Adding Specialist Palliative Care to Transplantation Pilot Trial

NCT05147935 | Suspended

• 1 other identifier: ASPECT-Pilot
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Specialist palliative care has been shown to be beneficial for patients experiencing serious illness, but has not been studied for patients being evaluated for liver transplantation. The investigators hope in the future to design a multi-center trial of a specialist palliative care intervention to measure the effects of specialist palliative care for patients undergoing liver transplant evaluation. This project represents a pilot to gather needed information to design such a future study.

Conditions

End Stage Liver DIsease

Outcome Measures

Primary Outcomes (2)

• Acceptability of Intervention

  Score on the Acceptability of Intervention Measure (AIM) which measures how acceptable participants find the intervention with 4 questions, each scored 1-5 with higher scores indicating greater acceptability.

  2 months

• Appropriateness of Intervention

  Score on the Intervention Appropriateness Measure (IAM), which measures how appropriate the palliative care intervention seems to the study participants with 4 questions, each scored 1-5 with higher scores indicating higher appropriateness.

  2 months

Study Arms (1)

Specialist Palliative Care

EXPERIMENTAL

All patients will be assigned to receive the intervention, consisting of two outpatient palliative care visits at Vanderbilt University Medical Center (VUMC).

Behavioral: Palliative Care Consultation

Interventions

Palliative Care Consultation BEHAVIORAL

In person or telehealth clinic visit with palliative care physician or nurse practitioner

Specialist Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (age 18 years or greater) undergoing evaluation for liver transplantation at Vanderbilt University Medical Center

You may not qualify if:

• Patient does not speak English fluently
• Patient lacks a telephone
• Patient is a prisoner
• Patient is deaf
• Patient currently receives specialist palliative care
• Patient is not a resident of Tennessee

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Myrick C Shinall, MD, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator Assistant Professor

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 7, 2021
• Study Start: March 31, 2022
• Primary Completion: May 1, 2023
• Study Completion: March 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)