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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12,174
- 试验地点
- 2
- 主要终点
- Presence of qualifying ACP documentation by the end of Phase 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients receiving hospice or program of All-Inclusive Care for the Elderly (PACE)
- •Patients who primarily reside in a skilled nursing facility
- •Incarcerated patients
研究组 & 干预措施
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.
干预措施: ACP Counselor Video Program (Other)
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.
干预措施: ACP Counselor Video Program (Other)
结局指标
主要结局
Presence of qualifying ACP documentation by the end of Phase 1
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点