Recruiting

Electronic Decision Support

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07382349

Conditions

MASLD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

eMPOWER Decision Aid

Study Details

Brief 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.

Conditions

MASLD

Study ID

NCT07382349

Start date

Jul 20, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

7200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Usual Care Group

Care providers will treat subject per standard of care

experimental: Electronic Decision Aid Group

the eMPOWER Decision Aid will be used to alert care providers to the patient specific recommendations for management of steatotic liver disease based on risk stratification

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Michael McGill

6153224643michael.g.mcgill@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Electronic Health Record
  • MASLD
  • Clinical Decision Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-07-21.