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临床试验/NCT01558817
NCT01558817已完成不适用

Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation With Informed Assent: A Pilot Study

University of Vermont6 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
6
主要终点
Cardiopulmonary Resuscitation Preference

研究概览

简要总结

Outcomes after in-hospital cardiopulmonary resuscitation (CPR) are very poor, particularly in patients with oxygen dependent chronic obstructive pulmonary disease (COPD) or metastatic cancer. Recent work found that in-hospital CPR is being performed more often before death with unchanging survival and that fewer CPR survivors are being discharged home, thus suggesting that CPR is increasingly performed without benefit and that the burden of this ineffective treatment is increasing. Unlike other medical procedures, CPR has become the default provided to all patients even those with tremendously poor outcomes. It is time to change the paradigm of CPR. Through comparing an innovative "informed assent" approach toward in-hospital CPR (informing patients that their underlying chronic illness makes outcomes of CPR so poor that CPR is not performed while allowing them to disagree) versus usual care in a group of chronically ill patients with reduced life expectancy, the investigators aspire to demonstrate that CPR delivery can be reduced. And in addition that DNR status increases, while preserving patient quality of life and decreasing the burden of this ineffective treatment to both patients and families. If effective, this informed assent intervention has the potential to revolutionize how the investigators discuss CPR with the investigators chronically ill patients.

研究设计

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

入排标准

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

入选标准

  • 18 years or older
  • Oxygen dependent COPD or Advanced Malignancy
  • Life expectancy of less than two years

排除标准

  • Subjects who have already firmly decided to undergo CPR
  • Subjects enrolled in a hospice program
  • Subjects unable to speak English
  • Subjects incapable of making their own decisions at the time of enrollment
  • Subjects cared for by the study investigator

结局指标

主要结局

Cardiopulmonary Resuscitation Preference

时间窗: Within couple of hours before the intervention and immediately (up to 2 days) after the intervention

The primary outcome will be the difference in the proportion of patients in the informed assent intervention and informational brochure groups reporting preferences to be DNR (do not rescusitate).

次要结局

  • Depression(Baseline (day of intervention) and 2 weeks after intervention)
  • Anxiety(Baseline (day of intervention) and two weeks after intervention)
  • Report on acceptability of the informed assent approach(Within couple of hours (up to 2 weeks) after intervention)
  • Resource utilization(Up to 6 months after intervention or until death)
  • DNR status preference(Two weeks after the intervention)
  • Physician Order for Life Sustaining Treatment (POLST)(Baseline (day of intervention) and 2 weeks after intervention)
  • Assessment of DNR status change or intervention follow-up from primary physician(Three months after the intervention)

研究者

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

Renee Stapleton

Associatet Professor, Pulmonary and Critical Care Medicine

University of Vermont

研究点 (6)

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