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Better Effectiveness After Transition - Heart Failure (BEAT-HF)

2016年5月10日 更新者：Michael Ong、University of California, Los Angeles

Variations in Care: Comparing Heart Failure Care Transition Intervention Effects

The purpose of this study is to compare the effect of implementing wireless remote monitoring combined with structured telephone monitoring, versus current care, on variation in rehospitalization among older patients hospitalized with heart failure at six medical centers.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

1437

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Davis、California、美国、95616
        • University of California, Davis
      • Irvine、California、美国、92697
        • University of California, Irvine
      • Los Angeles、California、美国、90095
        • University of California, Los Angeles
      • Los Angeles、California、美国、90048
        • Cedars-Sinai Medical Center
      • San Diego、California、美国、92093
        • University of California, San Diego
      • San Francisco、California、美国、94143
        • University of California, San Francisco

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • patients hospitalized at any of the six medical centers who are being actively treated for heart failure.

Exclusion Criteria:

  • patients who have previously received a transplant, are being evaluated for a transplant, or who are on the wait list for a transplant,
  • patients who are enrolled or enrolling in hospice, or are expected to expire shortly after discharge,
  • patients with dementia,
  • patients who are admitted from a skilled nursing facility (SNF), or who we anticipate will be discharged to a long term stay in a SNF,
  • patients who do not have a working land line phone or reliable cell service,
  • patients on chronic dialysis,
  • patients who cannot identify a usual source of care (free clinic is acceptable) and who will not be assigned a provider upon discharge,
  • patients with the following cardiovascular conditions: patients with valvular disorders requiring surgical intervention (except for those with incidental valvular disease, who will be included), acute myocardial infarction (except for those with demand ischemia, who will be included), percutaneous coronary intervention
  • patients expected to enroll in hospice or expire after discharge,
  • patients who are unable to use the intervention equipment (e.g., unable to stand on the weight scale), or who are otherwise unable to comply with the intervention

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：Current Care
Patients will receive the current care provided to heart failure patients at each of the study sites
实验性的：Care Transition Intervention
Care transition intervention beginning prior to discharge and through six months post-discharge.
其他：Structured Telephone / Remote Outpatient Monitoring
During their hospitalization, patients will receive education on their condition and will be taught to use a wireless remote monitoring device that they will use from home on a daily basis for six months following hospital discharge. Patients will receive structured telephone phone calls from a centralized call center nurse at least once a week for the first month post-discharge, and monthly for the remainder of the six month study period. Patients may receive additional calls depending upon the information gathered during the scheduled call center phone calls and/or their health status as ascertained by the data (weight, heart rate, blood pressure, answers to general health and heart failure-related questions) transmitted daily by the wireless remote monitoring device.
其他名称：
  • 远程监控
  • Care Transition Intervention
  • Care Transitions Intervention
  • Structured Telephone Monitoring

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
180 day rehospitalization rate
大体时间：at 180 days post-discharge
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
at 180 days post-discharge

次要结果测量

结果测量
措施说明
大体时间
7 day mortality rate
大体时间：within 7 days post-discharge
Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.
within 7 days post-discharge
Change in quality of Life
大体时间：as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
Quality of life scores will be measured using standardized questionnaires, and data captured during enrollment will be compared with data captured during three post-discharge phone calls
as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
30 day mortality rate
大体时间：at 30 days post-discharge
Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.
at 30 days post-discharge
180 day mortality rate
大体时间：at 180 days post-discharge
Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.
at 180 days post-discharge
30 day rehospitalization rate
大体时间：at 30 days post-discharge
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
at 30 days post-discharge
7 day rehospitalization rate
大体时间：within 7 days post-discharge
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
within 7 days post-discharge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of California, Los Angeles

合作者

University of California, San Diego
University of California, Davis
University of California, San Francisco
University of California, Irvine
Cedars-Sinai Medical Center

调查人员

  • 首席研究员：Michael K Ong, MD, PhD、University of California, Los Angeles

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年10月1日

初级完成 (实际的)

2014年3月1日

研究完成 (实际的)

2014年3月1日

研究注册日期

首次提交

2011年5月18日

首先提交符合 QC 标准的

2011年5月23日

首次发布 (估计)

2011年5月25日

研究记录更新

最后更新发布 (估计)

2016年5月11日

上次提交的符合 QC 标准的更新

2016年5月10日

最后验证

2014年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • R01HS019311 (美国 AHRQ 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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