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CirrhosisRx CDS System

NCT05967273 — Not applicable, Recruiting, 2106 participants, University of California, San Francisco

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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

RegistryNCT05967273
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, health services research
Enrollment2106 (Estimated)
SponsorUniversity of California, San Francisco (Other)
ConditionsCirrhosis, Decision Support Systems, Clinical
InterventionsCirrhosisRx CDS (Other)
Datesstart 2025-01-14, primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2023-08-01, last updated 2026-04-01
Locations1 site in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
CirrhosisRxExperimentalOther: CirrhosisRx CDSProviders 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.
Usual CareNo interventionProviders in this arm will not have access to the CirrhosisRx CDS system.
  • 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.

+Outcome measures

Primary outcomes

  • Aggregate adherence to quality measures [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

  • Inpatient mortality [During the hospitalization, approximately 7 days]: This outcome is death during the admission

Other outcomes

  • Reach of CirrhosisRx [Through study completetion, approximately 36 months]: Number of patients and clinicians randomized to CirrhosisRx
  • Adoption of CirrhosisRx [Through study completetion, approximately 36 months]: Proportion of clinicians using CirrhosisRx in the intervention arm
  • Implementation of CirrhosisRx [Through study completetion, approximately 36 months]: Proportions of clinicians implementing an order set through CirrhosisRx
  • Maintenance of CirrhosisRx [Through study completetion, approximately 36 months]: Rate of use over time and contamination rate
  • Average time spent on CirrhosisRx [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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
University of California San Francisco Medical CenterSan Francisco, CaliforniaUnited StatesRecruiting

+Investigators

  • Jin Ge, MD, MBA, Principal investigator, University of California, San Francisco

My Notes