Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,494
- 试验地点
- 19
- 主要终点
- Quality of Life (QOL)
研究概览
简要总结
This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are:
Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), Model 2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal training to deliver Palliative Care services)
Primary Outcome: The change in quality of life from baseline to 3 months post enrollment as assessed by FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary).
Primary Hypothesis: Compared to consultative PC, the trained hepatologist-led PC for ESLD patients will show superior primary outcome. In the event of nonsignificant superiority, the trained hepatologist-led PC led will show non-inferiority (NI) by ruling out a 4-point reduction (NI margin) in mean of the primary outcome as compared to the consultative PC.
Power: The study has 83.2% power to detect minimal clinically important difference (MCID) of 9 points in mean of the primary outcome between the two randomized arms. We have 79.2% power for the noninferiority hypothesis, under assumption that the trained hepatologist-led PC arm performs better than the consultative PC arm by half of the above MCID.
Setting: 19 Clinical Centers across US are recruited to participate in this study.
Qualitative nested study will interview patients, caregivers and providers to assess their experiences with participating in the palliative care trial.
详细描述
This is a two armed comparative effectiveness cluster randomized controlled trial (RCT), to assess the effectiveness of two pragmatic PC models for patients with ESLD (Consultative PC vs. Trained hepatologist led PC). To prevent bias at the level of providers, randomization will take place at the level of clinical centers; however patients will be the unit of inference. There is no standard of care arm.
Embedded within this cluster-RCT is a qualitative study will be undertaken to evaluate the patient/caregiver experiences in the two PC models, using semi structured interviews.
To execute this project, we have identified 19 clinical centers to participate; 8 Veterans Health Administration (VHA) systems and 11 non-VHA, Academic Medical Centers.
Comparative Approaches:
- Consultative PC led approach (Model 1): The PC model will include: 1) routine PC consults, using a standardized checklist , 2) in-person or telehealth visits at initial, 1, 2 and 3 months. .
- Trained hepatologist led PC (Model 2): The Hepatologist Led PC model will comprise: 1) Hepatologist training (through E Learning modules), and 2) in person or telehealth visits utilizing the same PC checklist as utilized in Model 1. The study visits will occur at initial, 1, 2 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.
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
盲法说明
The study investigators were masked to comparative outcomes measures until the study was completed and database was locked.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients were adults (≥18 years) with:
- •cirrhosis and a decompensation event indicative of ESLD (such as ascites, variceal bleeding or hepatic encephalopathy) within the prior 6 months, or
- •hepatocellular cancer (HCC) except Barcelona Stage D, or multifocal HCC (as defined by standard guidelines and confirmed by treating hepatologist).
- •Additional inclusion criteria included English literacy and the capacity to complete study assessments.
排除标准
- •were hepatologist assessed life expectancy <6 months, prior liver transplantation, anticipated liver transplantation within 3 months, inability to consent, or receipt of PC within the previous three months.
研究组 & 干预措施
Model 1: Consultative Palliative Care
Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist.
干预措施: Palliative Care (Other)
Model 2: Trained Hepatologist- led PC
A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1
干预措施: Palliative Care (Other)
结局指标
主要结局
Quality of Life (QOL)
时间窗: Mean change in FACT-Hep total score from baseline to 3 months
FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary) will be used to assess QOL. This is a 45 item self-reported instrument. FACT-Hep total score is the primary outcome. The scores range from 0 to 180. Higher scores reflect better QOL. This measure is for patients only.
次要结局
- Patient Satisfaction(Change in FAMCARE-P scores from baseline to 3 months.)
- Patient's Symptom Burden(Change in ESAS total score from baseline to 3 months)
- Patient's Depression Severity(Change in PHQ-9 scores from baseline to 3 months)
- Caregiver Burden (Completed by the Caregivers of Patients Who Were Enrolled as a Dyad). Caregivers Were Consented Separately.(Change in ZBI-12 scores from baseline to 3 months)
- Patient's Symptom Burden(Change in ESAS total score from baseline to 3 months)
- Patient's Depression Severity(Change in PHQ-9 scores from baseline to 3 months)
- Patient Satisfaction(Change in FAMCARE-P scores from baseline to 3 months.)
- Distress(Change in Distress from baseline to 3 months)
- Goal Concordant Care Questionnaire/ GCC (Patients)(Change in GCC scales from baseline to 3 months)
- Caregiver Burden (Completed by the Caregivers of Patients Who Were Enrolled as a Dyad). Caregivers Were Consented Separately.(Change in ZBI-12 scores from baseline to 3 months)
- Caregiver Quality of Life(Change in caregiver QoL from baseline to 3 months)
- Goal Concordant Care/ GCC (Caregivers)(Change in GCC from baseline to 3 months)
- Mortality Over 12 Months.(Survival over 12 months)
研究者
Manisha Verma
Director, Research, Department of Medicine
Albert Einstein Healthcare Network