A STEPPED NTERVENTION FOR MEDS ADHERENCE & BP CONTROL

描述(研究人员摘要)：我们建议进行一项随机的 非控制性高血压多元文化人群的对照试验 患者测试阶梯式护理干预的有效性，涉及2个 阶段：(1)血压自我远程监测(STM)，使用 一种电话传输系统，通过该系统，包含在 BP监护仪，将BP测量结果发送给商业服务机构(Lifelink 监测)然后由谁将测量结果发送给患者的医疗保健 提供方；和(2)电话护士案例管理(NCM)，由 商用服务(U-Med)。护士病例经理会打来电话 患者每月一次，并提供有关血压控制和依从性的咨询 到药物治疗方案。所有处于干预状态的患者将开始 STM；3个月后，血压得到控制的患者仍在 STM状态；血压仍未得到控制的患者随后被随机分组， 一半到NCM自我远程监测；另一半继续进行STM( 设计使我们能够评估干预的每一臂的效果 分开，和组合；此外，还会有通常的护理 条件)。重点是一种干预战略，这种战略很容易转移到 各种常见的医疗保健情况。这两种干预措施都是商业化的 提供，因此可获得广泛的医疗保健 提供者，包括规模较小的社区诊所。的一个创新方面 干预是这两个商业服务将一起工作； 护士病例经理将从Lifelink收到BP报告，护士将 然后将其作为咨询的基础。我们将测试该方案的有效性 对12个社区诊所的干预，这些诊所为经济上的 纽约的弱势群体，主要是非洲裔美国人和西班牙裔美国人 城市。主要结果衡量标准是服药依从性，由 电子药物事件监测(MEMS)，以及药房再灌装记录 作为英国石油公司的控制。研究时间为1年。的多层次焦点 干预是对提供者和患者行为的干预。我们将进行 在研究出院时对每个患者进行评估，记录临床血压数据 过去12个月的测量值(如果有)、医生预约次数、急诊率 就诊、用药变化和医生对此做出反应的证据 干预措施。这项研究的长期目标是评估 将医疗干预和成本效益干预分开，并合并。

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.