Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus
Condition: Telemedicine
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Diabetes generates significant morbidity, mortality, and costs within the Veterans Health
      Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based
      care are among the highest-risk diabetes patients in VHA, and contribute disproportionately
      to VHA's massive burden of diabetes complications and costs. VHA critically needs effective,
      practical management alternatives for Veterans whose diabetes does not respond to
      clinic-based management. The proposed study will address this need by leveraging VHA's unique
      Home Telehealth capacity to deliver comprehensive telemedicine-based management for Veterans
      with persistently poor diabetes control despite clinic-based care. Because this intensive
      intervention is delivered using only existing Home Telehealth workforce, infrastructure, and
      technical resources - which are ubiquitous at VHA centers nationwide - it could represent an
      effective, practical approach to improving outcomes in Veterans with PPDM, potentially
      translating to a substantial reduction in VHA's diabetes burden.
    

Detailed description: 
      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. The investigators 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.

      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.

      Two hundred Veterans with PPDM from two sites (Durham, North Carolina (NC) and Richmond,
      Virginia (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.

      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.
    

Intervention name(s): PRACTICE-DM; Standard VA Home Telehealth
Intervention type(s): Other; Other
Intervention description(s): Five-component diabetes intervention: 1) telemonitoring; 2) self-management support; 3) diet/activity support; 4) medication management; and 5) depression support.; Standard VA HT care coordination and telemonitoring.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: VA Home Telehealth (HT) nurses will deliver the 5 intervention components during telephone encounters. The standard encounter frequency will be every two weeks, but may be extended to every 4 weeks for participants achieving their HbA1c goal. Should Veterans relapse while receiving the lower encounter frequency, HT will return to every-two-week encounters until the next HbA1c assessment. The 5 intervention components are: Telemonitoring, Self-management support, Diet/activity support, Medication management, & Depression support
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Complex Care; Outcomes; Telemedicine; Rural Health; Diabetes