CirrhosisRx CDS for Liver Cirrhosis

Overseen By Jin Ge, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Children, Non-cirrhosis, Ambulatory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

2106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, CirrhosisRx CDS, designed to help doctors manage the care of patients with liver cirrhosis more effectively. Researchers aim to determine if this tool improves adherence to important treatment guidelines and leads to better health outcomes for patients. The trial compares patients whose doctors use CirrhosisRx CDS with those receiving regular care without the tool. Individuals hospitalized with cirrhosis due to chronic liver disease may be suitable candidates for this study. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future care for liver 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.

What prior data suggests that the CirrhosisRx CDS system is safe for inpatient cirrhosis care?

Research has shown that the CirrhosisRx CDS system is a new tool that helps doctors manage cirrhosis care more effectively. Although specific data about its safety for patients is not available, it's important to note that a clinical decision support (CDS) system does not affect patient health in the same way as a drug or surgery. Instead, it assists doctors by organizing and displaying crucial medical information. Therefore, the usual safety concerns for drugs or surgeries do not apply. The primary focus is on how well it aids doctors in improving patient care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CirrhosisRx CDS system because it offers a fresh approach to managing liver cirrhosis. Unlike traditional treatment options that rely heavily on manual data interpretation and decision-making, this system aggregates and organizes clinical data in a user-friendly way. It also links to order sets that align with national guidelines, potentially enhancing the precision and efficiency of care. This could lead to more personalized treatment plans and improved outcomes for patients with cirrhosis.

What evidence suggests that the CirrhosisRx CDS is effective for cirrhosis care?

Research has shown that the CirrhosisRx CDS system, which participants in this trial may receive, could improve care for people with cirrhosis. In a study, researchers designed this system to organize and display crucial health information for cirrhosis care, aiming to help doctors adhere to quality care guidelines. Previous evidence indicates that these support systems can enhance patient care by assisting doctors in following national guidelines. For instance, when similar systems were used, patients with alcohol-related cirrhosis improved significantly, with some even being removed from transplant lists. This suggests that CirrhosisRx might ensure more consistent and effective care. ^{1 2 3 4 6}

Who Is on the Research Team?

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?

Group I: CirrhosisRx Experimental Treatment 1 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 Care Active Control 1 Intervention

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

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 5618 patients with cirrhosis followed for a median of 3 years, nearly 60% of patients were prescribed potentially unsafe drugs, highlighting a significant risk for adverse drug reactions (ADRs).

The most commonly used medications included proton pump inhibitors and diuretics, with almost half of all prescriptions falling under safety recommendations, indicating a need for personalized pharmacotherapy to enhance safety in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Drug Prescriptions and Potential Safety in Patients with Cirrhosis: A Retrospective Real-World Study. Weersink, RA., Taxis, K., Drenth, JPH., et al.[2020]

In a study of 400 patients with liver cirrhosis, 20% of prescribed drugs were inadequately dosed, leading to a significant number of adverse drug reactions (ADRs), with 78% of these being preventable.

Patients receiving inadequately dosed medications experienced more ADRs and were more likely to be hospitalized, resulting in an additional 94 hospital days, highlighting the critical need for careful drug dosing in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose adjustment in patients with liver cirrhosis: impact on adverse drug reactions and hospitalizations. Franz, CC., Hildbrand, C., Born, C., et al.[2021]

Medicine-related problems (MRPs) are common in patients with liver cirrhosis, with reported frequencies ranging from 14% to 23.4% across various studies, highlighting a significant concern in this patient population.

The causes of MRPs include drug interactions, inappropriate dosing, and the use of contraindicated medications, along with patient-related factors and healthcare system issues, indicating that effective management should address both medication therapy and patient behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medicine use and medicine-related problems in patients with liver cirrhosis: a systematic review of quantitative and qualitative studies. Cheema, E., Al-Aryan, A., Al-Hamid, A.[2020]

In a study of 57 patients with decompensated cirrhosis, 375 medication-related problems (MRPs) were identified, with nonadherence and indication issues being the most common types, highlighting the complexity of managing their medications.

Pharmacist-led interventions successfully resolved 58.9% of MRPs and were linked to a significant reduction in unplanned hospital admissions over 12 months, demonstrating the effectiveness of this approach in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication-Related Problems in Outpatients With Decompensated Cirrhosis: Opportunities for Harm Prevention. Hayward, KL., Patel, PJ., Valery, PC., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 78 critically ill patients with decompensated cirrhosis, a high incidence of drug-related problems was identified, with 394 issues reported, primarily due to drug-drug interactions (48.7%).

Approximately 27% of these drug-related problems resulted in preventable harm, including temporary harm (19.8%) and permanent harm (5.8%), highlighting the need for clinical pharmacist interventions to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying characteristics of drug-related problems in critically ill patients with decompensated liver cirrhosis. Aghili, M., Neelathahalli Kasturirangan, M.[2020]

In a study of 38 elderly patients with drug-induced liver injury (DILI), approximately 32.3% of DILI-drug pairs were deemed 'avoidable' using the Liverpool adverse drug reactions avoidability tool (LAAT), indicating potential for prevention strategies.

The findings suggest that a significant portion of DILI cases in this population could be prevented, highlighting the importance of using tools like LAAT for improving patient safety and reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avoidability of drug-induced liver injury (DILI) in an elderly hospital cohort with cases assessed for causality by the updated RUCAM score. Danjuma, MI., Almasri, H., Alshokri, S., et al.[2020]

A study of 74 liver transplant recipients revealed that the most critical syndromes influencing the decision for orthotopic liver transplantation (OTL) included portal hypertension, liver cell insufficiency, and cholestasis, highlighting the complexity of assessing patients' conditions.

The majority of patients (66.3%) were classified as Child-Pugh class B and C, indicating severe liver disease, and the syndromal approach was deemed the most effective method for determining the urgency and necessity of liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prognosis for patients with chronic diseases of the liver in formulating indications to orthotopic liver transplantation]. Malomuzh, OI., Krel', PE., Got'e, SV., et al.[2009]

Recent advances in therapies for cirrhosis, including antiviral treatments and psychopharmacological therapy for alcohol-use disorder, can help prevent cirrhosis and its complications, improving patient outcomes.

Evidence-based pharmacotherapeutic approaches can effectively manage complications of cirrhosis, such as hepatic encephalopathy and ascites, and address non-pain symptoms like fatigue and muscle cramps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review article: current and emerging therapies for the management of cirrhosis and its complications. Tapper, EB., Ufere, NN., Huang, DQ., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A quality improvement project involving around 30 healthcare professionals demonstrated that staff education and the implementation of a care bundle significantly improved the management of patients with decompensated liver cirrhosis.

The collaboration between hepatology and medical teams, along with focused training, led to better clinical outcomes for hospitalized patients, highlighting the importance of interdisciplinary approaches in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decompensated cirrhosis: targeted training of acute medical teams to improve quality of care in first 24 hours. Tan, M., Adjetey, A., Wee, C., et al.[2022]

Citations

1.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT05967273

UCSF Cirrhosis Trial → CirrhosisRx CDS System

This study intends to compare effect of CirrhosisRx versus usual care on adherence to quality measures and clinical outcomes through a pragmatic randomized ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05967273

Study Details | NCT05967273 | CirrhosisRx CDS System

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" ...

3.

reporter.nih.gov

reporter.nih.gov/project-details/11089425

Outcomes - Clinical Studies - NIH RePORTER

This proposal will leverage my ongoing KL2 work in which I designed “CirrhosisRx,” a cirrhosis-specific CDS system, to address these evidence gaps by: Comparing ...

4.

withpower.com

withpower.com/trial/phase-liver-cirrhosis-6-2024-b735f

CirrhosisRx CDS for Liver Cirrhosis

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 ...

5.

journals.lww.com

journals.lww.com/ajg/fulltext/2023/10001/s1493_design_of_a_clinical_decision_support_system.2454.aspx

S1493 Design of a Clinical Decision Support System for...

In this study, we applied principles from these approaches to design a CDS system for cirrhosis management, called CirrhosisRx.

6.

trialx.com

trialx.com/clinical-trials/listings/303676/cirrhosisrx-cds-system/?&radius=50

CirrhosisRx CDS System | Clinical Research Trial Listing ...

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 ...