Default Options in Advance Directives
2019年3月29日 更新者：Scott Halpern、University of Pennsylvania
In a multicenter, randomized clinical trial of default options in advance directives among patients with incurable diseases, we will determine whether this simple and readily scalable intervention can improve patients quality of life and reduce resource utilization without reducing the number of days that patients are alive and living outside of an acute-care hospital.
研究概览
地位
完全的
研究类型
介入性
注册 (预期的)
270
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
- Penn Presbyterian Medical Center
-
Philadelphia、Pennsylvania、美国、19107
- Pennsylvania Hospital
-
Philadelphia、Pennsylvania、美国、19104
- The Perelman Center for Advance Medicine
-
Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
-
-
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
- Fluent in English
- Has seen current physician at least once prior to current visit
- Resident of Pennsylvania or New Jersey
- One or more of the following diagnoses:
- Amyotrophic lateral sclerosis
- Stage IIIB or IV non-small cell lung cancer, pancreatic cancer, or cholangiocarcinoma
- Stage IV breast, colon, esophageal, gastric, pancreatic, prostate, uterine, cervical, ovarian, or urothelial cancer; paraganglioma, or pheochromocytoma
- Stage C or D hepatocellular carcinoma
- Stage IV renal cell carcinoma
- Stage IV or V chronic kidney disease
- Mesothelioma or any malignancy metastatic to the pleura
- Other incurable interstitial lung diseases with at least severe restriction on most recent pulmonary function tests or eligible for long-term oxygen therapy
- Chronic obstructive pulmonary disease with at least severe airflow obstruction on most recent spirometry or eligible for long-term oxygen therapy
- Congestive heart failure with NYHA Class IV status or Class III plus 1 heart failure related hospitalization in the past 12 months or ACC stage D or C classification with 1 heart failure related hospitalization in the past 12 months
Exclusion Criteria:
- Currently listed for or being considered for solid organ transplant
- Patients with a previously signed advance directive or living will.
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Life-extension default
Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards life extension (vs.
comfort oriented care) unless the subject specifies otherwise.
The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be provided unless patients specifically opt-out from such selections.
It also will state that upon discharge from the hospital, long-term care (vs.
hospice care) will be provided unless the patient chooses otherwise.
|
|
|
实验性的：Comfort default
Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards comfort and relief of pain and suffering (vs.
life extension) unless the subject specifies otherwise.
The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be not provided unless patients specifically opts into such selections.
It also will state that upon discharge from the hospital, hospice care (vs.
long-term care) will be provided unless the patient chooses otherwise.
|
|
|
无干预：Standard advance directive
Subjects in the standard advance directive (AD) group will receive an AD that will have no options pre-selected.
|
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 |
|---|---|---|
|
Hospital free days
大体时间：6 months
|
The primary outcome is "Hospital-Free Days" (HFDs), a measure that PI Halpern has been developing in collaboration with Dr. Jeffrey Silber at Penn's Center for Outcomes Research.
As the name describes, HFDs represent the number of days alive and not in an acute care facility.
Although this is a simple concept, and provides an outcome measure of obvious importance to patients, the use of HFDs as a primary outcome in an RCT is highly innovative.
To bolster confidence in the results, we will evaluate two key variations on the theme.
First, we will explore "Healthcare Facility-Free Days," which represents the number of days alive where a patient is in neither an acute care facility, a chronic care facility, or a nursing home.
We will also evaluate HFDs within a defined period of follow-up - 6 months in this case.
This is analogous to the established outcome of ventilator-free days used commonly in RCTs among ICU patients
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hospital and ICU admissions
大体时间：up to 1 year
|
The numbers of admissions will be analyzed as count data.
From the dates of hospital and ICU admissions, we will calculate the proportion of each patient's total survival time during study follow-up that was spent in the hospital or ICU.
|
up to 1 year
|
|
Costs of care
大体时间：up to 1 year
|
We will combine all costs of inpatient and outpatient hospice, hospital stays, and life-sustaining procedures.
The perspective will be that of all potential payers.
Costs will be inflated to the date on which analyses are performed using the U.S. gross domestic product deflator
|
up to 1 year
|
|
Hospice utilization
大体时间：up to 1 year
|
We will analyze hospice utilization in 2 ways: (a) time from advance directive completion to hospice enrollment; and (b) duration of hospice utilization prior to death.
|
up to 1 year
|
|
Choices to receive 4 potentially life-sustaining interventions, and the concordance of these choices with whether the interventions were actually received
大体时间：up to 1 year
|
We will record selections that patients made on their advance directives about 4 specific life-sustaining interventions.
Utilizing data from the Pennsylvania Healthcare Cost Containment Consortium and the New Jersey Department of Health and Senior Services, we will be able to determine which patients received each intervention.
Thus, we will be able to reliably evaluate the proportions of patients who received unwanted interventions.
Because we cannot determine the denominator of patients with indications for these interventions, we will not evaluate the proportions of patients who went without desired services.
|
up to 1 year
|
|
Choices regarding post-hospitalization care, and the concordance of these choices with the care actually received
大体时间：up to 1 year
|
Patients will indicate on their advance directives forms their selections for post-hospitalization care.
We will utilize data from the Pennsylvania Health Care Cost Containment Consortium and New Jersey Department of Health and Senior Services to asses if the care patient indicate is the care they receive.
|
up to 1 year
|
|
Decision conflict
大体时间：up to 1 year
|
The decision conflict scale is a well-validated instrument used to assess patients' certainty in making healthcare decisions.
The DCS will be sent home with consenting patients to complete and return along with their advance directive forms and an instruction sheet explaining to patients that they should complete their advance directive forms first, followed by the DCS, and both should be mailed to the research team in the provided stamped envelope.
|
up to 1 year
|
|
Decision satisfaction
大体时间：up to 1 year
|
Satisfaction will also be measured with the CANHELP instrument's global satisfaction with end-of-life care question.
|
up to 1 year
|
|
Quality of Life using the McGill Quality of Life (MQOL) instrument.
大体时间：up to 1 year
|
The MQOL is a well-Validated and widely used scale designed specifically for patients with serious illnesses.
The MQOL can be completed by family members on behalf of patients who have lost the capacity to complete it themselves.
Thus, we will have surrogates (the individuals identified on patients' advance directive forms as their appointed healthcare agents) complete the MQOL for incapacitated patients to minimize missing data.
|
up to 1 year
|
|
Surrogates' Perception of the quality of death and dying
大体时间：within 3 months of patient death
|
Because we are recruiting patients with serious life-limiting illnesses, we anticipate that some patients will die over the course of this study period.
We will speak with surrogates of deceased patients to assess their perceived quality of death and dying using Prigerson's Quality of Death measure.
|
within 3 months of patient death
|
|
Post-traumatic stress in surrogates
大体时间：within 3 months of patient death
|
The risk of post-traumatic stress disorder in surrogates among deceased patients will be assessed using the Impact of Events Scale.
The IES is a valid and reliable scale that has been used frequently to assess PTSD risk among family members of critically ill patients.
|
within 3 months of patient death
|
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。
一般刊物
- Halpern SD, Small DS, Troxel AB, Cooney E, Bayes B, Chowdhury M, Tomko HE, Angus DC, Arnold RM, Loewenstein G, Volpp KG, White DB, Bryce CL. Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201742. doi: 10.1001/jamanetworkopen.2020.1742.
- Gabler NB, Cooney E, Small DS, Troxel AB, Arnold RM, White DB, Angus DC, Loewenstein G, Volpp KG, Bryce CL, Halpern SD. Default options in advance directives: study protocol for a randomised clinical trial. BMJ Open. 2016 Jun 6;6(6):e010628. doi: 10.1136/bmjopen-2015-010628.
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 (实际的)
2014年1月1日
初级完成 (实际的)
2016年11月1日
研究完成 (实际的)
2016年11月1日
研究注册日期
首次提交
2013年12月16日
首先提交符合 QC 标准的
2013年12月16日
首次发布 (估计)
2013年12月20日
研究记录更新
最后更新发布 (实际的)
2019年4月1日
上次提交的符合 QC 标准的更新
2019年3月29日
最后验证
2019年3月1日
更多信息
与本研究相关的术语
其他研究编号
- UPenn 819325
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.
Life-extension default advance directive的临床试验
-
Corporal Michael J. Crescenz VA Medical Center完全的特发性肺纤维化 | 慢性阻塞性肺病 | 充血性心力衰竭 | 恶性肿瘤 | 严重或非常严重的气流阻塞和/或接受或有资格接受长期氧疗 | 其他无根治性间质性肺病 | 过去一年 NYHA IV 级或 NYHA III 级加 1 次住院 | 任何 3B 或 4 期实体瘤美国