Metabolic Dysfunction-associated Steatotic Liver DiseaseNCT07159386
Advanced Fibrosis Detection for MASLD in Primary Care
A study testing EHR alert in people with Metabolic Dysfunction-associated Steatotic Liver Disease, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-associated Steatotic Liver Disease
- What is being tested?
- EHR alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis code for MASLD
- Type 2 diabetes mellitus will
- 1. All physicians, physician assistants, and nurse practitioners delivering primary care during the intervention phase of the study.
Who cannot join
- 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.
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Chloe Bays, MPH, 843-876-8688, coopechl@musc.edu
Andrew Schreiner, MD, MSCR, 843-876-8688, schrein@musc.edu
About this study
Official title: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care
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.
Read the detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly nonalcoholic fatty liver disease [NAFLD]) affects an estimated 1in 3 persons in the U.S., a prevalence expected to increase over the next decade. MASLD's rising prevalence and its association with diabetes and obesity make it a chronic disease well-suited for initial management by primary care providers (PCPs). PCPs can impact MASLD care by first detecting advanced fibrosis, which is the best predictor of cirrhosis, hepatocellular carcinoma, and liver-related mortality in affected patients. Recently issued guidelines from the American Association for the Study of Liver Diseases recommend the sequential use of non-invasive liver tests, the Fibrosis-4 Index (FIB-4) followed by confirmatory liver stiffness measurement (LSM) with vibration-controlled elastography (VCTE), to detect advanced fibrosis in patients with MASLD. FIB-4 is attractive in primary care due to the low-cost and broad availability of its inputs, but PCPs have little experience with FIB-4 calculation, limited comfort with its interpretation, and infrequent access to confirmatory liver stiffness testing. The guidelines provide a clinical threshold for hepatology engagement, recommending referral for patients with advanced fibrosis, while those with low-risk MASLD remain in primary care. Incorporating advanced fibrosis detection into the already overwhelming workload of PCPs requires thoughtful application of electronic health record (EHR)technologies to avoid contributing to PCP alert fatigue and burnout. In this work, investigators aim to evaluate the adoption, penetration, fidelity, sustainability, and performance of a novel, non-interruptive EHR alert for MASLD fibrosis risk assessment in a primary care network by performing a stepped wedge, cluster randomized trial in patients with known or suspected MASLD (Aim 1). This proposal aligns with NIDDK's scientific goal to disseminate, implement, and evaluate evidence-based care strategies in community care settings where the burden of MASLD hides in plain sight.
- Being tested
- EHR alert
- Keywords
- Diabetes, Liver, Obesity
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: EHR alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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.
Measured: Up to five years after implementation of the intervention.
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.
Measured: 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.
We will measure the fidelity, and sustainability of the MASLD care intervention. We will quantify this outcomes using Proctor's implementation outcomes framework.
Measured: 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.
We will measure the sustainability of the MASLD care intervention. We will quantify this outcomes using Proctor's implementation outcomes framework.
Measured: Up to five years after implementation of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start16 Mar 2026
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Andrew Schreiner, Medical University of South Carolina
- Investigators
- Andrew Schreiner, MD, MSCR, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159386
- Sponsor's protocol ID
- Pro00145783
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be used internally for implementation evaluation and quality improvement.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care
- ClinicalTrials.gov ID
- NCT07159386
- Acronym / sponsor ID
- Pro00145783
- Keywords
- Diabetes, Liver, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly nonalcoholic fatty liver disease [NAFLD]) affects an estimated 1in 3 persons in the U.S., a prevalence expected to increase over the next decade. MASLD's rising prevalence and its association with diabetes and obesity make it a chronic disease well-suited for initial management by primary care providers (PCPs). PCPs can impact MASLD care by first detecting advanced fibrosis, which is the best predictor of cirrhosis, hepatocellular carcinoma, and liver-related mortality in affected patients. Recently issued guidelines from the American Association for the Study of Liver Diseases recommend the sequential use of non-invasive liver tests, the Fibrosis-4 Index (FIB-4) followed by confirmatory liver stiffness measurement (LSM) with vibration-controlled elastography (VCTE), to detect advanced fibrosis in patients with MASLD. FIB-4 is attractive in primary care due to the low-cost and broad availability of its inputs, but PCPs have little experience with FIB-4 calculation, limited comfort with its interpretation, and infrequent access to confirmatory liver stiffness testing. The guidelines provide a clinical threshold for hepatology engagement, recommending referral for patients with advanced fibrosis, while those with low-risk MASLD remain in primary care. Incorporating advanced fibrosis detection into the already overwhelming workload of PCPs requires thoughtful application of electronic health record (EHR)technologies to avoid contributing to PCP alert fatigue and burnout. In this work, investigators aim to evaluate the adoption, penetration, fidelity, sustainability, and performance of a novel, non-interruptive EHR alert for MASLD fibrosis risk assessment in a primary care network by performing a stepped wedge, cluster randomized trial in patients with known or suspected MASLD (Aim 1). This proposal aligns with NIDDK's scientific goal to disseminate, implement, and evaluate evidence-based care strategies in community care settings where the burden of MASLD hides in plain sight.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Month 6 | Experimental | Other: EHR alertAll 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). |
| Month 12 | Experimental | Other: EHR alertAll 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). |
| Month 18 | Experimental | Other: EHR alertAll 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). |
| Month 24 | Experimental | Other: EHR alertAll 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). |
| Month 30 | Experimental | Other: EHR alertAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis code for MASLD
- Type 2 diabetes mellitus will
- 1. All physicians, physician assistants, and nurse practitioners delivering primary care during the intervention phase of the study.
Key exclusion criteria (4 listed)
- 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.
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHR alertDiagnoses 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. | Other | Month 12, Month 18, Month 24, Month 30, Month 6 |
Primary outcome
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)
4 secondary outcomes
Implementation Adoption: Percentage of eligible MASLD patients who receive an order for liver stiffness testing.
Time frame: Up to five years after implementation of the intervention.
Implementation Penetration: Percentage of PCPs who order liver stiffness testing for eligible MASLD patients.
Time frame: 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.
Time frame: 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.
Time frame: Up to five years after implementation of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. Data will be used internally for implementation evaluation and quality improvement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Schreiner, MD, MSCR principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR alert in people with Metabolic Dysfunction-associated Steatotic Liver Disease, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Schreiner, MD, MSCR ((843) 876-0888, schrein@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of advanced fibrosis (time frame: Up to five years after implementation of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.