Alzheimer DiseaseAD-ACPNCT06565169
Improving PCP Advance Care Planning for People With ADRD
A study testing Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training and Care as Usual in people with Alzheimer Disease and Dementia, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alzheimer Disease, Dementia, Alzheimer's Disease (Incl Subtypes)
- What is being tested?
- Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training and Care as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Improving Primary Care Clinician's Advance Care Planning Alzheimer's Disease and Related Dementias
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.
Read the 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.
- Being tested
- Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training, Care as Usual
- Keywords
- Advance Care Planning, Primary Care, Goals of Care, Communication
- Medical subject headings
- Alzheimer Disease, Dementia, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia TrainingBehavioural
Also called AD-ACP
Included in arm/group descriptions
Care as UsualBehavioural
Included in arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (14)
Surrogate Decision-Maker
Choice of a surrogate decision-maker for the PLwD documented in the medical record.
Measured: 18 months
Decision-Making Capacity
Assessment and report of decision-making capacity for the PLwD documented in the medical record.
Measured: 18 months
Portable Advance Care Planning (ACP) Orders
Completion of portable ACP orders using a state-approved DNR or POLST form documented in the medical record.
Measured: 18 months
Prognosis Discussion
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.
Measured: 18 months
Hospital Transfers
Number of emergency room visits and hospital admissions.
Measured: 30 months
Adoption
The percentage of active users at each clinic who have completed at least one training of either type
Measured: 30 months
Length-of-Stay
Duration of hospitalizations from day of admission to day of discharge.
Measured: 30 months
Palliative Care Referral
Percent of PLwD with a referral order to Palliative Care in the medical record.
Measured: 30 months
Hospice Referral
Percent of PLwD with a referral order to Hospice in the medical record.
Measured: 30 months
Goal-concordant care
Number of documented code status and health care proxy in the medical records
Measured: 30 months
Acceptability
Scores of Organizational Readiness to Implementing Change (ORIC) - range 12-60 with higher scores indicating greater organizational readiness
Measured: 6 months after provider training
Appropriateness
Scores of Intervention Appropriateness Measure (IAM) - range 4-20 with higher scores indicating greater appropriateness
Measured: 30 months
Feasibility
Scores of Feasibility of Intervention Measure (FIM) - range 4-20 with higher scores indicating greater feasibility
Measured: 30 months
Fidelity
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.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start19 Mar 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Chrissy Kistler, University of Pittsburgh
- Investigators
- Christine E. Kistler, MD, MASc, Principal investigator, University of Pittsburgh, Department of Medicine, Division of Geriatric MedicineLaura C. Hanson, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565169
- Sponsor's protocol ID
- STUDY23080154
- Other IDs
- 24-0203, 1R01AG083828
- Acronym
- AD-ACP
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. In addition, every attempt will be made to publish results in peer-reviewed journals. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
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.
PubMed 29204975Ernecoff 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.
PubMed 29288881Kistler 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.
PubMed 33400605Drabo 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.
PubMed 31494079Lund 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.
PubMed 30891850Kelley 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.
PubMed 22948931Dinnen 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.
PubMed 31462421Boustani 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.
PubMed 12779304Xie 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.
PubMed 18187696Tinetti 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.
PubMed 22734792Bernstein 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.
PubMed 31783848
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Primary Care Clinician's Advance Care Planning Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT06565169
- Acronym / sponsor ID
- AD-ACP / STUDY23080154
- Keywords
- Advance Care Planning, Primary Care, Goals of Care, Communication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Institute on Aging (NIA)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Advance Care Planning Training | Experimental | Behavioral: Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training1. 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 |
| Care as Usual: No Training | Active comparator | Behavioral: Care as UsualThese 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia TrainingAlso: AD-ACPIncluded in arm/group descriptions | Behavioural | Intervention: Advance Care Planning Training |
| Care as UsualIncluded in arm/group descriptions | Behavioural | Care as Usual: No Training |
Primary outcome
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.
14 secondary outcomes
Surrogate Decision-Maker
Time frame: 18 months
Decision-Making Capacity
Time frame: 18 months
Portable Advance Care Planning (ACP) Orders
Time frame: 18 months
Prognosis Discussion
Time frame: 18 months
Hospital Transfers
Time frame: 30 months
Adoption
Time frame: 30 months
Length-of-Stay
Time frame: 30 months
Palliative Care Referral
Time frame: 30 months
Hospice Referral
Time frame: 30 months
Goal-concordant care
Time frame: 30 months
Acceptability
Time frame: 6 months after provider training
Appropriateness
Time frame: 30 months
Feasibility
Time frame: 30 months
Fidelity
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 29204975Levine 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.
- Background: PubMed 29288881Ernecoff 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.
- Background: PubMed 33400605Kistler 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.
- Background: PubMed 31494079Drabo 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.
- Background: PubMed 30891850Lund 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.
- Background: PubMed 22948931Kelley 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.
- Background: PubMed 31462421Dinnen 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.
- Background: PubMed 12779304Boustani 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.
- Background: PubMed 18187696Xie 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.
- Background: PubMed 22734792Tinetti 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.
- Background: PubMed 31783848Bernstein 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.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. In addition, every attempt will be made to publish results in peer-reviewed journals. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine E. Kistler, MD, MASc principal investigator
University of Pittsburgh, Department of Medicine, Division of Geriatric Medicine
Laura C. Hanson, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care Team Advance Care Planning With People with Alzheimer's Disease or a Related Dementia Training and Care as Usual in people with Alzheimer Disease and Dementia, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goals of Care Discussions (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06565169, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.