Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400498
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-06
First Post:
2024-05-01
Brief Title:
Surprise Question in End of Life SeQuEL Care and the Effect of Prompting Palliative Care Consultation End-Stage Liver Disease
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SeQuEL
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 patients 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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None