Surprise Question in End of Life (SeQuEL) Care and the Effect of Prompting Palliative Care Consultation: End-Stage Liver Disease

NCT ID: NCT06400498

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2025-08-05

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.

Conditions

End-Stage Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

No Palliative Care Consultation Prompt Group

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 Type: NO_INTERVENTION

No interventions assigned to this group

Palliative Care Consultation Prompt Group

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.

Group Type: ACTIVE_COMPARATOR

Prompted Palliative Care Consult

Intervention Type: BEHAVIORAL

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. If the treating clinician feels a palliative care consultation would be indicated for the patient, the clinical decision support tool will facilitate the placement of a palliative care consultation by the treating clinician. If the treating clinician feels that a palliative care consultation would not be indicated, then the clinical decision support will record a reason it is not indicated.

Interventions

Prompted Palliative Care Consult

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. If the treating clinician feels a palliative care consultation would be indicated for the patient, the clinical decision support tool will facilitate the placement of a palliative care consultation by the treating clinician. If the treating clinician feels that a palliative care consultation would not be indicated, then the clinical decision support will record a reason it is not indicated.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mohana Karlekar

Associate Professor of Medicine, Division of General Internal Medicine and Public Health, MD, FACP, FAAHPM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohana Karlekar, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

Ferrell BR, Twaddle ML, Melnick A, Meier DE. National Consensus Project Clinical Practice Guidelines for Quality Palliative Care Guidelines, 4th Edition. J Palliat Med. 2018 Dec;21(12):1684-1689. doi: 10.1089/jpm.2018.0431. Epub 2018 Sep 4.

Reference Type: BACKGROUND

PMID: 30179523 (View on PubMed)

Reframing Palliative Care | Messages Matter | On-Demand Webinar.; 2017. https://www.capc.org/events/recorded-webinars/reframing-palliative-care-messages-matter/

Reference Type: BACKGROUND

Radbruch L, De Lima L, Knaul F, Wenk R, Ali Z, Bhatnaghar S, Blanchard C, Bruera E, Buitrago R, Burla C, Callaway M, Munyoro EC, Centeno C, Cleary J, Connor S, Davaasuren O, Downing J, Foley K, Goh C, Gomez-Garcia W, Harding R, Khan QT, Larkin P, Leng M, Luyirika E, Marston J, Moine S, Osman H, Pettus K, Puchalski C, Rajagopal MR, Spence D, Spruijt O, Venkateswaran C, Wee B, Woodruff R, Yong J, Pastrana T. Redefining Palliative Care-A New Consensus-Based Definition. J Pain Symptom Manage. 2020 Oct;60(4):754-764. doi: 10.1016/j.jpainsymman.2020.04.027. Epub 2020 May 6.

Reference Type: BACKGROUND

PMID: 32387576 (View on PubMed)

Baumann AJ, Wheeler DS, James M, Turner R, Siegel A, Navarro VJ. Benefit of Early Palliative Care Intervention in End-Stage Liver Disease Patients Awaiting Liver Transplantation. J Pain Symptom Manage. 2015 Dec;50(6):882-6.e2. doi: 10.1016/j.jpainsymman.2015.07.014. Epub 2015 Aug 22.

Reference Type: BACKGROUND

PMID: 26303186 (View on PubMed)

Rogal SS, Hansen L, Patel A, Ufere NN, Verma M, Woodrell CD, Kanwal F. AASLD Practice Guidance: Palliative care and symptom-based management in decompensated cirrhosis. Hepatology. 2022 Sep;76(3):819-853. doi: 10.1002/hep.32378. Epub 2022 Apr 22. No abstract available.

Reference Type: BACKGROUND

PMID: 35103995 (View on PubMed)

Holden JH, Shamseddeen H, Johnson AW, Byriel B, Subramoney K, Cheng YW, Saito A, Ghabril M, Chalasani N, Sachs GA, Orman ES. Palliative Care and Hospice Referrals in Patients with Decompensated Cirrhosis: What Factors Are Important? J Palliat Med. 2020 Aug;23(8):1066-1075. doi: 10.1089/jpm.2019.0501. Epub 2020 Feb 24.

Reference Type: BACKGROUND

PMID: 32091954 (View on PubMed)

Woodrell CD, Goldstein NE, Moreno JR, Schiano TD, Schwartz ME, Garrido MM. Inpatient Specialty-Level Palliative Care Is Delivered Late in the Course of Hepatocellular Carcinoma and Associated With Lower Hazard of Hospital Readmission. J Pain Symptom Manage. 2021 May;61(5):940-947.e3. doi: 10.1016/j.jpainsymman.2020.09.040. Epub 2020 Oct 6.

Reference Type: BACKGROUND

PMID: 33035651 (View on PubMed)

Shinall MC Jr, Karlekar M, Martin S, Gatto CL, Misra S, Chung CY, Porayko MK, Scanga AE, Schneider NJ, Ely EW, Pulley JM, Jerome RN, Dear ML, Conway D, Buie R, Liu D, Lindsell CJ, Bernard GR. COMPASS: A Pilot Trial of an Early Palliative Care Intervention for Patients With End-Stage Liver Disease. J Pain Symptom Manage. 2019 Oct;58(4):614-622.e3. doi: 10.1016/j.jpainsymman.2019.06.023. Epub 2019 Jul 2.

Reference Type: BACKGROUND

PMID: 31276810 (View on PubMed)

Moroni M, Zocchi D, Bolognesi D, Abernethy A, Rondelli R, Savorani G, Salera M, Dall'Olio FG, Galli G, Biasco G; on behalf of the SUQ-P group. The 'surprise' question in advanced cancer patients: A prospective study among general practitioners. Palliat Med. 2014 Jul;28(7):959-964. doi: 10.1177/0269216314526273. Epub 2014 Mar 24.

Reference Type: BACKGROUND

PMID: 24662237 (View on PubMed)

Moss AH, Ganjoo J, Sharma S, Gansor J, Senft S, Weaner B, Dalton C, MacKay K, Pellegrino B, Anantharaman P, Schmidt R. Utility of the "surprise" question to identify dialysis patients with high mortality. Clin J Am Soc Nephrol. 2008 Sep;3(5):1379-84. doi: 10.2215/CJN.00940208. Epub 2008 Jul 2.

Reference Type: BACKGROUND

PMID: 18596118 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

240233

Identifier Type: -

Identifier Source: org_study_id