Palliative Care Consults for Liver Disease

(SeQuEL Trial)

Overseen By Cheryl Gatto, PhD, PMP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Prior palliative care, Prisoner, Liver transplant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether reminders in a hospital's electronic system can increase palliative care consultations for people with End-Stage Liver Disease. Palliative care focuses on relieving symptoms and improving quality of life for patients with serious illnesses. Participants are divided into two groups: one group receives a prompt for palliative consultation, while the other does not. The trial is open to adults hospitalized with End-Stage Liver Disease who have not received palliative care in the last three months. Doctors of participants will receive prompts if there is a significant concern about the patient's life expectancy. As an unphased trial, this study offers participants the opportunity to contribute to improving care strategies for others with similar conditions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for patients with End-Stage Liver Disease?

Research has shown that palliative care is safe and beneficial for people with end-stage liver disease. Studies indicate that patients can easily handle this type of care, which often controls symptoms more effectively. Those who receive palliative care tend to experience a better quality of life and receive improved care at the end of life.

While specific data on safety concerns is lacking, palliative care is generally regarded as a supportive approach that manages symptoms and enhances comfort. It is not a medication but a method to improve the patient's overall experience during their illness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of a systematic approach to palliative care consultations for patients with liver disease. Unlike standard care, where palliative consultations are often initiated at the discretion of the clinician or upon patient request, this approach uses a clinical decision support tool to prompt consultations based on specific criteria. This ensures that patients with serious illness are consistently evaluated for palliative care, which could lead to more timely and tailored support. The trial aims to reveal whether this proactive method improves patient outcomes, making it a potentially valuable addition to liver disease management.

What evidence suggests that prompted palliative care consults are effective for end-stage liver disease?

This trial will compare two approaches: one group will receive a prompt for palliative care consultations, while the other will not. Research has shown that palliative care consultations can greatly improve care for patients with liver disease. Patients who receive these consultations are more likely to have important discussions about their treatment goals than those who do not. Clear guidelines for when to have palliative care consultations have increased their use in patients with severe liver disease. This approach can enhance quality of life and help meet both the emotional and physical needs of patients. Overall, evidence supports that timely palliative care consultations can be a valuable part of managing severe liver disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Mohana Karlekar, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for hospitalized adults with End-Stage Liver Disease. It's designed to see if electronic prompts about palliative care consultations can affect the number of these consultations and increase hospital-free days.

Inclusion Criteria

Patient is admitted to the study hospital

Patient meets phenotype criteria for End-Stage Liver Disease

Patient's treating physician, physician associate, or nurse practitioner answers 'No' to a prompt in the electronic health record asking, 'Would you be surprised if this patient died in the next 12 months?'

Exclusion Criteria

Patient is known to be a prisoner

I have had a liver transplant.

I have received palliative care consultation at VUMC in the last 3 months or during my current hospital stay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Intervention

Participants are randomized to either receive a palliative care consultation prompt or no prompt

48 hours

Electronic health record intervention

Follow-up

Participants are monitored for survival and hospital-free days up to 90 days post-enrollment

90 days

Ongoing monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Prompted Palliative Care Consult

Trial Overview The study is testing whether an electronic prompt for doctors to consider palliative care consultation makes a difference in how often these services are used by patients with advanced liver disease.

How Is the Trial Designed?

Group I: No Palliative Care Consultation Prompt Group Active Control 1 Intervention

When a patient is randomized to the No Palliative Care Consultation Prompt Group, no prompt will occur. A treating clinician can choose to place or discontinue a palliative care consultation at any time. A patient may choose to request or decline a palliative care consultation at any time.

Group II: Palliative Care Consultation Prompt Group Active Control 1 Intervention

When a patient is randomized to the Palliative Care Consultation Prompt Group, a clinical decision support tool in the electronic health record will inform the treating clinician of the patient's serious illness and the results of the Surprise Question and prompt the treating clinician to consider a palliative care consultation. A treating clinician can choose to place or discontinue a palliative care consultation at any time, retaining full autonomy to deliver the appropriate patient care. A patient may choose to request or decline a palliative care consultation at any time.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

The Supportive and Palliative Care Indicator Tool (SPICT) demonstrated excellent performance in identifying liver patients who may need specialist palliative care, with a sensitivity of 93% and a positive predictive value of 93% based on a review of 117 medical notes.

The Bristol Prognostic Screening Tool (BPST) also showed good performance for identifying palliative care needs, but both tools had only moderate ability to predict 12-month mortality, indicating they are more effective for referral purposes than for mortality prediction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do screening tools assess palliative care needs and 12-month mortality in patients admitted to hepatology in-patient wards? Low, J., Carroll, C., Wilson, J., et al.[2022]

Patients with advanced liver disease experience significant symptom burden and have considerable palliative care needs, highlighting the importance of improving their quality of life.

There is a global variability in the involvement of palliative care for these patients, indicating a need for further research and development of new care models to enhance access to specialist palliative services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Role of Palliative Care in Patients with Advanced Liver Disease. Jordan, RI., Tandon, P.[2021]

Patients evaluated for liver transplantation who received palliative care (PC) were generally younger and had more severe liver disease, as indicated by higher MELD scores and rates of hepatic encephalopathy, compared to those who did not receive PC.

Utilization of PC services was associated with improved end-of-life outcomes, including a significantly lower likelihood of dying in the ICU and a higher likelihood of having advance care planning discussions and family meetings, indicating better quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Care and End-of-Life Outcomes in Patients Considered for Liver Transplantation: A Single-Center Experience in the US Midwest. Kieffer, SF., Tanaka, T., Ogilvie, AC., et al.[2023]

In a study involving 524 family members of veterans, those who received palliative consultations reported significantly better overall care outcomes in the last month of life, with scores averaging 65 compared to 54 for those without consultations.

Earlier palliative consultations were linked to even better outcomes, particularly in communication and emotional support, highlighting the importance of timely palliative care interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do palliative consultations improve patient outcomes? Casarett, D., Pickard, A., Bailey, FA., et al.[2022]

In a study of 44,933 hospitalized patients, those with liver disease were younger and had a higher in-hospital mortality rate (28%) compared to cancer patients (16.8%), highlighting the severity of liver disease in hospital settings.

Patients with liver disease were more likely to receive palliative care consultations focused on goals of care (81.7%) rather than pain management (10.9%), yet both groups showed similar improvements in symptoms and changes in resuscitation preferences after consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Palliative Care Consultations for Hospitalized Patients With Liver Disease. Ufere, NN., O'Riordan, DL., Bischoff, KE., et al.[2020]

Specialist palliative care can significantly improve symptoms and facilitate advance care planning for patients on liver transplant waiting lists, but these patients often receive limited palliative care support.

Healthcare professionals, particularly liver physicians, are hesitant to refer patients to palliative care due to concerns about the perceived curative nature of liver transplants and a lack of clarity on referral criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Care for Patients with End-Stage Liver Disease on the Liver Transplant Waiting List: An International Systematic Review. Vijeratnam, SS., Candy, B., Craig, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6823143/

OUTCOMES OF PALLIATIVE CARE CONSULTATIONS ... Patients with liver disease were more likely to receive PC consultations to address goals of care (81.7% vs. 67.9%, p<0.0001) as opposed to pain management ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0885392425008711

Palliative Care for Advanced Liver Disease: Hepatology ... The purpose of this paper is to describe hepatologist and PC clinicians' experiences delivering PC to patients with ALD to guide future ...

3. withpower.com withpower.com/trial/phase-liver-diseases-11-2024-ae013

Palliative Care Consults for Liver Disease (SeQuEL Trial) Research shows that using standardized criteria for palliative care consults in patients with end-stage liver disease increased the use of these services.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12530434/

Examining the implementation of home-based palliative ... Secondary outcome measures include changes in health-related QoL using the Chronic Liver Disease Questionnaire, depression severity, goals of ...

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/jpm.2024.0171

Palliative Care Referral Patterns and Outcomes for Patients ... This retrospective study on palliative care referrals and outcomes for patients with end-stage liver disease shows that inpatient consultation generally occurs ...

6. mdpi.com mdpi.com/2673-4389/5/3/39

Palliative Care in End-Stage Liver Disease Multiple studies have demonstrated that palliative care improves symptom control and enhances quality of life in ESLD patients [38,73,74]. The pioneering study ...

7. jdc.jefferson.edu jdc.jefferson.edu/cgi/viewcontent.cgi?article=1043&context=einsteinfp

Understanding the Role of Palliative Care Within Routine ... Purpose of Review This paper aims to investigate the crucial role of palliative care in the management of chronic liver disease. (CLD) and ...