Advance Care Planning, Alzheimer's Disease, Dementia
Conditions
Keywords
ADRD, dissemination and implementation science, Goal Concordant Care
Brief summary
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.
Interventions
OTHERACP 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.
Sponsors
Tufts Medical Center
National Institute on Aging (NIA)
Dana-Farber Cancer Institute
Emory University
University of Colorado, Denver
Wake Forest University Health Sciences
Trustees of Dartmouth College
Dartmouth-Hitchcock Medical Center
Northern California Institute of Research and Education
Mayo Clinic Arizona ADRC
Feinstein Institute for Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Pragmatic, randomized, delayed-start trial with routine care as the control during the first 24 months
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of qualifying ACP documentation by the end of Phase 1 | 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. |
| Occurrence of adjudicated goal-concordant care during the last 3 months of life | 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. |
Countries
United States
Contacts
CONTACTDiya Patel, Bachelors
CONTACTCarly Bridden
PRINCIPAL_INVESTIGATORMichael Paasche-Orlow
Tufts Medical Center
Outcome results
None listed