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NCT Number: NCT05967273

CirrhosisRx CDS System

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.

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Key information

Conditions

Cirrhosis Decision Support Systems, Clinical Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Jin Ge, MD, MBA

CONTACT

[email protected]

415-502-8070

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Aggregate adherence to quality measures

    Time frame: During the hospitalization, approximately 7 days

    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.

Secondary outcomes

  1. Inpatient mortality

    Time frame: During the hospitalization, approximately 7 days

    This outcome is death during the admission

Other outcomes

  1. Reach of CirrhosisRx

    Time frame: Through study completetion, approximately 36 months

    Number of patients and clinicians randomized to CirrhosisRx

  2. Adoption of CirrhosisRx

    Time frame: Through study completetion, approximately 36 months

    Proportion of clinicians using CirrhosisRx in the intervention arm

  3. Implementation of CirrhosisRx

    Time frame: Through study completetion, approximately 36 months

    Proportions of clinicians implementing an order set through CirrhosisRx

  4. Maintenance of CirrhosisRx

    Time frame: Through study completetion, approximately 36 months

    Rate of use over time and contamination rate

  5. Average time spent on CirrhosisRx

    Time frame: Through study completetion, approximately 36 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Ge, MD, MBA

CONTACT

[email protected]

415-502-8070

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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