Advanced Fibrosis Detection for MASLD in Primary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a diagnosis code for MASLD
Type 2 diabetes mellitus will
Disqualifiers
All patients with cirrhosis, complications of cirrhosis (e.g. portal hypertension, hepatic encephalopathy), hepatocellular carcinoma, or previous liver transplant will be excluded.
pregnant women.
Trial design
Design model
Single group
Treatments tested in this trial
EHR alert
Other interventionDiagnoses 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.
Treatment groups
225 Participants
are divided into 5 treatment groupsGroup A: Month 6Experimental treatment 1 intervention
Group B: Month 12Experimental treatment 1 intervention
Group C: Month 18Experimental treatment 1 intervention
Group D: Month 24Experimental treatment 1 intervention
Group E: Month 30Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection of advanced fibrosis
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)
Time frame
Up to five years after implementation of the intervention.Secondary outcomes
1
Implementation Adoption: Percentage of eligible MASLD patients who receive an order for liver stiffness testing.
For the implementation outcomes, we will measure the adoption of the MASLD care intervention. We will quantify this outcomes using Proctor's implementation outcomes framework.
Time frame
Up to five years after implementation of the intervention.2
Implementation Penetration: Percentage of PCPs who order liver stiffness testing for eligible MASLD patients.
We will measure the penetration of the MASLD care intervention. We will quantify this outcomes using Proctor's implementation outcomes framework.
Time frame
Up to five years after implementation of the intervention.3
Implementation Fidelity: Percentage of eligible MASLD patients who complete liver stiffness testing after receiving an order.
We will measure the fidelity, and sustainability of the MASLD care intervention. We will quantify this outcomes using Proctor's implementation outcomes framework.
Time frame
Up to five years after implementation of the intervention.4
Implementation Sustainability: Percentage of clinics maintaining use of the MASLD fibrosis risk assessment alert over time.
We will measure the sustainability of the MASLD care intervention. We will quantify this outcomes using Proctor's implementation outcomes framework.
Time frame
Up to five years after implementation of the intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov