Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/9/2019 |
| Start Date: | December 21, 2018 |
| End Date: | May 30, 2021 |
Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)
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.
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.
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, 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.
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.
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, 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.
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.
Inclusion Criteria:
- Veterans with persistently poorly-controlled type 2 diabetes mellitus defined as the
presence of 2 HbA1c values 8.5% during the prior year (none <8.5%) despite 2
appointments with a VHA Primary Care Provider (PCP) or Endocrinology during this
period.
Exclusion Criteria:
- age >70
- life expectancy <5 years, or other comorbidities that would offset the benefits of
HbA1c <8.5%
- inability to communicate by telephone
- dementia or psychosis
- active alcohol/substance disorder
- pregnancy
- prior hypoglycemic seizure/coma
- refusal to perform self-monitored blood glucose (SMBG)
- use of insulin infusion pumps
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