System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Publications

Journal Article Ahead of print 3 citations

PubMed: 41973444 DOI: 10.1001/jamainternmed.2026.0571

Palliative Care Intervention for Patients With End-Stage Liver Disease: A Cluster Randomized Clinical Trial.

JAMA Intern Med

Authors: Manisha Verma, Victor Navarro, Andrzej Kosinski, Tamar Taddei, Richard Kalman, A Sidney Barritt Iv, Simona Jakab, Marina Serper, Eric Orman, Maya Balakrishnan, Mina Rakoski, Don Rockey, Kristel Hunt, Roniel Cabrera, Ayse Aytaman, Binu John, Gyorgy Baffy, Rohit Nathan, Elliot Tapper, Marina Roytman, Brendan McGuire, Nicholas Hoppmann, Christopher Woodrell, Marie Bakitas, Yang Yue, Bryce Reeve, Li Lin, Rebecca Tantala, Michael Volk

Affiliations

  • Department of Medicine, Jefferson Einstein Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania.
  • Duke Clinical Research Institute and Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Duke University, Durham, North Carolina.
  • Department of Medicine, Yale University, Connecticut.
  • Department of Medicine, University of North Carolina, Chapel Hill.
  • Department of Medicine, West Haven VA Medical Center, West Haven, Connecticut.
  • Department of Medicine, University of Pennsylvania, Philadelphia.
  • Department of Medicine, Indiana University, Indianapolis.
  • Department of Medicine, Baylor College of Medicine, Houston, Texas.
  • Department of Medicine, Loma Linda University, Loma Linda, California.
  • Department of Medicine, Medical University of South Carolina, Charleston.
  • Department of Medicine, VA Bronx Health Care, Bronx, New York.
  • Department of Medicine, University of Florida, Florida.
  • Department of Medicine, Brooklyn VA Medical Center, Brooklyn, New York.
  • Department of Medicine, University of Miami, Florida.
  • Department of Medicine, VA Boston Health Care, Boston, Massachusetts.
  • Department of Medicine, Banner Health, Phoenix, Arizona.
  • Department of Medicine, University of Michigan, Ann Arbor, Michigan.
  • Department of Medicine, University of California, San Francisco, Fresno.
  • Department of Medicine, University of Alabama, Birmingham.
  • Department of Medicine, Mount Sinai Health System, New York, New York.
  • Department of Medicine, Baylor Scott & White Health, Dallas, Texas.

Abstract

IMPORTANCE

Palliative care improves quality of life (QoL) in advanced illnesses, but data in end-stage liver disease (ESLD) are limited. It is unknown whether palliative care delivered by hepatologists is effective when compared with palliative care specialists.

OBJECTIVE

To compare the effectiveness of palliative care delivered by trained hepatologists with the care delivered by conventional palliative care specialists in improving QoL at 3 months.

DESIGN, SETTING, AND PARTICIPANTS

This comparative effectiveness cluster randomized trial for US patients treated for ESLD in 19 US medical centers compared a palliative care intervention delivered by palliative care-trained hepatologists (hepatologist group; 11 centers) with palliative care specialists (consultative group; 8 centers). Eligible patients were US adults with either decompensated cirrhosis or hepatocellular cancer who had a life expectancy of at least 6 months, had not received or scheduled liver transplantation, or had not received palliative care in the prior 3 months. Hepatologists in hepatologist group alone received primary palliative care training. Data collection occurred from January 2019 through June 2025; analysis was conducted from July to September 2025.

INTERVENTION

Participants received 4 palliative care visits over 3 months delivered by either palliative care-trained hepatologists or palliative care specialists, using a structured palliative care checklist.

MAIN OUTCOMES AND MEASURES

Superiority or a priori noninferiority of the effect of palliative care delivered by hepatologists vs palliative care specialists on change in QoL at 3 months, measured by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) total score (higher scores indicating better QoL). Secondary outcomes included change in symptom burden, distress, depression, satisfaction from baseline to 3 months, and mortality.

RESULTS

A total of 935 patients were enrolled (mean [SD] age, 63.0 [10.3] years; 275 female [29%]; 130 Hispanic ethnicity [14%]; 144 Black [15%], 736 White [79%]). From baseline to 3 months, QoL improved in both groups (adjusted mean: hepatologist, 8.01 [95% CI, 5.38 to 10.65]; consultative, 7.02 [95% CI, 4.34 to 9.71]; both P < .001). Although superiority was not found in change in QoL, prespecified noninferiority analysis showed that the improvement in the hepatologist group was noninferior to the consultative group (adjusted mean difference, 0.98 [95% CI, -2.86 to 4.83]; P = .01). Symptom burden (adjusted mean difference, -7.52 [95% CI, -9.89 to -5.15] vs -5.31 [95% CI, -7.60 to -3.03]) and depression (adjusted mean difference, -1.18 [95% CI, -1.78 to -0.57] vs -0.90 [95% CI, -1.49 to -0.31]) improved in both groups, without significant between-group differences. Patient satisfaction improved more in the hepatologist group compared with the palliative care group (adjusted mean difference, 3.37 [95% CI, 2.24 to 4.49] vs 0.91 [95% CI, -0.15 to 1.96]; P = .002). Mortality at 3 months was similar in both groups.

CONCLUSIONS AND RELEVANCE

This cluster trial found that palliative care delivered by trained hepatologists was comparable with palliative care delivered by palliative care specialists in improving QoL in patients with ESLD and was associated with greater improvement in patient satisfaction, demonstrating the effectiveness among enrolled patients.

TRIAL REGISTRATION

ClinicalTrials.Gov Identifier: NCT03540771.

MeSH

Liver Diseases, Depression, End Stage Liver Disease, Internal Medicine, Liver, Palliative Care, Gastroenterologists