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

Colorectal cancer (CRC) is the third leading cause of cancer-related deaths in the United States. Despite national goals to increase CRC screening, rates in Federally Qualified Health Centers (FQHCs) are suboptimal at about 40%. This paper describes the design and implementation plan for the Colorectal Cancer Awareness, Research, Education and Screening-Rural Expansion, Access, and Capacity for Health (CARES-REACH) study that accelerates the adoption of evidence-based screening practices. Informed by a community-based participatory research framework and implementation science approaches, CARES-REACH features a stepped wedge design with extension for maintenance to support an implementation strategy focused on organizational, provider, and patient levels to boost initial and repeat screening among average-risk, age-eligible adults. This study implements a core set of evidence-based interventions (EBIs), including low-literacy patient education, provider education, system-wide electronic medical record tools (provider prompts and patient reminders), fecal immunochemical test kit distribution, plus an organization-wide cancer control champion who motivates providers, coaches patients, and monitors system-wide screening activities. Study aims to: 1) Implement an organization-wide multilevel CRC intervention using EBIs plus a cancer control champion in FQHCs in rural and urban Florida; 2) explore whether practice setting and population characteristics may differentially impact annual CRC Uniform Data System (UDS) rates; and 3) conduct a comprehensive evaluation of the implementation and resource requirements for FQHCs. Our hypothesis is that the UDS rates will increase by ten percentage points per year. Findings will inform multilevel strategies to enhance cancer screening in health systems, inform scale-up, and benefit patients and communities. NCT04464668 (Date Registered: 2020-07-09). • Implementation study to improve colorectal cancer screening in FQHCs. • Stepped wedge design to evaluate real-world implementation science outcomes. • Cancer Control Champion facilitates a multilevel, evidence-based intervention.