What side effects are associated with this type of intervention?

Common treatments for liver cirrhosis include acetyl-L-carnitine, branched-chain amino acids, and direct-acting antiviral (DAA) therapy. Acetyl-L-carnitine may cause gastrointestinal issues such as nausea and diarrhea. Branched-chain amino acids are generally well-tolerated but can occasionally lead to gastrointestinal discomfort. DAA therapy, used for hepatitis C virus co-infection, can cause fatigue, headache, and nausea. Additionally, all treatments for liver cirrhosis may carry the risk of liver function deterioration and should be monitored closely by healthcare providers.

What prior FDA approvals exist?

The provided context does not mention specific FDA-approved drugs for the treatment of liver cirrhosis. Generally, treatments for liver cirrhosis focus on managing symptoms and complications, such as antiviral medications for hepatitis B and C, which can prevent further liver damage. Additionally, diuretics, beta-blockers, and lactulose are commonly used to manage complications like ascites, variceal bleeding, and hepatic encephalopathy. Liver transplantation remains the definitive treatment for end-stage liver cirrhosis.

What other types of research exist?

Promising, novel alternatives to the Decision Aid Tool for Liver Cirrhosis patients considering treatment in 2024 include: 1) Pharmaceutical Computerized Decision Support (CDS) systems, which can incrementally target high-value projects and provide quick benefits despite resource limitations. 2) Multicriteria Decision-Making Methods in Network Meta-Analysis, which offer a flexible and computationally direct way to select optimal treatments by considering multiple criteria. 3) The SPACE framework, which provides a structured process for conducting feasibility assessments to ensure the use of fit-for-purpose data in decision-making.

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Implementation Strategy Training for Liver Cancer (OASIS Trial)

N/A

Waitlist Available

Led By Shari S Rogal, MD MPH

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Veterans post-transplant

Veterans with active hepatocellular carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks, 6 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new decision aid tool that uses machine learning to help healthcare providers choose the best strategies for implementing effective medical practices. The focus is on Veterans with cirrhosis who need cancer screenings. The tool aims to improve screening rates by identifying and overcoming barriers specific to each medical center.

Who is the study for?

This trial is for veterans who've had recent medical care at a VA center and have liver cirrhosis or related complications, as well as healthcare providers involved in improving care at these centers. It's not for those who've had a liver transplant or currently have active liver cancer.

What is being tested?

Project OASIS is testing a new decision aid tool against the current one to see which better identifies barriers and matches strategies to improve healthcare implementation. This study randomly assigns different VA centers to use either the new or current tool.

What are the potential side effects?

Since this trial involves training on decision aid tools rather than medications, there are no direct physical side effects expected from participating in this study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a veteran who has undergone a transplant.

Select...

I am a veteran with active liver cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks, 6 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks, 6 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks, 6 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adoption as assessed by % improvement in HCC screening performance

Effectiveness as assessed by patient outcomes

Implementation as assessed by fidelity to HCC screening recommendations

+2 more

Secondary study objectives

Acceptability of Intervention Measure (AIM)

Feasibility of Intervention Measure (FIM)

Intervention Appropriateness Measure (IAM)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OASIS DAExperimental Treatment1 Intervention

Half of the sites will be randomized to receive training on the OASIS decision aid.

Group II: Current DA ToolActive Control1 Intervention

Half of the sites will be randomized to receive training on the current decision aid tool.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cirrhosis include physical exercise, pharmacological interventions, and secondary prevention strategies for variceal bleeding. Physical exercise helps improve muscle strength and overall physical function, which can be compromised in cirrhosis patients. Pharmacological treatments, such as beta-blockers, work by reducing portal hypertension, thereby decreasing the risk of variceal bleeding. Secondary prevention strategies, including variceal band ligation and sclerotherapy, directly address and manage esophageal varices to prevent rebleeding. These treatments are crucial as they aim to manage symptoms, prevent complications, and improve the quality of life for liver cirrhosis patients.

Secondary prevention of variceal bleeding in adults with previous oesophageal variceal bleeding due to decompensated liver cirrhosis: a network meta-analysis.Effect of Liuweiwuling tablet on biochemical and virological parameters, and quality of life in patients with hepatitis B virus-related cirrhosis: A protocol for a systematic review and meta-analysis.Physical exercise for people with cirrhosis.