Digital Clinic for Alcoholism and Liver Disease

(DALC Trial)

Recruiting at 1 trial location

Overseen By Camille Kezer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Inability to provide consent

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

Trial Summary

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}

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.

Research Team

Douglas Simonetto, MD

Principal Investigator

Mayo Clinic

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 have liver disease related to alcohol use.

Exclusion Criteria

Provider: Providers in other divisions

I am unable to give consent by myself.

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

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Ria Health

Industry Sponsor

Trials

2

Recruited

160+

Findings from Research

A multidisciplinary clinic for alcohol-associated liver disease (ALD) showed promising early outcomes, with 51 patients seen in the first year and significant improvements in liver function, as indicated by a decrease in the mean MELD-Na score from 14 to 11.3 over 6 months.

Patients in the clinic experienced a notable reduction in hospital utilization, with emergency department visits dropping from 0.51 to 0.20 per person-month and inpatient admissions decreasing from 0.34 to 0.14 per person-month, suggesting effective management of their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and early experience of a novel multidisciplinary alcohol-associated liver disease clinic. Mellinger, JL., Winder, GS., Fernandez, AC., et al.[2022]

Individuals with co-occurring alcohol use disorders (AUD) and alcohol-associated liver disease (ALD) often lack access to effective treatment, particularly in rural areas where specialty care is limited.

Implementing telehealth within an integrated care model could enhance access to treatment for AUD and ALD, potentially improving recovery outcomes by addressing both conditions simultaneously.

NCBI (Pubmed)

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. Osman, M., Koneru, G., Weber, A.[2023]

A pilot study involving 60 adults with alcohol-associated liver disease (ALD) showed that a mobile health intervention significantly increased engagement in alcohol use disorder (AUD) treatment, with 27.3% of participants in the intervention group seeking treatment compared to 13.3% in the control group after 6 months.

The intervention was highly acceptable to participants, with 91% expressing satisfaction, and it also suggested a trend towards reduced alcohol consumption, indicating that mobile health tools can be effective in supporting treatment engagement among ALD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving alcohol treatment engagement using integrated behavioral interventions in alcohol-associated liver disease: A randomized pilot trial. Mellinger, JL., Medley, S., Kidwell, KM., et al.[2023]

An integrated approach combining hepatology and addiction medicine significantly improved the uptake of medical alcohol therapy, screening for hepatic fibrosis, and vaccination for viral hepatitis in inpatients with alcohol use disorder.

While this integrated care model enhanced certain medical outcomes, it did not show a difference in early alcohol remission rates compared to patients receiving only addiction medicine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated hepatology and addiction care for inpatients with alcohol use disorder improves outcomes: a prospective study. Mahle, R., McLean Diaz, P., Marshall, C., et al.[2023]

Alcohol-associated liver disease is the leading cause of hospitalization for chronic liver disease, with rising rates of alcohol-associated hepatitis over the past 20 years, highlighting the need for effective postdischarge management.

There is currently no standardized approach for managing patients after hospitalization for alcohol-associated hepatitis, necessitating strategies that address both liver disease and alcohol use disorder to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Patients After Treatment of Severe Alcohol-associated Hepatitis. Shetty, A., Ibrahim, B., Eskander, B., et al.[2023]

Individuals diagnosed with alcohol-associated liver disease (ALD) see their diagnosis as a strong motivator to quit drinking, but they often struggle to find effective resources for alcohol cessation due to overwhelming information about their condition.

An mHealth app designed for alcohol cessation was well-received by patients with ALD, showing high usage rates and positive feedback on its self-tracking and motivational features, indicating its potential as a supportive tool for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing a Digital Health App for Patients With Alcohol-Associated Liver Disease: Mixed Methods Usability Study. Park, LS., Kornfield, R., Yezihalem, M., et al.[2023]

References

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

Feasibility and early experience of a novel multidisciplinary alcohol-associated liver disease clinic. [2022]

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]

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]

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]

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

Management of Patients After Treatment of Severe Alcohol-associated Hepatitis. [2023]

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

Testing a Digital Health App for Patients With Alcohol-Associated Liver Disease: Mixed Methods Usability Study. [2023]