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Recruiting INTERVENTIONAL NCT06565169

Improving PCP Advance Care Planning for People With ADRD (AD-ACP)

Improving Primary Care Clinician's Advance Care Planning Alzheimer's Disease and Related Dementias

Sponsor: National Institute on Aging (NIA)

Updated 6 times since 2024 Last updated: Apr 9, 2026 Started: Mar 19, 2025 Primary completion: May 31, 2027 Completion: May 31, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06565169, this observational or N/A phase trial focuses on Aging and Alzheimer Disease and remains actively recruiting participants. Sponsored by National Institute on Aging (NIA), it has been updated 6 times since 2025, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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 (AD/ADRD) in a cluster randomized control trial. In 20 primary clinics, the advance care planning practices, including goals of care discussions will be examined as the primary outcome, with secondary outcomes including health care utilization, and implementation outcomes. The AD ACP intervention will be tested to determine whether it can enable primary care teams to better conduct goals of care (GOC) discussions more efficiently and thus increase the number of GOC discussions held as compared to controls. The AD ACP Toolkit will be delivered to 10 intervention primary care clinics and usual care to 10 control clinics using a computerized case-finding algorithm within a large integrated health care system. The primary aim is to conduct a trial comparing the AD ACP Toolkit to usual care on GOC discussions and other ACP measures. The second aim is to examine the 18-month healthcare utilization outcomes for all PLwD with \>50% 5-year mortality risk between intervention and control. Secondary analyses will be conducted to examine outcomes by key patient and team characteristics. Lastly (aim 3), implementation will be assessed...

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 (AD/ADRD) in a cluster randomized control trial. In 20 primary clinics, the advance care planning practices, including goals of care discussions will be examined as the primary outcome, with secondary outcomes including health care utilization, and implementation outcomes. The AD ACP intervention will be tested to determine whether it can enable primary care teams to better conduct goals of care (GOC) discussions more efficiently and thus increase the number of GOC discussions held as compared to controls. The AD ACP Toolkit will be delivered to 10 intervention primary care clinics and usual care to 10 control clinics using a computerized case-finding algorithm within a large integrated health care system. The primary aim is to conduct a trial comparing the AD ACP Toolkit to usual care on GOC discussions and other ACP measures. The second aim is to examine the 18-month healthcare utilization outcomes for all PLwD with \>50% 5-year mortality risk between intervention and control. Secondary analyses will be conducted to examine outcomes by key patient and team characteristics. Lastly (aim 3), implementation will be assessed via surveys in the intervention clinics followed by interviews to explain variations in those outcomes. This work will improve how to incorporate ACP approaches for aging-related conditions by primary care teams and may be adaptable to other outpatient specialties such as oncology or cardiology.

Status Flow

~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshotNot Yet Recruiting~Jan 2025 – ~Mar 2025 · 59 days · monthly snapshotNot Yet Recruiting~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshotNot Yet Recruiting~Apr 2025 – ~Feb 2026 · 10 months · monthly snapshotRecruiting~Feb 2026 – ~Apr 2026 · 2 months · monthly snapshotRecruitingApr 16, 2026 – present · 3 months · daily APIRecruiting

Change History

6 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Recruiting

    Phase: NANone

  2. Feb 2026 — Apr 2026 [monthly]

    Recruiting NA

  3. Apr 2025 — Feb 2026 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  4. Mar 2025 — Apr 2025 [monthly]

    Not Yet Recruiting NA

  5. Jan 2025 — Mar 2025 [monthly]

    Not Yet Recruiting NA

Show 1 earlier version
  1. Sep 2024 — Jan 2025 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • National Institute on Aging (NIA)
  • University of North Carolina, Chapel Hill
  • University of Pittsburgh
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations