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

伸出援手 2：急诊室发起的高血压移动健康干预连接多个卫生系统的随机临床试验

• 批准号: 10791418
• 负责人: William Joseph Meurer
• 金额: $ 59.93万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-24 至 2028-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10791418
• 关键词: Accident and Emergency department; Address; American; Antihypertensive Agents; Appointment; Appointments and Schedules; Black American; Black race; Blinded; Blood Pressure; Blood Pressure Monitors; Cardiovascular Diseases; Cardiovascular system; Caring; Chronic Disease; Control Groups; Data; Dementia; Diagnosis; Diastolic blood pressure; Eligibility Determination; Emergency Department patient; Emergency department visit; Enrollment; Epidemic; Ethnic Population; Evidence based intervention; Federally Qualified Health Center; Feedback; Frequencies; Goals; Guidelines; Healthcare Systems; High Prevalence; Home; Home Blood Pressure Monitoring; Hypertension; Individual; Inequity; Institution; Instruction; Intervention; Low income; Myocardial Infarction; Participant; Patient Recruitments; Patients; Persons; Pharmaceutical Preparations; Population; Primary Care; Randomized; Stroke; Testing; Transportation; Underserved Population; Unemployment; Work; arm; blood pressure control; blood pressure reduction; cardiovascular risk factor; disease disparity; falls; follow-up; health equity; hypertension control; hypertensive; intervention participants; mHealth; medically underserved population; middle age; models and simulation; modifiable risk; mortality; novel strategies; primary care provider; primary care visit; racial population; randomized, clinical trials; safety net; simulation; standard of care; treatment arm; treatment as usual; treatment duration

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).

高血压是心血管疾病最重要的可改变危险因素。美国黑人有 任何种族或民族中高血压患病率最高且血压 (BP) 控制率最低 美国的一个群体，导致心血管疾病的差异。低收入美国人也 高血压负担过重。为了实现健康公平，高血压的新方法 管理层需要利用安全网医疗保健系统来覆盖服务不足的人群。 解决高血压流行问题的一种方法是识别和治疗未经诊断、未经治疗、 或高血压治疗不足的人——那些在医疗保健系统中被忽视的人。我们 在 Reach Out 1 (R01MD011516) 中做到了这一点，这是一项针对高血压的移动健康 (mHealth) 8 臂析因试验 从安全网急诊室招募的患者。在大约 500 名中年黑人参与者中，43% 是 失业； 21% 没有诊断出高血压； 51% 没有服用抗高血压药物 药物治疗，22% 的人没有初级保健提供者。总体而言，收缩压下降了 9.2 mmHg（95% 6 个月后 CI -12.2 至 - 6.3），治疗组之间没有差异。伸出援手 1 已成功注册 高血压、医疗服务不足的人群接受移动医疗干预。尽管大幅减少 总体而言，由于缺乏对照组，BP 的 Reach Out mHealth 干预措施的效果尚不确定。 Reach Out 2 提议在随机、开放、盲法中测试 Reach Out 1 中最有前途的组件。 终点（PROBE）对照试验。伸出援手 2，继续我们的工作与相同的安全网 ED 和联邦 合格的健康中心。在《Reach Out 2》中，我们将比较常规护理和 6 个月的提示自我监控 血压 (SMBP) 监测，提供定制反馈并促进初级保健预约和 运输。常规护理组将收到 ED 后与初级保健提供者进行跟进的指示 释放。 6个月后，干预参与者将进入长期延长治疗期 SMBP 监测。为了将我们的发现结合起来，我们将使用基于慢性疾病代理的模拟模型 估计实施“Reach Out 2”后心肌梗塞、中风和痴呆症的减少情况 在美国各地的安全网急诊室。我们提案的总体目标是确定低技术含量是否 对于从安全网急诊室招募的患者，移动健康干预将比常规护理更能降低血压 了解此类干预措施对国家的潜在影响。因为安全网 ED 是锚 照顾大量医疗服务不足的高血压患者的机构、移动医疗战略 这里发起的行动具有减少心血管不平等的巨大潜力。为了发挥这一潜力，证据- 必须确定降低血压的干预措施（目标 1），评估长期参与（目标 2），以及 他们的影响得到了理解（目标 3）。