A clinical decision support tool for metabolic dysfunction-associated steatohepatitis in real-world clinical settings: a mixed-method implementation research study protocol
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: 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. Materials & methods: 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. Conclusion: 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.
Shareable abstract
Madrigal Pharmaceuticals, Inc., and DEARhealth, Inc., have developed a digital clinical decision support tool for NASH/MASH. The group has provided details about a pilot implementation study to assess the effectiveness and feasibility of the tool in real-world practice settings.
Plain language summary
Nonalcoholic steatohepatitis, also known as metabolic dysfunction-associated steatohepatitis, or MASH, is a disease where the liver becomes inflamed and damaged. If MASH is not caught early and managed properly, the liver can stop working normally and/or develop liver cancer. There are guidelines for diagnosing and treating MASH, but doctors do not always use them and the disease may not be caught in time. Many patients do not know about this disease or what they can do to manage it. We have developed an online tool for doctors and a mobile app for patients to learn about and manage MASH. The tool will be tested at hospitals, in clinics, and with patients to see how well it works to screen for and manage the disease. Participating doctors and patients will complete surveys so we can understand their experiences with the tool. If the tool works, it could be used by many different doctors to help them identify MASH and give patients better care. The mobile app could help patients feel empowered to make decisions about their disease.
Supplementary Material
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© 2024 Madrigal Pharmaceuticals. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
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Received: 17 May 2024
Accepted: 13 August 2024
Published online: 20 September 2024
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A clinical decision support tool for metabolic dysfunction-associated steatohepatitis in real-world clinical settings: a mixed-method implementation research study protocol. (2024) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2024-0085
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