DOI: 10.3886/e212582v1
title: PB-ICRC

description: Although implementation intentions (I2)-based tools have been found to enhance colorectal cancer (CRC) screening uptake effectively, prior studies have not tested to scale their implementation into routine primary care delivery settings or hard-to-reach populations such as those with limited English proficiency. In this study, we will conduct a cluster -randomized trial in 20 clinics participating in the DARTNet Institute/American Academy of Family Physicians National Research Network. Specific aims for the project will be: 1) to test whether a Normalization Process Theory-informed Participatory Learning in Action (NPT-PLA intervention) implementation of a proven Implementation Intentions-based colorectal cancer screening tool (“I2”) versus usual quality improvement (control) implementation in primary care practices using a cluster randomized trail improves screening uptake (i.e. screening order and completion) or I2 tool completion within 6 months of patient enrollment; and 2) to evaluate the facilitators and barriers of each implementation arm using the 2022 expanded Normalization Process Theory (NPT) framework. A secondary aim will be to determine whether CRC screening outcomes vary between patients with versus without limited English proficiency. Multi-disciplinary clinic ‘implementation teams’ that include clinic staff and patients whose preferred language is Spanish will meet monthly during the first 6 months of clinic participation and aim to integrate I2 into routine primary care. The “I2” CRC screening tool has been tested in multiple NCI-funded studies by KUMC Prof. KA Greiner. The I2 tool addresses the “when,” “where” and “how” details of stool sample or colonoscopy screening. Primary (Aim 1) outcomes will be CRC screening orders placed (by clinic staff) and completion of CRC screening (by patients) over 6 months of patient follow-up after exposure to the I2 tool. I2 tool completion will be a secondary outcome. For Aim 2, outcomes will include responses to a survey of clinic staff based on the NPT domains (the “NOMAD”) to assess staff comprehension of their role in implementing the I2-based CRC screening tool, its salience, their buy-in, feasibility of altering workflows, and the potential for sustainability of using the tool in their clinical setting. We will also conduct summative qualitative focus group discussions in all participating clinics after 6 months of clinic participation. Key personnel include the Multiple PIs (KA Greiner, J LeMaster from KUMC and the DARTNet Institute’s Research Director Christina Hester PhD (a former KUMC graduate), KUMC Biostatistician B Gajewski and an international NPT expert, A MacFarlane, from the University of Limerick, Ireland. The I2 tool will be delivered via an on-line RedCap® survey or (if patients prefer) by paper form; and has been customized for use in English and Spanish. We will aim to enroll at least 100 patients in each clinic in the first 6 months of clinic participation (2000 in total study-wide). All patients enrolled and eligible for CRC screening will be offered the I2 tool to guide decision-making about CRC screening. Their choices will be communicated to clinics for order entry. The study will provide important information on barriers and facilitators of embedding NPT-PLA interventions in “real-world” primary care clinical settings, where competing clinician responsibilities, including language interpretation and cultural sensitivity must be navigated to promote CRC or other cancer screening successfully.