Cirrhosis, Decision Support Systems, Clinical
Conditions
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.
Interventions
OTHERCirrhosisRx 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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Children (age \< 18 years) * patients who do not meet the cirrhosis definition criteria as noted above * ambulatory patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Inpatient mortality | During the hospitalization, approximately 7 days | This outcome is death during the admission |
Countries
United States
Contacts
CONTACTJin Ge, MD, MBA
PRINCIPAL_INVESTIGATORJin Ge, MD, MBA
University of California, San Francisco
Outcome results
None listed