mGlide RCT: A Clinical Glide Path to Close the Guideline-to-Practice Gap in HTN Management

翻译后摘要：这个A1应用程序是在回应PAR-15-279，“战略，以增加交付的指导方针- 为有健康差异的人群提供基础护理”。高血压（HTN）是最重要的中风， 心血管疾病（CVD）危险因素。不幸的是，HTN的治疗严重不足。的86 在美国，有100万患有HTN的成年人，4000万人（46%）血压控制不佳 （英国石油公司）。这个问题在少数民族中更为严重。在这项研究中，我们展示了移动健康（移动的健康） 技术）可以提高卒中幸存者和非卒中初级保健患者的HTN控制率， 中风和心血管疾病的高危人群我们的干预被称为mGlide。干预参与者将自我- 每天使用无线血压监测仪和智能手机监测他们的血压。手机会把这个BP传给一个 数据库自动我们将使用滑动路径的框架来管理传输的BP数据。格莱德 路径，基于降落飞机的概念，建立了每个BP读数的预期轨迹， 患者的界限由指南和提供者输入设定。在家监测BP;卫生保健团队 当患者血压偏离预期范围时发出警报。每周为医疗保健部门生成一次警报 一组未受控制的HTN患者名单。这有利于早期干预，同时避免信息 超载。在一项初步研究（R21 HS 021794）中，我们将50名卒中幸存者随机分配至mGlide组（n=26）与常规治疗组 （n=24）。我们的干预团队包括一名一线协调员，他对患者进行BP自我监测培训 以及与患者的医生共同管理患者的HTN的药剂师。我们的结果证实了 mGlide用于实现HTN控制的可接受性、高可行性和有前景的有效性。根据这4- 我们建议试用期更长。我们的合作临床中心包括联邦合格的健康中心 服务于低收入和少数民族（拉丁裔，非裔美国人，苗族）社区。在这项RCT研究中，我们将 将450名患有不受控制的HTN的受试者随机分配至mGlide干预（n=225）与临床护理状态 对照组（n=225）。目标1将检查两组在6个月和12个月时HTN的控制情况 随机化后3个月。目标2将检查mGlide对提供者的可用性和提供者的经验， 对mGlide的满意度。它还将检查是否药物管理不同的参与者， 这两个群体。目标3将检查mGlide组的患者是否对护理更满意， 他们在管理HTN时更加“活跃”，并具有更强的自我效能感。目标4将是一个 提供mGlide护理的成本效益分析。我们的长期目标是预防中风， 通过提高卫生系统的效率和有效性，改善人群的心血管健康。的结果 我们的mGlide随机对照试验将为使用现成的mHealth技术桥接 为少数群体服务的低资源卫生系统中HTN治疗的指南与实践差距。

Abstract: This A1 application is in response to PAR-15-279, “Strategies to Increase Delivery of Guideline- Based Care to Populations with Health Disparities.” Hypertension (HTN) is the most important stroke and cardiovascular disease (CVD) risk factor. Unfortunately, there is substantial under-treatment of HTN. Of the 86 million adults with prevalent HTN in the U.S., 40 million (46%) have inadequately controlled blood pressure (BP). This problem is worse among minority groups. In this study, we demonstrate how mHealth (mobile health technology) can improve HTN control rates in stroke survivors and primary care patients without stroke, but who are at a high risk of stroke and CVD. Our intervention is called mGlide. Intervention participants will self- monitor their BP daily using a wireless BP monitor and a smart phone. The phone will transmit this BP to a database automatically. We will use the framework of glide paths to manage the transmitted BP data. The glide path, based on the concept of landing an airplane, establishes an expected trajectory of BP readings for each patient with bounds set by guidelines and provider input. BP is monitored at home; the health care team is alerted when patient BP deviates from expected bounds. Alerts are generated once a week for the health care team with a list of patients with uncontrolled HTN. This facilitates early intervention while avoiding information overload. In a pilot study (R21HS021794), we randomized 50 stroke survivors to mGlide (n=26) vs. usual care (n=24). Our intervention team included a front-line coordinator who trained the patient on BP self-monitoring and a pharmacist who co-managed the patient's HTN with the patient's physician. Our results confirm excellent acceptability, high feasibility and promising efficacy of mGlide for achieving HTN control. Based upon this 4- month pilot we propose a longer trial. Our partnering clinical centers include Federally Qualified Health Centers that serve low income and minority (Latino, African American, Hmong) communities. In this RCT study, we will randomize 450 participants with uncontrolled HTN to the mGlide intervention (n=225) vs. state-of-clinical-care comparison (n=225). Aim 1 will examine how well HTN is controlled in the two groups at 6 months and 12 months after randomization. Aim 2 will examine mGlide usability for providers and provider experience and satisfaction with mGlide. It will also examine whether medications are managed differently for participants in the two groups. Aim 3 will examine whether patients are more satisfied with care in the mGlide group, whether they are more “activated” and have a greater sense of self-efficacy in managing their HTN. Aim 4 will be a cost-effectiveness analysis of providing mGlide care. Our long-term goal is to prevent stroke and improve cardiovascular health in populations by increasing health system efficiency and effectiveness. The results from our mGlide RCT will provide evidence for the use of readily available mHealth technology for bridging the guideline-to-practice gap in HTN treatment in low resource health systems serving minority groups.