Advancing Ethical Goals In Society Trial

NCT07824245 — Not applicable, Not yet recruiting, 12174 participants, Tufts Medical Center

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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)

Registry	NCT07824245, acronym AEGIS
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, health services research
Enrollment	12174 (Estimated)
Sponsor	Tufts Medical Center (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
Conditions	Advance Care Planning, Dementia, Alzheimer's Disease
Interventions	ACP Counselor Video Program (Other)
Dates	start 2027-03-01 (estimated), primary completion 2029-03-01 (estimated), completion 2031-03-01 (estimated), first posted 2026-09-17, last updated 2026-09-17
Locations	2 sites in United States

-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. 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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Immediate-Start Intervention	Experimental	Other: ACP Counselor Video Program	Participants 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 Program	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.

ACP Counselor Video Program (Other): 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.

+Outcome measures

Primary outcomes

Presence of qualifying ACP documentation by the end of Phase 1 [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 [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.

+Eligibility

Sex: All, ages: 65 Years to any

Inclusion Criteria:

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

  1. Diagnosed with Alzheimer's Disease or Related Dementias (ADRD) based on a pre-specified ICD-10 code list, or
  2. Estimated 1-year mortality risk of at least 20%, based on a prespecified health-system mortality-risk algorithm, or
  3. Age 90 and above

Exclusion Criteria:

* Patients receiving hospice or program of All-Inclusive Care for the Elderly (PACE)
* Patients who primarily reside in a skilled nursing facility
* Incarcerated patients

+Locations (2)

Facility	City	Country	Status
Dartmouth Health	Lebanon, New Hampshire	United States
Northwell Health	New Hyde Park, New York	United States

+Investigators

Michael Paasche-Orlow, Principal investigator, Tufts Medical Center

+Funding

NIH grants: U19AG090271