Madrigal Pharmaceuticals, Inc., West Conshohocken, PA 19428, USA.
DEARhealth, Westlake Village, CA 91362, USA.
J Comp Eff Res. 2024 Oct;13(10):e240085. doi: 10.57264/cer-2024-0085. Epub 2024 Sep 20.
A clinical decision support (CDS) tool for metabolic dysfunction-associated steatohepatitis (MASH) was developed to align health systems with clinical guidelines detailed in the MASH Clinical Care Pathway and improve patients' proactive self-management of their disease. The tool includes a provider-facing web-based application and a mobile application (app) for patients. This protocol outlines a pilot study that will systematically evaluate the implementation of the tool in real-world clinical practice settings. This implementation research study will use a simultaneous mixed-methods design and is guided by the Consolidated Framework for Implementation Research. The CDS tool for MASH will be piloted for ≥3 months at multiple US-based sites with eligible gastroenterologists and hepatologists (n = 5-10 per site) and their patients (n = 50-100 per site) with MASH or suspected MASH. Each pilot site may choose one or all focus areas within the tool (i.e., risk stratification, screening and referral, or patient care management), based on on-site capabilities. Prior to and at the end of the pilot period, providers and patients will complete quantitative surveys and partake in semi-structured interviews. Outcomes will include understanding the feasibility of implementing the tool in real-world clinical settings, its effectiveness in increasing patient screenings and risk stratification for MASH, its ability to improve provider and patient knowledge of MASH, barriers to adoption of the tool and the tool's capacity to enhance patient engagement and satisfaction with their care. Findings will inform the scalable implementation of the tool to ensure patients at risk for MASH are identified early, referred to specialty care when necessary and managed appropriately. Successful integration of the patient app can contribute to better health outcomes for patients by facilitating their active participation in the management of their condition.
代谢相关脂肪性肝炎（MASH）临床决策支持（CDS）工具旨在使医疗系统与 MASH 临床护理路径中详细的临床指南保持一致，并提高患者对疾病的积极自我管理能力。该工具包括面向提供者的基于网络的应用程序和面向患者的移动应用程序（app）。本方案概述了一项试点研究，该研究将系统地评估该工具在真实临床实践环境中的实施情况。这项实施研究将采用同时进行的混合方法设计，并以实施研究综合框架为指导。MASH 的 CDS 工具将在多个美国基地点进行为期≥3 个月的试点，纳入符合条件的胃肠病学家和肝病学家（每个基地点 5-10 名）及其患有 MASH 或疑似 MASH 的患者（每个基地点 50-100 名）。每个试点基地点可根据自身能力选择工具内的一个或所有重点领域（即风险分层、筛查和转诊或患者护理管理）。在试点开始前和结束时，提供者和患者将完成定量调查并参与半结构式访谈。结果将包括了解该工具在真实临床环境中实施的可行性、其提高 MASH 患者筛查和风险分层的效果、其提高提供者和患者对 MASH 的认识的能力、工具采用的障碍以及该工具增强患者对其护理的参与度和满意度的能力。研究结果将为该工具的可扩展实施提供信息，以确保及早发现有患 MASH 风险的患者，必要时将其转至专科护理，并对其进行适当管理。患者应用程序的成功整合可以通过促进患者积极参与自身病情的管理，为患者带来更好的健康结果。
