NCT06565169 Improving PCP Advance Care Planning for People With ADRD
| NCT ID | NCT06565169 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-03-19 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 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 1. * 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. Exclusion Criteria: 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.
Contact & Investigator
Christine E. Kistler, MD, MASc
PRINCIPAL INVESTIGATOR
University of Pittsburgh, Department of Medicine, Division of Geriatric Medicine
Frequently Asked Questions
Who can join the NCT06565169 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06565169 currently recruiting?
Yes, NCT06565169 is actively recruiting participants. Contact the research team at KISTLERC@pitt.edu for enrollment information.
Where is the NCT06565169 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06565169 clinical trial?
NCT06565169 is sponsored by University of Pittsburgh. The principal investigator is Christine E. Kistler, MD, MASc at University of Pittsburgh, Department of Medicine, Division of Geriatric Medicine. The trial plans to enroll 120 participants.
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