Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
- Conditions
- End Stage Liver Disease
- Interventions
- Other: Palliative Care
- Registration Number
- NCT03540771
- Lead Sponsor
- Albert Einstein Healthcare Network
- Brief Summary
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).
14 Clinical Centers across US are recruited to participate in this study.
- Detailed Description
This is a two armed multicenter 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. Parallel to this cluster-RCT, 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 14 clinical centers to participate; 7 Veterans Health Administration (VHA) systems and 7 non-VHA, Academic Medical Centers.
Comparative Approaches:
1. Consultative PC led approach (Model 1): The PC model will include: 1) routine PC consults, using a standardized checklist , 2) in-person visits at initial, 1, 2 and 3 months. .
2. Trained hepatologist led PC (Model 2): The Hepatologist Led PC model will comprise: 1) Hepatologist training (through E Learning modules), and 2) in person visits utilizing the same PC checklist as utilized in Model 1. The in-person visits will occur at initial, 1, 2 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.
Adult patients 18 years of age or older will be enrolled. With 14 clinical centers in different geographic locations and diversity in race/ ethnicity, 1260 patient/ caregiver dyads will be enrolled.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1260
Patients with new onset or ongoing complications of End Stage Liver Disease including Hepatocellular Cancer (HCC) (irrespective of their transplant status), with a caregiver willing to participate.
MELD> 30 or Expected life expectancy of less than 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Model 1: Consultative Palliative Care 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. Model 2: Trained Hepatologist- led PC Palliative Care 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
- Primary Outcome Measures
Name Time Method Quality of Life (QOL) Change in QOL 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. The scores range from 0 to 160. Higher scores reflect better QOL.
- Secondary Outcome Measures
Name Time Method Patient's symptom burden Change in ESAS scores from baseline to 3 months Edmonton Symptom Assessment Scale (ESAS) will evaluate 11 symptoms (pain, fatigue, myalgia, sexual dysfunction, anxiety, sleep disturbance, appetite, well-being, dyspnea, pruritus and ability to think clearly) on a 10-point scale, where 0 is no symptom and 10 is the maximum severity of symptom.
Patient's depression severity Change in PHQ-9 scores from baseline to 3 months PHQ-9 (Personal Health Questionnaire) is one of the very commonly used tools to assess severity of depression in different settings, and has 9 questions. Each question is rated on a 4 point scale, with total score ranging from 0 to 27. Higher scores reflects greater severity of depression. Scores from 0-4 equates to no depression, 5-9 mild, 10-14 moderate, 15-19 mod severe and \>20 reflects severe depression.
Caregiver burden Change in ZBI-12 scores from baseline to 3 months Zarit Burden Interview-12 (ZBI-12) a short, validated instrument is extensively used for palliative care research in diverse populations. It has high internal consistency, reliability and convergent validity to assess caregiver burden. It has high correlation \[Rho (95% CI) 0.95 (0.92- 0.96)\] with the long form, and is less burdensome. The sensitivity and specificity is 92% and 94% with a cutoff score of 12.
Patient Satisfaction Change in FAMCARE-P scores from baseline to 3 months. FAMCARE-P13 (Family Satisfaction with Cancer Care- Patient scale) is a brief validated instrument used to assess patient satisfaction with outpatient palliative care interventions. It measures the availability of care, symptom management, psychosocial care and information sharing including support for decision making. It consists of 13 questions, with Likert scale response options with high reliability. Higher scores imply better satisfaction from the care received.
Trial Locations
- Locations (19)
University of Florida
🇺🇸Gainesville, Florida, United States
Miami VA Medical Center
🇺🇸Miami, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Banner Health- University Medical Center
🇺🇸Phoenix, Arizona, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
UCSF Fresno
🇺🇸Fresno, California, United States
Loma Linda Unversity Health
🇺🇸Loma Linda, California, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
VA New York Harbor
🇺🇸Brooklyn, New York, United States
Durham V.A. Medical Center
🇺🇸Durham, North Carolina, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
VA West Haven
🇺🇸West Haven, Connecticut, United States
Corporal Michael J. Crescenz VA Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
UNC Liver Center
🇺🇸Chapel Hill, North Carolina, United States
VA Boston
🇺🇸Boston, Massachusetts, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States
VA Bronx
🇺🇸Bronx, New York, United States