search
Back to results

CirrhosisRx CDS System

Primary Purpose

Cirrhosis, Decision Support Systems, Clinical

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CirrhosisRx CDS
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CirrhosisRx

Usual Care

Arm Description

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.

Providers in this arm will not have access to the CirrhosisRx CDS system.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Inpatient mortality
This outcome is death during the admission

Full Information

First Posted
June 8, 2023
Last Updated
July 20, 2023
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT05967273
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2024 (Anticipated)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Decision Support Systems, Clinical

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CirrhosisRx
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Providers in this arm will not have access to the CirrhosisRx CDS system.
Intervention Type
Other
Intervention Name(s)
CirrhosisRx CDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aggregate adherence to quality measures
Description
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.
Time Frame
During the hospitalization, approximately 7 days
Secondary Outcome Measure Information:
Title
Inpatient mortality
Description
This outcome is death during the admission
Time Frame
During the hospitalization, approximately 7 days
Other Pre-specified Outcome Measures:
Title
Reach of CirrhosisRx
Description
Number of patients and clinicians randomized to CirrhosisRx
Time Frame
Through study completetion, approximately 36 months
Title
Adoption of CirrhosisRx
Description
Proportion of clinicians using CirrhosisRx in the intervention arm
Time Frame
Through study completetion, approximately 36 months
Title
Implementation of CirrhosisRx
Description
Proportions of clinicians implementing an order set through CirrhosisRx
Time Frame
Through study completetion, approximately 36 months
Title
Maintenance of CirrhosisRx
Description
Rate of use over time and contamination rate
Time Frame
Through study completetion, approximately 36 months
Title
Average time spent on CirrhosisRx
Description
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
Time Frame
Through study completetion, approximately 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Ge, MD, MBA
Phone
415-502-8070
Email
jin.ge@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Ge, MD, MBA
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Ge, MD, MBA
Phone
415-502-8070
Email
jin.ge@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CirrhosisRx CDS System

We'll reach out to this number within 24 hrs