Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC) (DALC)

Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC): A Randomized Pragmatic Clinical 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Diseases; Alcohol Use Disorder
• Intervention / Treatment: Other: DALC Digital Clinic

Detailed Description

This will be a pilot study with a pragmatic trial design wherein all hepatology providers at the Mayo Clinic in Rochester, MN and Scottsdale, AZ will be invited to participate in the study. Consented providers will be randomized to the Digital ALD/AUD Clinic (DALC) arm or standard of care. Provides randomized to standard of care arm will continue to enroll their patients with ALD in the Interactive Care Plan (ICP), a nursing led program started at Mayo in 2021 for longitudinal remote care of patients with compensated and decompensated cirrhosis. All patients will receive nursing education on alcohol abstinence at ICP enrollment and longitudinal management of their liver disease (current state). Providers randomized to the intervention arm will be able to refer their patients with ALD, to the DALC in addition to standard of care.

The target sample size will be 40 providers (20 providers per arm) and the investigators anticipate 150 patients with ALD will be seen during the study period across both arms. The number of ICP eligible patients seen versus the number of ICP referred patients will be recorded for all providers. Clinically relevant outcomes including hepatic decompensation, MELD 3.0 score, liver chemistries, alcohol use or relapse, liver-related hospitalizations, medication compliance, and mortality will be recorded as part of current ICP program, in both arms. Data will be collected retrospectively from the available medical records at the end of the study period, and no research contact will be made with the patients after initial consent for those patients being offered the DALC. The study duration will be 6 months after the initial Hepatology appointment. At study enrollment and completion, providers will be asked to fill out a survey regarding their satisfaction with ALD/AUD treatment. Consented providers will be informed that they may drop out of the study at any time.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provider-Hepatology Providers at Mayo Clinic Rochester and Scottsdale
• Patient-Age ≥ 18 y.o.
• Patient-Alcohol-associated liver disease

Exclusion Criteria:

• Provider-Providers in other divisions
• Patient-Inability to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Arm; Primary care providers will treat subject per standard of care utilizing the Interactive Care Plan program.
Other: Digital Clinic Arm; The Ria Treatment Platform (RTP) application will be downloaded onto the patient's smart phone or tablet.	Other: DALC Digital Clinic; Providers randomized to the intervention arm will be able to refer their patients with ALD, to the DALC in addition to standard of care. Patients with providers randomized to the intervention arm will be consented by the study team. After appropriate consent, the referred patients will be instructed by our study team to download the RTP application in their smart devices (smartphones or tablets).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median delta MELD-3.0 from baseline to end of study.	The primary aim of this study is to improve clinical outcomes in patients with ALD as defined as median delta MELD-3.0 from baseline to the end of the study.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained alcohol abstinence	Secondary aims include sustained alcohol abstinence which is obtained by asking the patient if they are continuing to not drink alcohol	6 months
Reduction of Number of hospitalizations	Secondary outcome measures include a reduction of number of hospitalizations in the DALC arm compared to the standard of care arm.	6 months
Greater provider satisfaction in DALC arm	Secondary outcome measures include greater provider satisfaction with AUD management in the DALC compared to standard of care based on surveys answered by providers. Provider outcome will be assessed by providing the provider a 12 question questionnaire with options to answer Extremely satisfied (5 pts), moderately satisfied (4 pts), neutral (3 pts), moderately dissatisfied (2 pts), very dissatisfied (1pt). The greater the points the greater the satisfaction.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Ria Health
• Investigators: Principal Investigator: Douglas Simonetto, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Alcohol; Liver; Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Alcoholism; Alcohol Drinking; Liver Diseases
• Other Study ID Numbers: 23-007870

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No