End-Stage Liver Disease
Conditions
Keywords
Palliative 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.
Interventions
BEHAVIORALPrompted 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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study will be performed as a single center, pragmatic, randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with palliative care consults placed within 48 hours after enrollment | 48 hours post-enrollment | Percentage of patients identified within the EHR identified with palliative care consults. |
| Hospital-free days by day 90 | 90 days post-enrollment | The number of calendar days between enrollment and day 90 in which the patient is alive and outside of an acute-care hospital. Days spent at home, at a rehabilitation facility, at a nursing facility, and at an inpatient hospice facility will count as hospital-free. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival to day 90 | 90 days post-enrollment | The number of calendar days in which the patient is alive between enrollment and day 90. |
Countries
United States
Outcome results
None listed