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NCT Number: NCT07382349

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

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.

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Key information

Conditions

MASLD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eMPOWER Decision Aid

Other

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.

Primary outcomes

  1. The primary objective of this pragmatic trial is to assess the efficacy of the electronic decision support aid for increasing linkage to hepatology care for high-risk participants with MASLD

    Time frame: Baseline to 12 months

    Number of participants with new referrals placed to Hepatology for evaluation of high-risk status

Secondary outcomes

  1. The secondary objective is to assess the efficacy of the electronic decision support aid for increasing elastography testing ordered by primary care and specialty care providers for indeterminate-risk participants with MASLD

    Time frame: Baseline to 12 months

    Number of participants with orders placed by primary care and specialty care providers for noninvasive elastography assessments for evaluation of indeterminate risk status

  2. Rate of Completion of Hepatology Referral

    Time frame: Baseline to 12 months

    Of patients referred to Hepatology, number of participants with completed referrals for evaluation of high-risk status

  3. Time to Completion of Hepatology Referral

    Time frame: Baseline to 12 months

    Of patients referred to Hepatology, time to completion of referrals placed to Hepatology for evaluation of high-risk status determined by FIB-4 scoring

  4. Rate of Completion of Noninvasive Elastography Studies

    Time frame: Baseline to 12 months

    Of patients ordered for noninvasive fibrosis testing, number of completed orders placed by primary care and specialty care providers for evaluation of indeterminate risk status

  5. Time to Completion of Noninvasive Elastography Studies

    Time frame: Baseline to 12 months

    Of patients ordered for noninvasive fibrosis testing, time to completion of orders placed by primary care and specialty care providers for evaluation of indeterminate risk status

Study contacts

Contact information is provided by the study sponsor or research team.

Michael McGill

CONTACT

[email protected]

6153224643

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • American Association for the Study of Liver Diseases

Registry information

Official study title

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

Acronym: eMPOWER

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 2, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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