Advance Care Planning for Alzheimer's and Dementia

(AD-ACP Trial)

Overseen By Christine E. Kistler, MD, MASc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: No recent visit, No ADRD diagnosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special toolkit can help people with Alzheimer's or similar conditions engage in more meaningful conversations about future care with their healthcare teams. The researchers aim to determine if this toolkit, which provides training for healthcare providers, improves the frequency and quality of these discussions compared to usual care. The trial is open to individuals with dementia who regularly visit primary care teams at specific clinics. Participants must have a confirmed diagnosis of Alzheimer's or a related condition and be seen by their primary care team during the trial period. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future care discussions for those with Alzheimer's.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Dementia Advance Care Planning Toolkit intervention is safe for facilitating goals of care discussions?

Research shows that Advance Care Planning (ACP) training for primary care teams focuses on improving communication. This training helps doctors and nurses communicate more effectively with patients who have Alzheimer's or dementia. Specific safety data for this training does not exist because it is not a drug or medical treatment; rather, it is an educational program to enhance care discussions.

Studies have found that advance care planning ensures that the care people receive aligns with their wishes and reduces hospital visits for those with dementia. The training teaches healthcare providers how to conduct these conversations respectfully and effectively.

As this is not a medication or medical device, there are no side effects or risks involved. The goal is to support better decision-making and planning for future care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Advance Care Planning (ACP) training for Alzheimer's and dementia because it offers a more comprehensive and tailored approach compared to standard care options. Unlike usual practices that might not specifically address the unique challenges of dementia, this training provides dementia-specific education, focusing on the different stages of the disease and associated challenges. It also enhances communication skills, teaching caregivers how to better engage with patients and respect cultural norms. Additionally, it supports clinical implementation by providing resources like coding information and templates, along with ongoing feedback and coaching, which are not typically part of standard care. This holistic approach aims to improve the quality of care for individuals with Alzheimer's and related dementias.

What evidence suggests that this trial's intervention could be effective for improving care planning in Alzheimer's and dementia?

Studies have shown that advance care planning (ACP) can greatly enhance care for people with dementia by ensuring that the care they receive aligns with their wishes. In this trial, some primary care teams will undergo Advance Care Planning Training, which includes dementia-specific education and ACP communication skills. One study demonstrated that training programs for primary care teams improved their support for dementia care. Research also shows that ACP is linked to fewer hospital visits and better alignment with patient preferences. These findings suggest that the ACP Toolkit training could improve care discussions and outcomes for those with dementia. Meanwhile, other primary care teams in this trial will continue with standard care, without the specialized training. ^{1 3 4 6 7}

Who Is on the Research Team?

Laura Hanson, MD

Principal Investigator

University of North Carolina, Chapel Hill

Christine E. Kistler, MD, MASc

Principal Investigator

University of Pittsburgh, Department of Medicine, Division of Geriatric Medicine

Are You a Good Fit for This Trial?

This trial is for people living with Alzheimer's Disease or a related dementia. Participants should be involved in primary care and willing to discuss their care preferences over an 18-month period. Specific eligibility criteria are not provided, but typically include factors like age, disease stage, and cognitive ability.

Inclusion Criteria

Primary care team member (PCTM) 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

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

I am receiving care at a clinic that uses the AD ACP Toolkit.

Exclusion Criteria

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) will be excluded

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Primary care teams receive the AD ACP Toolkit intervention to facilitate goals of care discussions with People Living with Dementia

18 months

Follow-up

Participants are monitored for healthcare utilization and implementation outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training

Trial Overview

The study compares usual care with a new approach where the primary care team receives training to better plan advanced care for patients with dementia. The goal is to see if this training improves discussions about future medical decisions between patients and caregivers.

How Is the Trial Designed?

Group I: Intervention: Advance Care Planning Training Experimental Treatment 1 Intervention

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

Group II: Care as Usual: No Training Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

The SHARE intervention, designed for adults aged 80 and older with possible cognitive impairment and their care partners, aims to improve advance care planning (ACP) communication in primary care settings through a structured approach that includes trained facilitators and personalized agenda-setting.

This randomized controlled trial will assess the effectiveness of the SHARE intervention on the quality of end-of-life care communication at 6 months, highlighting the importance of addressing caregiver burden and clinician barriers in ACP discussions for individuals with cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharing Health Care Wishes in Primary Care (SHARE) among older adults with possible cognitive impairment in primary care: Study protocol for a randomized controlled trial. Wolff, JL., Cagle, J., Echavarria, D., et al.[2023]

Advance care planning is crucial for individuals with dementia to ensure their end-of-life care aligns with their personal wishes, especially as they may lose decision-making capacity early in the disease.

The article highlights the challenges faced by people with dementia in creating advance care plans and suggests potential solutions to improve the process, emphasizing the need for supportive healthcare policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance care planning in dementia. Dening, KH.[2017]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06565169

Improving PCP Advance Care Planning for People With ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10787044/

Evaluating the Pragmatic Characteristics of Advance Care ...

In RCTs testing ACP interventions to support PLWD, only 23% of outcome measures were highly pragmatic, and most of these measured healthcare ...

3.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.70283

Advancing dementia preparedness in Low and Middle Income ...

This study validated the effectiveness of a training program for PCPs to improve early detection and dementia care support, demonstrating ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0020748920300614

Advance care planning for people living with dementia

Advance care planning was associated with decreased hospitalizations, increased concordance between care received and prior wishes and increased completion of ...

5.

withpower.com

withpower.com/trial/phase-alzheimer-disease-8-2024-a189a

Advance Care Planning for Alzheimer's and Dementia

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 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11953564/

Primary care preparedness to care for patients with ADRD

A total of 1245 of 3498 practices (36%) responded. Most practices reported systems to detect patients with ADRD (67%) and refer patients for ...

7.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14210

Sharing health care wishes among older adults with cognitive ...

We tested a remote multicomponent ACP model (SHARE) versus minimally enhanced usual care in 273 person–family dyads from eight primary care practices.