Hospital-at-Home Care Model to Optimize End-of-Life (EOL) Care for Patients With Hematologic Malignancies: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Enrollment Rate
研究概览
简要总结
This study is evaluating an intervention, which the investigators call "Optimize End of Life (EOL) Care at Home," that entails remote patient monitoring and home-based supportive care for patients with advanced hematologic malignancies.
详细描述
This research study is a single arm pilot feasibility study, which is the first-time investigators are examining this care at home intervention in patients with advanced hematologic malignancies.
The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs) and hospital care at home (e.g. providing maximal supportive care to to address and manage patients' symptoms) and structured communications oncology clinicians to optimize end of life care for patients with advanced hematologic malignancies.
Participants will include 3 groups:
1) Enrolled patients with advanced hematologic malignancies receiving the end of life (EOL) care at home intervention; 2) caregivers of these patients; and 3) oncology clinicians caring for these patients.
Participants will be in this research study for approximately six months after consent. It is expected that about 30 patients, 30 caregivers, and 15 oncology clinicians will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •age 18 or older
- •diagnosed with relapsed or refractory hematologic malignancy
- •must be receiving treatment with non-curative intent or supportive care alone based on the intent of chemotherapy as reported in order entry or Electronic Health Record
- •deemed eligible to receive EOL care at home based on the primary oncologist's assessment
- •Able to communicate and respond to questionnaires in English or with the assistance of an interpreter.
- •residing within 50 miles of MGH. Of note, patients requiring supportive transfusions in the oncology clinic will still be eligible to participate.
排除标准
- •Those with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written informed consent as determined by the primary oncologist.
研究组 & 干预措施
End of Life (EOL) Care at at Home
End of Life (EOL) Care at at Home intervention entails the following: patient-reported symptoms and home monitored vital signs and body weight with appropriate triggers for phone calls and home visits, and regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care.
干预措施: End of Life (EOL) Care at at Home (Other)
结局指标
主要结局
Enrollment Rate
时间窗: 6 months
The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% (95% confidence interval +/- 18%) of eligible patients are enrolled in the study.
Retention Rate
时间窗: 6 months
The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 80% of enrolled participants will complete a minimum of 60% of their daily assessments (i.e. patient-reported symptoms)
次要结局
- Acceptability of the intervention(6 months)
- Caregiver Quality of Life (CareGiver Oncology QOL)(6 months)
- Patient Quality of Life (Functional Assessment of Cancer Therapy-General - Fact-G)(up to 6 months)
- Patient Symptom Burden (using the Edmonton Symptom Assessment Scale-revise)(up to 6 months)
- Patient psychological distress (using the Hospital Anxiety and Depression Scale (HADS))(Up to 6 months)
- Caregiver psychological distress (using the Hospital Anxiety and Depression Scale (HADS))(Up to 6 months)
- Caregiver Satisfaction with patient's end of life (EOL) care using the FAMCARE(Up to 6 months)
- Caregiver Burden(up to 6 months)
- Health Care Utilization(6 months)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital