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

mGlide RCT：缩小 HTN 管理指南与实践差距的临床滑行路径

• 批准号: 10400214
• 负责人: KAMAKSHI LAKSHMINARAYAN
• 金额: $ 76.38万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-18 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10400214
• 关键词: Address; Adherence; Adult; Adverse event; African American; Age; American Heart Association; Blood Pressure; Blood Pressure Monitors; Cardiovascular Diseases; Caring; Cellular Phone; Client satisfaction; Clinic Visits; Clinical; Clinical effectiveness; Communities; Comparison arm; Cost Effectiveness Analysis; Data; Databases; Early Intervention; Effectiveness; Emergency Care; Event; Federally Qualified Health Center; Focus Groups; Frequencies; Goals; Guidelines; Health Resources; Health Status; Health Technology; Health system; Healthcare; Home Blood Pressure Monitoring; Home Care Services; Hypertension; Intervention; Latino; Literature; Low income; Measures; Medical Care Team; Minority; Minority Groups; Modeling; Monitor; Participant; Patient Care; Patient Education; Patients; Perception; Pharmaceutical Preparations; Pharmacists; Physicians; Pilot Projects; Population; Population Heterogeneity; Primary Health Care; Probability; Provider; Public Health; Quality-Adjusted Life Years; Race; Randomized; Reading; Recording of previous events; Research; Research Personnel; Risk Factors; Self Efficacy; Site; Specific qualifier value; Stroke; Stroke prevention; Structure; Subgroup; Surveys; Technology; Telephone; Visit; active method; arm; base; cardiovascular disorder risk; cardiovascular health; care providers; clinical care; clinical center; cost; cost effectiveness; cost estimate; economic evaluation; economic impact; experience; health care service utilization; health disparity; health economics; high risk; hospitalization rates; hypertension control; hypertension treatment; improved; intervention participants; mHealth; medication compliance; member; minority communities; mortality; recruit; response; satisfaction; stroke risk; stroke survivor; treatment as usual; two-arm trial; urgent care; usability; wireless

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.

摘要：此 A1 申请是为了响应 PAR-15-279，“增加指南交付的策略 - 对健康差异人群进行基础护理。” 不幸的是，在这 86 种疾病中，高血压治疗不足。 在美国，有 100 万成年人患有高血压，其中 4000 万 (46%) 血压控制不佳 (BP)。在这项研究中，我们展示了 mHealth（移动医疗）如何解决这一问题。 技术）可以提高中风幸存者和无中风的初级保健患者的高血压控制率，但是 我们的干预措施称为 mGlide，参与者将自我干预。 每天使用无线血压监测仪和智能手机监测血压。手机会将血压传输至智能手机。 我们将使用滑翔路径框架来管理传输的 BP 数据。 路径，基于飞机着陆的概念，建立了每个血压读数的预期轨迹 患者在家中接受指南和提供者输入的血压监测； 当患者血压偏离预期范围时发出警报 每周为医疗保健生成一次警报。 团队列出了未受控制的高血压患者名单，这有助于早期干预，同时避免信息泄露。 在一项试点研究 (R21HS021794) 中，我们将 50 名中风幸存者随机分为 mGlide (n=26) 组和常规治疗组。 (n=24)。我们的干预团队包括一名一线协调员，他对患者进行血压自我监测培训。 一位药剂师与患者的医生共同管理患者的高血压，我们的结果证实效果非常好。 mGlide 在实现 HTN 控制方面的可接受性、高可行性和有前景的功效基于此 4-。 一个月的试点，我们建议进行更长的试验。我们的合作临床中心包括联邦合格的健康中心。 在这项随机对照试验研究中，我们将服务于低收入和少数族裔（拉丁裔、非裔美国人、苗族）社区。 将 450 名患有不受控制的 HTN 的参与者随机分为 mGlide 干预组 (n=225) 与临床护理状态 比较 (n=225) 目标 1 将检查两组在 6 个月和 12 个月时的 HTN 控制情况。 随机化后几个月，目标 2 将检查 mGlide 的可用性和提供者的体验。 它还将检查参与者的药物管理是否有所不同。 目标 3 将检查患者是否对 mGlide 组的护理更满意。 他们在管理 HTN 方面更加“活跃”并且具有更强的自我效能感。 提供 mGlide 护理的成本效益分析 我们的长期目标是预防中风并改善状况。 通过提高卫生系统的效率和有效性来改善人群的心血管健康。 我们的 mGlide RCT 将为使用现成的 mHealth 技术来弥合 服务少数群体的资源匮乏的卫生系统中高血压治疗指南与实践之间的差距。

项目成果

Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial.

移动健康干预缩小高血压治疗实践指南的差距：mGlide 随机对照试验方案。

• 发表时间: 2021-01-25
• 影响因子: 1.7
• 作者: Lakshminarayan, Kamakshi;Murray, Thomas A;Westberg, Sarah M;Connett, John;Overton, Val;Nyman, John A;Culhane;Pergament, Shannon L;Drawz, Paul;Vollbrecht, Emily;Xiong, Txia;Everson
• 通讯作者: Everson