~80 spots leftby May 2027

Advance Care Planning for Alzheimer's and Dementia

(AD-ACP Trial)

Recruiting in Palo Alto (17 mi)
CE
LC
Overseen byLaura Hanson, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
No Placebo Group

Trial Summary

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

CE

Christine E. Kistler, MD, MASc

Principal Investigator

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

LC

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.
See 3 more

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

Treatment Details

Interventions

  • Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training (Behavioral Intervention)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention: Advance Care Planning TrainingExperimental Treatment1 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 TrainingActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+
David Apelian profile image

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone profile image

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+
Dr. Peggy P. McNaull profile image

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus profile image

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC