A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3,999
- 试验地点
- 4
- 主要终点
- Days at home in the last 180 days of life among patients surviving at least 180 days after enrolling in HBPC
研究概览
简要总结
Background: To effectively alleviate suffering and improve quality of life for patients with serious illness and their caregivers, palliative care (PC) services must be offered across multiple settings. Research is needed to determine how best to optimize home-based palliative care (HBPC) services to meet the needs of individuals with high symptom burden and functional limitations.
Aim: The investigators will compare a standard HBPC model that includes routine home visits by a nurse and provider with a more efficient tech-supported HBPC model that promotes timely inter-professional team coordination via synchronous video consultation with the provider while the nurse is in the patient's home. The investigators hypothesize that tech-supported HBPC will be as effective as standard HBPC.
Design: Cluster randomized trial. Registered nurses (n~130) will be randomly assigned to the tech-supported or standard HBPC model so that half of the patient-caregiver dyads will receive one of the two models.
Setting/Participants: Kaiser Permanente (15 Southern California and Oregon sites). Patients (n=10,000) with any serious illness and a prognosis of 1-2 years and their caregivers (n=4,800)
Methods: Patients and caregivers will receive standard PC services: comprehensive needs assessment and care planning, pain and symptom management, education/skills training, medication management, emotional/spiritual support; care coordination, referral to other services, and 24/7 phone assistance.
Results: Primary patient outcomes: symptom improvement at 1 month and days spent at home in the last six months of life; caregiver outcome: perception of preparedness for caregiving.
Conclusion: Should the more efficient tech-supported HBPC model achieves comparable improvements in outcomes that matter most to patients and caregivers, this would have a lasting impact on PC practice and policy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serious illness with 12-24 month life expectancy
- •Homebound
- •Need for skilled nursing care (only at KP Southern California)
- •English or Spanish speakers
排除标准
- •Currently receiving HBPC
- •Caregiver Inclusion Criteria:
- •Non-professional family, friend or other caregiver
- •English or Spanish speakers
结局指标
主要结局
Days at home in the last 180 days of life among patients surviving at least 180 days after enrolling in HBPC
时间窗: Baseline to 12 months
Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS)
时间窗: Change from baseline to 1 month
The ESAS is a 10-item survey measuring symptom severity. Scores range from 0-100 with higher scores indicating worse symptoms.
Caregiver preparedness for caregiving using the Preparedness for Caregiving Scale
时间窗: Change from baseline to 1 month
The Preparedness for Caregiving Scale is a 9-item survey measuring caregivers' perception of their preparedness for caregiving. Scores range from 0-36 with higher scores indicating higher perception of preparedness
次要结局
- Caregiver acute and post-acute care utilization(Baseline to 12 months)
- Days at home between study enrollment and death or study completion (365 days)(Variable, up to 12 months)
- Patient quality of life measured with the PROMIS-10 survey(Change from baseline to 1 and 6 months)
- Patient general distress measured with the distress thermometer(Change from baseline to 1 and 6 months)
- Patient satisfaction-care experience measured by a study-specific survey(1 and 6 months)
- Patient acute and post-acute care utilization(Baseline to 12 months)
- Caregiver quality of life measured with the PROMIS-10(Change from baseline to 1 and 6 months)
- HBPC clinician perception of facilitators and barriers to implementation of HBPC services(Yearly, up to four years)
- Patient outpatient health care utilization(Baseline to 12 months)
- Caregiver burden measured with the Zarit-12 Caregiver Burden Scale(Change from baseline to 1 and 6 months)
- Caregiver outpatient health care utilization(Baseline to 12 months)
- Palliative performance scale will be measured using all data available from routine clinical practice as documented in the electronic medical record (EMR)(Baseline and variable time periods due to reliance on available data from the EMR)
- Patient enrollment in and days on hospice before death(Baseline to 12 months)
- Patient death(Baseline to 12 months)