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

基本信息

批准号：
9912838
负责人：
KAMAKSHI LAKSHMINARAYAN
金额：
$ 75.87万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-18 至 2023-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9912838
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 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 Blood Pressure Monitoring Self Efficacy Site Specific qualifier value Stroke Stroke prevention Structure Subgroup Surveys Technology Telephone Visit Wireless Technology 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

项目摘要

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应用是对PAR-15-279的回应，“增加指南的交付策略 - 高血压（HTN）是最重要的中风，并且心血管疾病（CVD）危险因素。不幸的是，HTN的严重处理不足。 86 在美国，百万成年人患有HTN的成年人，有4000万（46％）的血压不足（bp）。在少数群体中，这个问题更糟。在这项研究中，我们演示了MHealth（移动健康）如何技术）可以提高中风存活率和无中风的初级保健患者的HTN控制率，但是中风和CVD的高风险。我们的干预称为mglide。干预参与者会自我使用无线BP监视器和智能手机每天监视他们的BP。手机将将此BP传输到数据库自动。我们将使用滑行路径的框架来管理传输的BP数据。滑行基于降落飞机的概念的路径，为每种飞机建立了预期的BP读数轨迹由指南和提供者输入设定的范围的患者。 BP在家中受到监控；医疗团队是当患者BP偏离预期范围时，请发出警报。每周生成一次警报以进行医疗保健团队与不受控制的HTN患者列表。此设施的早期干预同时避免信息超载。在一项试点研究（R21HS021794）中，我们随机将50个中风存活与mglide（n = 26）相对于通常的护理（n = 24）。我们的干预团队包括一个前线协调员，他培训了患者的BP自我监控以及与患者的HTN与患者的物理学共同管理的药剂师。我们的结果证实了极好的可接受性，高可行性和MGLIDE实现HTN控制的效率。基于这个4- 一个月的飞行员我们提出了更长的试验。我们的合作临床中心包括联邦资格的保健中心为低收入和少数民族（拉丁裔，非裔美国人，苗族）社区提供服务。在这项RCT研究中，我们将将450名参与者随机与MGLIDE干预（n = 225）相比临床护理比较（n = 225）。 AIM 1将检查6个月的两组中HTN的控制能力，12 随机化几个月。 AIM 2将检查提供者和提供商经验的MGlide可用性以及对mglide的满意度。它还将检查对参与者的药物是否有所不同两组。 AIM 3将检查患者是否对MGLIDE组的护理更满意，是否他们更“被激活”，在管理HTN时具有更大的自我效能感。 AIM 4将是提供MGlide护理的成本效益分析。我们的长期目标是防止中风和改善通过提高卫生系统效率和有效性，人群中的心血管健康。结果我们的MGLIDE RCT将为使用随时可用的MHealth技术桥接提供证据在为少数群体提供的低资源卫生系统中，HTN治疗的实践差距。