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NCT Number: NCT06565169

Improving PCP Advance Care Planning for People With ADRD

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Kathryn Wessell, MPH

CONTACT

[email protected]

919-966-2939

Laura C. Hanson, MD, MPH

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training

Behavioral

Included in arm/group descriptions

Other names: AD-ACP

Care as usual

Behavioral

Included in arm/group descriptions

Primary outcomes

  1. Goals of Care Discussions

    Time frame: 18 months

    Presence of a documented Goals of Care (GOC) discussion between the primary care team member and the Person Living with Dementia (PLwD) or their surrogate decision-maker. Medical record documentation of discussion must include a) communication about dementia stage or prognosis AND b) decision-making for at least one major treatment: CPR/mechanical ventilation, hospitalization, treatments for infections, artificial/feeding/hydration, OR hospice.

Secondary outcomes

  1. Surrogate Decision-Maker

    Time frame: 18 months

    Choice of a surrogate decision-maker for the PLwD documented in the medical record.

  2. Decision-Making Capacity

    Time frame: 18 months

    Assessment and report of decision-making capacity for the PLwD documented in the medical record.

  3. Portable Advance Care Planning (ACP) Orders

    Time frame: 18 months

    Completion of portable ACP orders using a state-approved DNR or POLST form documented in the medical record.

  4. Prognosis Discussion

    Time frame: 18 months

    Discussion of prognosis or future medical complications of Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD) between the primary care team member and the PLwD or their surrogate decision-maker documented in the medical record.

  5. Hospital Transfers

    Time frame: 30 months

    Number of emergency room visits and hospital admissions.

  6. Adoption

    Time frame: 30 months

    The percentage of active users at each clinic who have completed at least one training of either type

  7. Length-of-Stay

    Time frame: 30 months

    Duration of hospitalizations from day of admission to day of discharge.

  8. Palliative Care Referral

    Time frame: 30 months

    Percent of PLwD with a referral order to Palliative Care in the medical record.

  9. Hospice Referral

    Time frame: 30 months

    Percent of PLwD with a referral order to Hospice in the medical record.

  10. Goal-concordant care

    Time frame: 30 months

    Number of documented code status and health care proxy in the medical records

  11. Acceptability

    Time frame: 6 months after provider training

    Scores of Organizational Readiness to Implementing Change (ORIC) - range 12-60 with higher scores indicating greater organizational readiness

  12. Appropriateness

    Time frame: 30 months

    Scores of Intervention Appropriateness Measure (IAM) - range 4-20 with higher scores indicating greater appropriateness

  13. Feasibility

    Time frame: 30 months

    Scores of Feasibility of Intervention Measure (FIM) - range 4-20 with higher scores indicating greater feasibility

  14. Fidelity

    Time frame: 30 months

    Scores of primary care team members on post-intervention quizzes, participation in clinic-level and primary care team member-level ACP audit-and-feedback, refresher sessions and in-services, periodic coaching from the research team.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine E. Kistler, MD, MASc

CONTACT

[email protected]

412-286-2507

Janelle J. Christensen, PhD, MPH

CONTACT

[email protected]

412-692-2481

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Aging (NIA)
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: AD-ACP

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 21, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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