CirrhosisRx CDS System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult (age ≥ 18 years) patients who have cirrhosis identified based on 1+ chronic liver disease and 1+ cirrhosis (or its complications) International Classification of Diseases, Revision 10 diagnosis codes OR mention of cirrhosis or portal hypertension (or their complications) in clinical documentation admitted at our institution.
Disqualifiers
Children (age < 18 years)
patients who do not meet the cirrhosis definition criteria as noted above
ambulatory patients
Trial design
Design model
Crossover
Treatments tested in this trial
CirrhosisRx CDS
Other interventionCirrhosisRx 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.
Treatment groups
2,106 Participants
are divided into 2 treatment groupsGroup A: CirrhosisRxExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
During the hospitalization, approximately 7 daysSecondary outcomes
1
Inpatient mortality
This outcome is death during the admission
Time frame
During the hospitalization, approximately 7 daysOther outcomes
1
Reach of CirrhosisRx
Number of patients and clinicians randomized to CirrhosisRx
Time frame
Through study completetion, approximately 36 months2
Adoption of CirrhosisRx
Proportion of clinicians using CirrhosisRx in the intervention arm
Time frame
Through study completetion, approximately 36 months3
Implementation of CirrhosisRx
Proportions of clinicians implementing an order set through CirrhosisRx
Time frame
Through study completetion, approximately 36 months4
Maintenance of CirrhosisRx
Rate of use over time and contamination rate
Time frame
Through study completetion, approximately 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov