30 Participants NeededMy employer runs this trial

Implementation Intervention for Alcoholism and Alcoholic Liver Disease

LH
Overseen ByLamia Haque, MD MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
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?

This trial aims to improve treatment for people with alcohol use disorder (AUD) and alcohol-associated liver disease (ALD) by integrating medications with brief counseling. It focuses on enhancing care in hepatology clinics to reduce liver-related complications. The trial educates clinicians in these clinics to better support patients with AUD and ALD through an implementation intervention. It suits healthcare professionals who work directly with liver disease patients in the specified medical system. As an unphased trial, this study allows patients to contribute to innovative care strategies that could significantly improve treatment outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this implementation intervention is safe?

Research has shown that treatments for alcohol use disorder, particularly when combined with counseling, can be safe for individuals with alcohol-related liver disease. Previous studies found that these treatments are generally well-tolerated. For instance, combining medication with counseling can reduce liver problems without major side effects.

Although specific data on this particular approach is not available, it emphasizes education and support rather than new drugs or risky procedures, suggesting a low risk for participants. Safety remains a priority, with the process involving education for both doctors and patients, ensuring careful monitoring and support throughout.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a comprehensive approach to treating alcoholism and alcoholic liver disease. Unlike standard treatments that typically focus solely on medication or counseling, this intervention combines clinician and patient education, clinical decision support, and feedback for healthcare providers. By focusing on educating hepatology clinicians and providing them with tools and feedback, the trial aims to enhance the overall quality of care and improve patient outcomes. This multi-faceted strategy has the potential to address gaps in current treatment methods and provide a more holistic approach to managing these conditions.

What evidence suggests that this implementation intervention is effective for alcohol use disorder and alcohol-associated liver disease?

Studies have shown that treating alcohol use disorder (AUD) can significantly reduce liver problems. For example, one study found that both therapy and medication for AUD improved liver function. Another study demonstrated that stopping alcohol use after an alcohol-related liver disease (ALD) diagnosis increased life expectancy and decreased liver issues. Additionally, combining treatments like counseling and support from healthcare providers effectively reduced alcohol use and improved liver health in people with liver disease. These findings suggest that a combined approach to treating AUD and ALD can be very beneficial.

In this trial, hepatology clinicians will engage in a multipronged intervention, including clinician education, patient education, clinical decision support, and clinician audit and feedback, to test its effectiveness in improving outcomes for patients with AUD and ALD.56789

Who Is on the Research Team?

LH

Lamia Haque

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for healthcare providers who care for patients with liver disease at hepatology clinics within the Yale School of Medicine and YNHH medical system.

Inclusion Criteria

* Must provide care for patients with liver disease at a hepatology clinical location within the Yale School of Medicine and YNHH medical system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Hepatology clinicians participate in educational sessions and implementation facilitation intervention

12 months
2 educational sessions (in-person or virtual)

Follow-up

Participants are monitored for the feasibility and acceptability of the intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Implementation Intervention

Trial Overview

The study is testing a program to help doctors offer medications and brief counseling for alcohol use disorder in people with alcohol-related liver disease, aiming to improve how this care is delivered in liver clinics.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Hepatology CliniciansExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Citations

Impact of Alcohol Use Disorder Treatment on Clinical ... - PMC

In adjusted analyses, behavioral and/or pharmacotherapy-based AUD treatment was associated with a significant reduction in incident hepatic decompensation (6.5% ...

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Implementation of Mobile-based Programs for Alcohol ...

The hypothesis is that the implementation of an adapted version of Connections for patients with ALD will improve rates of alcohol cessation and improve liver ...

Designing clinical trials to address alcohol use and ...

Although abstinence from alcohol after diagnosis of ALD improves life expectancy and reduces the risk of decompensation of liver disease, few ...

Efficacy of Psychosocial Interventions in Inducing and ...

In this study, the investigators randomized 61 patients with alcoholic cirrhosis or symptomatic alcoholic hepatitis and severe alcohol abuse ...

EASL Clinical Practice Guidelines: Management of alcohol ...

Alcoholic steatohepatitis is considered a progressive lesion, which increases the risk of cirrhosis and HCC. The principal morphological features of ASH include ...

Inpatient Screening, Brief Intervention, and Referral to ...

“Epidemiology of Alcohol Consumption and Societal Burden of Alcoholism and Alcoholic Liver Disease.” ... Outcomes for Alcoholic Hepatitis: A ...

Treatment of alcohol use disorder in patients with liver ...

One such treatment is the approach avoidance training program, in which patients are requested to respond with avoidance to pictures of alcoholic drinks (by ...

Designing clinical trials to address alcohol use and ... - PMC

In the USA, a report from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) showed that 52% of cirrhosis-related deaths in 2019 were attributable ...