A STEPPED NTERVENTION FOR MEDS ADHERENCE & BP CONTROL

描述（研究者摘要）：我们建议进行一项随机 在未控制的高血压患者的多文化人群中进行的对照试验 患者测试阶梯式护理干预的有效性， 阶段：（1）血压（BP）的自我远程监测（STM）， 电话传输系统，通过该系统， BP监测器，将BP测量值发送到商业服务（Lifelink 监测），然后将测量结果发送给患者的医疗保健 提供者;和（2）基于电话的护士病例管理（NCM），由 市售服务（U-Med）。护士病例管理员会打电话给 患者每月一次，并提供有关血压控制和依从性的咨询 药物治疗方案。干预条件下的所有患者将开始 STM; 3个月后，BP得到控制的患者仍留在 STM条件;然后将血压保持不受控制的患者随机分组， 一半用于NCM +自我远程监护;另一半仅继续STM（ 设计使我们能够评估干预的每个分支的效果， 此外，还会有一个特殊的治疗方案。 条件）。重点是一项干预战略， 各种常见的医疗保健情况。这两种干预措施都是商业性的 因此可以获得广泛的医疗保健服务 提供者，包括较小的社区诊所。的创新方面 干预措施是这两个商业服务将一起工作; 护士病例管理员将收到来自Lifelink的BP报告，护士将 然后作为咨询的基础。我们将测试 * 在12个社区诊所采取干预措施， 在纽约的弱势群体，主要是非洲裔美国人和西班牙裔人口 市主要的结局指标是药物依从性，由以下因素决定： 电子药物事件监测（MEMS）和药房再填充记录，以及 BP控制研究持续时间为1年。的多层次焦点 干预是对提供者以及病人的行为。我们会进行 在研究出院时对每例患者进行审查，记录门诊BP数据 过去12个月内的测量结果（如有）、医生预约、ER 访问，药物变化，以及医生对 干预措施。这项研究的长期目标是评估 医疗和成本效益的干预措施分开，并结合起来。

DESCRIPTION (investigator's abstract): We propose to conduct a randomized controlled trial in a multicultural population of uncontrolled, hypertensive patients to test the effectiveness of a stepped-care intervention involving 2 stages: (1) Self-Telemonitoring (STM) of blood pressure (BP) which uses a telephone transmission system by which an easy-to-use modem, contained in the BP monitor, sends the BP measurements to a commercial service (Lifelink Monitoring) who then sends the measurements to the patient's health care provider; and (2) Telephone-Based Nurse Case Management (NCM), provided by a commercially available service (U-Med). The nurse case managers will call patients once/month, and provide counseling regarding BP control, and adherence to medication regimens. All patients in the intervention condition will begin with STM; after 3 months, patients whose BP has come under control remain in the STM condition; patients whose BP remain uncontrolled are then randomized, half to NCM + Self-Telemonitoring; the other half to continue in STM only (the design allows us to evaluate the effects of each arm of the intervention separately, and the combination; in addition, there will be a Usual Care condition). The focus is on an intervention strategy which readily transfers to a variety of usual health care situations. Both interventions are commercially available, and therefore are accessible to a wide range of health care providers, including smaller community-based clinics. An innovative aspect of the intervention is that the 2 commercial services will work together; the nurse case managers will receive BP reports from Lifelink, which the nurse will then use as a basis for counseling. We will test the effectiveness of the interventions in 12 community-based clinics, which serve an economically disadvantaged, largely African American and Hispanic population, in New York City. The main outcome measures are medication adherence, determined by electronic drug event monitoring (MEMS), and pharmacy refill records, as well as BP control. Study duration is 1 year. The multilevel focus of the interventions is on provider as well as patient behavior. We will conduct reviews for each patient at study discharge, recording data on clinic BP measurements during the previous 12 months, if any, doctor appointments, ER visits, medication changes, and evidence that the physician has responded to the interventions. The long-term goals of the research are to assess the medical and cost effectiveness of the interventions separately, and combined.