LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
研究概览
简要总结
The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.
详细描述
The main purpose of this study is to compare two types of care - usual hepatology care and usual hepatology care with early involvement of palliative care clinicians to see which is better for improving the experience of hospitalized patients with advanced liver disease (AdvLD).
The investigators aim to find out whether introducing hospitalized patients with AdvLD to the palliative care team that specializes in symptom management can improve the quality of life and physical and psychological symptoms that patients and families experience during their hospitalizations as well as enhance the quality of patients' end of life care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent:
- •Ascites (requiring diuretics or serial large volume paracenteses)
- •Spontaneous bacterial peritonitis
- •Hepatic hydrothorax (requiring diuretics)
- •Variceal bleed (with one or more occurrences)
- •Overt hepatic encephalopathy (requiring medications)
- •Ability to comprehend English
排除标准
- •Prior history of liver transplantation
- •Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent
- •Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer)
- •Presence of hepatocellular carcinoma beyond Milan criteria
- •Are already receiving hospice care
- •Receive a score of <10 on the Simplified Animal Naming Test
- •Caregiver Inclusion Criteria
- •Adult caregiver (≥ 18 years of age)
- •A relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone
- •Ability to comprehend English and can complete questionnaires
- •Caregiver Exclusion Criteria
- •Inability to comprehend English
结局指标
主要结局
Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
时间窗: Up to 4 weeks
Compare patient quality of life (FACIT-Pal) scores up to 4 weeks adjusting for baseline quality of life scores between the study arms. Score range 0-184 with higher scores indicating better quality of life.
次要结局
- Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)(Up to 6 months)
- Patient End-of-Life (EOL) Care Communication with Clinicians(Final assessment prior to patient death or at 6 months)
- Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)(Up to 6 months)
- Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)(Up to 6 months)
- Patient FACIT-Pal Score longitudinally between study arms(Up to 6 months)
- Documentation of Patient End-of-Life (EOL) Care Preferences(After patient death, up to 60 months)
研究者
Nneka nnaoke Ufere
Assistant Professor
Massachusetts General Hospital