Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center clinics: A stepped-wedge, multilevel intervention trial.

Background Colorectal cancer is the third leading cause of cancer-related deaths in the United States. Despite the Healthy People 2030 goal of 70.5%, colorectal cancer (CRC) screening rates in Federally Qualified Health Centers (FQHCs) are suboptimal at about 40%. The Colorectal Cancer Awareness, Research, Education and Screening-Rural Expansion, Access, and Capacity for Health ( CARES-REACH ) study seeks to address this disparity and accelerate the adoption and utilization of effective, evidence-based CRC screening practices. This paper describes the CARES-REACH study design and implementation methods. Methods Informed by a community-based participatory research (CBPR) framework and enriched by implementation science approaches, CARES-REACH features a stepped wedge design with extension for maintenance to support an implementation strategy focused on multiple levels: organizational, provider, and patient levels that entail processes to boost initial and repeat screening among average risk and age-eligible adults. This multilevel study entails the implementation of a core set of evidence-based interventions (EBIs) that include low literacy patient education (English, Spanish, and Haitian Creole language); provider education, system-wide electronic medical record (EMR) tools including provider prompts and patient reminders, FIT (fecal immunochemical test) kit distribution, plus an organization-wide cancer control champion who motivates providers, coaches and navigates patients, and monitors system-wide CRC screening activities. Trial Registration NCT04464668.