CirrhosisRx CDS System

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Cirrhosis; Decision Support Systems, Clinical

Treatments: Other: CirrhosisRx CDS

Study type: Interventional

Funder types: Other

Identifiers

NCT05967273

23-39379

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult (age ≥ 18 years) patients who have a previous history of cirrhosis identified based on 1+ chronic liver disease and 1+ cirrhosis (or its complications) International Classification of Diseases, Revision 10 diagnosis codes admitted at our institution.

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2,106 participants in 2 patient groups

CirrhosisRx

Experimental group

Description:

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.

Treatment:

Other: CirrhosisRx CDS

Usual Care

No Intervention group

Description:

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