Improving PCP Advance Care Planning for People With ADRD

NCT ID: NCT06565169

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2027-05-31

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.

Detailed Description

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.

Conditions

Alzheimer Disease; Dementia; Alzheimer's Disease (Incl Subtypes); Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Included in arm/group descriptions

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.

Group Type: ACTIVE_COMPARATOR

Care as Usual

Intervention Type: BEHAVIORAL

Included in arm/group descriptions

Interventions

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

Included in arm/group descriptions

Intervention Type: BEHAVIORAL

Care as Usual

Included in arm/group descriptions

Intervention Type: BEHAVIORAL

Other Intervention Names

AD-ACP

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

• 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).

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Chrissy Kistler

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine E. Kistler, MD, MASc

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, Department of Medicine, Division of Geriatric Medicine

Laura C. Hanson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christine E. Kistler, MD, MASc

Role: CONTACT

KISTLERC@pitt.edu

412-286-2507

Janelle J. Christensen, PhD, MPH

Role: CONTACT

jjc157@pitt.edu

412-692-2481

Facility Contacts

Laura C. Hanson, MD, MPH

Role: primary

laura_hanson@med.unc.edu

Kathryn Wessell, MPH

Role: backup

kwessell@email.unc.edu

919-966-2939

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 31462421 (View on PubMed)

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Other Identifiers

24-0203

Identifier Type: OTHER

Identifier Source: secondary_id

1R01AG083828

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY23080154

Identifier Type: -

Identifier Source: org_study_id