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
| Registry | NCT05967273 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, health services research |
| Enrollment | 2106 (Estimated) |
| Sponsor | University of California, San Francisco (Other) |
| Conditions | Cirrhosis, Decision Support Systems, Clinical |
| Interventions | CirrhosisRx CDS (Other) |
| Dates | start 2025-01-14, primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2023-08-01, last updated 2026-04-01 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| CirrhosisRx | Experimental | Other: CirrhosisRx CDS | 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. |
| Usual Care | No intervention | Providers in this arm will not have access to the CirrhosisRx CDS system. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of California San Francisco Medical Center | San Francisco, California | United States | Recruiting |