CirrhosisRx CDS System

NCT05967273 | Recruiting DMC

• 1 other identifier: 23-39379
• Study Type: interventional
• Target: 2,106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Decision Support Systems, Clinical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inpatient mortality

  During the hospitalization, approximately 7 days

Other Outcomes (5)

• Reach of CirrhosisRx

  Through study completetion, approximately 36 months

• Adoption of CirrhosisRx

  Through study completetion, approximately 36 months

• Implementation of CirrhosisRx

  Through study completetion, approximately 36 months

Study Arms (2)

CirrhosisRx

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Providers in this arm will not have access to the CirrhosisRx CDS system.

Interventions

CirrhosisRx CDS OTHER

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.

CirrhosisRx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin Ge, MD, MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Ge, MD, MBA

CONTACT

415-502-8070; jin.ge@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a stepped-wedge cluster randomization of primary treatment teams. We will have 8 clusters consisting of at least one teaching medicine team, one non-teaching medicine team, one intensive care team, and equal numbers of other teams. The clusters will be assigned to the CirrhosisRx CDS intervention versus "usual care" with clusters crossing over from "usual care" to CirrhosisRx at 4 month intervals. All clusters will eventually be exposed to both arms of the study.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: August 1, 2023
• Study Start: January 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)