Advancing Ethical Goals In Society Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorTufts Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients receiving hospice or program of All-Inclusive Care for the Elderly (PACE)
Patients who primarily reside in a skilled nursing facility
Incarcerated patients
Trial design
Design model
Parallel
Treatments tested in this trial
ACP Counselor Video Program
Other interventionParticipants 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.
Treatment groups
12,174 Participants
are divided into 2 treatment groupsGroup A: Immediate-Start InterventionExperimental treatment 1 intervention
Group B: Routine Care/Delayed-Start InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From randomization through the end of Phase 1 (24 months).2
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.
Time frame
Final 3 months of life among participants who die during Phase 1, up to 24 months after randomization.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tufts Medical Center
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Dana-Farber Cancer Institute
Collaborator
Emory University
Collaborator
University of Colorado, Denver
Collaborator
Wake Forest University Health Sciences
Collaborator
Trustees of Dartmouth College
Collaborator
Dartmouth-Hitchcock Medical Center
Collaborator
Northern California Institute of Research and Education
Collaborator
Mayo Clinic Arizona ADRC
Collaborator
Feinstein Institute for Medical Research
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: