Clinical trial NCT06565169: Improving PCP Advance Care Planning for People With ADRD
Official title: Improving Primary Care Clinician's Advance Care Planning Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia
Alzheimer's Disease (Incl Subtypes)
Aging
Keywords: Advance Care Planning
Primary Care
Goals of Care
Communication
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: National Institute on Aging (NIA)
First posted: 2024-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Goals of Care Discussions
timeFrame: 18 months
Secondary outcomes:
measure: Surrogate Decision-Maker
timeFrame: 18 months
measure: Decision-Making Capacity
timeFrame: 18 months
measure: Portable Advance Care Planning (ACP) Orders
timeFrame: 18 months
measure: Prognosis Discussion
timeFrame: 18 months
measure: Hospital Transfers
timeFrame: 30 months
measure: Adoption
timeFrame: 30 months
measure: Length-of-Stay
timeFrame: 30 months
measure: Palliative Care Referral
timeFrame: 30 months
measure: Hospice Referral
timeFrame: 30 months
measure: Goal-concordant care
timeFrame: 30 months
measure: Acceptability
timeFrame: 6 months after provider training
measure: Appropriateness
timeFrame: 30 months
measure: Feasibility
timeFrame: 30 months
measure: Fidelity
timeFrame: 30 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of Pittsburgh, Department of Medicine, Division of Geriatric Medicine
name: Christine E. Kistler, MD, MASc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Laura C. Hanson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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