Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT06565169

Conditions

Alzheimer Disease

Dementia

Alzheimer's Disease (Incl Subtypes)

Aging

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Care as Usual

Study Details

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.

Conditions

Alzheimer Disease

Dementia

Alzheimer's Disease (Incl Subtypes)

Aging

Study ID

NCT06565169

Start date

Mar 19, 2025

Status verified date

Apr, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention: Advance Care Planning Training

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

active comparator: Care as Usual: No Training

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.

Interventions

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

Included in arm/group descriptions

Care as Usual

Included in arm/group descriptions

Primary outcome measure

  • Goals of Care Discussions [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Christine E. Kistler, MD, MASc

412-286-2507KISTLERC@pitt.edu

Janelle J. Christensen, PhD, MPH

412-692-2481jjc157@pitt.edu

Locations

University of North Carolina, Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Laura C. Hanson, MD, MPH

laura_hanson@med.unc.edu

Kathryn Wessell, MPH

919-966-2939kwessell@email.unc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • Advance Care Planning
  • Primary Care
  • Goals of Care
  • Communication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-14.