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临床试验/NCT07159386
NCT07159386招募中不适用

Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2026年3月16日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
225
试验地点
1
主要终点
Detection of advanced fibrosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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:

结局指标

主要结局

Detection of advanced fibrosis

时间窗: 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)

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Schreiner

Associate Professor-Faculty

Medical University of South Carolina

研究点 (1)

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