Improving PCP Advance Care Planning for People With ADRD

NCT06565169 | Recruiting DMC

• 3 other identifiers: STUDY2308015424-02031R01AG083828
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Advance Care Planning; Primary Care; Goals of Care; Communication

Outcome Measures

Primary Outcomes (1)

• Goals of Care Discussions

  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.

  18 months

Secondary Outcomes (14)

• Surrogate Decision-Maker

  18 months

• Decision-Making Capacity

  18 months

• Portable Advance Care Planning (ACP) Orders

  18 months

• Prognosis Discussion

  18 months

• Hospital Transfers

  30 months

Study Arms (2)

Intervention: Advance Care Planning Training

EXPERIMENTAL

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

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

Care as Usual: No Training

ACTIVE COMPARATOR

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.

Behavioral: Care as Usual

Interventions

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

Included in arm/group descriptions

Also known as: AD-ACP

Intervention: Advance Care Planning Training

Care as Usual BEHAVIORAL

Included in arm/group descriptions

Care as Usual: No Training

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• University of Pittsburgh: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (11)

• Levine DM, Linder JA, Landon BE. Characteristics and Disparities among Primary Care Practices in the United States. J Gen Intern Med. 2018 Apr;33(4):481-486. doi: 10.1007/s11606-017-4239-z. Epub 2017 Dec 4.

  PMID: 29204975 BACKGROUND

• Ernecoff NC, Wessell KL, Gabriel S, Carey TS, Hanson LC. A Novel Screening Method to Identify Late-Stage Dementia Patients for Palliative Care Research and Practice. J Pain Symptom Manage. 2018 Apr;55(4):1152-1158.e1. doi: 10.1016/j.jpainsymman.2017.12.480. Epub 2017 Dec 27.

  PMID: 29288881 BACKGROUND

• Kistler CE, Beeber AS, Winzelberg GS, Gabriel SL, Wretman CJ, Hanson LC. Evaluation of a Training Toolkit to Improve Clinicians' Skills for Dementia Advance Care Planning. J Palliat Med. 2021 Aug;24(8):1183-1190. doi: 10.1089/jpm.2020.0638. Epub 2021 Jan 5.

  PMID: 33400605 BACKGROUND

• Drabo EF, Barthold D, Joyce G, Ferido P, Chang Chui H, Zissimopoulos J. Longitudinal analysis of dementia diagnosis and specialty care among racially diverse Medicare beneficiaries. Alzheimers Dement. 2019 Nov;15(11):1402-1411. doi: 10.1016/j.jalz.2019.07.005. Epub 2019 Sep 4.

  PMID: 31494079 BACKGROUND

• Lund JL, Kuo TM, Brookhart MA, Meyer AM, Dalton AF, Kistler CE, Wheeler SB, Lewis CL. Development and validation of a 5-year mortality prediction model using regularized regression and Medicare data. Pharmacoepidemiol Drug Saf. 2019 May;28(5):584-592. doi: 10.1002/pds.4769. Epub 2019 Mar 19.

  PMID: 30891850 BACKGROUND

• Kelley AS, McGarry K, Fahle S, Marshall SM, Du Q, Skinner JS. Out-of-pocket spending in the last five years of life. J Gen Intern Med. 2013 Feb;28(2):304-9. doi: 10.1007/s11606-012-2199-x. Epub 2012 Sep 5.

  PMID: 22948931 BACKGROUND

• Dinnen T, Williams H, Yardley S, Noble S, Edwards A, Hibbert P, Kenkre J, Carson-Stevens A. Patient safety incidents in advance care planning for serious illness: a mixed-methods analysis. BMJ Support Palliat Care. 2019 Aug 28;12(e3):e403-10. doi: 10.1136/bmjspcare-2019-001824. Online ahead of print.

  PMID: 31462421 BACKGROUND

• Boustani M, Peterson B, Hanson L, Harris R, Lohr KN; U.S. Preventive Services Task Force. Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Jun 3;138(11):927-37. doi: 10.7326/0003-4819-138-11-200306030-00015.

  PMID: 12779304 BACKGROUND

• Xie J, Brayne C, Matthews FE; Medical Research Council Cognitive Function and Ageing Study collaborators. Survival times in people with dementia: analysis from population based cohort study with 14 year follow-up. BMJ. 2008 Feb 2;336(7638):258-62. doi: 10.1136/bmj.39433.616678.25. Epub 2008 Jan 10.

  PMID: 18187696 BACKGROUND

• Tinetti ME, McAvay GJ, Murphy TE, Gross CP, Lin H, Allore HG. Contribution of individual diseases to death in older adults with multiple diseases. J Am Geriatr Soc. 2012 Aug;60(8):1448-56. doi: 10.1111/j.1532-5415.2012.04077.x. Epub 2012 Jun 26.

  PMID: 22734792 BACKGROUND

• Bernstein A, Rogers KM, Possin KL, Steele NZR, Ritchie CS, Kramer JH, Geschwind M, Higgins JJ, Wohlgemuth J, Pesano R, Miller BL, Rankin KP. Dementia assessment and management in primary care settings: a survey of current provider practices in the United States. BMC Health Serv Res. 2019 Nov 29;19(1):919. doi: 10.1186/s12913-019-4603-2.

  PMID: 31783848 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Communication

Interventions

Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

Study Officials

• Christine E. Kistler, MD, MASc

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

  PRINCIPAL INVESTIGATOR

• Laura C. Hanson, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine E. Kistler, MD, MASc

CONTACT

412-286-2507; KISTLERC@pitt.edu

Janelle J. Christensen, PhD, MPH

CONTACT

412-692-2481; jjc157@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI and all personnel involved in the outcomes assessment will remain masked to study arm assignment until the end of the study, while the UNC site co-investigators will deliver training and feedback reports to intervention sites and will not be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 21, 2024
• Study Start: March 19, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From 9 months after publication and indefinitely
• Access Criteria: Data may be requested to achieve aims in an approved proposal by contacting the PI and The North Carolina Translational and Clinical Science Institue (TraCS)

Locations

US (1)