End Stage Liver DIseaseNCT05238779
An Integrative Model for Palliative Care in End-Stage Liver Disease
An observational study of End Stage Liver DIsease, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to understand the impact of palliative care in ESLD on quality of life, emergency room or hospital visits, and on care provider burden, and to work to develop the best way to provide palliative care in ESLD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Liver DIsease
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2022to 12 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with ESLD and their caregivers
Who may be able to join
- Primary participant:
- admission for decompensated cirrhosis, age ≥ 18
- willingness to sign consent
- able to read and understand English
- presence of decompensated cirrhosis with portal hypertension (jaundice, ascites, HE, hepatohydrothorax, AKI, HRS and/or variceal bleeding) or HCC
- Caregiver:
Show all 10Show fewer
- identified as the primary caregiver of the participant
- age ≥ 18
- willingness to sign consent
- able to read and understand English
Who cannot join
- Primary participant:
- prior liver transplant
- lack of capacity to provide informed consent (in the judgement of the investigator)
- already in receipt of palliative or hospice care
- those who are likely to receive a LT during the index admission
- Caregiver:
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to understand the impact of palliative care in ESLD on quality of life, emergency room or hospital visits, and on care provider burden, and to work to develop the best way to provide palliative care in ESLD.
Read the detailed description
Patients with end-stage liver disease (ESLD) have multiple symptoms that impact their quality of life and result in more emergency room and hospital visits. Palliative care is a medical model that can help alleviate pain and suffering and reduce need for urgent medical care and can do so while continuing other appropriate medical care. While palliative care consults are used in those with ESLD, despite the pain and suffering that accompanies ESLD, palliative care is often used too little and too late.
- Conditions
- End Stage Liver DIsease
- Being tested
- Standard of care including palliative care
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care including palliative careOther
Usual care includes laboratory evaluations, imaging, and certain procedures and medications. In some cases of patients undergoing transplant evaluation, usual care will also include multiple visits with members of the liver transplant team. A palliative care consult will also be part of standard of care. The primary goal of the palliative care consult is not to arrange hospice (though that can be done in appropriate situations) but to identify and try to address the impacts of the disease and its symptoms on patient's life.
| Study group | Role | What they receive |
|---|---|---|
| End Stage Liver Disease (ESLD) | Patients with ESLD Receives: Other: Standard of care including palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom intensity
Edmonton Symptom Assessment System (ESAS) - participants rate the intensity of common symptoms on 0-10 scale with 0= no symptom and 10=worst symptom imaginable. Scores range from 0 to 90 with higher scores indicating worse symptoms.
Measured: Up to 60 days
Change in liver disease QOL
Short-Form Liver Disease QOL - The SF-LDQOL includes 36 disease-targeted items representing nine domains: symptoms of liver disease, effects of liver disease, memory/concentration, sleep, hopelessness, distress, loneliness, stigma of liver disease and sexual problems. The minimum and maximum values of the scale are 0-100 with higher scores indicating better QOL.
Measured: Up to 60 days
Change in depression
Patient Health Questionnaire 9 (PHQ-9) is a self-report instrument which assesses depression. Scores range from 0 to 27 with higher scores indicating worse depression.
Measured: Up to 60 days
Change in anxiety
Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a self-report instrument which assesses anxiety. Scores range from 0 to 21 with higher scores indicating greater anxiety.
Measured: Up to 60 days
Change in perform ordinary tasks
The Karnofsky Performance Status will be used to assess participants ability to perform ordinary tasks. Scores range from 0 to 100 with higher scores indicating greater ability.
Measured: Up to 60 days
Change in caregiver burden
The Zarit Burden Interview
Measured: Up to 60 days
Hospital readmissions and/or Emergency room (ER) visits
Number of participants with ER visits or who are readmitted to the hospital during the study period
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start6 Jan 2022
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Wedd, MD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238779
- Sponsor's protocol ID
- HM20023178
- Status last verified
- Jul 2023
- First submitted
- 7 Feb 2022
- Last updated
- 7 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative Model for Palliative Care in End-Stage Liver Disease
- ClinicalTrials.gov ID
- NCT05238779
- Acronym / sponsor ID
- HM20023178
- Conditions
- End Stage Liver DIsease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to understand the impact of palliative care in ESLD on quality of life, emergency room or hospital visits, and on care provider burden, and to work to develop the best way to provide palliative care in ESLD.
Detailed description
Patients with end-stage liver disease (ESLD) have multiple symptoms that impact their quality of life and result in more emergency room and hospital visits. Palliative care is a medical model that can help alleviate pain and suffering and reduce need for urgent medical care and can do so while continuing other appropriate medical care. While palliative care consults are used in those with ESLD, despite the pain and suffering that accompanies ESLD, palliative care is often used too little and too late.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End Stage Liver Disease (ESLD) | – | Other: Standard of care including palliative carePatients with ESLD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with ESLD and their caregivers
Key inclusion criteria (10 listed)
- admission for decompensated cirrhosis, age ≥ 18
- willingness to sign consent
- able to read and understand English
- presence of decompensated cirrhosis with portal hypertension (jaundice, ascites, HE, hepatohydrothorax, AKI, HRS and/or variceal bleeding) or HCC
- identified as the primary caregiver of the participant
Key exclusion criteria (7 listed)
- prior liver transplant
- lack of capacity to provide informed consent (in the judgement of the investigator)
- already in receipt of palliative or hospice care
- those who are likely to receive a LT during the index admission
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care including palliative careUsual care includes laboratory evaluations, imaging, and certain procedures and medications. In some cases of patients undergoing transplant evaluation, usual care will also include multiple visits with members of the liver transplant team. A palliative care consult will also be part of standard of care. The primary goal of the palliative care consult is not to arrange hospice (though that can be done in appropriate situations) but to identify and try to address the impacts of the disease and its symptoms on patient's life. | Other | End Stage Liver Disease (ESLD) |
Primary outcome
Change in symptom intensity
Time frame: Up to 60 days
Edmonton Symptom Assessment System (ESAS) - participants rate the intensity of common symptoms on 0-10 scale with 0= no symptom and 10=worst symptom imaginable. Scores range from 0 to 90 with higher scores indicating worse symptoms.
Change in liver disease QOL
Time frame: Up to 60 days
Short-Form Liver Disease QOL - The SF-LDQOL includes 36 disease-targeted items representing nine domains: symptoms of liver disease, effects of liver disease, memory/concentration, sleep, hopelessness, distress, loneliness, stigma of liver disease and sexual problems. The minimum and maximum values of the scale are 0-100 with higher scores indicating better QOL.
Change in depression
Time frame: Up to 60 days
Patient Health Questionnaire 9 (PHQ-9) is a self-report instrument which assesses depression. Scores range from 0 to 27 with higher scores indicating worse depression.
Change in anxiety
Time frame: Up to 60 days
Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a self-report instrument which assesses anxiety. Scores range from 0 to 21 with higher scores indicating greater anxiety.
Change in perform ordinary tasks
Time frame: Up to 60 days
The Karnofsky Performance Status will be used to assess participants ability to perform ordinary tasks. Scores range from 0 to 100 with higher scores indicating greater ability.
Change in caregiver burden
Time frame: Up to 60 days
The Zarit Burden Interview
Hospital readmissions and/or Emergency room (ER) visits
Time frame: 60 days
Number of participants with ER visits or who are readmitted to the hospital during the study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for End Stage Liver DIsease
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
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CytOSorb TreatMent Of Critically Ill PatientS Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Wedd, MD, MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver DIsease, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom intensity (time frame: Up to 60 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.