Comparative Effectiveness of Health System vs. Multilevel Interventions to Reduce Hypertension Disparities

 描述(由申请人提供)：尽管有有效的治疗方法，高血压(HTN)仍然是美国发病率和死亡率的重要贡献者。尽管采取了有针对性的举措来减少差异，但在性传播疾病的流行和控制方面仍然存在种族和族裔差异。HTN在受教育程度较低的人群和农村居民中也更为普遍。减少HTN护理差异的障碍是复杂的，包括与患者及其家人、医疗保健提供者、执业环境、社区和政策相关的因素。很少有减少HTN的方法将多层次的战略结合到一个务实和可持续的计划中；在服务不足的社区改善以患者为中心的结果；并明确解决差异。我们将比较以临床为基础的护理标准加上审计、反馈和教育(SCP)的有效性，以及使用协作护理团队、社区卫生工作者和专家咨询来提供因地制宜的、适当分步护理(CC/分步护理)的干预措施的有效性，以减少HTN患者之间的差异并改善以患者为中心的结果，无论是否有其他并发症。我们将利用耐心和广泛的利益相关者参与，并应用以社区为基础的参与性研究的原则来完善和调整干预方案和材料，以适应参与组织、诊所地点和人口的需求。我们假设CC/分级护理在改善患者血压控制和自我管理行为方面将比SCP更有效，CC/分级护理将在更大程度上减少种族/民族、社会经济和城乡/非农村差异。马里兰州的30家初级保健诊所，包括联邦合格的健康中心，将招募63名患者(总数=1,890人)参加我们的大型、前瞻性和务实的整群随机试验。我们将有足够的统计能力来检测不同组之间13%的BP控制率差异(假设20%的自然减少率)。在UH3期间，每6个月10家诊所的3个队列将随机接受SCP或CC/分级护理，为期2年。符合条件的患者包括≥18年、非西班牙裔黑人、非西班牙裔白人或西班牙裔，在参与的诊所接受护理，以及患有或不伴有糖尿病、高脂血症或抑郁症等共病的未受控制的HTN。主要的患者层面分析比较SCP和CC/阶梯式护理，在时间指标(0/1)、干预指标以及时间和干预的交互作用上比较SCP与控制下的血压(&lt；140/90 mm Hg)、收缩压、患者活动和慢性病自我管理的回归百分比，以评估CC/阶梯式护理随时间的变化是否在统计学上好于SCP。预先指定的子组分析测试跨种族/民族、农村/城市居住地、医疗补助/非医疗补助状况和跨步骤的异质性。拟议的干预措施如果有效，将有可能在现实世界的初级保健实践中实现可持续性和可扩展性，特别是在安全网卫生中心中，因为它将利益攸关方纳入项目的所有阶段。

 DESCRIPTION (provided by applicant): Despite the availability of effective therapy, hypertension (HTN) remains a significant contributor to morbidity and mortality in the United States. Racial and ethnic disparities in HTN prevalence and control persist despite targeted initiatives to reduce disparities. HTN is also more prevalent among persons with less education and among rural residents. Barriers to reducing disparities in HTN care are complex and include factors related to patients and their families, healthcare providers, practice settings, communities, and policies. Few approaches to reducing HTN combine multi-level strategies into a pragmatic and sustainable plan; improve patient- centered outcomes in underserved communities; and explicitly address disparities. We will compare the effectiveness of clinic-based standard of care plus audit, feedback and education (SCP) to an intervention that uses a collaborative care team, a community health worker and specialist consultation to deliver contextualized, appropriately stepped care (CC/stepped care) for reducing disparities and improving patient-centered outcomes among patients with HTN, with or without other comorbidities. We will use patient and broad stakeholder engagement and apply principles of community-based participatory research to refine and adapt intervention protocols and materials to the needs of participating organizations, clinic sites, and populations. We hypothesize that CC/stepped care will be more effective than SCP at improving patient BP control and self-management behaviors, and that CC/stepped care will reduce racial/ethnic, socioeconomic, and rural/non-rural disparities to a greater extent than SCP. Thirty primary care clinics, including Federally Qualified Health Centers, across Maryland will recruit 63 patients each (total=1,890) into our large, prospective and pragmatic cluster randomized trial. We will have adequate statistical power to detect a difference in BP control rates of 13% between groups (assuming 20% attrition). In the UH3 period, every 6 months 3 cohorts of 10 clinics each will be randomized to receive SCP or CC/stepped care for 2 years. Eligible patients are ≥18 years, non-Hispanic black, non-Hispanic white, or Hispanic, receive care at participating clinics, and have uncontrolled HTN with or without comorbidities such as diabetes, hyperlipidemia, or depression. The main patient-level analysis compares SCP to CC/stepped care, regressing percent with BP under control (<140/90 mm Hg), systolic BP, patient activation and chronic disease self management on time indicators (0/1), an intervention indicator, and interactions of time and intervention to assess whether the change over time in CC/stepped care is statistically better than SCP. Pre-specified subgroup analyses test for heterogeneity across race/ethnicity, rural/urban residence, Medicaid/ non-Medicaid status and across steps. The proposed Intervention, if effective, will have potential for sustainability and scalability in real-world prmary care practices, especially among safety-net health centers, due to its inclusion of stakeholders at all phases of the project.