Home-Based Blood Pressure Interventions for African Americans

描述（由申请人提供）： 本研究将进行一项随机试验，以检查两种组织干预措施的有效性和成本效益，旨在改善高风险，非洲裔美国人家庭护理人群中的BP控制。两种待测试的干预措施包括：（i）“基本”干预措施，在病人接受传统的急性期后家庭保健时，向护士、医生和病人提供关键的“及时”信息;以及（ii）“增强”干预将患者转变为基于家庭的HTN支持计划，其扩展信息，在指数家庭护理入院后的18个月内，患者和初级保健医生可获得监测和反馈。干预措施将相对于常规护理和彼此进行评估。 随机化将在护士层面进行，护士最初随机分配到特定组（常规护理、基础治疗或增强治疗）将决定研究期间分配到该特定护士护理的所有新患者的状态。该分析将估计基本和增强干预措施对护理实践和护理过程、患者高血压管理（例如药物依从性）和BP结局以及成本的影响。行为和结果将在固定的时间点进行测量，分析将根据选定的护士特征以及患者特征（包括年龄、性别、BP、合并症和入院时的非正式支持）进行调整。这些因变量的测量将从主要和次要数据的组合中得出，包括患者记录、患者评估工具、患者访谈、家庭BP监测仪和尿液检查以及管理文件。回归模型将用于控制三组护士之间的差异，这些差异可能会影响护理实践或过程。回归模型还将用于控制可能影响行为，服务使用，BP或其他健康结果的患者群体之间的差异。将检验这些模型生成的治疗-对照组差异（两种治疗）估计值的统计学显著性，以确定在护士和患者水平观察到的差异在多大程度上归因于替代干预策略。

DESCRIPTION (provided by applicant): This study will conduct a randomized trial to examine the effectiveness and cost-effectiveness of two organizational interventions aimed at improving BP control among a high-risk, African American home care population. The two interventions to be tested include (i) a "basic" intervention delivering key "just-in-time" information to nurses, physicians and patients while the patient is receiving traditional post-acute home health care; and (ii) an "augmented" intervention transitioning patients to a Home-Based HTN Support Program that extends the information, monitoring and feedback available to patients and primary care physicians for an 18-month period beyond an index home care admission. The interventions will be assessed relative to usual care and to each other. Randomization will occur at the nurse level, and a nurse's initial random assignment to a specific group (usual care, basic treatment or augmented treatment) will determine the status for all new patients allocated to that particular nurse's care for the duration of the study. The analysis will estimate the impact of the basic and augmented interventions on nursing practices and processes of care, on patient hypertension management (e.g. medication adherence) and BP outcomes, and on costs. Behaviors and outcomes will be measured at fixed points in time, and analyses will adjust for selected nurse characteristics, as well as for patient characteristics including age, gender, BP, co-morbidities and informal support at admission. Measures of these dependent variables will be derived from a combination of primary and secondary data, including patient records, patient assessment instruments, patient interviews, home BP monitors and urine tests, and administrative files. Regression models will be used to control for differences among nurses in the three groups with respect to characteristics that might influence practices or processes of care. Regression models also will be used to control for differences across patient groups that might influence behavior, service use, BP or other health outcomes. Estimates of treatment-control group differences (for both treatments) generated by these models will be tested for statistical significance to determine the extent to which observed differences at the nurse and patient levels are attributable to the alternative intervention strategies.