A collaborative model to improve BP control and minimize racial disparities-CCC

描述（由申请人提供）： 只有34%的高血压患者的血压（BP）得到控制，导致不必要的中风，心肌梗死和其他心血管事件。通过医生/药剂师协作管理（PPCM）可以改善血压控制。我们的长期目标是使用PPCM实现卓越的BP控制率，该PPCM可在不同社区的私人诊所中实施。我们的模型在有效性试验中实现了89%的BP控制，并表明PPCM可能克服典型的种族和社会经济障碍。本申请的目的是在具有地理、种族和民族多样性的诊所中进行大型多中心临床试验，以确定该模型的实施程度。这个以实践为基础的研究网络（PBRN）是独一无二的，拥有大量的少数民族人口，在运作和社区规模方面具有很大的多样性。这项前瞻性、随机分组试验使用了27家诊所，在648名患者中匹配并随机分配到积极干预组（2组）或对照组。干预9个月后，一个干预组将继续干预9个月后，而另一个将停止it. We也将随机18例患者每个诊所到一个被动观察组（n=486），以确定是否PPCM更广泛地实施在诊所。所有三组患者将接受24个月的随访。我们将通过追求以下目标来实现我们的目标并检验我们的中心假设：目标1：确定与随机分配到对照组的诊所患者相比，随机分配到PPCM的诊所患者在9个月时是否可以实现更好的BP控制。主要假设：与对照组相比，随机分配至两个PPCM BP干预组的诊所患者在9个月时的BP控制显著更好。目标二：确定与9个月后随机分配至PPCM停药的诊所患者和对照诊所患者相比，随机分配至继续PPCM的诊所患者是否实现了更好的长期BP控制。我们的创新方法解决了关键的组织障碍和挑战现有的方法，以实现更好的BP控制。这项研究是新颖的，因为它将：1）是测试该模型的最大研究，2）使用群集随机设计，包括比以前使用的更多的诊所，3）使用具有广泛地理分布的多样化诊所组，4）包括来自少数群体的大量患者，以评估潜在的健康差异，5）评估效果是否可以长期持续，6）包括标准化的BP测量，而不是容易出错的办公室BP，7）最大限度地减少选择偏差，和8）评估“被动观察组”，以评估整个实践中PPCM的传播。我们预计，我们的研究将发现收缩压的6-8 mm Hg差异，如果广泛应用于类似环境，将导致冠状动脉死亡减少20-30%，卒中死亡减少25-40%。

DESCRIPTION (provided by applicant): Blood pressure (BP) is controlled in only 34% of patients with high BP, leading to unnecessary strokes, myocardial infarctions and other cardiovascular events. BP control can be improved with physician/ pharmacist collaborative management (PPCM). Our long-range goal is to achieve excellent BP control rates using PPCM that can be implemented in private practices in diverse communities. Our model achieved 89% BP control in an efficacy trial and suggests that PPCM might overcome typical racial and socioeconomic barriers. The objective of this application is to conduct a large multi-center clinical trial in clinics with geographic, racial and ethnic diversity to determine the extent to which the model is implemented. This practice-based research network (PBRN) is unique with a large minority population and great diversity in operation and community size. This prospective, cluster-randomized trial uses 27 clinics, matched and randomized to the active intervention (2 groups) or a control group in 648 patients. Following 9 months of the intervention, one intervention group will continue the intervention following 9 months while the other will discontinue it. We will also randomize 18 patients per clinic into a passive observation group (n=486) to determine if PPCM is implemented more broadly in the clinic. Patients in all three groups will be followed for 24 months. We will accomplish our objectives and test our central hypothesis by pursing the following aims: Aim 1: To determine if patients in clinics randomized to PPCM can achieve better BP control at 9 months compared to patients in clinics randomized to the control group. Primary Hypothesis: BP control at 9 months will be significantly greater in patients from clinics randomized to the two PPCM BP intervention groups compared to the control group. Aim 2: To determine if patients in clinics randomized to continuation of PPCM achieve better long-term BP control compared to patients in clinics randomized to discontinuation of PPCM after 9 months and to patients in control clinics. Our innovative approach addresses critical organizational barriers and challenges existing approaches to achieving better BP control. This study is novel because it will: 1) be the largest study to test this model, 2) use a cluster randomized design to include many more clinics than previously used, 3) use a diverse group of clinics with broad geographic distribution, 4) include large numbers of patients from minority groups to assess potential health disparities, 5) evaluate whether the effect can be sustained long-term, 6) include standardized BP measurements rather than error-prone office BPs, 7) minimize selection bias, and 8) evaluate a "passive observation group" to evaluate dissemination of PPCM throughout the practice. We expect that our study will find a 6-8 mm Hg difference in systolic BP which would lead to 20-30% fewer coronary deaths and 25-40% fewer stroke deaths if applied across broadly across similar settings.