CirrhosisRx CDS System

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05967273
• Collaborator: (none)
• Enrollment: 2,106
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 60.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis; Decision Support Systems, Clinical	Other: CirrhosisRx CDS	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2106 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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
• Anticipated Study Start Date: Jul 1, 2024
• Anticipated Primary Completion Date: Jun 1, 2027
• Anticipated Study Completion Date: Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CirrhosisRx 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.	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.
No Intervention: Usual Care Providers in this arm will not have access to the CirrhosisRx CDS system.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Inpatient mortality [During the hospitalization, approximately 7 days]

   This outcome is death during the admission

Other Outcome Measures

1. Reach of CirrhosisRx [Through study completetion, approximately 36 months]

   Number of patients and clinicians randomized to CirrhosisRx

2. Adoption of CirrhosisRx [Through study completetion, approximately 36 months]

   Proportion of clinicians using CirrhosisRx in the intervention arm

3. Implementation of CirrhosisRx [Through study completetion, approximately 36 months]

   Proportions of clinicians implementing an order set through CirrhosisRx

4. Maintenance of CirrhosisRx [Through study completetion, approximately 36 months]

   Rate of use over time and contamination rate

5. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco Medical Center	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05967273
• Other Study ID Numbers: 23-39379
• First Posted: Aug 1, 2023
• Last Update Posted: Aug 1, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Cirrhosis; Fibrosis

Study Results

No Results Posted as of Aug 1, 2023