Adding Specialist Palliative Care to Transplantation Pilot Trial

Not Applicable

Suspended

• Conditions: End Stage Liver DIsease
• Interventions: Behavioral: Palliative Care Consultation

• Registration Number: NCT05147935
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-07
• Study Start: 2022-03-31
• Primary Completion: 2023-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-27
• Last Update Posted: 2024-07-30
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

1. Patient does not speak English fluently
2. Patient lacks a telephone
3. Patient is a prisoner
4. Patient is deaf
5. Patient currently receives specialist palliative care
6. Patient is not a resident of Tennessee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Specialist Palliative Care	Palliative Care Consultation	All patients will be assigned to receive the intervention, consisting of two outpatient palliative care visits at Vanderbilt University Medical Center (VUMC).

Primary Outcome Measures

Name	Time	Method
Appropriateness of Intervention	2 months	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.
Acceptability of Intervention	2 months	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States