Outcomes of Blood Pressure Management in Diabetes Patients with Comorbidities

描述(由申请人提供)：这项拟议研究的目标是在糖尿病患者中调查血压管理的预测因素、模式和结果，以便利用这些信息来优化现有的血压指南。我们将使用关联的登记-索赔数据库来调查通过合并疾病控制BP的模式，评估BP与不良后果之间的关系，并为具有复杂健康状况的糖尿病患者开发BP管理指南原型。具体目的是：(1)评估特定的血管和非血管并发症对2型糖尿病患者随时间的血压模式的影响。我们假设，糖尿病患者的血压轨迹会有所不同，他们有特定的共存条件和不同的管理干预措施。(2)。评估糖尿病患者的共病负担、血压控制和血压水平变化与不良临床结局(中风、缺血性心脏事件、住院和死亡)之间的关系。我们假设，复杂的健康状况，而不是血压水平，将更有力地预测有多种并发症和脆弱性的糖尿病患者的不良事件。然而，对于那些没有复杂健康状况的患者，我们假设血压水平将是不良结果的预测因子。(3)使用特定目标1和2的结果，开发将复杂患者的不良事件概率降至最低的指南原型。我们将使用有关特定并发症的BP轨迹的信息和来自预测不良临床结果的回归模型的数据，以生成将更多数据元素纳入复杂糖尿病患者现有BP指南的可能性。这是一项分析性流行病学研究。它将使用包含糖尿病管理措施(HbA1c、低密度脂蛋白水平、血压水平等)的临床糖尿病登记的二级数据分析，这些数据将与健康维护组织和联邦医疗保险的索赔相联系。通过密歇根大学参与医生团体执业(PGP)医疗保险示范项目，可以获得医疗保险索赔。该项目为UM分配了在UM接受医疗保险收费服务的人群；糖尿病登记中的大多数联邦医疗保险患者都是被分配的。参与者将是2005-2008年间约20,000名登记的患者，其中约70%的人将在登记中提出索赔和多种BP措施。利用这一相关的登记数据，这项研究将调查从中老年到高龄、具有不同共病负担的糖尿病患者的血压水平。主要结果包括中风、新的缺血性心脏事件、死亡和住院增加。作为预测糖尿病患者血压水平和临床结果的最感兴趣的协变量是冠状动脉疾病、复杂的健康状况(定义为共病负担)和年龄。本研究结果将为糖尿病合并复杂健康状况患者改善血压管理提供实用的临床依据。

DESCRIPTION (provided by applicant): The goal of the proposed research is to investigate predictors, patterns and outcomes of blood pressure (BP) management among patients with diabetes and coexisting health conditions, in order to use this information to optimize existing BP guidelines. We will use a linked registry-claims database to investigate the pattern of BP control by comorbidities, assess the relation between BP and adverse outcomes, and develop guideline prototypes for BP management in diabetes patients with complex health status. The Specific Aims are: (1) To assess the effect of specific vascular and nonvascular comorbidities on BP patterns over time in patients with type 2 diabetes mellitus. We hypothesize that trajectories of BP will be different in diabetes patients who have specific coexisting conditions and different management interventions. (2). To evaluate the association between comorbidity burden, BP control and changes in BP level, and adverse clinical outcomes (stroke, ischemic cardiac events, hospitalization, and death) in diabetes patients. We hypothesize that complex health status, rather than BP level, will more strongly predict adverse events in diabetes patients with multiple comorbidities and vulnerabilities. For those patients without a complex health status, however, we hypothesize that BP level will be a predictor of adverse outcomes. (3) Using the results from Specific Aims 1 and 2, to develop guideline prototypes that minimize the probability of adverse events in complex patients. We will use information regarding the trajectories of BP for specific comorbidities and data from the regression models which predict adverse clinical outcomes, to generate the probabilities of incorporating additional data elements into existing BP guidelines for complex diabetes patients. This is an analytic epidemiology study. It will use secondary data analysis of a clinical diabetes registry containing measures of diabetes management (HbA1c, LDL level, BP level, among others) that will be linked to claims from a Health Maintenance Organization and Medicare. Medicare claims are available through the University of Michigan's participation in the Physician Group Practice (PGP) Medicare Demonstration Project. This project assigns UM a population of fee-for service Medicare patients cared for at UM; most Medicare patients in the diabetes registry are assigned. Participants will be the approximately 20,000 registry patients from 2005-2008, approximately 70% of whom will have claims and multiple BP measures on the registry. Using this linked registry data, this research will investigate blood pressure (BP) level among patients with diabetes from middle to advanced old age, with different comorbidity burdens. Major outcomes include stroke, new ischemic cardiac event, death, and increased hospitalization. Covariates of most interest as predictors of both BP level and clinical outcomes in diabetes are coronary artery disease, complex health status (defined as comorbidity burden) and age. Results of this research will provide practical clinical evidence for modifying BP management in patients with diabetes and complex health status.