2106 Participants Needed

CirrhosisRx CDS for Liver Cirrhosis

JG
Overseen ByJin Ge, MD, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is CirrhosisRx CDS safe for humans?

The research articles focus on the safety of drug use in patients with liver cirrhosis, highlighting risks of adverse drug reactions (unwanted side effects) and drug-related problems in these patients. However, they do not provide specific safety data for CirrhosisRx CDS.12345

How is the CirrhosisRx CDS treatment different from other treatments for liver cirrhosis?

CirrhosisRx CDS is unique because it involves a pharmacist-led, patient-oriented medication education intervention that helps identify and resolve medication-related problems, reducing the risk of unplanned hospital admissions for patients with decompensated cirrhosis.25678

What data supports the effectiveness of the treatment CirrhosisRx CDS for liver cirrhosis?

The use of a clinical decision support (CDS) tool in the electronic health record has been shown to improve adherence to quality metrics in cirrhosis management, which may lead to shorter hospital stays.89101112

Who Is on the Research Team?

JG

Jin Ge, MD, MBA

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who have been previously diagnosed with cirrhosis, as confirmed by specific diagnosis codes. It's not open to children, those without a proper cirrhosis diagnosis, or patients who aren't hospitalized.

Inclusion Criteria

I am an adult with a history of cirrhosis diagnosed by specific health codes.

Exclusion Criteria

My liver is not severely damaged.
I am under 18 years old.
I can walk on my own without help.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive care with or without the CirrhosisRx CDS system during hospitalization

1 week
Inpatient stay

Follow-up

Participants are monitored for adherence to quality measures and clinical outcomes

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • CirrhosisRx CDS
Trial Overview The study tests CirrhosisRx CDS against usual care to see if it better follows national quality measures and improves outcomes for hospitalized patients with cirrhosis.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: CirrhosisRxExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
Providers in this arm will not have access to the CirrhosisRx CDS system.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Published Research Related to This Trial

In a study of 1,001 patients with decompensated cirrhosis, 8.6% of those with alcohol-related cirrhosis were able to improve enough to be delisted from the liver transplant waiting list, with a median improvement time of 29 months.
Factors such as a lower MELD score and higher platelet count at admission were associated with a higher likelihood of delisting due to improvement, and long-term outcomes after delisting were favorable, with a 76% chance of remaining free from liver-related death or needing a transplant after five years.
A notable proportion of liver transplant candidates with alcohol-related cirrhosis can be delisted because of clinical improvement.Pose, E., Torrents, A., Reverter, E., et al.[2022]
The implementation of a clinical decision support (CDS) tool in the electronic health record significantly improved adherence to quality metrics for cirrhosis management, with notable increases in diagnostic paracentesis (from 29.6% to 51.1%) and social work involvement (from 36.6% to 88.9%).
Using the CDS tool also led to significant reductions in both intensive care and hospital lengths of stay, as well as a decrease in the in-hospital development of infections, indicating improved patient care outcomes.
Use of a Cirrhosis Admission Order Set Improves Adherence to Quality Metrics and May Decrease Hospital Length of Stay.Bhavsar-Burke, I., Guardiola, JJ., Hamade, N., et al.[2023]
In a study of 5,138 cirrhosis patients, one-third died during their initial hospitalization, highlighting the severe impact of liver cirrhosis on survival rates.
Patients with alcohol-related cirrhosis (ALC) experienced higher rates of complications and mortality compared to non-ALC patients, often presenting at a younger age and with more severe liver disease.
Alcohol associated liver cirrhotics have higher mortality after index hospitalization: Long-term data of 5,138 patients.Jain, P., Shasthry, SM., Choudhury, AK., et al.[2021]

Citations

A notable proportion of liver transplant candidates with alcohol-related cirrhosis can be delisted because of clinical improvement. [2022]
Use of a Cirrhosis Admission Order Set Improves Adherence to Quality Metrics and May Decrease Hospital Length of Stay. [2023]
Alcohol associated liver cirrhotics have higher mortality after index hospitalization: Long-term data of 5,138 patients. [2021]
Decompensated cirrhosis: targeted training of acute medical teams to improve quality of care in first 24 hours. [2022]
Review article: current and emerging therapies for the management of cirrhosis and its complications. [2023]
Prevalence of Drug Prescriptions and Potential Safety in Patients with Cirrhosis: A Retrospective Real-World Study. [2020]
Identifying characteristics of drug-related problems in critically ill patients with decompensated liver cirrhosis. [2020]
Dose adjustment in patients with liver cirrhosis: impact on adverse drug reactions and hospitalizations. [2021]
Avoidability of drug-induced liver injury (DILI) in an elderly hospital cohort with cases assessed for causality by the updated RUCAM score. [2020]
Medicine use and medicine-related problems in patients with liver cirrhosis: a systematic review of quantitative and qualitative studies. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Medication-Related Problems in Outpatients With Decompensated Cirrhosis: Opportunities for Harm Prevention. [2023]
12.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Prognosis for patients with chronic diseases of the liver in formulating indications to orthotopic liver transplantation]. [2009]
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