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

Alcohol Use Disorder Clinical Trial

— DALC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319222
• Other study ID #: 23-007870
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Douglas Simonetto, MD
• Phone: 1-507-284-1649
• Email: dalc[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Liver Diseases

Intervention

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).

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Ria Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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