Effects of Repeated Decision Making Among Surrogates of Seriously Ill Patients
2015年1月27日 更新者：Scott Halpern、University of Pennsylvania
Pilot Study of Repeated Decision Making in Surrogates
Decision making capacity fatigues after repeated decisions similar to skeletal muscle.
The result is decision fatigue, in which subsequent decisions are altered toward the status quo.
Surrogates are at risk for decision fatigue yet it has not been studied.
We propose a randomized study in the outpatient setting in surrogates and patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on surrogate self-control and subsequent choices.
研究概览
详细说明
Just as skeletal muscle fatigues after repeated use, decision-making capacity fatigues when repeated choices are made.
This phenomenon, in which people experience diminished concentration and willpower after repeated decision-making, is termed decision fatigue.
People experiencing decision fatigue are more likely to bias subsequent choices toward the status quo.
By choosing the status quo, the decision-maker reserves the option to make an alternate choice at a later time, thereby preserving possibilities.
Patients and their surrogates often make complex medical decisions for which they may have little experience.
Although clearly at high risk, decision fatigue has not been studied in this population.
To elucidate these questions, we propose a four-arm study of surrogates and patients in a population at high risk for making complex decisions.
Surrogates will be randomly assigned to varied levels of decision making effort to assess for the development of resultant decision fatigue and whether it alters subsequent decisions.
研究类型
介入性
注册 (实际的)
132
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
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- Perelman Center for Advanced Medicine at the University of Pennsylvania
-
-
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:
- Patients must have one of the following diagnoses: aplastic anemia, multiple myeloma, myelodysplastic syndrome, acute myeloid leukemia, stage IIIB or IV lung cancer, mesothelioma and/or stage IIIB or IV gastrointestinal cancer (pancreatic, biliary, esophageal, gastric, hepatocellular, colon), stage IV melanoma.
- Patients must have at least one surrogate at their clinic visit who is willing to enroll with them as a pair to be included.
- Surrogates are eligible if an eligible patient identifies them as as a surrogate and both consent for the study.
- All participants must be over the age 18
- All participants must be fluent in English
Exclusion Criteria:
- Patients and surrogates will be excluded if they are illiterate or have a medical condition known to alter Stroop performance. These include individuals who are visually impaired such that they cannot read a computer screen, blind or colorblind, patients given sedating medications during their appointment and individuals with past medical history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness.
- Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the mechanical ventilation hypothetical scenario and the hypothetical life sustaining therapy question.
- Surrogates and patients are ineligible if their paired participant is excluded for any of the above reasons.
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
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：DLST Only
Surrogates will complete the Stroop test then answer the hypothetical life sustaining therapy (LST)
|
|
|
实验性的：Contemplate only
Surrogates will contemplate each of the 3 scenarios but not make any decisions, then complete the Stroop test and answer the hypothetical LST question
|
Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
|
|
实验性的：Decide with advice
Surrogates will make decisions on 4 scenarios with physician advice, then complete the Stroop test and answer the hypothetical LST question.
Within this arm, surrogates will receive two positive recommendations (i.e. to go ahead with the intervention) and two negative recommendations (i.e. to decline the intervention).
These positive and negative recommendations will be randomly assigned upon study enrollment.
With four hypothetical scenarios, there are six possible options for recommendation variations.
|
Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
|
|
实验性的：Decide without advice
Surrogates will make decisions on 4 scenarios without physician advice, then complete the Stroop test and the hypothetical LST question.
|
Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making.
We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
|
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 |
|---|---|---|
|
Stroop Test Score
大体时间：Approximately 15 minutes
|
Measurement of score will be done at the conclusion of instrument completion.
The Stroop test is a standard measure of self control that requires three tasks.
The last task is the most difficult where the participant must suppress the urge to read the word which is the easier task and instead say the color it is printed in.
Standard scoring is the number correct in the Word trial minus the Color-Word trials.
This data will be collected immediately following completion.
|
Approximately 15 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evidence of status quo bias
大体时间：Approximately 10 minutes
|
Evidence of status quo bias as assessed by hypothetical decision to limit life sustaining therapy or to continue treatment.
To assess for status quo bias, we will use the following technique: after the initial four hypothetical questions and Stroop testing, participants will be asked a hypothetical question about life sustaining therapy (LST).
In the question, continuing life sustaining therapy will be counted as maintaining the status quo.
This is based on current norms in American health care where life sustaining therapy is continued until a patient or surrogate specifically request otherwise.
|
Approximately 10 minutes
|
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
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
2012年11月1日
初级完成 (实际的)
2013年4月1日
研究完成 (实际的)
2013年4月1日
研究注册日期
首次提交
2012年11月1日
首先提交符合 QC 标准的
2012年11月5日
首次发布 (估计)
2012年11月7日
研究记录更新
最后更新发布 (估计)
2015年1月29日
上次提交的符合 QC 标准的更新
2015年1月27日
最后验证
2015年1月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 816697
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.