Back to resultsAdding Specialist Palliative Care to Transplantation Pilot Trial (ASPECT-Pilot)
Primary Purpose
End Stage Liver DIsease
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Care Consultation
Sponsored by
About this trial
This is an interventional supportive care trial for End Stage Liver DIsease
Eligibility Criteria
Inclusion Criteria:
- adult patients (age 18 years or greater) undergoing evaluation for liver transplantation at Vanderbilt University Medical Center
Exclusion Criteria:
- 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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Specialist Palliative Care
Arm Description
All patients will be assigned to receive the intervention, consisting of two outpatient palliative care visits at Vanderbilt University Medical Center (VUMC).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05147935
First Posted
November 23, 2021
Last Updated
July 20, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05147935
Brief Title
Adding Specialist Palliative Care to Transplantation Pilot Trial
Acronym
ASPECT-Pilot
Official Title
Adding Specialist Palliative Care to Transplantation Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver DIsease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Specialist Palliative Care
Arm Type
Experimental
Arm Description
All patients will be assigned to receive the intervention, consisting of two outpatient palliative care visits at Vanderbilt University Medical Center (VUMC).
Intervention Type
Behavioral
Intervention Name(s)
Palliative Care Consultation
Intervention Description
In person or telehealth clinic visit with palliative care physician or nurse practitioner
Primary Outcome Measure Information:
Title
Acceptability of Intervention
Description
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.
Time Frame
2 months
Title
Appropriateness of Intervention
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients (age 18 years or greater) undergoing evaluation for liver transplantation at Vanderbilt University Medical Center
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrick C Shinall, MD, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adding Specialist Palliative Care to Transplantation Pilot Trial
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