Adding Specialist Palliative Care to Transplantation Pilot Trial

End Stage Liver DIsease Clinical Trial

— ASPECT-Pilot  

Official title:

Adding Specialist Palliative Care to Transplantation Pilot Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05147935
• Other study ID #: ASPECT-Pilot
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: March 2024

Study information

• Verified date: July 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: March 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver DIsease
• Liver Diseases

Intervention

Behavioral:
• Palliative Care Consultation
In person or telehealth clinic visit with palliative care physician or nurse practitioner

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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