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

改善血压控制并尽量减少种族差异的协作模式——DCC

• 批准号: 7577264
• 负责人: William R. Clarke
• 金额: $ 73.29万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-15 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7577264
• 关键词: Address; Blood Pressure; Cardiovascular system; Cessation of life; Clinic; Clinical; Clinical Pharmacists; Clinical Trials; Clinical Trials Data Monitoring Committees; Communities; Conduct Clinical Trials; Control Groups; Coronary; Data; Data Collection; Data Coordinating Center; Data Set; Event; Geographic Distribution; Goals; Hypertension; Intervention; Iowa; Lead; Leadership; Link; Measurement; Medical; Minority; Minority Groups; Modeling; Monitor; Multi-Institutional Clinical Trial; Myocardial Infarction; Online Systems; Operative Surgical Procedures; Patients; Performance; Pharmacists; Physicians; Population; Private Practice; Procedures; Publications; Randomized; Randomized Controlled Clinical Trials; Research; Research Design; Selection Bias; Stroke; System; Testing; United States National Institutes of Health; Universities; blood pressure regulation; clinical application; clinical research site; data management; design; distributed data; efficacy trial; group intervention; health disparity; improved; innovation; novel; practice-based research network; prospective; protocol development; public health relevance; quality assurance; racial and ethnic; socioeconomics

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.

描述（由申请人提供）： 血压（BP）仅在34％的高BP患者中受到控制，导致不必要的中风，心肌梗塞和其他心血管事件。医师/药剂师协作管理（PPCM）可以改善BP控制。我们的远程目标是使用PPCM实现出色的BP控制率，这些PPCM可以在不同社区的私人实践中实施。我们的模型在有效试验中实现了89％的BP控制，并表明PPCM可能会克服典型的种族和社会经济障碍。该应用的目的是在具有地理，种族和种族多样性的诊所进行大型多中心临床试验，以确定实施模型的程度。这个基于实践的研究网络（PBRN）是独一无二的，其运营和社区规模的多样性众多。这项前瞻性的，簇的试验使用了27个诊所，与648名患者的主动干预（2组）或一个对照组匹配并随机分配。在干预9个月后，一个干预小组将在9个月后继续进行干预，而另一个将停止干预。我们还将每个诊所将18例患者随机分为一个被动观察组（n = 486），以确定在诊所中是否更广泛地实施了PPCM。所有三组的患者将遵循24个月。我们将通过追求以下目的来实现目标，并测试中心假设：目标1：与随机分配给对照组的诊所相比，与随机分配给对照组的诊所相比，在9个月内随机分配给PPCM的患者是否可以在9个月中获得更好的BP对照。主要假设：与对照组相比，从随机到两个PPCM BP干预组的诊所的患者中，9个月的BP对照将明显更大。目标2：与诊所中的患者相比，在9个月后随机停用PPCM的诊所和对照诊所患者的诊所中，与诊所中的患者相比，与诊所中的患者相比，诊所中的患者是否可以实现更好的长期BP对照。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。 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）评估一个“被动观察组”，以评估整个练习过程中PPCM的传播。我们希望我们的研究在收缩BP中会发现6-8 mm的HG差异，如果在类似情况下广泛应用，则冠状动脉死亡人数减少了20-30％，中风死亡减少了25-40％。公共卫生相关性：我们希望使用我们的干预模型达到60％的血压（BP）控制率，而对照组为35％，干预措施将克服少数群体和较低社会经济群体的传统差异。如果在美国目前利用美国临床药剂师的所有诊所中应用，则收缩BP的6-8 mm HG差异将降低冠状动脉死亡近20％，中风死亡减少了近20％，中风死亡减少了25％。