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Introducing palliative care within the treatment of end-stage liver disease: a randomized controlled trial
Investigator (PI): Navarro, Victor J; Verma, Manisha
Performing Organization (PO): (Current): Einstein Healthcare Network / (215) 456-6629
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2024
Record Source/Award ID: PCORI/PLC-1609-36714
Funding: Total Award Amount: $14,169,700
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Problem: Since palliative care (PC) practitioners are in short supply and patients with end-stage liver disease (ESLD) in great need of their services, this project aims to show the benefit of PC delivered by hepatologists, the typical primary care providers for such patients. Outcomes: Fourteen clinical centers will be randomly assigned to one of two approaches for PC care delivery; centers will offer either PC delivered by a PC consultant within a reasonable period of time (2 weeks) after entry, or immediately by their own hepatologist who received training in PC. We expect to show that the latter approach will allow patients with ESLD to have a better quality of life than patients who receive PC from a PC consultant. We will also show caregivers of patients who receive PC by their own hepatologist will show less distress. Importance to patients: The number of patients with ESLD is expected to increase over the next few decades. Literature shows that PC is infrequently given to these patients, and often it is delayed until the very end of life, when PC consultants only have hospice care to offer. Therefore, the earlier benefits of PC, including symptom management, disease acceptance, and caregiver support, are denied to them. Patient stakeholders: Patients with liver disease and caregivers were engaged to conceive and design this research. They affirmed the importance of the research topic, contributed to the specific aims, hypotheses, and methods. Patients/caregivers will remain involved throughout the study as part of the research advisory board, at the highest levels of governance. They will maintain the patient centeredness of the research approach, and also provide guidance to investigators to overcome potential barriers such as sluggish recruitment or suboptimal retention. Provider stakeholders include hepatologists and PC providers. Hepatologists will learn how to incorporate key skills within their routine practice that will improve patients' quality of life and will expand the scope and productivity of their practice. PC providers will benefit by having less pressure placed upon them to care for the backlog of patients with liver disease and their complex medical illnesses, the likes of which may impede their comfort in delivering PC in all but the last stages of life, when only comfort care can be offered. Upon completion, providers will collaborate with the patient/caregiver research advisory board to analyze data, submit the analysis for scientific peer review, and present the findings at national meetings and in peer reviewed medical journals. Our providers have been assembled strategically, to sample various areas of the U.S. with representation of urban, suburban, and rural patients. Our clinical centers include investigators poised to quickly disseminate findings through Veterans Administration and non-Veterans Administration health systems, assuring maximal impact of this research.
MeSH Terms:
  • Caregivers
  • End Stage Liver Disease /*therapy
  • Gastroenterology /methods
  • Health Services Accessibility
  • Health Services Research
  • Hospices
  • Hospitals, Veterans
  • Humans
  • Palliative Care /*organization & administration
  • Patient-Centered Care
  • Primary Health Care /organization & administration
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • United States
  • United States Department of Veterans Affairs
Country: United States
State: Pennsylvania
Zip Code: 19141
UI: 20181694
CTgovId: NCT03540771
Project Status: Ongoing
Record History: ('2018: Start date changed from 2017 to 2018 and project extended to 2024.',)