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

Trial Summary

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 data supports the effectiveness of the treatment Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training?

Research shows that training primary care clinicians in advance care planning (ACP) for dementia increases their confidence and skills in discussing care preferences with patients and families. This training led to more documentation of care preferences and improved communication about future care decisions. ^{1 2 3 4 5}

Is the Advance Care Planning training for Alzheimer's and Dementia safe for humans?

The research does not provide specific safety data for the Advance Care Planning training, but it focuses on improving communication skills for clinicians, which generally poses no safety risks to participants. ^{1 2 4 6 7}

How does the Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training differ from other treatments for Alzheimer's and dementia?

This treatment is unique because it focuses on training primary care clinicians to improve communication and planning for future healthcare decisions with patients who have Alzheimer's or dementia. It enhances clinicians' skills in advance care planning (ACP) by addressing different stages of dementia, which is not typically the focus of standard treatments for these conditions. ^{1 2 4 8 9}

What is the purpose of this trial?

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.

Research Team

Christine E. Kistler, MD, MASc

Principal Investigator

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

Laura Hanson, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Training Toolkit to Improve Clinicians' Skills for Dementia Advance Care Planning. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Educating Dutch General Practitioners in Dementia Advance Care Planning: A Cluster Randomized Controlled Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Advance Care Planning in Community-Dwelling Patients With Dementia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

SHARING Choices: Design and rationale for a pragmatic trial of an advance care planning intervention for older adults with and without dementia in primary care. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia. [2023]

7. England pubmed.ncbi.nlm.nih.gov

General practitioners perceptions on advance care planning for patients living with dementia. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Implementing advance care planning in early dementia care: results and insights from a pilot interventional trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Advance care planning in dementia. [2017]