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临床试验/NCT01589120
NCT01589120Unknown不适用

Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
248
试验地点
2
主要终点
knowledge

研究概览

简要总结

The purpose of this study is to compare the decision making of subjects with advanced CHF having a verbal discussion about goals of care compared to subjects using a video.

详细描述

Aim #1: To compare the impact of the intervention on the distribution of end-of-life knowledge, decisional conflict, and preferences among 248 subjects with advanced heart failure randomly assigned to one of two ACP modalities: 1. a video visually depicting the goals of care along with a patient checklist (intervention, 124 subjects), or 2. usual care, i.e., verbal narrative (control, 124 subjects).

Hypothesis #1: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:

1a. Have more knowledge about their choices

1b. Have less decisional conflict about their decisions

1c. Opt for comfort care and less likely to choose life-prolonging measures

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • A diagnosis of advanced heart failure as defined by ALL THREE of the following:
  • New York Heart Association Class III or IV (NYHA III or IV) (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest).
  • Hospitalization for heart failure within the last six months. AND
  • Age greater than or equal to
  • Additionally ONE of the following must be met:
  • According to the attending physician's best judgment the patient's survival is limited to 2 years but may very well be less than 1 year (i.e. the physician would not be surprised if the patient died within one year from any cause) OR
  • Three heart failure hospitalizations in the last year OR
  • One of the following:
  • Two Systolic Blood Pressures < 90 within the last 6 months in the ambulatory setting
  • Na < 130 within the last 6 months
  • NTproBNP > 3,000
  • EGFR < 35
  • High diuretic use (160 mg po Lasix or 100 mg po torsemide or equivalent total daily dose)

排除标准

  • New patient
  • A transplant or mechanical circulatory support candidate
  • Major psychiatric illness as determined by the attending that would make this study inappropriate.
  • Any patient that has been excluded for transplant or mechanical circulatory support due to psychological or psychiatric co-morbidities.

结局指标

主要结局

knowledge

时间窗: 5 minutes after survey

knowledge of the goals of care for CHF

preferences

时间窗: 5 minutes after survey

preferences for goals of care

次要结局

  • decisional conflict(5 minutes after survey)
  • stability(5 minutes after survey and then at 1, 3, and 6 months)
  • concordance of preferences(by the end of one year)
  • advance care planning discussion(by 6 months)
  • quality of life(after 6 months)
  • referral to hospice(by one year)
  • place of death(by one year)
  • caregiver bereavement score(by one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angelo E. Volandes, MD

Principal Investigator

Massachusetts General Hospital

研究点 (2)

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