A Study of Electronic Clinical Decision Support Tools for Steatotic Liver Disease
ConditionMASLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Solid Organ Transplant Recipient
Existing Hepatology Relationship Evidenced by Prior Hepatology Visit Within 3 Years
Active Cancer Diagnoses
Diagnoses for Alcohol-Related Conditions
Trial design
Design model
Parallel
Treatments tested in this trial
eMPOWER Decision Aid
Other interventionAn 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.
Treatment groups
7,200 Participants
are divided into 2 treatment groupsGroup A: Usual Care GroupNo intervention 0 interventions
Group B: Electronic Decision Aid GroupExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Baseline to 12 monthsSecondary 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
Number of participants with orders placed by primary care and specialty care providers for noninvasive elastography assessments for evaluation of indeterminate risk status
Time frame
Baseline to 12 months2
Rate of Completion of Hepatology Referral
Of patients referred to Hepatology, number of participants with completed referrals for evaluation of high-risk status
Time frame
Baseline to 12 months3
Time to Completion of Hepatology Referral
Of patients referred to Hepatology, time to completion of referrals placed to Hepatology for evaluation of high-risk status determined by FIB-4 scoring
Time frame
Baseline to 12 months4
Rate of Completion of Noninvasive Elastography Studies
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
Time frame
Baseline to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
American Association for the Study of Liver Diseases
Collaborator
Source ClinicalTrials.gov