Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.
Department of Neurology, University of Michigan, Ann Arbor, MI, USA.
Trials. 2020 Jun 3;21(1):456. doi: 10.1186/s13063-020-04340-z.
Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations.
Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months.
The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities.
This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.
高血压是心血管疾病最重要的可改变危险因素,也是美国死亡的主要原因。急诊科是一个未被充分利用的机会,可以影响到难以接触到的人群。每年有 1.36 亿人到急诊科就诊,几乎所有人的血压都至少测量和记录一次。此外,越来越多的非裔美国人和社会经济地位较低的患者在急诊科患者人群中所占比例过高。在电子健康记录和移动健康时代,急诊科有可能成为慢性病管理的一个不可或缺的合作伙伴。电子健康记录与移动健康行为干预相结合,可以识别高血压患者,从而影响到那些未被触及的人群。
Reach Out 是一项多因素、行为干预研究,旨在降低急诊科患者人群的血压。潜在的参与者通过电子健康记录中的自动警报来识别,在同意后,他们会收到一个带回家的血压袖带。在最初的筛选阶段,他们会被提示每周提交血压读数。持续高血压的应答者随后被随机分为三个组件臂之一,这些组件臂的强度水平不同:(1)健康行为短信(每日 vs. 无),(2)血压自我监测(每日 vs. 每周),以及(3)促进初级保健提供者预约安排和交通(是 vs. 否)。如果参与者被随机分配接受促进初级保健提供者预约安排,如果他们没有建立初级保健提供者的关系,将在当地合格的联邦健康中心建立这种关系。参与者将随访 12 个月。
Reach Out 研究旨在确定哪种行为干预组件或“剂量”的组件有助于在 1 年后降低收缩压(目标 1)。该研究还将评估初级保健提供者预约协助对在城市安全网急诊科接受治疗的高血压患者的总初级保健随访就诊次数的影响(目标 2)。理想情况下,Reach Out 系统将有助于高血压管理,成为安全网医院和合格的联邦健康中心的典范,以改善服务不足社区的慢性病管理。
这项研究在 clinicaltrials.gov 上注册,标识符为 NCT03422718。该记录于 2018 年 1 月 30 日首次向公众开放,随后于 2019 年 3 月 25 日开始招募患者。