A cluster randomized trial of a Multicomponent Clinical Care Pathway (MCCP) to improve MASLD diagnosis and management in primary care: study protocol

作者：Kyler M. Godwin, Larissa Grigoryan, Aaron P. Thrift, Hao T. Duong, Fasiha Kanwal, Traber Davis Giardina, Himabindu Kadiyala, Andrew J. Zimolzak, Kavish R. Patidar, Hashem B. El‐Serag · 发表于：BMC Health Services Research · 年份：2025 · DOI：10.1186/s12913-025-12737-2 · 被引用次数：3 · 研究领域：Liver Disease Diagnosis and Treatment、Liver Disease and Transplantation、Liver Diseases and Immunity

BACKGROUND: Metabolic dysfunction associated steatotic liver disease (MASLD) is the most common chronic liver disorder in the world. Most patients with MASLD are undiagnosed, untreated and unreferred. Treatment depends on diagnosis and accurate staging of fibrosis risk, and therefore screening at the primary care setting coupled with consistent, timely, evidence-based, widely accessible, and testable management processes is critical. Randomized controlled trials of methods for screening, diagnosis, severity stratification, and referral are lacking. We previously validated the MASLD clinical care pathway (MCCP), a multistep algorithmic process geared to support primary care settings in screening, diagnosis, risk stratification, and suggested referral and treatment of patients with MASLD. We will evaluate the effectiveness of the MCCP intervention compared to usual care in improving MASLD care process and patient outcomes. METHODS: A two-arm, parallel, cluster-randomized trial will assess the effect of the MCCP intervention comprised of an e-trigger and structured provider education on screening, diagnosis, referral, and treatment for MASLD. Clusters are Veterans Affairs (VA) patient-centered primary care clinics, called Patient Aligned Care Teams (PACTs). This 4-year study will include three phases: (1) formative assessment to explore barriers to feasibility and acceptability of intervention among providers and patients and adapt MCCP for utilization by VA PACTs, (2) cluster-r...