Digital Clinic for Alcoholism and Liver Disease

(DALC Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Douglas Simonetto, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Inability to provide consent

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction. The primary aim of this study is to improve clinical outcomes in patients with ALD through the implementation of a novel digital health platform for personalized multi-disciplinary treatment of patients with ALD and AUD. Secondary aims include improvement in provider and patient-reported outcomes including satisfaction with AUD treatment.

Do I need to stop my current medications for this trial?

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 healthcare provider.

What data supports the effectiveness of the treatment DALC Digital Clinic for alcohol-associated liver disease and alcohol use disorder?

Research suggests that integrated care models, which combine treatment for alcohol use disorder and liver disease, can improve access to care and recovery outcomes, especially in rural areas. Additionally, mobile health interventions have shown promise in increasing treatment engagement among patients with alcohol-associated liver disease. ^{1 2 3 4 5}

How is the DALC Digital Clinic treatment different from other treatments for alcohol-associated liver disease and alcohol use disorder?

The DALC Digital Clinic is unique because it uses a multidisciplinary approach and telehealth to provide integrated care for alcohol-associated liver disease and alcohol use disorder, especially benefiting those in rural areas with limited access to specialty care. This digital clinic offers a novel way to improve access and support for alcohol cessation through mobile health interventions, which are not commonly available for this patient population. ^{1 2 3 5 6}

Eligibility Criteria

This trial is for individuals with alcohol-associated liver disease (ALD) and alcohol use disorder (AUD). It's designed to see if a digital clinic can help improve their health outcomes. Participants should be comfortable using digital tools for treatment.

Inclusion Criteria

Provider: Hepatology Providers at Mayo Clinic Rochester and Scottsdale

I am 18 years old or older.

I have liver disease related to alcohol use.

Exclusion Criteria

Provider: Providers in other divisions

I am unable to give consent by myself.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized multi-disciplinary treatment through a digital health platform or standard care

6 months

Ongoing digital and in-person interactions

Follow-up

Participants are monitored for clinical outcomes such as hepatic decompensation, MELD 3.0 score, and alcohol use

6 months

Treatment Details

Interventions

• DALC Digital Clinic (Behavioural Intervention)

Trial Overview The DALC Digital Clinic, a multidisciplinary online platform, is being tested to see if it can enhance the care of patients with ALD and AUD by improving health results, reducing costs, increasing access to care, and boosting satisfaction for both providers and patients.

Participant Groups

Group I: Digital Clinic Arm Experimental Treatment 1 Intervention

The Ria Treatment Platform (RTP) application will be downloaded onto the patient's smart phone or tablet.

Group II: Standard of Care Arm Active Control 1 Intervention

Primary care providers will treat subject per standard of care utilizing the Interactive Care Plan program.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Rochester, MN

Mayo Clinic Arizona Scottsdale, AZ

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

Ria Health Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility and early experience of a novel multidisciplinary alcohol-associated liver disease clinic. [2022] Alcohol cessation improves mortality in alcohol-associated liver disease (ALD), but access to treatment is limited. To address this gap, implementation and early feasibility and outcomes of a multidisciplinary ALD clinic are described.

2. England pubmed.ncbi.nlm.nih.gov

Integrated care models for co-occurring alcohol use disorders and alcohol-associated liver disease in rural communities: Telehealth considerations and opportunities. [2023] Alcohol use disorders (AUD) and alcohol-associated liver disease (ALD) have growing impacts on public health, yet many do not receive evidence-based care. People with co-occurring AUD and ALD, especially those in rural communities with less access to specialty care, are most in need of novel integrated care models. The use of telehealth to facilitate co-location within an integrated care model may help to improve access to AUD and ALD care while reducing barriers and improving recovery outcomes for both the substance use disorder and liver disease.

3. United States pubmed.ncbi.nlm.nih.gov

Improving alcohol treatment engagement using integrated behavioral interventions in alcohol-associated liver disease: A randomized pilot trial. [2023] Alcohol cessation improves mortality in alcohol-associated liver disease (ALD), but few ALD patients will engage in treatment. We aimed to demonstrate the feasibility and acceptability of a mobile health intervention to increase alcohol use disorder (AUD) treatment among ALD patients.

4. United States pubmed.ncbi.nlm.nih.gov

Integrated hepatology and addiction care for inpatients with alcohol use disorder improves outcomes: a prospective study. [2023] Growing literature highlights the need to integrate hepatology and addiction care to improve outcomes for patients with alcohol use disorder and alcohol-associated liver disease. However, prospective data for this approach are lacking.

5. United States pubmed.ncbi.nlm.nih.gov

Management of Patients After Treatment of Severe Alcohol-associated Hepatitis. [2023] Alcohol-associated liver disease is the leading indication for hospitalization among patients with chronic liver disease. Rates of hospitalization for alcohol-associated hepatitis have been rising over the last 2 decades. Patients with alcohol-associated hepatitis carry significant morbidity and mortality, but there is a lack of standardized postdischarge management strategies to care for this challenging group of patients. Patients warrant management of not only their liver disease but also their alcohol use disorder. In this review, we will discuss outpatient management strategies for patients who were recently hospitalized and discharged for alcohol-associated hepatitis. We will discuss short management of their liver disease, long-term follow-up, and review-available treatment options for alcohol use disorder and challenges associated with pursuing treatment for alcohol use disorder.

6. Canada pubmed.ncbi.nlm.nih.gov

Testing a Digital Health App for Patients With Alcohol-Associated Liver Disease: Mixed Methods Usability Study. [2023] Alcohol-associated liver disease (ALD) is increasingly common and associated with serious and costly health consequences. Cessation of drinking can improve ALD morbidity and mortality; however, support for cessation is not routinely offered to those diagnosed with ALD, and continued drinking or resumption of drinking after diagnosis is common. Mobile health (mHealth) has the potential to offer convenient and scalable support for alcohol cessation to those diagnosed with ALD, but mHealth interventions for alcohol cessation have not been designed for or evaluated in a population with ALD.