Advancing Ethical Goals In Society Trial (AEGIS)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Dementia; Alzheimer's Disease; Advance Care Planning
• Intervention / Treatment: Other: ACP Counselor Video Program

• Study Type: Interventional
• Enrollment (Estimated): 12174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diya Patel, Bachelors; Phone Number: 774-218-6634; Email: diya.patel1@tuftsmedicine.org
• Study Contact Backup: Name: Carly Bridden; Email: Carly.Bridden@tuftsmedicine.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Health
      • Contact: Lori Henault; Phone Number: 617-869-3324; Email: lori.e.henault@hitchcock.org
      • Principal Investigator: Angelo E Volandes
  • New York
    • New Hyde Park, New York, United States, 11042
      • Northwell Health
      • Contact: Christian Nouryan; Phone Number: 516-273-8699; Email: CNouryan@northwell.edu
      • Principal Investigator: Edith Burns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate-Start Intervention; Participants in this arm will be offered the ACP Counselor Video Program in addition to routine care during both Phase 1 and Phase 2.	Other: ACP Counselor Video Program; 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.
Other: Routine Care/Delayed-Start Intervention; 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.	Other: ACP Counselor Video Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Final 3 months of life among participants who die during Phase 1, up to 24 months after randomization.

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: University of Colorado, Denver; Dana-Farber Cancer Institute; Emory University; National Institute on Aging (NIA); Northern California Institute of Research and Education; Wake Forest University Health Sciences; Dartmouth-Hitchcock Medical Center; Trustees of Dartmouth College; Feinstein Institute for Medical Research; Mayo Clinic Arizona ADRC
• Investigators: Principal Investigator: Michael Paasche-Orlow, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: September 10, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: ADRD; Goal Concordant Care; dissemination and implementation science
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: 00006552; 1U19AG090271-01A1 (U.S. NIH Grant/Contract); 535804 (Other Identifier: NIH - HSSID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: De-identified data from the study will be made publicly available through the data repository prior to the end of the performance period and, when applicable, by the time of any publications.
• IPD Sharing Access Criteria: Sharing of de-identified data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No