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

这项研究将评估一个全面的远程医疗干预的退伍军人与持续贫困 糖尿病控制，尽管临床为基础的退伍军人健康管理局（VHA）的护理。因为这种方法是 设计用于通过现有的家庭远程医疗（HT）服务提供，该服务在整个VHA中无处不在， 代表了一个有效的，实用的替代退伍军人的糖尿病是难治性的诊所为基础的护理。 尽管临床医生和研究人员的努力已经改善了VHA的糖尿病控制， 持续性控制不良的糖尿病（PPDM）没有从这些进展中获益。我们定义 PPDM作为血红蛋白A1 c（HbA 1c）≥8.5%的维持>1年，尽管接受了基于临床的 糖尿病患者在此期间符合此定义的退伍军人-约占所有退伍军人类型的12% 2型糖尿病-对VHA的糖尿病并发症和费用负担不成比例。 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良的潜在因素可以改善这些高血糖患者的结局， 风险老兵不幸的是，医疗保健系统很少集成全面的基于远程医疗的 将护理纳入现实世界的实践，即使是像PPDM这样的临床难治性疾病。这一差距源于这样一个事实， 基于远程医疗的全面糖尿病护理以前没有被设计用于实际交付 在现实世界的条件下。为了使远程医疗发挥其潜力，作为一种手段，以减轻负担， PPDM，必须制定干预措施，重点是通过现有劳动力进行可行的交付， 基础设施和技术资源，以便最终实现有效实施。在此之前， 当基于诊所的护理证明不足时，患有PPDM的退伍军人将没有其他选择。 拟议的试验将评估实用远程医疗，以改善退伍军人的控制和参与 临床难治性糖尿病（PRACTICE-DM），一种新型的综合性远程医疗干预 用于PPDM，其设计用于VHA内的实际交付。本研究的具体目的是：1） 确定PRACTICE-DM的有效性; 2）评估PRACTICE-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PRACTICE-DM相关的成本。 来自两个研究中心（达勒姆，NC和里士满，VA）的200名PPDM退伍军人将随机分配至 接受两种HT提供的干预措施之一：1）PRACTICE 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、药物管理和抑郁症 支持;或2）主动控制，标准HT护理协调和远程监护。这两种干预措施将是 在12个月内交付，所有参与者将继续接受常规VHA护理。 主要研究结局将是HbA 1c从研究基线至12个月的变化。次级 结果由理论框架指导，将包括糖尿病自我护理，糖尿病负担，自我， 功效和抑郁症状。将对20个干预组进行定性访谈 退伍军人，HT护士提供干预，以及每个站点的管理员。干预成本将 全面评估并与标准HT护理协调和远程监护进行比较。 虽然VHA是远程医疗的领导者，但其远程医疗能力目前未得到充分利用， PPDM的退伍军人这些退伍军人对诊所护理很难接受，因此对疾病的贡献不成比例 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， 为PPDM设计的综合管理，旨在改善这种高风险、高风险的 成本人口。由于拟议的干预措施是为使用现有的HT服务提供服务而设计的， 代表了一种有效、实用的方法，可以减轻VHA中糖尿病控制不良的负担。

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.