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

NCT07382349 | Not Yet Recruiting

• 1 other identifier: 241192
• Study Type: interventional
• Target: 7,200
• Locations: 1 country
• Sites: 1

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

Keywords

Electronic Health Record; MASLD; Clinical Decision Support

Outcome Measures

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

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

  Baseline to 12 months

Secondary Outcomes (5)

• 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

  Baseline to 12 months

• Rate of Completion of Hepatology Referral

  Baseline to 12 months

• Time to Completion of Hepatology Referral

  Baseline to 12 months

• Rate of Completion of Noninvasive Elastography Studies

  Baseline to 12 months

• Time to Completion of Noninvasive Elastography Studies

  Baseline to 12 months

Study Arms (2)

Usual Care Group

NO INTERVENTION

Care providers will treat subject per standard of care

Electronic Decision Aid Group

EXPERIMENTAL

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

Other: eMPOWER Decision Aid

Interventions

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.

Electronic Decision Aid Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Association for the Study of Liver Diseases: collaborator
• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• Spann A, Bishop KM, Weitkamp AO, Stenner SP, Nelson SD, Izzy M. Clinical decision support automates care gap detection among primary care patients with nonalcoholic fatty liver disease. Hepatol Commun. 2023 Feb 9;7(3):e0035. doi: 10.1097/HC9.0000000000000035. eCollection 2023 Mar 1.

  PMID: 36757410 BACKGROUND

• Spann A, Bishop K, Marbach S, Ji X, Slaughter J, Weitkamp A, Stenner S, Nelson S, Lopez C, Theobald C, Izzy M. Electronic decision aids enhance management of primary care patients with steatotic liver disease: Proof of concept pilot study. Hepatol Commun. 2025 Sep 5;9(9):e0794. doi: 10.1097/HC9.0000000000000794. eCollection 2025 Sep 1.

  PMID: 40906885 BACKGROUND

Study Officials

• Ashley Spann, MD, MSACI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael McGill

CONTACT

6153224643; michael.g.mcgill@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Transplant Hepatology

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)