Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)

这项研究将评估对持续贫困的退伍军人进行全面的远程医疗干预 糖尿病控制，尽管以诊所为基础的退伍军人健康管理局(VHA)的护理。因为这种方法是 旨在通过现有的家庭远程健康(HT)服务交付，这些服务在整个VHA中无处不在，它可以 为那些糖尿病难以得到临床治疗的退伍军人提供了一种有效、实用的替代方案。 尽管临床医生和研究人员的努力已经改善了VHA对糖尿病的控制，但患有 持续性控制不良的糖尿病(PPDM)并没有从这些进展中受益。我们定义 PPDM作为维持血红蛋白A1c(HbA1c)≥为8.5%的1年，尽管接受了临床 在此期间进行糖尿病护理。符合这一定义的退伍军人--约占所有退伍军人的12% 2糖尿病--对VHA的糖尿病并发症和费用负担造成不成比例的影响。 虽然基于诊所的护理在PPDM中不够有效，但基于远程医疗的管理 全面解决糖尿病控制不佳的因素可以改善这些高血糖患者的预后 风险退伍军人。不幸的是，医疗保健系统很少集成基于远程医疗的全面 将医疗保健转化为现实世界的实践，即使是像PPDM这样的临床难以治愈的疾病。这种差距源于这样一个事实： 全面的基于远程医疗的糖尿病护理以前并没有被设计用于实际交付 在真实世界的条件下。为了让远程医疗发挥其潜力，减轻 PPDM，必须制定干预措施，强调通过现有劳动力提供可行的服务， 基础设施和技术资源，以便最终能够实现有效执行。在那之前， 当基于临床的护理被证明是不充分的时，患有PPDM的退伍军人将别无选择。 拟议的试验将评估远程医疗的实用性，以改善退伍军人的控制和参与度 临床难治性糖尿病(Practice-DM)--一种新的、全面的远程医疗干预 对于为在VHA内实际交付而设计的PPDM。本研究的具体目的是：1) 确定实践-DM的有效性；2)评估实践-DM的可接受性和 使用混合方法过程评估的效果；以及3)了解与实践-DM相关的成本。 来自两个地点(北卡罗来纳州达勒姆和弗吉尼亚州里士满)的200名患有PPDM的退伍军人将被随机分配到 接受两种羟色胺提供的干预措施之一：1)实践-DM，一种综合干预措施 远程监护、自我管理支持、饮食/活动支持、用药管理和抑郁 支持；或2)主动控制、标准的HT护理协调和远程监护。这两项干预都将是 在12个月内交付，所有参与者将继续接受通常的VHA护理。 主要研究结果将是HbA1c从研究基线改变到12个月。第二个 结果由一个理论框架指导，将包括糖尿病自我护理，糖尿病负担，自我 疗效和抑郁症状。定性访谈将与20个干预组进行 退伍军人、提供干预的HT护士以及每个站点的管理人员。干预成本将是 全面评估并与标准的HT护理协调和远程监测进行比较。 尽管VHA在远程医疗方面处于领先地位，但其远程医疗能力目前在以下方面未得到充分利用 使用PPDM的退伍军人。这些退伍军人对以临床为基础的护理很难接受，因此对 糖尿病并发症和费用。这项研究将利用VHA独特的远程医疗基础设施提供 为PPDM设计的全面管理，目标是改善这一高风险、高风险的结果 让人口付出代价。因为提议的干预是为使用现有的超文本传输服务而设计的，它可以 代表了一种有效、实用的方法，以减轻VHA范围内糖尿病控制不力的负担。

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. 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.