Guided electronic tools to help clinicians manage MASLD
Official title: Randomized Controlled Trial of Electronic Clinical Decision Support Systems for Improving Care Management and Clinical Outcomes for Adults With Steatotic Liver Disease
Run by Vanderbilt University Medical Center · NCT07382349 · Data updated 2026-11-12
Aimed at testing whether an electronic decision support tool used in primary care and specialty settings can help clinicians better manage MASLD in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 7200 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | July 20, 2026 |
| Main results expected | February 2030 |
| Study ends | February 2030 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT07382349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with MASLD or hepatic steatosis and at least one cardiometabolic risk factor who visit participating clinics.
✕Probably not a fit
Patients without the specified MASLD risk profile or those not managed in participating clinics may not benefit from the tool.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pragmatic randomized trial at Vanderbilt sites will compare usual care to using the eMPOWER decision aid embedded in the electronic health record. Providers receive patient-specific recommendations for MASLD care based on clinical features and risk factors, with primary and secondary outcomes focused on care linkage and noninvasive fibrosis testing. Participants are adults with MASLD or related liver conditions followed for 12 months after a 3-year study period. Primary endpoint is referral linkage to hepatology; secondary endpoints include fibrosis assessment completion, referral completion, and time to elastography or referrals. Qualitative surveys and interviews with clinicians will assess acceptance and barriers to use.
Why it matters
Potential benefit: If successful, clinicians may more consistently refer patients for hepatology care and complete noninvasive fibrosis assessments, potentially improving MASLD management.
How similar studies have gone: Prior work with electronic decision support in liver disease care has shown potential improvements, but this specific MASLD-focused tool is being evaluated in a pragmatic setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age ≥ 18 years) * Outpatient clinic visit (in-person or telemedicine) at a participating clinic site * Demonstrated Screening Need due to High Risk Profile, which includes the following: Diagnostic Codes for MASLD or Hepatic Steatosis on Imaging PLUS at least one cardiometabolic risk factors; OR Chronically Elevated Liver Enzymes (\> 6 months); OR patient with impaired glycemic control (prediabetes/diabetes); OR 2 or more cardiometabolic risk factors present Exclusion Criteria: * Solid Organ Transplant Recipient * Existing Hepatology Relationship Evidenced by Prior Hepatology Visit Within 3 Years * Active Cancer Diagnoses * Diagnoses for Alcohol-Related Conditions * Pregnant Individuals * Receiving Palliative Care Services
Where it's running
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Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Ashley Spann, MD, MSACI — Vanderbilt University Medical Center
- Study coordinator: Michael McGill
- Email: michael.g.mcgill@vumc.org
- Phone: 6153224643
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.