Recruiting

MASLD Management

Sponsor:

Medical University of South Carolina

Code:

NCT07159386

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EHR alert

Study Details

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.

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Study ID

NCT07159386

Start date

Mar 16, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Patients

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

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Month 6

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).

experimental: Month 12

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).

experimental: Month 18

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).

experimental: Month 24

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).

experimental: Month 30

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).

Interventions

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 measure

  • Detection of advanced fibrosis [ Time Frame: Up to five years after implementation of the intervention. ]

Central Contacts and Locations

Central contacts

Andrew Schreiner, MD, MSCR

(843) 876-0888schrein@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Chloe Bays, MPH

843-876-8688coopechl@musc.edu

Andrew Schreiner, MD, MSCR

843-876-8688schrein@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • Diabetes
  • Liver
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-03-31.