Clinical decision support automates care gap detection among primary care patients with nonalcoholic fatty liver disease.
Ashley Spann, Kristy M Bishop, Asli O Weitkamp...
https://pubmed.ncbi.nlm.nih.gov/36757410/Actively Recruiting
Led by Vanderbilt University Medical Center · Updated on 2026-07-21
7200
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effectiveness of an electronic clinical decision support system called eMPOWER for managing metabolic dysfunction-associated steatotic liver disease MASLD. This randomized trial aims to improve provider decision-making and assess how well the system is accepted and integrated within primary care, endocrinology, and gastroenterology settings. The study is conducted within clinical practices at Vanderbilt University Medical Center over three years with individual participant follow-up for 12 months. Participants are randomly assigned to one of two groups usual care or the intervention group using the eMPOWER decision aid. This electronic tool is embedded in the health record and alerts providers with patient-specific recommendations based on clinical data and risk profiles during and between clinical encounters. The study compares usual care with the use of this decision support system to see if it improves linkage to hepatology care and completion of fibrosis assessments and referrals. During the study, participants undergo routine clinical visits where providers receive or do not receive decision support alerts depending on the group. Researchers will track outcomes such as referral orders to hepatology, completion of elastography testing, and timing of these procedures over 12 months. They will also collect post-study feedback from clinicians about the decision aid. The total participation timeline per individual is approximately one year, with data collected from baseline through follow-up appointments.
CONDITIONS
A Study of Electronic Clinical Decision Support Tools for Steatotic Liver Disease
M
Michael McGill
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Vanderbilt University Medical Center
Lead Sponsor
American Association for the Study of Liver Diseases
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | eMPOWER Decision Aid | Usual Care | Guideline‑Based Pathway |
|---|---|---|---|
| What this is | An electronic health record‑embedded decision aid that alerts providers with patient‑specific MASLD risk stratification recommendations during and between clinic visits | Routine outpatient care without added electronic decision support for MASLD risk stratification | Noninvasive risk‑stratification using clinical and lab data such as FIB‑4 followed by elastography or enhanced blood testing for further evaluation |
| Role in this study | Investigational decision support tool applied to high‑risk MASLD patients | Control arm delivering usual outpatient MASLD risk evaluation | Current recommended primary care workflow for MASLD risk assessment |
| Primary use | To increase linkage to hepatology care and ordering of elastography by identifying high‑risk MASLD patients | Standard risk assessment without electronic prompts, relying on clinician initiative | Guideline‑recommended screening and risk stratification to detect clinically significant fibrosis |
| How it is given or performed | Embedded alerts in EHR during outpatient visits plus asynchronous communications between encounters | Usual outpatient workflows without added decision support tool | Primary care providers use routine labs to calculate FIB‑4, then order elastography or enhanced fibrosis labs as indicated |
| Evidence status | Effectiveness for improving linkage and testing is being evaluated; prior pilot studies exist | Standard practice; efficacy varies by provider awareness and follow‑up practices | Supported by guideline consensus as effective risk stratification for MASLD fibrosis |
| Important limitations | Pilot data limited; impact on long‑term outcomes still unproven | Clinician discretion leads to inconsistent MASLD detection and referral | Requires routine use of non‑invasive tests and adherence to follow‑up protocols |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive usual care or have their providers use the eMPOWER Decision Aid, which gives patient-specific recommendations for managing MASLD during outpatient visits.
Outpatient clinic visits as scheduled
Duration - Up to 12 months after treatment start
Researchers track referrals to hepatology and completion of fibrosis tests, and collect feedback from clinicians after the study period.
Data collected during routine visits
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Ashley Spann, Kristy M Bishop, Asli O Weitkamp...
https://pubmed.ncbi.nlm.nih.gov/36757410/Ashley Spann, Kristy Bishop, Sarah Marbach...
https://pubmed.ncbi.nlm.nih.gov/40906885/Vanderbilt University Medical Center
Lead Sponsor
American Association for the Study of Liver Diseases
Collaborating Sponsor