NCT07159386

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
52mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Mar 2026Sep 2030

First Submitted

Initial submission to the registry

August 5, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

August 5, 2025

Last Update Submit

March 30, 2026

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords

DiabetesLiverObesity

Outcome Measures

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)

    Up to five years after implementation of the intervention.

Secondary Outcomes (4)

  • Implementation Adoption: Percentage of eligible MASLD patients who receive an order for liver stiffness testing.

    Up to five years after implementation of the intervention.

  • Implementation Penetration: Percentage of PCPs who order liver stiffness testing for eligible MASLD patients.

    Up to five years after implementation of the intervention.

  • Implementation Fidelity: Percentage of eligible MASLD patients who complete liver stiffness testing after receiving an order.

    Up to five years after implementation of the intervention.

  • Implementation Sustainability: Percentage of clinics maintaining use of the MASLD fibrosis risk assessment alert over time.

    Up to five years after implementation of the intervention.

Study Arms (5)

Month 6

EXPERIMENTAL

All clinics will begin the study in the control phase. The intervention will be introduced in 5 steps with 5-6 clinics per step at intervals of 6 months. The transition phase from the control period to the intervention period will last 1 month and provide time for rolling out educational content and access to the MASLD fibrosis risk assessment EHR alert. A computer-generated randomization program will assign clinics to one of the 5 pre-defined transition steps (months 6, 12, 18, 24, and 30).

Other: EHR alert

Month 12

EXPERIMENTAL

All clinics will begin the study in the control phase. The intervention will be introduced in 5 steps with 5-6 clinics per step at intervals of 6 months. The transition phase from the control period to the intervention period will last 1 month and provide time for rolling out educational content and access to the MASLD fibrosis risk assessment EHR alert. A computer-generated randomization program will assign clinics to one of the 5 pre-defined transition steps (months 6, 12, 18, 24, and 30).

Other: EHR alert

Month 18

EXPERIMENTAL

All clinics will begin the study in the control phase. The intervention will be introduced in 5 steps with 5-6 clinics per step at intervals of 6 months. The transition phase from the control period to the intervention period will last 1 month and provide time for rolling out educational content and access to the MASLD fibrosis risk assessment EHR alert. A computer-generated randomization program will assign clinics to one of the 5 pre-defined transition steps (months 6, 12, 18, 24, and 30).

Other: EHR alert

Month 24

EXPERIMENTAL

All clinics will begin the study in the control phase. The intervention will be introduced in 5 steps with 5-6 clinics per step at intervals of 6 months. The transition phase from the control period to the intervention period will last 1 month and provide time for rolling out educational content and access to the MASLD fibrosis risk assessment EHR alert. A computer-generated randomization program will assign clinics to one of the 5 pre-defined transition steps (months 6, 12, 18, 24, and 30).

Other: EHR alert

Month 30

EXPERIMENTAL

All clinics will begin the study in the control phase. The intervention will be introduced in 5 steps with 5-6 clinics per step at intervals of 6 months. The transition phase from the control period to the intervention period will last 1 month and provide time for rolling out educational content and access to the MASLD fibrosis risk assessment EHR alert. A computer-generated randomization program will assign clinics to one of the 5 pre-defined transition steps (months 6, 12, 18, 24, and 30).

Other: EHR alert

Interventions

EHR alertOTHER

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.

Month 12Month 18Month 24Month 30Month 6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis code for MASLD
  • Type 2 diabetes mellitus will

You may not qualify if:

  • 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.
  • \. All physicians, physician assistants, and nurse practitioners delivering primary care during the intervention phase of the study.
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Schreiner, MD, MSCR

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Schreiner, MD, MSCR

CONTACT

(843) 876-0888schrein@musc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Study design: A stepped-wedge, cluster randomized clinical trial with an open cohort design using convergent, parallel mixed-methods to study: (i) the detection of advanced fibrosis in patients with known MASLD; and (ii) the implementation of a non-interruptive EHR alert for MASLD fibrosis risk assessment in primary care. All outcomes will be compared between unexposed (control) and exposed (intervention) periods. Randomization and Blinding: All clinics will begin the study in the control phase. The intervention will be introduced in 5 steps with 5-6 clinics per step at intervals of 6 months. The transition phase from the control period to the intervention period will last 1 month and provide time for rolling out educational content and access to the EHR alert. A computer-generated randomization program will assign clinics to one of the 5 pre-defined transition steps (months 6, 12, 18, 24, and 30).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor-Faculty

Study Record Dates

First Submitted

August 5, 2025

First Posted

September 8, 2025

Study Start

March 16, 2026

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Data will be used internally for implementation evaluation and quality improvement.

Locations

US(1)