Choice Sets for Advance Directives
2016年1月5日 更新者：University of Pennsylvania
A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives
There is a large gap between the care seriously ill patients want and the care they receive.
Advance directives (ADs) offer an opportunity for patients to express specific end-of-life preferences to avoid unwanted care.
As promising as ADs may be for improving the quality of care near the end of life, rates of AD completion remain low and previous efforts to encourage their completion have had limited success.
Principles of behavioral economics, such as the effects of defaults and other framing effects, may offer a novel approach to bridge the gap in end-of-life care.
The goal of this study is to test whether the framing effect of expanding choice sets can increase the completion of and specification of choices within advance directives.
研究概览
详细说明
This study has been designed as two sequential randomized trials to test two separate expanded choice set interventions, with the second randomization enrollment being contingent on results from the first.
All enrolled subjects will be asked if they would like to complete an advance directive and will have been randomized to receive either an expanded answer choice set or a standard answer choice, as described in detail elsewhere.
Only those subjects who express a desire to complete an advance directive from both arms will then be randomized again in a stratified fashion to receive either a standard advance directive or one with an expanded choice set for the decisions regarding life-sustaining therapy, as described in detail elsewhere.
研究类型
介入性
注册 (实际的)
321
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
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New Jersey
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Camden、New Jersey、美国、08103
- Lourdes-Camden
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Market Street DaVita
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Philadelphia、Pennsylvania、美国、19104
- Philadelphia 42nd Street DaVita
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Philadelphia、Pennsylvania、美国、19104
- Philadelphia PMC-Lombard DaVita
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Philadelphia、Pennsylvania、美国、19104
- University City DaVita
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Philadelphia、Pennsylvania、美国、19106
- Franklin DaVita
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Philadelphia、Pennsylvania、美国、19107
- PDI Walnut Tower DaVita
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Philadelphia、Pennsylvania、美国、19123
- Callowhill DaVita
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Philadelphia、Pennsylvania、美国、19131
- City Line DaVita
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Philadelphia、Pennsylvania、美国、19146
- South Broad Street
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Philadelphia、Pennsylvania、美国、19149
- Cottman DaVita
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Philadelphia、Pennsylvania、美国
- South Philadelphia DaVita
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Radnor、Pennsylvania、美国、19087
- Radnor DaVita
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Willow Grove、Pennsylvania、美国、19090
- Abington DaVita
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Willow Grove、Pennsylvania、美国、19090
- Willow Grove DaVita
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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
18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:
- Age 18 or older
- Proficient in English
- Chronic hemodialysis for minimum 90 days
- Does not currently have a living will
Exclusion Criteria:
- Blindness
- Cognitive impairment that prohibits subject's provision of informed consent
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Expanded AD Choice
"Would you like to complete an advance directive with the assistance of any person(s) you choose?" 4 answer choices:
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无干预：Standard AD Choice
"Would you like to complete an advance directive with the assistance of any person(s) you choose?" 2 answer choices:
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实验性的：Expanded Life-sustaining therapy Choice
For each hypothetical illness state described in the living will: 4 answer choices:
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无干预：Standard Life-sustaining Therapy Choice
For each hypothetical illness state described in the living will: 3 answer choices:
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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 |
|---|---|---|
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advance directive
大体时间：up to 4 weeks
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return of a completed and signed advance directive
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up to 4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Medical Outcomes Study Short Form-12v2
大体时间：baseline and 3 months
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change from baseline in Short Form-12v2 score at 3 months
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baseline and 3 months
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McGill Quality of Life Questionnaire
大体时间：baseline and 3 months
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change from baseline in McGill Quality of Life Questionnaire at 3 months
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baseline and 3 months
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Satisfaction with Decision Scale
大体时间：baseline
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satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
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baseline
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Decisional Conflict Scale
大体时间：up to 4 weeks
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Decisional Conflict Scale measured immediately after completion of an advance directive
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up to 4 weeks
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no life-sustaining therapy preference specified
大体时间：up to 4 weeks
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among all patients who complete an AD, the proportion of subjects who choose not to specify a preference for life-sustaining therapy on at least 1 clinical scenario within the AD
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up to 4 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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hospital admissions
大体时间：up to 4 years
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number of hospital admissions from enrollment to study completion
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up to 4 years
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ICU admissions
大体时间：up to 4 years
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number of ICU admissions from enrollment to study completion
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up to 4 years
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Hospice admission
大体时间：up to 4 years
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up to 4 years
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death
大体时间：up to 4 years
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up to 4 years
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demographics of patients (ineligible) whom already completed a living will
大体时间：enrollment
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enrollment
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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。
调查人员
- 首席研究员：Scott D Halpern, MD, PhD、University of Pennsylvania
- 研究主任：Katherine R Courtright, MD、University of Pennsylvania
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。
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
2014年7月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2015年10月1日
研究注册日期
首次提交
2014年7月16日
首先提交符合 QC 标准的
2014年8月4日
首次发布 (估计)
2014年8月5日
研究记录更新
最后更新发布 (估计)
2016年1月7日
上次提交的符合 QC 标准的更新
2016年1月5日
最后验证
2016年1月1日
更多信息
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.