Clinical trial NCT05967273: CirrhosisRx CDS System
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis
Decision Support Systems, Clinical
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 2106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aggregate adherence to quality measures
timeFrame: During the hospitalization, approximately 7 days
Secondary outcomes:
measure: Inpatient mortality
timeFrame: During the hospitalization, approximately 7 days
Other outcomes:
measure: Reach of CirrhosisRx
timeFrame: Through study completetion, approximately 36 months
measure: Adoption of CirrhosisRx
timeFrame: Through study completetion, approximately 36 months
measure: Implementation of CirrhosisRx
timeFrame: Through study completetion, approximately 36 months
measure: Maintenance of CirrhosisRx
timeFrame: Through study completetion, approximately 36 months
measure: Average time spent on CirrhosisRx
timeFrame: Through study completetion, approximately 36 months
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jin Ge, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: