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

Vanderbilt University Medical Center

Status: Begins enrollment in 4 months

Conditions: MASLD

Treatments: Other: eMPOWER Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT07382349

241192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,200 participants in 2 patient groups

Usual Care Group

No Intervention group

Description:

Care providers will treat subject per standard of care

Electronic Decision Aid Group

Experimental group

Description:

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

Treatment:

Other: eMPOWER Decision Aid