Advancing Ethical Goals In Society Trial (AEGIS)
16 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
12174
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Diya Patel, Bachelors
- Telefoonnummer: 774-218-6634
- E-mail: diya.patel1@tuftsmedicine.org
Studie Contact Back-up
- Naam: Carly Bridden
- E-mail: Carly.Bridden@tuftsmedicine.org
Studie Locaties
-
-
New Hampshire
-
Lebanon, New Hampshire, Verenigde Staten, 03756
- Dartmouth Health
-
Contact:
- Lori Henault
- Telefoonnummer: 617-869-3324
- E-mail: lori.e.henault@hitchcock.org
-
Hoofdonderzoeker:
- Angelo E Volandes
-
-
New York
-
New Hyde Park, New York, Verenigde Staten, 11042
- Northwell Health
-
Contact:
- Christian Nouryan
- Telefoonnummer: 516-273-8699
- E-mail: CNouryan@northwell.edu
-
Hoofdonderzoeker:
- Edith Burns
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
- 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
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
|
Ander: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Presence of qualifying ACP documentation by the end of Phase 1
Tijdsspanne: 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
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Michael Paasche-Orlow, Tufts Medical Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 maart 2027
Primaire voltooiing (Geschat)
1 maart 2029
Studie voltooiing (Geschat)
1 maart 2031
Studieregistratiedata
Eerst ingediend
10 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
16 september 2026
Eerst geplaatst (Werkelijk)
17 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 september 2026
Laatste update ingediend die voldeed aan QC-criteria
16 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 00006552
- 1U19AG090271-01A1 (Subsidie/contract van de Amerikaanse NIH)
- 535804 (Andere identificatie: NIH - HSSID)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
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-toegangscriteria voor delen
Sharing of de-identified data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .