NCT07159386 · Medical University of South Carolina
Advanced Fibrosis Detection for MASLD in Primary Care
What this study is about
This proposal evaluates the implementation of a novel, non-interruptive, electronic health record alert for metabolic dysfunction-associated steatotic liver disease (MASLD) fibrosis risk assessment in primary care patients with MASLD using a stepped wedge, cluster randomly assigned design. This work will generate generalizable data to dramatically enhance MASLD management in primary care.
View original scientific description
This proposal evaluates the implementation of a novel, non-interruptive, electronic health record alert for metabolic dysfunction-associated steatotic liver disease (MASLD) fibrosis risk assessment in primary care patients with MASLD using a stepped wedge, cluster randomized design. This work will generate generalizable data to dramatically enhance MASLD management in primary care.
Interventions
OTHER
EHR alert
Diagnoses of MASLD (based on ICD 9/10 code) in a patient's EHR history, visit, or problem list, will cue a non-interruptive alert to appear and prompt clinicians to use the integrated EPIC© FIB-4 calculation SmartPhrase. The tool displays the FIB-4 risk score, the advanced fibrosis risk, and the clinical guidance. LSM by ultrasound with elastography will be recommended for patients with FIB-4 \>1.3 (FIB-4 \>2.0 if age \>65) and the decision support will urge clinicians to order US with elastography through the SmartSet. LSM results will be documented in the EHR and categorized as low-risk MASLD (LSM \<8 kPa) or advanced fibrosis (LSM \>8 kPa). Results will be disseminated to the ordering PCPs and the patients. PCPs will receive information on patient counseling for MASLD, and the expanding roles of weight loss, reduced alcohol use, and exercise on disease management. PCPs will be encouraged to refer patients with advanced fibrosis to a hepatology specialist, in accordance with guidelines.
Primary outcome measures
Detection of advanced fibrosis
Time frame: Up to five years after implementation of the intervention.
The primary clinical outcome of interest is the detection of advanced fibrosis. This outcome will be determined by reviewing US with elastography results from the medical record. Advanced fibrosis will be categorized by LSM \>8 kPa (no advanced fibrosis is LSM \<8 kPa)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients with a diagnosis code for MASLD
- Type 2 diabetes mellitus will
Exclusion criteria
- All patients with cirrhosis, complications of cirrhosis (e.g. portal hypertension, hepatic encephalopathy), hepatocellular carcinoma, or previous liver transplant will be excluded.
- pregnant women. Clinicians Clinicians will also be study participants, as we will be surveying them for feedback on the MASLD fibrosis risk assessment intervention. The MUSC primary care network at last count employed 122 clinicians across the 27 primary care practices. Inclusion criteria: 1\. All physicians, physician assistants, and nurse practitioners delivering primary care during the intervention phase of the study. Exclusion criteria: None
Where
- Charleston, South Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations