Triggered Palliative Care for Advanced Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days)
研究概览
简要总结
The objective of this study is to generate preliminary data for a large multi-site randomized clinical trial of a model of palliative care consultation for patients with advanced dementia, and for their family caregivers.
详细描述
Alzheimer's disease and related dementias affect 5 million Americans at an annual cost of $215 billion. Dementia is a contributing cause for 1 in 3 deaths, and is the only major cause of death with no effective prevention or treatment. Dementia-specific palliative care is needed to address the unique symptoms and treatment decisions relevant to this disease.
Investigators therefore propose to develop and pilot test a model of palliative care consultation for advanced dementia patients, triggered by hospitalization for a serious acute illness. After systematic refinement of operational protocols and tools with stakeholders, they will enroll persons with advanced dementia plus an acute illness associated with high risk of death in the coming year. Patients will be enrolled with their family decision-makers (N=60 dyads) in a randomized feasibility trial. Intervention dyads will receive specialty palliative care consultation during hospital admission, plus post-discharge collaborative care by their outpatient primary care provider and a palliative care nurse practitioner. Control dyads will receive usual care.
The research objective is to generate preliminary data for a large multi-site randomized controlled trial of a model of palliative care consultation for advanced dementia.
Specific aims are:
Aim 1: To develop a best-practice model of palliative care consultation for advanced dementia triggered by hospital admission for serious acute illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Diagnosis of dementia from Alzheimer's or other underlying cause
- •Global Deterioration Scale (GDS) Stage 5, 6 or 7
- •acute illness hospitalization
排除标准
- •No English-speaking family decision-maker
- •Primary physician expects study to be too stressful for family caregiver
研究组 & 干预措施
Specialty Palliative Care
Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers.
干预措施: Specialty Palliative Care (Behavioral)
Control
Usual care.
结局指标
主要结局
Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days)
时间窗: From time of hospital discharge up to 60 days
Includes emergency department visits and hospital admissions during measure interval
次要结局
- Patient Comfort End of Life in Dementia (CAD-EOLD)(60 days)
- Number of Participants With Burdensome Treatments(From time of hospital discharge up to 60 days)
- Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up(From time of hospital discharge up to 60 days)
- Caregiver Strain(Interview at 60 days after hospitalization)
- Number of Palliative Care Domains in Treatment Plan(From time of hospital discharge up to 60 days)
- Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST)(From time of hospital discharge up to 60 days)