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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
7,200
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.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGThe 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 months
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 months
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 months
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 months
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 months
Time to Completion of Noninvasive Elastography Studies
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
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Time frame: Baseline to 12 months