treatment - Comparative Effectiveness, TRL - Applied/Translational
Keywords: Diabetes, Outcomes - Patient, Telemedicine/Telehealth
MeSH Terms: none