Advanced Fibrosis Detection for MASLD in Primary Care
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: EHR alert.
- Кому может быть актуально
- Состояния в реестре: Metabolic Dysfunction-associated Steatotic Liver Disease. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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 elastogra
Первичные конечные точки
- Detection of advanced fibrosis [Срок оценки: Up to five years after implementation of the intervention.]
Вторичные конечные точки (4)
- Implementation Adoption: Percentage of eligible MASLD patients who receive an order for liver stiffness testing. [Срок оценки: Up to five years after implementation of the intervention.]
- Implementation Penetration: Percentage of PCPs who order liver stiffness testing for eligible MASLD patients. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Up to five years after implementation of the intervention.]
Критерии участия
Patients
Критерии включения
- Patients with a diagnosis code for MASLD
- Type 2 diabetes mellitus will
Критерии исключения
- 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.
Критерии включения
1\. All physicians, physician assistants, and nurse practitioners delivering primary care during the intervention phase of the study.
Критерии исключения
None
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Одна группа
- Маскирование
- Простое слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- Medical University of South Carolina — Charleston
Идентификаторы
NCT: NCT07159386 · Pro00145783