Clinical trial NCT06400498: Surprise Question in End of Life (SeQuEL) Care and the Effect of Prompting Palliative Care Consultation: End-Stage Liver Disease
Official title: Pragmatic Trial Investigating Surprise Question in End of Life (SeQuEL) Care and the Effect of Prompting Palliative Care Consultation on Provider Referral Rates and Subsequent Outcomes for Hospitalized Adults With Serious Illnesses: End-Stage Liver Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: End-Stage Liver Disease
Keywords: Palliative Care
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be performed as a single center, pragmatic, randomized clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Palliative care is specialized medical care focused on providing patients with relief from the symptoms, pain, and stress of serious illness, regardless of diagnosis, by anticipating, preventing, and treating suffering. The goal is to improve quality of life for both the patient and the patient's family. Palliative care is appropriate at any age and at any stage in a serious illness. It may be provided together with curative treatment, and includes intensive focus on symptom and pain management, psychosocial and spiritual support, and assistance in advance care planning.

There is potential benefit to introducing palliative care earlier in the course of illness for patients with chronic liver disease. For some patients with cirrhosis, palliative care has been shown to improve physical and emotional symptoms. In a recent observational study, it was found that for patients with End-Stage Liver Disease (ESLD) on the waiting list for liver transplant, an early palliative care intervention counteracted the progression of worsening symptoms and significantly improved pruritus, appetite, anxiety, depression, fatigue, and well-being. Moreover, the introduction of palliative care within the care course of patients with decompensated cirrhosis is endorsed by an AASLD (American Association for the Study of Liver Diseases) practice guidance document.

Despite the available evidence regarding the potential benefits of specialized palliative care across multiple serious illnesses, the incorporation of palliative care consultation into clinical practice in many settings is inconsistent and often too late in the clinical trajectory. In an effort to introduce palliative care sooner and more consistently into patients' care pathways, the study team will explore an interruptive provider nudge to prompt palliative care consideration in ESLD. This integrated approach will also help bridge the knowledge gap as to whether systematically prompting palliative care consultation can improve referral rates and outcomes for patients with ESLD.

The processes used to 1) identify hospitalized patients with ESLD, 2) query a provider about their status, and 3) prompt consideration of palliative care consultation are amenable to conduct through the electronic health record. Step 1 will employ phenotyping of clinical and admission characteristics readily extractable from the medical record. Step 2 will utilize the "Surprise Question" as a screening tool for identification of potentially unmet palliative care needs. In previous studies of serious illness, patients for whom consideration of palliative care consultation might be appropriate have used the "Surprise Question", which asks the treating clinician "would you be surprised if this patient died in the next 12 months?" Step 3 will harness the capability to prompt a provider to consider appropriately indicated, complementary, supportive care that may be otherwise underutilized while managing the patient's immediate health crisis.

Given the preliminary evidence that specialist palliative care may improve the quality and quantity of time spent alive and outside of the hospital for patients with serious illness and the incomplete implementation of specialty palliative care in current clinical practice, the study team will evaluate the effect of prompting consideration of palliative care consultation in the electronic health record on provider referral rates to the palliative care service and hospital-free days among hospitalized patients with ESLD.

Eligibility criteria: Inclusion Criteria:

* Patient is an adult (age ≥ 18 years).
* 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 have received any VUMC palliative care consultation during the prior 3 months and/or the current admission.
* Patient is known to be a prisoner.
* Patient has received a liver transplant.

Primary outcomes:
measure: Percentage of patients with palliative care consults placed within 48 hours after enrollment
timeFrame: 48 hours post-enrollment
measure: Hospital-free days by day 90
timeFrame: 90 days post-enrollment
Secondary outcomes:
measure: Survival to day 90
timeFrame: 90 days post-enrollment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Mohana Karlekar, MD
role: PRINCIPAL_INVESTIGATOR
References:
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