Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 884
- 试验地点
- 10
- 主要终点
- Incidence of Hospital Transfers (Patients)
研究概览
简要总结
Millions of Americans have late-stage Alzheimer's and related dementias (ADRD), causing suffering due to loss of awareness of self and family, progressive dependency, physical and neuropsychiatric symptoms, and physical, emotional and financial strain for caregivers. Investigators now propose a multi-site randomized clinical trial of the ADRD Palliative Care (ADRD-PC) program for persons with late-stage ADRD and their family caregivers, triggered during hospitalization. Investigators aim to learn if this program of dementia-specific palliative care, standardized caregiver education, and transitional care is effective to reduce burdensome hospital transfers, improve symptom treatment and control, augment supportive services, and reduce nursing home transitions for patients, and to improve caregiver outcomes of communication, shared decision-making and distress.
详细描述
Investigators have designed the ADRD Palliative Care (ADRD-PC) program of dementia-specific palliative and transitional care, and shown its feasibility and potential efficacy. Delivered by interdisciplinary hospital palliative care teams, ADRD-PC addresses 1) prognostic awareness, 2) symptom management, 3) shared decision-making, and 4) transition to community support services.
The research objective is to conduct a multi-site efficacy randomized clinical trial (RCT) of the ADRD-PC program. Investigators will enroll 424 dyads of hospitalized patients with late-stage ADRD (Global Deterioration Scale (GDS) 6-7 or GDS 5 with significant co-morbidity) with their family caregivers, and an additional 50 dyads that identify as Hispanic/Latino at 5 geographically diverse sites of the Palliative Care Research Cooperative group - University of North Carolina, University of Colorado, Massachusetts General Hospital (Harvard University), Indiana University, and Emory University. The primary hypothesis is that ADRD-PC will reduce hospital transfers (Aim 1). Additional hypotheses are that ADRD-PC will improve patient-centered outcomes of symptom treatment, symptom control, use of community palliative care or hospice, and nursing home transitions (Aim 2); and caregiver outcomes of communication, decision-making and distress (Aim 3).
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Randomization allocation to study arms is concealed from all study personnel until the point of randomization assignment.
In the ADRD-PC Study, the overall PI (Dr. Hanson) and the research staff Clinical Research Coordinators (CRC) collecting data in 30- and 60-day interviews (data source for primary outcome and most secondary outcomes) are masked to study assignment until planned study arm reveal during final analyses. CRCs will conduct 60-day electronic health record (EHR) reviews only after dyads complete study participation, as EHR content has the potential to reveal study arm assignment. As with most behavioral clinical interventions, participants and care providers cannot be masked.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with ADRD Inclusion Criteria:
- •aged 55 or older
- •hospitalized
- •have a physician-confirmed diagnosis of ADRD
- •staged GDS 6 or 7; or GDS 5 with additional co-morbidity defined by Charlson Comorbidity Index scored 5 or higher
- •Caregiver Inclusion Criteria:
- •the adult (aged 18 or older) legally authorized representative (LAR) for healthcare and have capacity to serve in this role
- •support the person with ADRD
- •can complete interviews in English or Spanish.
排除标准
- •Dyads will be excluded if
- •the LAR is not a family caregiver
- •the patient currently receives palliative care or hospice
- •patient or caregiver would be unduly stressed
- •dyad is not successfully randomized.
结局指标
主要结局
Incidence of Hospital Transfers (Patients)
时间窗: 60 days post index hospital discharge
Number of hospital transfers (number of emergency room visits + number of hospital admissions )/(person-days of follow-up) within 60 days after discharge from the index hospitalization.
次要结局
- Symptom Treatment (Patients)(60 days post hospital discharge)
- Symptom Control for Physical Symptoms (Patients)(60 days post hospital discharge)
- Symptom Control for Neuropsychiatric Symptoms-Severity (Patients)(60 days post hospital discharge)
- Symptom Control for Neuropsychiatric Symptoms-Distress (Patients)(60 days post hospital discharge)
- Access to Hospice (Patients)(60 days post hospital discharge)
- Access to Community-based Palliative Care (Patients)(60 days post hospital discharge)
- Transition to Nursing Home Level of Care (Patients)(60 days post hospital discharge)
- Documented Discussion of Dementia Prognosis (Patients)(60 days post hospital discharge)
- Documented Discussion of Goals of Care (Patients)(60 days post hospital discharge)
- Shared Decision-making - Hospitalization (Patients)(60 days post hospital discharge)
- Shared Decision-making - Burdensome Treatment (Patients)(60 days post hospital discharge)
- Caregiver Distress Score (Caregivers)(60 days post hospital discharge)
- Caregiver Burden (Caregiver)(60 days post hospital discharge)