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

backgroundMetabolic 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.

methodsA 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-randomized trial to examine the effectiveness of the MCCP compared to usual care, and (3) summative evaluation to identify patient and provider characteristics associated with effectiveness of MCCP and plan for future implementation. The primary outcome will be a composite dichotomous variable for making a new MASLD diagnosis and completing severity risk stratification of MASLD. Secondary outcomes include referral and receipt of hepatology specialty care for patients with MASLD and advanced fibrosis. DISCUSSION: Our randomized controlled trial will be the first to systematically implement the MCCP using strategies that are clinically relevant, adaptable and scalable. If successful, the MCCP will improve outcomes for patients with MASLD through early detection, accurate risk stratification, and timely treatment within primary care settings.

trial registrationThis trial has been registered on clinicaltrails.gov (# NCT06671886), registration date: 10-31-2024.