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

NCT ID: NCT06319222

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2026-06-30

Brief Summary

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.

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.

Conditions

Alcohol Use Disorder; Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Digital Clinic Arm

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

Group Type: OTHER

DALC Digital Clinic

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ria Health

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Douglas (Doug) A. Simonetto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Simonetto, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

23-007870

Identifier Type: -

Identifier Source: org_study_id