Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC): A Randomized Pragmatic Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcohol Use Disorder
- Sponsor
- Mayo Clinic
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Median delta MELD-3.0 from baseline to end of study.
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Douglas (Doug) A. Simonetto
Principal Investigator
Mayo Clinic
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
Outcomes
Primary Outcomes
Median delta MELD-3.0 from baseline to end of study.
Time Frame: 6 months
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.
Secondary Outcomes
- Sustained alcohol abstinence(6 months)
- Reduction of Number of hospitalizations(6 months)
- Greater provider satisfaction in DALC arm(6 months)