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

卫生系统与多层次干预措施减少高血压差异的有效性比较

基本信息

批准号：
9019632
负责人：
LISA A COOPER
金额：
$ 104.8万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-28 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9019632
关键词：
Address African American Awareness Behavior Cardiovascular Diseases Caring Chronic Disease Chronic Kidney Failure Clinic Clinical Cluster randomized trial Communities Community Health Comorbidity Complex Computerized Medical Record Consultations Development Diabetes Mellitus Diagnosis Disease Education Educational Background Educational workshop Ethnic Origin Family Federally Qualified Health Center Feedback General Population Goals Growth Health Health Personnel Health Services Accessibility Health system Heart Heterogeneity Hispanics Hospitalization Hyperlipidemia Hypertension Individual Insurance Carriers Intervention Knowledge Laws Leadership Life Light Low income Maryland Measures Medicaid Medical Mental Depression Minority Morbidity - disease rate Not Hispanic or Latino Outcome Participant Patient Education Patient-Focused Outcomes Patients Performance Persons Pharmaceutical Preparations Phase Policies Policy Maker Population Populations at Risk Prevalence Primary Health Care Process Protocols documentation Provider Puerto Rican Race Randomized Recruitment Activity Reporting Research Risk Risk Behaviors Risk Factors Rural Rural Population Self Management Site Specialist Specific qualifier value Stroke Structure Subgroup System Testing Time Translational Research United States abstracting base blood pressure reduction blood pressure regulation cardiovascular disorder risk chronic care model clinical risk cohort collaborative care community based participatory research community organizations community setting comparative effectiveness compare effectiveness effective intervention effective therapy ethnic minority population evidence base experience health organization heart disease risk high risk hypertension control hypertension treatment improved innovation mortality patient oriented programs prospective public health relevance racial and ethnic racial and ethnic disparities residence rural area safety net socioeconomics standard of care

项目摘要

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.

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因素。尽管采取了有针对性的举措来减少差异，但在高血压病的流行和控制方面的种族和族裔差异仍然存在。高血压病在受教育程度较低的人和农村居民中也更为普遍。减少HTN护理差异的障碍很复杂，包括与患者及其家人、医疗保健提供者、实践环境、社区和政策相关的因素。很少有减少HTN的方法将联合收割机多层次战略结合成一个务实和可持续的计划;在服务不足的社区改善以患者为中心的结果;并明确解决差距。我们将比较基于临床的护理标准加审计，反馈和教育（SCP）的有效性，以使用协作护理团队，社区卫生工作者和专家咨询提供情境化，适当的阶梯式护理（CC/阶梯式护理）的干预措施，以减少差异并改善以患者为中心的结果HTN患者，有或没有其他合并症。我们将利用患者和广泛的利益相关者参与，并应用基于社区的参与性研究的原则，以完善和调整干预方案和材料，以满足参与组织，诊所和人群的需求。我们假设CC/阶梯式护理在改善患者血压控制和自我管理行为方面比SCP更有效，并且CC/阶梯式护理将在更大程度上减少种族/民族，社会经济和农村/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（总计= 1，890名）参加我们的大型，前瞻性和务实的集群随机试验。我们将有足够的统计学把握度来检测两组之间13%的血压控制率差异（假设20%的损耗）。在UH 3阶段，每6个月将随机分配3个队列，每个队列10个诊所，接受SCP或CC/阶梯式护理，为期2年。合格患者为≥18岁、非西班牙裔黑人、非西班牙裔白色或西班牙裔，在参与诊所接受治疗，患有不受控制的HTN，伴或不伴合并症，如糖尿病、高脂血症或抑郁症。主要的患者水平分析比较了SCP与CC/阶梯式护理，回归百分比包括血压控制（<140/90 mm Hg）、收缩压、患者激活和慢性疾病自我管理时间指标（0/1）、干预指标以及时间和干预的相互作用，以评估CC/阶梯式护理随时间的变化是否在统计学上优于SCP。预先规定的亚组分析检验了人种/种族、农村/城市居民、医疗补助/非医疗补助状态和跨步骤的异质性。拟议的干预措施，如果有效，将有潜力的可持续性和可扩展性，在现实世界的初级保健实践，特别是在安全网卫生中心，由于其包括利益相关者在项目的所有阶段。