MASLD
Conditions
Keywords
Electronic Health Record, MASLD, Clinical Decision Support
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.
Detailed 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.
Interventions
OTHEReMPOWER 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.
Sponsors
Vanderbilt University Medical Center
American Association for the Study of Liver Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to 12 months | Number of participants with new referrals placed to Hepatology for evaluation of high-risk status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of participants with orders placed by primary care and specialty care providers for noninvasive elastography assessments for evaluation of indeterminate risk status |
| Rate of Completion of Hepatology Referral | Baseline to 12 months | Of patients referred to Hepatology, number of participants with completed referrals for evaluation of high-risk status |
| Time to Completion of Hepatology Referral | Baseline to 12 months | Of patients referred to Hepatology, time to completion of referrals placed to Hepatology for evaluation of high-risk status determined by FIB-4 scoring |
| Rate of Completion of Noninvasive Elastography Studies | Baseline to 12 months | 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 to Completion of Noninvasive Elastography Studies | Baseline to 12 months | 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 |
Countries
United States
Contacts
CONTACTMichael McGill
PRINCIPAL_INVESTIGATORAshley Spann, MD, MSACI
Vanderbilt University Medical Center
Outcome results
None listed