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临床试验/NCT03028961
NCT03028961已完成不适用

Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients

Stanford University2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2017年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
2
主要终点
ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record

研究概览

简要总结

The purpose of the proposed research study is to evaluate whether bone marrow transplant patients prefer the Stanford letter advance care planning tool to the standard Advance directive.

Completion of advance care planning prior to BMT is very important, but not often done. The investigators believe that the Stanford Letter will be preferred by patients and will allow them to feel more comfortable and share more of their wishes with family members and the medical team.

详细描述

PRIMARY OBJECTIVES I. To compare advance care planning (ACP) completion rate amongst bone marrow transplant (BMT) recipients receiving the Stanford Letter versus the traditional advance directive (AD) through a prospective, pilot randomized controlled trial (RCT).

SECONDARY OBJECTIVES:

I. To evaluate differences in patient preference for choice to prolong life following completion of the ACP tool in each group.

II. To assess uncertainty with decision making regarding end of life care following completion of the ACP tool in each group.

III. To explore patient understanding of and satisfaction with the ACP tool in each group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All BMT patients at Stanford who are adults and give consent

排除标准

  • Less than 18 years of age

结局指标

主要结局

ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record

时间窗: Up to BMT day 0

The chi-square (X\^2) test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.

次要结局

  • Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation(Up to BMT day 0)
  • Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results(Up to BMT day 0)
  • Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS(within 28 days of ACP completion)
  • Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS(within 28 days of ACP completion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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