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改善 ADRD 患者的 PCP 预先护理计划 (AD-ACP)

2026年9月21日 更新者:Chrissy Kistler、University of Pittsburgh

改善初级保健临床医生的阿尔茨海默病和相关痴呆症的预先护理计划

This study will test the Dementia Advance Care Planning (AD ACP) Toolkit intervention to usual care in facilitating goals of care (GOC) discussions between People Living with Dementia (PLwD) and primary care team members over an 18-month period. The primary outcome is to assess the frequency and quality of GOC discussions with PLwD. Secondary outcomes include the identification of preferred surrogates, assessment of decisional capacity, and the completion of portable ACP orders. This randomized clinical trial aims to determine if the AD ACP Toolkit can enhance ACP practices and improve care planning outcomes for PLwD compared to the standard care approach.

研究概览

详细说明

This project will test an advance care planning (ACP) toolkit for primary care teams caring for patients living with Alzheimer's Disease and related dementias (AD/ADRD) in a cluster randomized control trial. In 20 primary clinics, the advance care planning practices, including goals of care discussions will be examined as the primary outcome, with secondary outcomes including health care utilization, and implementation outcomes. The AD ACP intervention will be tested to determine whether it can enable primary care teams to better conduct goals of care (GOC) discussions more efficiently and thus increase the number of GOC discussions held as compared to controls. The AD ACP Toolkit will be delivered to 10 intervention primary care clinics and usual care to 10 control clinics using a computerized case-finding algorithm within a large integrated health care system. The primary aim is to conduct a trial comparing the AD ACP Toolkit to usual care on GOC discussions and other ACP measures. The second aim is to examine the 18-month healthcare utilization outcomes for all PLwD with >50% 5-year mortality risk between intervention and control. Secondary analyses will be conducted to examine outcomes by key patient and team characteristics. Lastly (aim 3), implementation will be assessed via surveys in the intervention clinics followed by interviews to explain variations in those outcomes. This work will improve how to incorporate ACP approaches for aging-related conditions by primary care teams and may be adaptable to other outpatient specialties such as oncology or cardiology.

研究类型

介入性

注册 (实际的)

101

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

    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina, Chapel Hill

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 至 99年 (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:

Primary care team member (PCTM) eligibility:

  • Must be an MD/APP, employed at a primary care clinic within UNC HEALTH clinics with ≥60 PLwD encounters per year, who sees older adult patients, along with their associated nurses and social workers.
  • Eligibility for training with AD ACP Toolkit will include the above and the provision of care at an intervention clinic.
  • For Aim 3, only the trained intervention site primary care team members will be eligible for the implementation surveys or the interviews.

PLwD eligibility:

  • Must be a PLwD age 65 years or older seen by either the intervention or control sites' primary care teams' MD/APP in the 18-month intervention window for Aim 1.
  • PLwD will be eligible only after we confirm the presence of the AD/ADRD diagnosis.
  • All PLwD with a ≥50% 5-year all-cause mortality risk seen by the PCTM MD/APP over the 18-month intervention period will be eligible for the healthcare utilization analyses in Aim 2.

Exclusion Criteria:

Primary care team member exclusion criteria:

  • We will exclude primary care team members who do not care for older adults (e.g. pediatricians or lactation nurses), are employed at geriatric specialty or dementia specialty clinics, or are without a primary care panel (e.g., only urgent care).

PLwD exclusion criteria:

  • Patients will be excluded if they have not been seen in the past 18 months by their primary care team, or if they do not have a diagnosis of ADRD.

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:支持治疗
  • 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
实验性的:Intervention: Advance Care Planning Training
  1. Dementia-specific education: Stage-specific findings and challenges, including AD/ADRD staging, capacity assessment, symptom burden, hospice guidelines, etc - 10-minute didactics, delivered via video conferencing and via the website
  2. ACP communication skills: Context-specific skills and tips on how to slow down, set the communication stage, active listening, respect for personhood and cultural norms, and common, useful language to prepare patients and families- 10-minute didactics, delivered via video conferencing and via the website
  3. Clinical implementation support: Coding and billing information for ACP and ACP templates, an action plan for each team member participant, monthly ACP audit-and-feedback to participants, monthly coaching sessions, site champion, refresher sessions, and educational in-services as needed - Resources at the end of the training session, available on the website, monthly feedback reports on ACP practices, periodic coaching

Included in arm/group descriptions

其他名称:
  • AD-ACP
有源比较器:Care as Usual: No Training

These primary care teams will not receive the Advance Care Planning training. Clinics randomized to the control arm will have access to voluntary, routine ACP training sessions provided by UNC HEALTH. We will provide the control clinics summary reports of their ACP practice outcomes at the end of the 18-month follow-up period, which can be used in future practice improvement efforts.

Included in arm/group descriptions

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
Goals of Care Discussions
大体时间:18 months

Presence of a documented Goals of Care (GOC) discussion between the primary care team member and the Person Living with Dementia (PLwD) or their surrogate decision-maker. Medical record documentation of discussion must include a) communication about dementia stage or prognosis AND b) decision-making for at least one major treatment: CPR/mechanical ventilation, hospitalization, treatments for infections, artificial/feeding/hydration, OR hospice.

18 months

次要结果测量

结果测量
措施说明
大体时间
Surrogate Decision-Maker
大体时间:18 months

Choice of a surrogate decision-maker for the PLwD documented in the medical record.

18 months
Decision-Making Capacity
大体时间:18 months

Assessment and report of decision-making capacity for the PLwD documented in the medical record.

18 months
Portable Advance Care Planning (ACP) Orders
大体时间:18 months

Completion of portable ACP orders using a state-approved DNR or POLST form documented in the medical record.

18 months
Prognosis Discussion
大体时间:18 months

Discussion of prognosis or future medical complications of Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD) between the primary care team member and the PLwD or their surrogate decision-maker documented in the medical record.

18 months
Hospital Transfers
大体时间:30 months

Number of emergency room visits and hospital admissions.

30 months
Adoption
大体时间:30 months

The percentage of active users at each clinic who have completed at least one training of either type

30 months
Length-of-Stay
大体时间:30 months

Duration of hospitalizations from day of admission to day of discharge.

30 months
Palliative Care Referral
大体时间:30 months

Percent of PLwD with a referral order to Palliative Care in the medical record.

30 months
Hospice Referral
大体时间:30 months

Percent of PLwD with a referral order to Hospice in the medical record.

30 months
Goal-concordant care
大体时间:30 months

Number of documented code status and health care proxy in the medical records

30 months
Acceptability
大体时间:6 months after provider training

Scores of Organizational Readiness to Implementing Change (ORIC) - range 12-60 with higher scores indicating greater organizational readiness

6 months after provider training
Appropriateness
大体时间:30 months

Scores of Intervention Appropriateness Measure (IAM) - range 4-20 with higher scores indicating greater appropriateness

30 months
Feasibility
大体时间:30 months

Scores of Feasibility of Intervention Measure (FIM) - range 4-20 with higher scores indicating greater feasibility

30 months
Fidelity
大体时间:30 months

Scores of primary care team members on post-intervention quizzes, participation in clinic-level and primary care team member-level ACP audit-and-feedback, refresher sessions and in-services, periodic coaching from the research team.

30 months

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:Christine E. Kistler, MD, MASc、University of Pittsburgh, Department of Medicine, Division of Geriatric Medicine
  • 首席研究员:Laura C. Hanson, MD, MPH、University of North Carolina, Chapel Hill

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

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)

2025年3月19日

初级完成 (估计的)

2027年4月30日

研究完成 (估计的)

2028年5月31日

研究注册日期

首次提交

2024年8月1日

首先提交符合 QC 标准的

2024年8月19日

首次发布 (实际的)

2024年8月21日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

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

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. In addition, every attempt will be made to publish results in peer-reviewed journals. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD 共享时间框架

From 9 months after publication and indefinitely

IPD 共享访问标准

Data may be requested to achieve aims in an approved proposal by contacting the PI and The North Carolina Translational and Clinical Science Institue (TraCS)

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

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.

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