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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Intervention 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).
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • 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.
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).
  • 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.
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).
  • 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.
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).
  • 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.
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).
  • 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.

Recruiting Locations

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Chloe Bays, MPH
843-876-8688
coopechl@musc.edu

More Details

Status
Recruiting
Sponsor
Medical University of South Carolina

Study Contact

Andrew Schreiner, MD, MSCR
(843) 876-0888
schrein@musc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.