Randomized Controlled Trial of Electronic Clinical Decision Support Systems for Improving Care Management and Clinical Outcomes for Adults With Steatotic Liver Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 7,200
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Usual Care Group
Care providers will treat subject per standard of care
Electronic Decision Aid Group
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
Intervention: eMPOWER Decision Aid (Other)
Outcomes
Primary Outcomes
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
Time Frame: Baseline to 12 months
Number of participants with new referrals placed to Hepatology for evaluation of high-risk status
Secondary Outcomes
- 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)
Investigators
Ashley Spann
Assistant Professor, Transplant Hepatology
Vanderbilt University Medical Center