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Набор по приглашению NCT06944353

Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED

Без фазы С лечением Non-Alcoholic Fatty Liver Disease Steatosis of Liver Metabolic Dysfunction-Associated Steatotic Liver Disease

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: STIRRED.
Кому может быть актуально
Состояния в реестре: Non-Alcoholic Fatty Liver Disease, Steatosis of Liver, 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
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Официальное название

Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED (STIRRED)

Обзор

Hepatic steatosis is a common radiographic "incidental finding" that is overlooked and underreported to patients. The investigators developed a clinical decision support system using machine learning and natural language processing that will prompt reporting to patients and provide ED clinicians risk stratified follow-up care recommendations. Data on both the implementation and effectiveness of our intervention resulting from this trial will inform future use with a goal of ultimately improving diagnostic safety and outcomes for patients with hepatic steatosis.

Подробное описание

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a public health crisis affecting one third of the US adult population. Steatotic liver disease is an obesity related disease with serious health and quality of life consequences. Hepatic steatosis is reported on \~10% of written radiology reports. Unfortunately, lack of awareness often leads to hepatic steatosis being overlooked by providers and unreported to patients leading to delays in diagnosis and referral to specialty care.

This project, Improving Diagnostic Safety through STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED), proposes to improve diagnostic safety by ensuring that patients receive timely notification of the new finding and referral to follow up care. The STIRRED CDSS intervention employs natural language processing and machine learning to identify hepatic steatosis in written emergency department (ED) radiology reports and combine it with common clinical data in the electronic health record to create an individualized risk profile and follow up recommendations for patients with suspected MASLD. This recommendation is communicated to the ED clinician during the ED discharge process via an OurPractice Advisory (OPA) and triggering outpatient referral for follow-up care stratified by risk level.

This trial will evaluate STIRRED across a large health system using a type 2 implementation-effectiveness stepped wedge cluster randomized trial across 11 Emergency Departments in a single health system. Effectiveness of providing risk-based care linkage and implementation outcomes will be evaluated.

Вмешательства

  • Поведенческое STIRRED
    The STIRRED intervention is a behavioral intervention directed at the treating ED clinicians. An Our Practice Advisory (OPA) will alert the clinician to the radiology finding of hepatic steatosis at the time of preparing the discharge materials. The OPA will prompt the clinician to discuss this finding with the patient and will automatically add hepatic steatosis to the discharge diagnoses and insert patient-facing discharge information about hepatic steatosis. It will additionally prompt the c

Первичные конечные точки

  • Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients [Срок оценки: 120 days post-ED discharge]
  • Implementation: Intervention fidelity [Срок оценки: Baseline at time of intervention delivery]

Критерии участия

Критерии включения

  • imaging finding of hepatic steatosis on ED imaging study
  • discharged from the ED to home
  • first Northwestern Medicine ED visit in the study period with a hepatic steatosis finding

Критерии исключения

  • admitted to the hospital
  • age < 18
  • pre-existing Liver Disease diagnosis (Liver Cancer, HCV, HBV, Cirrhosis, NAFLD/MASLD/NASH/MASH, Alcohol Liver Disease, PSC, PBC and autoimmune hepatitis)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Northwestern Memorial Hospital — Chicago

Публикации

  • McCarthy DM, VanWagner LB, Rafferty MR, Cameron KA, Lee J, Dong S, Fellner A, Kontrick AV. Improving diagnostic safety through STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED): Protocol for an effectiveness implementation trial. Contemp Clin Trials. 2026 Feb;161:108187. doi: 10.1016/j.cct.2025.108187. Epub 2025 Dec 15. PMID 41407098

Идентификаторы

NCT: NCT06944353 · R01HS029777 · R01HS029777

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗