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

776 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Prompted Palliative Care Consult for liver disease?

Research shows that using standardized criteria for palliative care consults in patients with end-stage liver disease increased the use of these services. Patients who received palliative care were more likely to be discharged with hospice services, suggesting improved end-of-life care. ^{1 2 3 4 5}

Is palliative care safe for patients with liver disease?

Palliative care is generally safe for patients, including those with liver disease. In a study of palliative care trials, only a small percentage of participants experienced serious adverse events, and none were directly linked to the care itself. ^{1 2 6 7 8}

How does palliative care differ from other treatments for liver disease?

Palliative care for liver disease focuses on improving quality of life and managing symptoms rather than curing the disease, which is different from other treatments that aim to address the underlying liver condition. It involves early intervention to help with symptom management and advance care planning, especially for patients with high symptom burden or those on the liver transplant waiting list. ^{1 2 6 9 10}

What is the purpose of this trial?

This is a single center randomized platform trial determining whether prompting consideration of palliative care consultation through the electronic health record impacts the number of palliative consultations placed and hospital-free days among hospitalized adults with End-Stage Liver Disease.

Research Team

Mohana Karlekar, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Standardized Criteria Increases Palliative Care Consultation Utilization in Patients With End-Stage Liver Disease: A Pilot Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Palliative Care Consultations for Hospitalized Patients With Liver Disease. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Do screening tools assess palliative care needs and 12-month mortality in patients admitted to hepatology in-patient wards? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

30-Day Readmission Rates in Patients Admitted for Heart Failure Exacerbation with and without Palliative Care Consultation: A Retrospective Cohort Study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Do palliative consultations improve patient outcomes? [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Palliative Care for Patients with End-Stage Liver Disease on the Liver Transplant Waiting List: An International Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Integrating Specialist Palliative Care in the Liver Transplantation Evaluation Process: A Qualitative Analysis of Hepatologist and Palliative Care Provider Views. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Participant Safety in Multisite, Randomized, Double-Blind, Placebo-Controlled Clinical Trials in Hospice/Palliative Care: Data from the Contracted Studies of the Australian National Palliative Care Clinical Studies Collaborative. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Emerging Role of Palliative Care in Patients with Advanced Liver Disease. [2021]

10. United States 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. [2023]