Optimizing Cirrhosis Emergency Care

Investigating Cirrhosis Risk and Patient Outcomes in Emergency Care

A
Archita Desai, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
1 participants needed
6 Locations

Brief description of study

Within our IU health system, utilizing retrospective data we developed a clinical decision instrument based on ED visits, named it as Cirrhosis Risk Instrument for Stratifying Post Emergency Department mortality (CRISPE) tool. This tool was designed to identify predictors of 14-day and 30-day mortality in individuals with cirrhosis. However, given the retrospective nature of our study, certain limitations exist, particularly regarding data collection, as it relies on chart reviews. To enhance the reliability of this tool, we aim to validate it prospectively in individuals with cirrhosis who present to the ED. Secondarily, we aim to collect patient-reported outcomes (PROs) and test the utility of these in predicting healthcare utilization (HCU) after an ED visit.

THIS STUDY IS ENROLLING BY INVITATION ONLY -   Participants will be recruited from among patients being seen at an IU Emergency Department and will be contacted in one of two ways: by telephone or in person at an IU Health clinic visit.

Detailed description of study

 

  • Our study is a prospective study including patient population with cirrhosis who experienced an ED visits.
  • After informed consent, patient-reported outcomes (surveys attached) will be collected within one week of ED discharge or post-ED hospitalization discharge.
  • Each survey tool will be accessible electronically or via paper for completion and all assessments are expected to take no more than 60–90 minutes.
  • For participants who complete the study in person, a member of the study team will conduct a subject interview including several measures to assess each subject’s demographics and quality of life as well as frailty and strength testing via a grip strength test, a sit to stand test and a balance test.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cirrhosis
  • Age: 18 years - 100 years
  • Gender: All

INCLUSION CRITERIA:
1.Age > 18 years 
2. Individuals who had cirrhosis identified by:
a.  ICD 10 codes 
b. liver biopsy
c. nodular liver on imaging with ascites OR varices/collaterals OR hepatocellular carcinoma OR  splenomegaly AND thrombocytopenia
3. ED visit at an IU Health facility


EXCLUSION CRITERIA:
•    Incarcerated
•    Post-liver transplant at time of ED visit
•    Under hospice care or discharge to hospice
•    Pregnant
•    Unable to provide consent

Updated on 20 Aug 2025. Study ID: GI-IIR-ED, 26810

This study investigates the use of the Cirrhosis Risk Instrument for Stratifying Post Emergency Department mortality (CRISPE) tool in individuals with cirrhosis. Cirrhosis is a condition where the liver becomes scarred and its function is impaired. The purpose of this study is to validate the CRISPE tool prospectively to predict 14-day and 30-day mortality in patients with cirrhosis who visit the emergency department (ED).

Participants will be asked to complete patient-reported outcomes (PROs) surveys within one week of discharge from the ED or post-ED hospitalization. These surveys can be completed electronically or on paper and are expected to take 60–90 minutes. Additionally, participants completing the study in person will undergo a subject interview and various tests to assess demographics, quality of life, frailty, and strength, including grip strength, sit to stand, and balance tests.

  • Who can participate: Adults over 18 years old with cirrhosis, identified by specific medical criteria, who have visited an IU Health emergency department are eligible. Individuals who are incarcerated, have had a liver transplant, are under hospice care, pregnant, or unable to provide consent are not eligible.
  • Study details: Participants will complete surveys about their health and experiences after an ED visit within a week of discharge, taking about 60–90 minutes. In-person participants will also participate in interviews and physical tests to measure strength and balance.
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only