CirrhosisRx CDS System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cirrhosis, Decision Support Systems, Clinical

Intervention / Treatment
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* Other: CirrhosisRx CDS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CirrhosisRx<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>Providers in this arm will not have access to the CirrhosisRx CDS system. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient mortality | This outcome is death during the admission | During the hospitalization, approximately 7 days |