Contemporary clinical trials · 2026
Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center Clinics: A stepped-wedge, multilevel intervention trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Montoya Samantha M, Olaore Pelumi, Bastardo-Acosta Janna, Abdulla Rania, Schell Michael J, Hidalgo Allan, Turner Barbara, Rider Monica, Kishun-Jit Nirmala, Pollard Jennifer, Friedman Mark, Byrne Margaret M, Christy Shannon M, Meade Cathy D, Gwede Clement K
Аннотация
BACKGROUND: 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.
METHODS: 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.
DISCUSSION: Findings will inform multilevel strategies to enhance cancer screening in health systems, inform scale-up, and benefit patients and communities.
CLINICAL TRIALS REGISTRATION: NCT04464668 (Date Registered: 2020-07-09).
METHODS: 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.
DISCUSSION: Findings will inform multilevel strategies to enhance cancer screening in health systems, inform scale-up, and benefit patients and communities.
CLINICAL TRIALS REGISTRATION: NCT04464668 (Date Registered: 2020-07-09).