A Study of Electronic Clinical Decision Support Tools for Steatotic Liver Disease

Официальное название

Randomized Controlled Trial of Electronic Clinical Decision Support Systems for Improving Care Management and Clinical Outcomes for Adults With Steatotic Liver Disease

Обзор

The overall objectives of this study are to determine the effectiveness of a participant-specific guided electronic decision support system on provider decision making for participants with metabolic-dysfunction associated steatotic liver disease (MASLD), and to determine the acceptance and barriers for use of an electronic health record embedded algorithm for MASLD care management within ambulatory primary care, endocrinology, and general gastroenterology settings.

Подробное описание

A pragmatic, randomized trial within selected clinical practices for primary care, endocrinology, and non-hepatology gastroenterology sites within Vanderbilt University Medical Center will be conducted over a period of 3 years with 12 months of follow up for each participant. Participants will be randomized 1:1 to intervention or usual care. In the intervention arm, the decision support aid (eMPOWER) will be used to alert consenting providers to participant-specific recommendations for steatotic liver disease care based on clinical features and risk factor profiles. The primary endpoint will be linkage to care determined by orders for referral to hepatology for advanced liver disease. Secondary outcomes will include completion of noninvasive fibrosis assessment tests for indeterminate risk participants by FIB-4 (1.3-2.67 for participants under 65, 2.0-2.67 for participants 65 and older), completion rates of hepatology referrals, and time analyses to complete either referrals or elastography studies. Post-study surveys and interviews to participating clinicians will be applied.

Вмешательства

• Другое eMPOWER Decision Aid
  An electronic health record embedded decision aid utilizing clinical data from both structured and unstructured clinical data to guide risk stratification and care management for patients with steatotic liver disease. Providers will be alerted to patient specific recommendations during the clinical encounter and between encounters through asynchronous communications related to subsequent testing.

Первичные конечные точки

• The primary objective of this pragmatic trial is to assess the efficacy of the electronic decision support aid for increasing linkage to hepatology care for high-risk participants with MASLD [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (5)

• The secondary objective is to assess the efficacy of the electronic decision support aid for increasing elastography testing ordered by primary care and specialty care providers for indeterminate-risk participants with MASLD [Срок оценки: Baseline to 12 months]
• Rate of Completion of Hepatology Referral [Срок оценки: Baseline to 12 months]
• Time to Completion of Hepatology Referral [Срок оценки: Baseline to 12 months]
• Rate of Completion of Noninvasive Elastography Studies [Срок оценки: Baseline to 12 months]
• Time to Completion of Noninvasive Elastography Studies [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

• Adult patients (age ≥ 18 years)
• Outpatient clinic visit (in-person or telemedicine) at a participating clinic site
• Demonstrated Screening Need due to High Risk Profile, which includes the following: Diagnostic Codes for MASLD or Hepatic Steatosis on Imaging PLUS at least one cardiometabolic risk factors; OR Chronically Elevated Liver Enzymes (> 6 months); OR patient with impaired glycemic control (prediabetes/diabetes); OR 2 or more cardiometabolic risk factors present

Критерии исключения

• Solid Organ Transplant Recipient
• Existing Hepatology Relationship Evidenced by Prior Hepatology Visit Within 3 Years
• Active Cancer Diagnoses
• Diagnoses for Alcohol-Related Conditions
• Pregnant Individuals
• Receiving Palliative Care Services

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

Диагностика

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Публикации

• Spann A, Bishop KM, Weitkamp AO, Stenner SP, Nelson SD, Izzy M. Clinical decision support automates care gap detection among primary care patients with nonalcoholic fatty liver disease. Hepatol Commun. 2023 Feb 9;7(3):e0035. doi: 10.1097/HC9.0000000000000035. eCollection 2023 Mar 1. PMID 36757410
• Spann A, Bishop K, Marbach S, Ji X, Slaughter J, Weitkamp A, Stenner S, Nelson S, Lopez C, Theobald C, Izzy M. Electronic decision aids enhance management of primary care patients with steatotic liver disease: Proof of concept pilot study. Hepatol Commun. 2025 Sep 5;9(9):e0794. doi: 10.1097/HC9.0000000000000794. eCollection 2025 Sep 1. PMID 40906885

Идентификаторы

NCT: NCT07382349 · 241192

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗