Reach Out 2: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple HealthSystems

高血压是心血管疾病最重要的可改变的危险因素。美国黑人拥有 在任何种族或民族中，高血压患病率最高，血压控制率最低 在美国，这是心血管疾病差异的原因之一。低收入的美国人也是 不成比例地承受着高血压的负担。实现健康公平，治疗高血压的新方法 需要利用安全网医疗保健系统来接触服务不足的人群的管理。 应对高血压流行的一种方法是识别和治疗未诊断、未治疗、 或者患有治疗不足的高血压--那些从医疗体系的裂缝中跌落的人。我们 在REACH OUT 1(R01MD011516)中做到了这一点，这是一项移动健康(MHealth)高血压的8臂因素试验 从安全网急诊室招募的患者。在约500名以黑人为主的中年参与者中，43%是 失业；21%的人没有高血压的诊断；51%的人没有服用降压药 还有22%的人没有初级保健提供者。总体而言，收缩压下降了9.2毫米汞柱(95% CI-12.2至-6.3)，6个月后，各治疗组之间无差异。联系成功注册的%1 将高血压、医疗服务不足的人群纳入移动健康干预。尽管有很大的减少 BP总体而言，鉴于缺乏对照组，REACH OUT移动健康干预的效果尚不确定。 Reach Out 2建议在随机、开放、盲目的情况下测试Reach Out 1最有希望的组件- 终点(探针)对照试验。联系2，继续我们的工作，使用相同的安全网-Ed和Federally 合格的健康中心。在Reach Out 2中，我们将把普通护理与6个月的自我监控进行比较 通过量身定制的反馈和方便的初级保健预约进行血压(SMBP)监控 交通。常规护理小组将收到指导，要求他们在教育结束后向初级保健提供者进行跟进 出院。6个月后，干预参与者将进入长期延长的治疗期 SMBP监测。为了将我们的发现与背景联系起来，我们将使用基于慢性病代理的模拟模型 估计如果实施REACH OUT 2，心肌梗死、中风和痴呆症的减少 在美国各地的安全网EDS中。我们提案的首要目标是确定低技术是否 在从安全网急诊室招募的患者中，移动健康干预将比通常情况下更多地降低血压 了解这种干预对国家的潜在影响。因为安全网EDS是锚定的 照顾大量医疗服务不足的高血压患者的机构，mHealth战略 在这里启动具有减少心血管不平等的巨大潜力。为了实现这一潜力，证据- 必须确定降低BP的基础干预措施(目标1)，评估长期参与情况(目标2)，以及 了解它们的影响(目标3)。

Hypertension is the most important modifiable risk factor for cardiovascular disease. Black Americans have the highest prevalence of hypertension and the lowest rates of blood pressure (BP) control of any racial or ethnic group in the U.S., contributing to cardiovascular disease disparities. Low-income Americans are also disproportionally burdened by hypertension. To achieve health equity, new approaches to hypertension management leveraging safety-net healthcare systems to reach underserved populations are needed. One approach to addressing the hypertension epidemic is to identify and treat people undiagnosed, untreated, or with undertreated hypertension - people who have fallen through the cracks in the healthcare system. We did this in Reach Out 1 (R01MD011516), a mobile health (mHealth) 8-arm factorial trial of hypertensive patients recruited from a safety-net ED. Among the ~500 majority Black, mid-life participants, 43% were unemployed; 21% did not carry a diagnosis of hypertension; 51% were not taking antihypertensive medications, and 22% did not have a primary care provider. Overall, systolic BP declined by 9.2 mmHg (95% CI -12.2 to - 6.3) after 6 months, without differences across treatment arms. Reach Out 1 successfully enrolled a hypertensive, medically underserved population into a mHealth intervention. Despite a very large reduction in BP overall, the efficacy of the Reach Out mHealth intervention is uncertain, given the lack of a control group. Reach Out 2 proposes to test the most promising components of Reach Out 1 in a randomized open, blinded- endpoint (PROBE) controlled trial. Reach Out 2, continues our work with the same safety-net ED and Federally Qualified Health Centers. In Reach Out 2, we will compare usual care, to 6-months of prompted self-monitored blood pressure (SMBP) monitoring with tailored feedback and facilitated primary care appointment and transportation. The usual care group will receive instructions to follow up with a primary care provider after ED discharge. After 6 months, the intervention participants will enter an extended treatment period of long-term SMBP monitoring. To contextualize our findings, we will use our chronic disease agent-based simulation model to estimate the reduction in myocardial infarction, stroke, and dementia if Reach Out 2 were to be implemented in safety-net EDs across the US. The overarching goal of our proposal is to determine whether a low-tech mHealth intervention will reduce BP more than usual care among patients recruited from a safety-net ED and to understand the potential national impact of such an intervention. Because safety-net EDs are anchor institutions that care for large populations of medically underserved hypertensive people, mHealth strategies initiated here have tremendous potential to reduce cardiovascular inequities. To reach this potential, evidence- based interventions to reduce BP must be identified (aim 1), long-term engagement evaluated (aim 2), and their impact understood (aim 3).