Improving Primary Care Clinician's Advance Care Planning Alzheimer's Disease and Related Dementias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Goals of Care Discussions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The PI and all personnel involved in the outcomes assessment will remain masked to study arm assignment until the end of the study, while the UNC site co-investigators will deliver training and feedback reports to intervention sites and will not be masked.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention: Advance Care Planning Training
- 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
- 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
- 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
干预措施: Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training (Behavioral)
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.
干预措施: Care as Usual (Behavioral)
结局指标
主要结局
Goals of Care Discussions
时间窗: 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.
次要结局
- Surrogate Decision-Maker(18 months)
- Prognosis Discussion(18 months)
- Hospital Transfers(30 months)
- Length-of-Stay(30 months)
- Hospice Referral(30 months)
- Goal-concordant care(30 months)
- Acceptability(6 months after provider training)
- Decision-Making Capacity(18 months)
- Portable Advance Care Planning (ACP) Orders(18 months)
- Appropriateness(30 months)
- Fidelity(30 months)
- Adoption(30 months)
- Palliative Care Referral(30 months)
- Feasibility(30 months)
研究者
Chrissy Kistler
Associate Professor
University of Pittsburgh