Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study

控制难治性高血压的血压：一项试点研究

• 批准号: 8031912
• 负责人: BRENT M EGAN
• 金额: $ 33.19万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-01 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8031912
• 关键词: Address; Adherence; Affect; Aldosterone Antagonists; Antihypertensive Agents; Behavior; Blood Pressure; Cardiovascular Diseases; Caring; Clinic; Clinical; Clinical Trials; Clinical effectiveness; Communities; Community Health Centers; Complex; Consultations; Controlled Clinical Trials; Data; Dimensions; Effectiveness; Enrollment; Environment; Evidence based treatment; Failure; Focus Groups; Foundations; Goals; Guidelines; Healthcare; Hypertension; Intervention; Interview; Learning; Life Style; Measurement; Medical; Methods; Monitor; Patient Noncompliance; Patients; Pattern; Pharmaceutical Preparations; Pilot Projects; Population Heterogeneity; Primary Health Care; Process; Provider; Questionnaires; Randomized; Renin; Research; Research Design; Residencies; Resistance; Safety; Site; Specialist; Surveys; Testing; Therapeutic; Training; Training Programs; Treatment Protocols; Visit; abstracting; arm; base; blood pressure regulation; community based practice; comparative effectiveness; compliance behavior; demographics; design; effectiveness research; evidence base; experience; health disparity; improved; insight; patient population; post intervention; success; treatment as usual; treatment strategy; volunteer; white coat hypertension

DESCRIPTION (provided by applicant): Controlling Blood Pressure in Treatment Resistant Hypertension: A Pilot Study. Background: Treatment resistant hypertension (TRH), i.e., blood pressure (BP) above goal on >3 BP medications affects millions of people and contributes to health disparities. In clinical trials, where patient compliance is confirmed and BP meds are systematically titrated to attain control, ~20% of patients have TRH, which suggests limited effectiveness of current treatment strategies contributes to TRH. This pilot study examines the feasibility, safety, and preliminary effectiveness of four evidence-based approaches to improving BP control in TRH. The four strategies include adding an aldosterone antagonist in eligible patients (AAEP), renin treatment-guided therapeutics (RTGT), clinical hypertension specialist care (CHSC), and RTGT+CHSC. Hypothesis: Defining pathophysiological mechanisms (RTGT) and/or expert consultation (CHSC) will improve BP control more than 'blindly' adding an aldosterone antagonist in eligible patients (AAEP). Specific aim: Assess the feasibility, safety, and preliminary comparative effectiveness in a diverse group of patients and clinical settings of four evidence-based treatment strategies for treatment resistant hypertension (TRH) to test the hypothesis that RTGT and/or CHSC are more effective than AAEP for controlling BP in TRH. Hypothesis: Eliciting patient, provider and staff experiences and insights post intervention will identify barriers and facilitators to implementing AAEP, RTGY, and CHSC that will inform design of the demonstration study. Specific Aim. Conduct post-intervention patient questionnaires and interviews and staff and provider focus groups and an online SWOT to identify barriers and facilitators to AAEP, RTGY and CHSC that will inform the demonstration study in real world practice settings. Methods: 8 diverse clinics (>1 community health centers, single & multi-site primary care clinics, community residency training programs) that provide care for a diverse patient population will be randomized to 1 of 4 study arms. Each cilnic will enroll 18 TRH patients (36/arm). All clinics receive BpTRU monitors and training to standardize BP measurements and 'eliminate' white coat hypertension. Key study data include patient demographics, visits, BP values, meds, and lab data. Post study focus groups and strengths, weaknesses, opportunities, threats (SWOT) analysis with providers and staff and patient questionnaire and interviews will be used to evaluate several dimensions of the study and guide the demonstration study design. Significance: TRH is common medical condition, and relatively ineffective treatment regimens are a significant contributing factor. The long-term goal is to establish practical, effective, and widely replicable approaches for controlling BP in TRH and reducing clinical complications and related health disparities. (End of Abstract) PUBLIC HEALTH RELEVANCE: Treatment resistant hypertension (TRH) is common medical condition, and relatively ineffective treatment regimens are a significant contributing factor. The long-term goal of the proposed research is to establish practical, effective, and widely replicable approaches for controlling blood pressure in TRH and reducing the associated clinical complications and health disparities.

描述（由申请人提供）： 控制治疗高血压中的血压：一项试点研究。背景：耐药高血压（TRH），即高于3 bp药物的血压（BP）影响数百万的人，并导致健康差异。在临床试验中，确认患者依从性并系统地滴定BP药物以获得控制，约有20％的患者患有TRH，这表明当前治疗策略的有效性有限。这项试点研究研究了四种改善TRH中BP控制的方法的可行性，安全性和初步有效性。这四种策略包括在合格患者（AAEP），肾素治疗引导的治疗药（RTGT），临床高血压专家护理（CHSC）和RTGT+CHSC中增加醛固酮拮抗剂。假设：定义病理生理机制（RTGT）和/或专家咨询（CHSC）将改善BP控制能力，而不是“盲目地”添加合格患者（AAEP）的醛固酮拮抗剂。具体目的：评估各种患者组的可行性，安全性和初步比较有效性以及四种基于证据的治疗抗药性高血压（TRH）的临床环境，以检验RTGT和/或CHSC的假设，即RTGT和/或CHSC比AAEP在TRH中更有效。假设：在干预后引起患者，提供者和员工的经验和见解将确定实施AAEP，RTGY和CHSC的障碍和促进者，这将为示范研究的设计提供信息。具体目标。进行干预后的患者问卷和访谈以及员工和提供者的焦点小组以及在线SWOT，以确定AAEP，RTGY和CHSC的障碍和促进者，这些障碍和促进者将在现实世界实践环境中为示范研究提供信息。方法：8个不同的诊所（> 1个社区卫生中心，单位和多站点初级保健诊所，社区居住培训计划），这些诊所为多样化的患者人群提供护理，将随机分为4个研究臂中的1个。每个CILNIC将注册18名TRH患者（36/ARM）。所有诊所都接受BPTRU监测和培训，以标准化BP测量并“消除”白色涂层高血压。关键研究数据包括患者人口统计，访问，BP值，药物和实验室数据。研究后的焦点小组和优势，劣势，机会，威胁（SWOT）分析与提供者和员工以及患者问卷以及访谈将用于评估研究的几个方面，并指导示范研究设计。意义：TRH是常见的医学状况，相对无效的治疗方案是重要的因素。长期目标是建立实用，有效且可复制的方法来控制TRH中的BP并减少临床并发症和相关的健康差异。 （抽象的结尾） 公共卫生相关性： 抗治疗高血压（TRH）是常见的医疗状况，相对无效的治疗方案是重要的因素。拟议研究的长期目标是建立实用，有效且可复制的方法，以控制TRH中的血压并减少相关的临床并发症和健康差异。