Advancing Ethical Goals In Society Trial (AEGIS)
16 september 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
12174
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Diya Patel, Bachelors
- Telefonnummer: 774-218-6634
- E-post: diya.patel1@tuftsmedicine.org
Studera Kontakt Backup
- Namn: Carly Bridden
- E-post: Carly.Bridden@tuftsmedicine.org
Studieorter
-
-
New Hampshire
-
Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Health
-
Kontakt:
- Lori Henault
- Telefonnummer: 617-869-3324
- E-post: lori.e.henault@hitchcock.org
-
Huvudutredare:
- Angelo E Volandes
-
-
New York
-
New Hyde Park, New York, Förenta staterna, 11042
- Northwell Health
-
Kontakt:
- Christian Nouryan
- Telefonnummer: 516-273-8699
- E-post: CNouryan@northwell.edu
-
Huvudutredare:
- Edith Burns
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Övrig: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Presence of qualifying ACP documentation by the end of Phase 1
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Michael Paasche-Orlow, Tufts Medical Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 mars 2027
Primärt slutförande (Beräknad)
1 mars 2029
Avslutad studie (Beräknad)
1 mars 2031
Studieregistreringsdatum
Först inskickad
10 september 2026
Först inskickad som uppfyllde QC-kriterierna
16 september 2026
Första postat (Faktisk)
17 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 00006552
- 1U19AG090271-01A1 (U.S.S. NIH-anslag/kontrakt)
- 535804 (Annan identifierare: NIH - HSSID)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
Sharing of de-identified data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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