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Advancing Ethical Goals In Society Trial (AEGIS)

16. september 2026 oppdatert av: Tufts Medical Center

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

12174

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth Health
        • Ta kontakt med:
        • Hovedetterforsker:
          • Angelo E Volandes
    • New York
      • New Hyde Park, New York, Forente stater, 11042
        • Northwell Health
        • Ta kontakt med:
        • Hovedetterforsker:
          • Edith Burns

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Annen: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Presence of qualifying ACP documentation by the end of Phase 1
Tidsramme: 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.
From randomization through the end of Phase 1 (24 months).
Occurrence of adjudicated goal-concordant care during the last 3 months of life
Tidsramme: 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.
Final 3 months of life among participants who die during Phase 1, up to 24 months after randomization.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tufts Medical Center

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Michael Paasche-Orlow, Tufts Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mars 2027

Primær fullføring (Antatt)

1. mars 2029

Studiet fullført (Antatt)

1. mars 2031

Datoer for studieregistrering

Først innsendt

10. september 2026

Først innsendt som oppfylte QC-kriteriene

16. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 00006552
  • 1U19AG090271-01A1 (U.S. NIH-stipend/kontrakt)
  • 535804 (Annen identifikator: NIH - HSSID)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

Sharing of de-identified data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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