An Integrative Model for Palliative Care in End-Stage Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in caregiver burden
研究概览
简要总结
The purpose of this research study is to understand the impact of palliative care in ESLD on quality of life, emergency room or hospital visits, and on care provider burden, and to work to develop the best way to provide palliative care in ESLD.
详细描述
Patients with end-stage liver disease (ESLD) have multiple symptoms that impact their quality of life and result in more emergency room and hospital visits. Palliative care is a medical model that can help alleviate pain and suffering and reduce need for urgent medical care and can do so while continuing other appropriate medical care. While palliative care consults are used in those with ESLD, despite the pain and suffering that accompanies ESLD, palliative care is often used too little and too late.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary participant:
- •admission for decompensated cirrhosis, age ≥ 18
- •willingness to sign consent
- •able to read and understand English
- •presence of decompensated cirrhosis with portal hypertension (jaundice, ascites, HE, hepatohydrothorax, AKI, HRS and/or variceal bleeding) or HCC
- •identified as the primary caregiver of the participant
- •willingness to sign consent
- •able to read and understand English
排除标准
- •Primary participant:
- •prior liver transplant
- •lack of capacity to provide informed consent (in the judgement of the investigator)
- •already in receipt of palliative or hospice care
- •those who are likely to receive a LT during the index admission
结局指标
主要结局
Change in caregiver burden
时间窗: Up to 60 days
The Zarit Burden Interview
Change in symptom intensity
时间窗: Up to 60 days
Edmonton Symptom Assessment System (ESAS) - participants rate the intensity of common symptoms on 0-10 scale with 0= no symptom and 10=worst symptom imaginable. Scores range from 0 to 90 with higher scores indicating worse symptoms.
Change in depression
时间窗: Up to 60 days
Patient Health Questionnaire 9 (PHQ-9) is a self-report instrument which assesses depression. Scores range from 0 to 27 with higher scores indicating worse depression.
Change in liver disease QOL
时间窗: Up to 60 days
Short-Form Liver Disease QOL - The SF-LDQOL includes 36 disease-targeted items representing nine domains: symptoms of liver disease, effects of liver disease, memory/concentration, sleep, hopelessness, distress, loneliness, stigma of liver disease and sexual problems. The minimum and maximum values of the scale are 0-100 with higher scores indicating better QOL.
Change in anxiety
时间窗: Up to 60 days
Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a self-report instrument which assesses anxiety. Scores range from 0 to 21 with higher scores indicating greater anxiety.
Change in perform ordinary tasks
时间窗: Up to 60 days
The Karnofsky Performance Status will be used to assess participants ability to perform ordinary tasks. Scores range from 0 to 100 with higher scores indicating greater ability.
Hospital readmissions and/or Emergency room (ER) visits
时间窗: 60 days
Number of participants with ER visits or who are readmitted to the hospital during the study period
次要结局
未报告次要终点