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临床试验/NCT03524534
NCT03524534已完成不适用

The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study

Kaiser Permanente0 个研究点目标入组 2,091 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,091
主要终点
Readmission for heart failure within 30-days

研究概览

简要总结

This study is a pragmatic randomized clinical trial to determine the effectiveness of two strategies of early follow-up in adults after hospitalization for heart failure: telephone follow-up with a heart failure care manager vs. in-person clinic visit with their primary care provider. The primary outcomes during 30-day follow-up will include readmission for heart failure, death and readmission for any cause. The study team aims to randomly assign 2400 patients during a 15-month period in a 1-to-1 ratio to either an initial structured telephone call with a heart failure care manager or an in-person primary care clinic visit within 7 days of discharge. A secondary goal is to increase the rate of any follow-up within 7 days of discharge to greater than 90 percent among all eligible patients.

详细描述

Heart failure (HF) affects >5 million adults nationally and is the leading cause of hospitalization among Medicare beneficiaries. Reducing hospitalization for heart failure (HF) and subsequent readmissions shortly after discharge is a nationally recognized health care delivery system priority. More than 20% of Medicare patients hospitalized for HF are readmitted within 30 days and this rate has not been declining over the past decade despite increasing attention to this problem. The data that will be collected could allow the study team to tailor the post-discharge follow-up program to patient characteristics to further improve the effectiveness of the interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All eligible patients hospitalized for confirmed acute heart failure at a Kaiser Permanente Northern California medical center

排除标准

  • •Planned discharge to a location other than their home. This includes a skilled nursing facility, nursing home or hospice facility.
  • •Planned discharge to home with hospice care.
  • •End-stage renal disease treated with chronic peritoneal dialysis or hemodialysis.
  • •Death during the index hospitalization.

研究组 & 干预措施

Telephone Follow-Up Intervention

Active Comparator

干预措施: Telephone Call (Other)

In-person follow-up intervention

Active Comparator

干预措施: In-Person Primary Care Clinical Follow-Up Visit (Other)

结局指标

主要结局

Readmission for heart failure within 30-days

时间窗: 30 days after discharge

To compare 30-day rates of heart failure-related readmission for subjects randomly assigned to initial heart failure care manager telephone visit vs. in-person primary care clinic visit within 7 days after discharge from a heart failure hospitalization.

次要结局

  • Readmission for any cause within 30 days(30 days after discharge)
  • Death from any cause within 30 days(30 days after discharge)
  • Increase in 7-day follow-up rates(7 days after discharge)

研究者

申办方类型
Other
责任方
Sponsor

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