A Study of Electronic Clinical Decision Support Tools for Steatotic Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eMPOWER Decision Aid.
- Who it may be relevant to
- Registry conditions: MASLD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial of Electronic Clinical Decision Support Systems for Improving Care Management and Clinical Outcomes for Adults With Steatotic Liver Disease
Overview
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
- Other eMPOWER 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.
Primary outcome measures
- 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]
Secondary outcome measures (5)
- 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 [Time frame: Baseline to 12 months]
- Rate of Completion of Hepatology Referral [Time frame: Baseline to 12 months]
- Time to Completion of Hepatology Referral [Time frame: Baseline to 12 months]
- Rate of Completion of Noninvasive Elastography Studies [Time frame: Baseline to 12 months]
- Time to Completion of Noninvasive Elastography Studies [Time frame: Baseline to 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Publications
- Spann A, Bishop KM, Weitkamp AO, Stenner SP, Nelson SD, Izzy M. Clinical decision support automates care gap detection among primary care patients with nonalcoholic fatty liver disease. Hepatol Commun. 2023 Feb 9;7(3):e0035. doi: 10.1097/HC9.0000000000000035. eCollection 2023 Mar 1. PMID 36757410
- Spann A, Bishop K, Marbach S, Ji X, Slaughter J, Weitkamp A, Stenner S, Nelson S, Lopez C, Theobald C, Izzy M. Electronic decision aids enhance management of primary care patients with steatotic liver disease: Proof of concept pilot study. Hepatol Commun. 2025 Sep 5;9(9):e0794. doi: 10.1097/HC9.0000000000000794. eCollection 2025 Sep 1. PMID 40906885
Identifiers
NCT: NCT07382349 · 241192