Nighttime Dosing of Anti-Hypertensive Medications: A Pragmatic Clinical Trial

描述（由申请人提供）：最近的两项小型临床试验报告，患有慢性肾脏疾病或糖尿病的高血压患者被分配在睡前服用至少一种抗高血压药物，其心血管事件的风险显著降低。 干预的简单性（改变给药时间），基础疾病的患病率，以及干预对改善健康的巨大潜在影响，使这一领域成为实用临床试验的理想主题。 因此，拟议的试验将确定抗高血压药物夜间给药对有心血管不良事件风险的患者的有效性。 该研究将在两个综合卫生系统进行，并将建立在调查小组的创新工作基础上：1）开发基于电子病历（EMR）的患者招募策略; 2）建立基于网络的互动平台，以获得知情同意; 3）从EMR中提取研究数据; 4）收集基于网络的个人健康记录的患者报告结果; 5）在常规初级保健环境中进行NIH和VA资助的多点试验，以改善高血压的管理。 在UH 2部分期间，研究者将在两个参与研究中心完善并实施一些创新和高效的患者招募、数据收集和知情同意策略。 在UH 3部分，该团队将进行随机实用试验，以检查夜间降压剂量的影响。该研究将在7个月的时间内从两个研究中心招募约1100名患者。 将对患者进行后续36-42个月的随访，以确定主要心血管事件的发生率。 其他研究终点包括门诊和睡眠时间血压，药物依从性，健康相关的生活质量，症状和医疗保健利用。 将使用基于EMR的算法识别合格患者。 知情同意将通过基于网络的交互式平台或与研究协调员的1-800电话联系获得。 研究数据将从两个参与研究中心的EMR和基于网络的个人健康记录中提取。 公共卫生相关性：这项研究将涉及进行一项简单实用的临床试验，以确定是否在夜间服用高血压药物，而不是在夜间服用。 早晨，导致高血压患者心血管疾病的风险较低。 该研究将从电子病历和个人健康记录中收集数据，并将使用创新网站收集患者的知情同意书。

DESCRIPTION (provided by applicant): Two recent small clinical trials reported that hypertensive patients with chronic kidney disease or diabetes who were assigned to take at least one antihypertensive at bedtime had a dramatically lower risk of cardiovascular events. The simplicity of the intervention (changing the timing of medication administration), the prevalence of the underlying condition, and the large potential impact of the intervention on improving health make this area an ideal topic for a pragmatic clinical trial. Thus, the proposed trial will determine the effectiveness of nighttime dosing of antihypertensive medications in patients at risk of adverse cardiovascular events. The study will be conducted at two integrated health systems and will build on the innovative work of the investigative team in: 1) developing electronic medical record (EMR) based patient recruitment strategies; 2) building interactive web-based platforms for obtaining informed consent; 3) extracting research data from EMRs; 4) collecting patient-reported outcomes web-based personal health records; and 5) conducting NIH and VA funded multi-site trials in routine primary care settings to improve management of hypertension. During the UH2 component, the investigators will refine and then implement a number of innovative and highly efficient strategies for patient recruitment, data collection, and obtaining informed consent at the two participating sites. During the UH3 component, the team will conduct randomized pragmatic trial to examine the impact of nighttime antihypertensive dosing. The study will enroll an estimated 1100 patients from the two sites during a seven-month period. Patients will be followed for the subsequent 36-42 months to determine the occurrence of major cardiovascular events. Other study endpoints include clinic and sleep time blood pressure, medication adherence, health related quality of life, symptoms, and healthcare utilization. Eligible patients will be identified using EMR-based algorithms. Informed consent will be obtained using an interactive web-based platform or a 1-800 telephone contact with a study coordinator. Study data will be extracted from EMRs at the two participating sites and from web-based personal health records. PUBLIC HEALTH RELEVANCE: This study will involve conducting a simple and practical clinical trial to determine if taking medication for high blood pressure at night, as opposed to in the morning, lead to a lower risk of cardiovascular disease in patients with hypertension. The study will collect data from electronic medical records and from personal health records and will use an innovative website to collect informed consent from patients.