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ASPECT-Pilot: Adding Specialist Palliative Care to Transplantation Pilot Trial

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05147935
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
10.1
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Palliative Care Consultation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Adding Specialist Palliative Care to Transplantation Pilot Trial
Actual Study Start Date :
Mar 31, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Specialist Palliative Care

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Myrick C Shinall, MD, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Myrick C. Shinall, Jr., MD, PhD, Study Principal Investigator Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT05147935
Other Study ID Numbers:
  • ASPECT-Pilot
First Posted:
Dec 7, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease

Study Results

No Results Posted as of Apr 12, 2022