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）： 控制难治性高血压的血压：一项试点研究。背景：难治性高血压 (TRH)，即使用 > 3 种血压药物治疗后血压 (BP) 高于目标，影响数百万人并造成健康差异。在临床试验中，确认患者的依从性并系统地调整血压药物以达到控制，约 20% 的患者患有 TRH，这表明当前治疗策略对 TRH 的影响有限。这项试点研究检验了四种改善 TRH 血压控制的循证方法的可行性、安全性和初步有效性。这四种策略包括在符合条件的患者中添加醛固酮拮抗剂（AAEP）、肾素治疗指导疗法（RTGT）、临床高血压专科护理（CHSC）和RTGT+CHSC。假设：明确病理生理机制 (RTGT) 和/或专家咨询 (CHSC) 比在符合条件的患者中“盲目”添加醛固酮拮抗剂 (AAEP) 更能改善血压控制。具体目标：评估四种难治性高血压 (TRH) 循证治疗策略在不同患者组和临床环境中的可行性、安全性和初步比较有效性，以检验 RTGT 和/或 CHSC 比 AAEP 更有效控制 TRH 血压的假设。假设：获取患者、提供者和工作人员的干预后经验和见解将确定实施 AAEP、RTGY 和 CHSC 的障碍和促进因素，从而为示范研究的设计提供信息。具体目标。进行干预后患者问卷调查和访谈、工作人员和提供者焦点小组以及在线 SWOT，以确定 AAEP、RTGY 和 CHSC 的障碍和促进因素，这将为现实世界实践环境中的示范研究提供信息。方法：为不同患者群体提供护理的 8 个不同诊所（> 1 个社区卫生中心、单点和多点初级保健诊所、社区住院医师培训计划）将被随机分配到 4 个研究组中的 1 个。每个中心将招募 18 名 TRH 患者（每组 36 名）。所有诊所均接受 BpTRU 监测仪和培训，以标准化血压测量并“消除”白大衣高血压。关键研究数据包括患者人口统计、就诊、血压值、药物和实验室数据。研究后焦点小组以及对提供者和工作人员的优势、劣势、机会、威胁 (SWOT) 分析以及患者问卷和访谈将用于评估研究的多个维度并指导示范研究设计。意义：TRH 是一种常见的疾病，相对无效的治疗方案是一个重要的促成因素。长期目标是建立实用、有效且可广泛复制的方法来控制 TRH 中的血压并减少临床并发症和相关的健康差异。 （摘要完） 公共卫生相关性： 难治性高血压（TRH）是常见的疾病，相对无效的治疗方案是一个重要的促成因素。拟议研究的长期目标是建立实用、有效且可广泛复制的方法来控制 TRH 血压并减少相关的临床并发症和健康差异。