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Palliative Care Consults for Liver Disease (SeQuEL Trial)

N/A
Waitlist Available
Led By Mohana Karlekar, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is an adult (age ≥ 18 years)
Be older than 18 years old
Must not have
Patient is known to have received any VUMC palliative care consultation during the prior 3 months and/or the current admission
Patient has received a liver transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post-enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether reminding doctors to consider palliative care for patients with End-Stage Liver Disease will increase the number of palliative care consultations and reduce the time patients spend in the hospital.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-medical intervention (electronic prompts), there are no direct medical side effects associated with it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received palliative care consultation at VUMC in the last 3 months or during my current hospital stay.
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I have had a liver transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post-enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post-enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hospital-free days by day 90
Percentage of patients with palliative care consults placed within 48 hours after enrollment
Secondary study objectives
Survival to day 90

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: No Palliative Care Consultation Prompt GroupActive Control1 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 GroupActive Control1 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.

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
903 Previous Clinical Trials
937,801 Total Patients Enrolled
Mohana Karlekar, MDPrincipal InvestigatorVanderbilt University Medical Center
~517 spots leftby Oct 2027