NCT07382349

A Study of Electronic Clinical Decision Support Tools for Steatotic Liver Disease

Randomized Controlled Trial of Electronic Clinical Decision Support Systems for Improving Care Management and Clinical Outcomes for Adults With Steatotic Liver Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 7,200 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objectives of this study are to determine the effectiveness of a participant-specific guided electronic decision support system on provider decision making for participants with metabolic-dysfunction associated steatotic liver disease (MASLD), and to determine the acceptance and barriers for use of an electronic health record embedded algorithm for MASLD care management within ambulatory primary care, endocrinology, and general gastroenterology settings.

Detailed description

A pragmatic, randomized trial within selected clinical practices for primary care, endocrinology, and non-hepatology gastroenterology sites within Vanderbilt University Medical Center will be conducted over a period of 3 years with 12 months of follow up for each participant. Participants will be randomized 1:1 to intervention or usual care. In the intervention arm, the decision support aid (eMPOWER) will be used to alert consenting providers to participant-specific recommendations for steatotic liver disease care based on clinical features and risk factor profiles. The primary endpoint will be linkage to care determined by orders for referral to hepatology for advanced liver disease. Secondary outcomes will include completion of noninvasive fibrosis assessment tests for indeterminate risk participants by FIB-4 (1.3-2.67 for participants under 65, 2.0-2.67 for participants 65 and older), completion rates of hepatology referrals, and time analyses to complete either referrals or elastography studies. Post-study surveys and interviews to participating clinicians will be applied.

Conditions

• MASLD

Interventions

Type	Name	Description
OTHER	eMPOWER Decision Aid	An electronic health record embedded decision aid utilizing clinical data from both structured and unstructured clinical data to guide risk stratification and care management for patients with steatotic liver disease. Providers will be alerted to patient specific recommendations during the clinical encounter and between encounters through asynchronous communications related to subsequent testing.

Timeline

• Start date: 2026-07-01
• Primary completion: 2030-02-01
• Completion: 2030-02-01
• First posted: 2026-02-02
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States