CirrhosisRx CDS System

Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05967273
• Other study ID #: 23-39379
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: June 2027

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: Jin Ge, MD, MBA
• Phone: 415-502-8070
• Email: jin.ge[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2106
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Decision Support Systems, Clinical
• Fibrosis
• Liver Cirrhosis

Intervention

Other:
• CirrhosisRx CDS
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.

Locations

Country	Name	City	State
United States	University of California San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reach of CirrhosisRx	Number of patients and clinicians randomized to CirrhosisRx	Through study completetion, approximately 36 months
Other	Adoption of CirrhosisRx	Proportion of clinicians using CirrhosisRx in the intervention arm	Through study completetion, approximately 36 months
Other	Implementation of CirrhosisRx	Proportions of clinicians implementing an order set through CirrhosisRx	Through study completetion, approximately 36 months
Other	Maintenance of CirrhosisRx	Rate of use over time and contamination rate	Through study completetion, approximately 36 months
Other	Average time spent on CirrhosisRx	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	Through study completetion, approximately 36 months
Primary	Aggregate adherence to quality measures	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.	During the hospitalization, approximately 7 days
Secondary	Inpatient mortality	This outcome is death during the admission	During the hospitalization, approximately 7 days