Advancing Ethical Goals In Society Trial (AEGIS)
2026年9月16日 更新者：Tufts Medical Center
ACP Educator Video Program to Promote Goal-Concordant Care in Older Patients and Those With Alzheimer's Disease and Related Dementias: Advancing Ethical Goals In Society (AEGIS)
The goal of this clinical trial is to make sure that the values of older persons aged 65 years or older with Alzheimer's Disease and Related Dementias (ADRD) or increased risk of mortality are known and respected, thereby reducing the burden of intrusive, unwanted medical interventions on their lives. The main aims of the study are:
- To assess the impact of our Advance Care Planning (ACP) Counselor Video Program on ACP documentation and receipt of goal-concordant care in a diverse sample of older adults with ADRD or other serious illness
- To compare resuscitation preferences, hospice use, healthcare utilization and costs
Researchers will randomize participants into two groups. All participants will continue to receive routine care. Participants randomized to the Immediate-Start Intervention group will be offered the ACP Counselor Video Program during both Phase 1 and Phase 2. Participants randomized to the Routine Care/Delayed-Start Intervention group will receive routine care alone during Phase 1 and will be offered the ACP Counselor Video Program beginning in Phase 2. Each phase will last two years. Both groups will have access to the intervention during Phase 2.
During the intervention, participants will:
- Meet with ACP counselors
- Watch ACP videos.
研究概览
研究类型
介入性
注册 (估计的)
12174
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。
学习联系方式
- 姓名：Diya Patel, Bachelors
- 电话号码：774-218-6634
- 邮箱：diya.patel1@tuftsmedicine.org
研究联系人备份
- 姓名：Carly Bridden
- 邮箱：Carly.Bridden@tuftsmedicine.org
学习地点
-
-
New Hampshire
-
Lebanon、New Hampshire、美国、03756
- Dartmouth Health
-
接触：
- Lori Henault
- 电话号码：617-869-3324
- 邮箱：lori.e.henault@hitchcock.org
-
首席研究员：
- Angelo E Volandes
-
-
New York
-
New Hyde Park、New York、美国、11042
- Northwell Health
-
接触：
- Christian Nouryan
- 电话号码：516-273-8699
- 邮箱：CNouryan@northwell.edu
-
首席研究员：
- Edith Burns
-
-
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
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
as ascertained within a month of randomization
- Age ≥65 years as of the cohort eligibility/index date
- At least one qualifying ambulatory encounter during the 12-month assessment window
One of the following
- Diagnosed with Alzheimer's Disease or Related Dementias (ADRD) based on a pre-specified ICD-10 code list, or
- Estimated 1-year mortality risk of at least 20%, based on a prespecified health-system mortality-risk algorithm, or
- Age 90 and above
Exclusion Criteria:
- Patients receiving hospice or program of All-Inclusive Care for the Elderly (PACE)
- Patients who primarily reside in a skilled nursing facility
- Incarcerated patients
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Immediate-Start Intervention
Participants in this arm will be offered the ACP Counselor Video Program in addition to routine care during both Phase 1 and Phase 2.
|
Participants will meet with ACP counselors to talk about their goals of care.
Participants and surrogates will watch and discuss videos about ACP options with the ACP counselor.
|
|
其他：Routine Care/Delayed-Start Intervention
Participants in the Routine Care/Delayed-Start Intervention arm will receive routine care during the first two years and are then given access to the intervention (ACP Counselor Video Program) for two years.
|
Participants will meet with ACP counselors to talk about their goals of care.
Participants and surrogates will watch and discuss videos about ACP options with the ACP counselor.
|
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 |
|---|---|---|
|
Presence of qualifying ACP documentation by the end of Phase 1
大体时间：From randomization through the end of Phase 1 (24 months).
|
This outcome will be the percentage of participants with qualifying ACP documentation.
Qualifying ACP documentation is defined as ACP documentation that is newly created or updated during Phase 1.
|
From randomization through the end of Phase 1 (24 months).
|
|
Occurrence of adjudicated goal-concordant care during the last 3 months of life
大体时间：Final 3 months of life among participants who die during Phase 1, up to 24 months after randomization.
|
This outcome is defined to be the percentage of decedents classified as having goal-concordant care.
|
Final 3 months of life among participants who die during Phase 1, up to 24 months after randomization.
|
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。
合作者
调查人员
- 首席研究员：Michael Paasche-Orlow、Tufts Medical Center
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 (估计的)
2027年3月1日
初级完成 (估计的)
2029年3月1日
研究完成 (估计的)
2031年3月1日
研究注册日期
首次提交
2026年9月10日
首先提交符合 QC 标准的
2026年9月16日
首次发布 (实际的)
2026年9月17日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月16日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 00006552
- 1U19AG090271-01A1 (美国 NIH 拨款/合同)
- 535804 (其他标识符：NIH - HSSID)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
We will create a deidentified data set that will be preserved and shared.
The purpose of creating this is to allow other investigators access to the data to advance inquiry in the field.
We share the NIH's goal for sharing data to allow scientists to expedite the translation of research results into knowledge, products, and procedures to improve human health.
To this end, we will make study data as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.
Manuscripts will be submitted for publication in high-quality peer-reviewed journals, following NIH Public Access Policy guidelines.
We will investigate opportunities for public forums, including those provided by the NIH.
We will include a data dictionary for all original and derived data elements, administrative guidance for tool administration, intervention protocol documentation, qualitative coding documentation, as well as all publications using it.
IPD 共享时间框架
De-identified data from the study will be made publicly available through the data repository prior to the end of the performance period and, when applicable, by the time of any publications.
IPD 共享访问标准
Sharing of de-identified data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.