改善 ADRD 患者的 PCP 预先护理计划 (AD-ACP)
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
地位
条件
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina, Chapel Hill
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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实验性的:Intervention: Advance Care Planning Training
|
Included in arm/group descriptions
其他名称:
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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
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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
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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
|
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Hospital Transfers
大体时间:30 months
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Number of emergency room visits and hospital admissions. |
30 months
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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
|
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Length-of-Stay
大体时间:30 months
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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
|
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Hospice Referral
大体时间:30 months
|
Percent of PLwD with a referral order to Hospice in the medical record. |
30 months
|
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Goal-concordant care
大体时间:30 months
|
Number of documented code status and health care proxy in the medical records |
30 months
|
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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
|
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Appropriateness
大体时间:30 months
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Scores of Intervention Appropriateness Measure (IAM) - range 4-20 with higher scores indicating greater appropriateness |
30 months
|
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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
|
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Fidelity
大体时间:30 months
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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
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
一般刊物
- Boustani M, Peterson B, Hanson L, Harris R, Lohr KN; U.S. Preventive Services Task Force. Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Jun 3;138(11):927-37. doi: 10.7326/0003-4819-138-11-200306030-00015.
- Levine DM, Linder JA, Landon BE. Characteristics and Disparities among Primary Care Practices in the United States. J Gen Intern Med. 2018 Apr;33(4):481-486. doi: 10.1007/s11606-017-4239-z. Epub 2017 Dec 4.
- Ernecoff NC, Wessell KL, Gabriel S, Carey TS, Hanson LC. A Novel Screening Method to Identify Late-Stage Dementia Patients for Palliative Care Research and Practice. J Pain Symptom Manage. 2018 Apr;55(4):1152-1158.e1. doi: 10.1016/j.jpainsymman.2017.12.480. Epub 2017 Dec 27.
- Kistler CE, Beeber AS, Winzelberg GS, Gabriel SL, Wretman CJ, Hanson LC. Evaluation of a Training Toolkit to Improve Clinicians' Skills for Dementia Advance Care Planning. J Palliat Med. 2021 Aug;24(8):1183-1190. doi: 10.1089/jpm.2020.0638. Epub 2021 Jan 5.
- Drabo EF, Barthold D, Joyce G, Ferido P, Chang Chui H, Zissimopoulos J. Longitudinal analysis of dementia diagnosis and specialty care among racially diverse Medicare beneficiaries. Alzheimers Dement. 2019 Nov;15(11):1402-1411. doi: 10.1016/j.jalz.2019.07.005. Epub 2019 Sep 4.
- Lund JL, Kuo TM, Brookhart MA, Meyer AM, Dalton AF, Kistler CE, Wheeler SB, Lewis CL. Development and validation of a 5-year mortality prediction model using regularized regression and Medicare data. Pharmacoepidemiol Drug Saf. 2019 May;28(5):584-592. doi: 10.1002/pds.4769. Epub 2019 Mar 19.
- Kelley AS, McGarry K, Fahle S, Marshall SM, Du Q, Skinner JS. Out-of-pocket spending in the last five years of life. J Gen Intern Med. 2013 Feb;28(2):304-9. doi: 10.1007/s11606-012-2199-x. Epub 2012 Sep 5.
- Dinnen T, Williams H, Yardley S, Noble S, Edwards A, Hibbert P, Kenkre J, Carson-Stevens A. Patient safety incidents in advance care planning for serious illness: a mixed-methods analysis. BMJ Support Palliat Care. 2019 Aug 28;12(e3):e403-10. doi: 10.1136/bmjspcare-2019-001824. Online ahead of print.
- Xie J, Brayne C, Matthews FE; Medical Research Council Cognitive Function and Ageing Study collaborators. Survival times in people with dementia: analysis from population based cohort study with 14 year follow-up. BMJ. 2008 Feb 2;336(7638):258-62. doi: 10.1136/bmj.39433.616678.25. Epub 2008 Jan 10.
- Tinetti ME, McAvay GJ, Murphy TE, Gross CP, Lin H, Allore HG. Contribution of individual diseases to death in older adults with multiple diseases. J Am Geriatr Soc. 2012 Aug;60(8):1448-56. doi: 10.1111/j.1532-5415.2012.04077.x. Epub 2012 Jun 26.
- Bernstein A, Rogers KM, Possin KL, Steele NZR, Ritchie CS, Kramer JH, Geschwind M, Higgins JJ, Wohlgemuth J, Pesano R, Miller BL, Rankin KP. Dementia assessment and management in primary care settings: a survey of current provider practices in the United States. BMC Health Serv Res. 2019 Nov 29;19(1):919. doi: 10.1186/s12913-019-4603-2.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY23080154
- 24-0203 (其他标识符:University of North Carolina, Chapel Hill)
- 1R01AG083828 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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
研究美国 FDA 监管的设备产品
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