CirrhosisRx CDS System

Pragmatic Randomized Controlled Trial to Evaluate the Effect of CirrhosisRx, a Novel Clinical Decision Support System, on Guideline-adherence and Clinical Outcomes for Patients With Cirrhosis

The aim of the study is to compare the effect of CirrhosisRx, a novel clinical decision support (CDS) system for inpatient cirrhosis care, versus "usual care" on adherence to national quality measures and clinical outcomes for hospitalized patients with cirrhosis.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis; Decision Support Systems, Clinical
• Intervention / Treatment: Other: CirrhosisRx CDS

Detailed Description

Each year, there over 200,000 hospitalizations for cirrhosis in the United States. Over one-third of these patients are readmitted within 30 days, and up to 10% will die in the hospital. Despite national quality measures and care guidelines, cirrhosis care remains suboptimal and highly variable.

Clinical Decision Support (CDS) systems present an attractive strategy to improve guideline-adherence due to low implementation costs. These systems, however, remain largely untested in cirrhosis care and it remains unknown whether they are effective at improving guideline-adherence and whether improving guideline-adherence changes clinical outcomes in cirrhosis care. The investigators have designed "CirrhosisRx," a cirrhosis-specific CDS system, to address these evidence gaps.

This study intends to compare effect of CirrhosisRx versus "usual care" on adherence to quality measures and clinical outcomes through a pragmatic randomized controlled trial (pRCT). Randomization will be based on stepped-wedge cluster randomization of treatment teams at our institution.

• Study Type: Interventional
• Enrollment (Estimated): 2106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin Ge, MD, MBA; Phone Number: 415-502-8070; Email: jin.ge@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco Medical Center
      • Contact: Jin Ge, MD, MBA; Phone Number: 415-502-8070; Email: jin.ge@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All adult (age ≥ 18 years) patients who have cirrhosis identified based on 1+ chronic liver disease and 1+ cirrhosis (or its complications) International Classification of Diseases, Revision 10 diagnosis codes OR mention of cirrhosis or portal hypertension (or their complications) in clinical documentation admitted at our institution.

Exclusion Criteria:

• Children (age < 18 years)
• patients who do not meet the cirrhosis definition criteria as noted above
• ambulatory patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CirrhosisRx; Providers in this arm will have access to the CirrhosisRx CDS system, which aggregates and organizes clinical data, presents them in clinically relevant/intuitive fashion for cirrhosis care, and linked to order sets consistent with national guidelines.	Other: CirrhosisRx CDS; CirrhosisRx is a cirrhosis-specific CDS that organizes clinical data into clinically relevant groupings and links them to order sets consistent with national practice guidelines for inpatient cirrhosis care.
No Intervention: Usual Care; Providers in this arm will not have access to the CirrhosisRx CDS system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggregate adherence to quality measures	This outcome is the aggregate adherence to five American Gastroenterological Association (AGA) and American Association for the Study of Liver Disease (AASLD) quality measures applicable to hospitalized patients with cirrhosis. The calculation for the measure will be the total number of admissions satisfying the five AGA/AASLD quality measures divided by the total number of addressable admissions (e.g. hospitalizations in which these quality metrics could be applied). In the cases which an admission could satisfying two or more metrics, this single admission will be multiple times per the number of times metrics could be potentially applied.	During the hospitalization, approximately 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inpatient mortality	This outcome is death during the admission	During the hospitalization, approximately 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of CirrhosisRx	Number of patients and clinicians randomized to CirrhosisRx	Through study completetion, approximately 36 months
Adoption of CirrhosisRx	Proportion of clinicians using CirrhosisRx in the intervention arm	Through study completetion, approximately 36 months
Implementation of CirrhosisRx	Proportions of clinicians implementing an order set through CirrhosisRx	Through study completetion, approximately 36 months
Maintenance of CirrhosisRx	Rate of use over time and contamination rate	Through study completetion, approximately 36 months
Average time spent on CirrhosisRx	Average time spent on CirrhosisRx - defined as the total time all clinicians spent on the system divided by the number of clinicians using the system	Through study completetion, approximately 36 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Jin Ge, MD, MBA, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis
• Other Study ID Numbers: 23-39379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No