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得到控制，导致不必要的中风、心肌梗死和其他心血管事件。医生/药师协同管理(PPCM)可以改善血压控制。我们的长期目标是使用可在不同社区的私人诊所实施的PPCM实现出色的BP控制率。我们的模型在一次疗效试验中实现了89%的BP控制，表明PPCM可能会克服典型的种族和社会经济障碍。该应用程序的目标是在具有地理、种族和民族多样性的诊所进行大型多中心临床试验，以确定该模式的实施程度。这个以实践为基础的研究网络(PBRN)是独一无二的，拥有大量的少数族裔人口，在操作和社区规模上具有极大的多样性。这项前瞻性、整群随机试验使用了27个诊所，将648名患者与积极干预组(2组)或对照组进行匹配和随机比较。干预9个月后，一个干预组将在9个月后继续干预，另一个干预组将停止干预。我们还将每个诊所的18名患者随机分为被动观察组(n=486)，以确定PPCM是否在临床上更广泛地实施。所有三组患者都将接受为期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说：目的1：确定随机使用PPCM的诊所患者在9个月时是否比随机使用PPCM的诊所患者在9个月时能够实现更好的血压控制。基本假设：与对照组相比，从诊所随机分到两个PPCM BP干预组的患者在9个月时的血压控制明显更好。目的：确定与9个月后随机停止PPCM的门诊患者和对照诊所的患者相比，随机接受PPCM治疗的患者是否获得了更好的长期血压控制。我们的创新方法解决了关键的组织障碍，并挑战了实现更好的BP控制的现有方法。这项研究之所以新颖，是因为它将：1)成为测试该模型的最大规模的研究；2)使用整群随机设计纳入比以前使用的更多的诊所；3)使用具有广泛地理分布的不同诊所组；4)包括大量来自少数族裔群体的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；以及8)评估“被动观察组”以评估PPCM在整个实践中的传播情况。我们预计，我们的研究将发现收缩压相差6-8毫米汞柱，如果在类似的环境中广泛应用，这将导致冠状动脉死亡减少20%-30%，中风死亡减少25%-40%。公共卫生相关性：我们希望使用我们的干预模式实现60%的血压(BP)控制率，而对照组为35%，该干预将克服少数族裔和较低社会经济群体的传统差异。如果应用于目前在美国使用临床药剂师的所有诊所，收缩压差6-8毫米汞柱将导致近20%的冠状动脉死亡和25%的中风死亡。

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. Public Health Relevance: We expect to achieve a 60% blood pressure (BP) control rate using our intervention model compared to 35% in the control group and the intervention will overcome traditional disparities in minority and lower socioeconomic groups. A 6-8 mm Hg difference in systolic BP, would result in nearly 20% fewer coronary deaths and 25% fewer stroke deaths if applied across all clinics that currently utilize clinical pharmacists in the U.S.