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Behavioral Intervention

Intervention: Advance Care Planning Training for Alzheimer's Disease (AD-ACP Trial)

N/A
Waitlist Available
Led By Laura C. Hanson, MD, MPH
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves communication strategies rather than medications, traditional side effects are not expected. However, participants may experience emotional or psychological discomfort when discussing sensitive topics about future health decline and end-of-life preferences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Goals of Care Discussions
Secondary study objectives
Acceptability
Adoption
Appropriateness
+11 more

Trial Design

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 Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,713 Previous Clinical Trials
28,036,691 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,535 Previous Clinical Trials
4,198,165 Total Patients Enrolled
University of PittsburghLead Sponsor
1,741 Previous Clinical Trials
16,339,897 Total Patients Enrolled
~80 spots leftby May 2027
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