Advance Care PlanningAEGISNCT07824245
Advancing Ethical Goals In Society Trial
A study testing ACP Counselor Video Program in people with Advance Care Planning and Dementia, run by Tufts Medical Center at 2 sites in United States.
Trial summary
The goal of this clinical trial is to make sure that the values of older persons aged 65 years or older with Alzheimer's Disease and Related Dementias (ADRD) or increased risk of mortality are known and respected, thereby reducing the burden of intrusive, unwanted medical interventions on their lives. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Advance Care Planning, Dementia, Alzheimer's Disease
- What is being tested?
- ACP Counselor Video Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,174 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2027to 1 Mar 2031
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- as ascertained within a month of randomization
- Age ≥65 years as of the cohort eligibility/index date
- At least one qualifying ambulatory encounter during the 12-month assessment window
- One of the following
- Diagnosed with Alzheimer's Disease or Related Dementias (ADRD) based on a pre-specified ICD-10 code list, or
- Estimated 1-year mortality risk of at least 20%, based on a prespecified health-system mortality-risk algorithm, or
- Age 90 and above
Who cannot join
- Patients receiving hospice or program of All-Inclusive Care for the Elderly (PACE)
- Patients who primarily reside in a skilled nursing facility
- Incarcerated patients
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Carly Bridden contact
United States2 sites
Dartmouth Health
Lebanon, New Hampshire, 03756
Lori Henault, 617-869-3324, lori.e.henault@hitchcock.org
Angelo E Volandes
Northwell Health
New Hyde Park, New York, 11042
Christian Nouryan, 516-273-8699, CNouryan@northwell.edu
Edith Burns
About this study
Official title: ACP Educator Video Program to Promote Goal-Concordant Care in Older Patients and Those With Alzheimer's Disease and Related Dementias: Advancing Ethical Goals In Society (AEGIS)
The goal of this clinical trial is to make sure that the values of older persons aged 65 years or older with Alzheimer's Disease and Related Dementias (ADRD) or increased risk of mortality are known and respected, thereby reducing the burden of intrusive, unwanted medical interventions on their lives. The main aims of the study are:
- To assess the impact of our Advance Care Planning (ACP) Counselor Video Program on ACP documentation and receipt of goal-concordant care in a diverse sample of older adults with ADRD or other serious illness
- To compare resuscitation preferences, hospice use, healthcare utilization and costs
Read more
Researchers will randomize participants into two groups. All participants will continue to receive routine care. Participants randomized to the Immediate-Start Intervention group will be offered the ACP Counselor Video Program during both Phase 1 and Phase 2. Participants randomized to the Routine Care/Delayed-Start Intervention group will receive routine care alone during Phase 1 and will be offered the ACP Counselor Video Program beginning in Phase 2. Each phase will last two years. Both groups will have access to the intervention during Phase 2.
During the intervention, participants will:
- Meet with ACP counselors
- Watch ACP videos.
- Conditions
- Advance Care Planning, Dementia, Alzheimer's Disease
- Being tested
- ACP Counselor Video Program
- Keywords
- ADRD, dissemination and implementation science, Goal Concordant Care
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP Counselor Video ProgramOther
Participants will meet with ACP counselors to talk about their goals of care. Participants and surrogates will watch and discuss videos about ACP options with the ACP counselor.
| Study group | Role | What they receive |
|---|---|---|
| Immediate-Start Intervention | Experimental | Participants in this arm will be offered the ACP Counselor Video Program in addition to routine care during both Phase 1 and Phase 2. Receives: Other: ACP Counselor Video Program |
| Routine Care/Delayed-Start Intervention | Other | Participants in the Routine Care/Delayed-Start Intervention arm will receive routine care during the first two years and are then given access to the intervention (ACP Counselor Video Program) for two years. Receives: Other: ACP Counselor Video Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of qualifying ACP documentation by the end of Phase 1
This outcome will be the percentage of participants with qualifying ACP documentation. Qualifying ACP documentation is defined as ACP documentation that is newly created or updated during Phase 1.
Measured: From randomization through the end of Phase 1 (24 months).
Occurrence of adjudicated goal-concordant care during the last 3 months of life
This outcome is defined to be the percentage of decedents classified as having goal-concordant care.
Measured: Final 3 months of life among participants who die during Phase 1, up to 24 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, randomized, delayed-start trial with routine care as the control during the first 24 months
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12,174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Dana-Farber Cancer Institute, Emory University, University of Colorado, Denver, Wake Forest University Health Sciences, Trustees of Dartmouth College, Dartmouth-Hitchcock Medical Center, Northern California Institute of Research and Education, Mayo Clinic Arizona ADRC, Feinstein Institute for Medical Research
- Responsible party
- Sponsor
- Investigators
- Michael Paasche-Orlow, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824245
- Sponsor's protocol ID
- 00006552
- Other IDs
- 1U19AG090271-01A1, 535804
- Acronym
- AEGIS
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will create a deidentified data set that will be preserved and shared. The purpose of creating this is to allow other investigators access to the data to advance inquiry in the field. We share the NIH's goal for sharing data to allow scientists to expedite the translation of research results into knowledge, products, and procedures to improve human health. To this end, we will make study data as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Manuscripts will be submitted for publication in high-quality peer-reviewed journals, following NIH Public Access Policy guidelines. We will investigate opportunities for public forums, including those provided by the NIH. We will include a data dictionary for all original and derived data elements, administrative guidance for tool administration, intervention protocol documentation, qualitative coding documentation, as well as all publications using it.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACP Educator Video Program to Promote Goal-Concordant Care in Older Patients and Those With Alzheimer's Disease and Related Dementias: Advancing Ethical Goals In Society (AEGIS)
- ClinicalTrials.gov ID
- NCT07824245
- Acronym / sponsor ID
- AEGIS / 00006552
- Conditions
- Advance Care Planning, Dementia, Alzheimer's Disease
- Keywords
- ADRD, dissemination and implementation science, Goal Concordant Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12,174 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Dana-Farber Cancer Institute, Emory University, University of Colorado, Denver, Wake Forest University Health Sciences, Trustees of Dartmouth College, Dartmouth-Hitchcock Medical Center, Northern California Institute of Research and Education, Mayo Clinic Arizona ADRC, Feinstein Institute for Medical Research
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 17 Sep 2026 (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.
The goal of this clinical trial is to make sure that the values of older persons aged 65 years or older with Alzheimer's Disease and Related Dementias (ADRD) or increased risk of mortality are known and respected, thereby reducing the burden of intrusive, unwanted medical interventions on their lives. The main aims of the study are:
- To assess the impact of our Advance Care Planning (ACP) Counselor Video Program on ACP documentation and receipt of goal-concordant care in a diverse sample of older adults with ADRD or other serious illness
- To compare resuscitation preferences, hospice use, healthcare utilization and costs
Researchers will randomize participants into two groups. All participants will continue to receive routine care. Participants randomized to the Immediate-Start Intervention group will be offered the ACP Counselor Video Program during both Phase 1 and Phase 2. Participants randomized to the Routine Care/Delayed-Start Intervention group will receive routine care alone during Phase 1 and will be offered the ACP Counselor Video Program beginning in Phase 2. Each phase will last two years. Both groups will have access to the intervention during Phase 2.
During the intervention, participants will:
- Meet with ACP counselors
- Watch ACP videos.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, randomized, delayed-start trial with routine care as the control during the first 24 months
| Arm | Type | Receives |
|---|---|---|
| Immediate-Start Intervention | Experimental | Other: ACP Counselor Video ProgramParticipants in this arm will be offered the ACP Counselor Video Program in addition to routine care during both Phase 1 and Phase 2. |
| Routine Care/Delayed-Start Intervention | Other | Other: ACP Counselor Video ProgramParticipants in the Routine Care/Delayed-Start Intervention arm will receive routine care during the first two years and are then given access to the intervention (ACP Counselor Video Program) for two years. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- as ascertained within a month of randomization
- Age ≥65 years as of the cohort eligibility/index date
- At least one qualifying ambulatory encounter during the 12-month assessment window
- One of the following
Key exclusion criteria (3 listed)
- Patients receiving hospice or program of All-Inclusive Care for the Elderly (PACE)
- Patients who primarily reside in a skilled nursing facility
- Incarcerated patients
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 |
|---|---|---|
| ACP Counselor Video ProgramParticipants will meet with ACP counselors to talk about their goals of care. Participants and surrogates will watch and discuss videos about ACP options with the ACP counselor. | Other | Immediate-Start Intervention, Routine Care/Delayed-Start Intervention |
Primary outcome
Presence of qualifying ACP documentation by the end of Phase 1
Time frame: From randomization through the end of Phase 1 (24 months).
This outcome will be the percentage of participants with qualifying ACP documentation. Qualifying ACP documentation is defined as ACP documentation that is newly created or updated during Phase 1.
Occurrence of adjudicated goal-concordant care during the last 3 months of life
Time frame: Final 3 months of life among participants who die during Phase 1, up to 24 months after randomization.
This outcome is defined to be the percentage of decedents classified as having goal-concordant care.
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 17 Sep 2026.
- Individual participant dataSharing planned: Yes. We will create a deidentified data set that will be preserved and shared. The purpose of creating this is to allow other investigators access to the data to advance inquiry in the field. We share the NIH's goal for sharing data to allow scientists to expedite the translation of research results into knowledge, products, and procedures to improve human health. To this end, we will make study data as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Manuscripts will be submitted for publication in high-quality peer-reviewed journals, following NIH Public Access Policy guidelines. We will investigate opportunities for public forums, including those provided by the NIH. We will include a data dictionary for all original and derived data elements, administrative guidance for tool administration, intervention protocol documentation, qualitative coding documentation, as well as all publications using it.
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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.
Carly Bridden contact
Michael Paasche-Orlow principal investigator
Tufts Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP Counselor Video Program in people with Advance Care Planning and Dementia, run by Tufts Medical Center at 2 sites 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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 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 2 sites 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?
Contact Diya Patel, Bachelors (774-218-6634, diya.patel1@tuftsmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of qualifying ACP documentation by the end of Phase 1 (time frame: From randomization through the end of Phase 1 (24 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.