PB-iCRC: Multi-site Practice-Based Implementation of a ColoRectal Cancer screening intervention

Project Summary/Abstract Although “implementation intentions”-based tools have been found to enhance colorectal cancer (CRC) screening uptake, prior studies have not tested to scale their implementation into routine primary care delivery settings serving hard-to-reach populations such as those with limited English proficiency. Our research group,

led by Prof. KA Greiner, has developed and tested an “I2” CRC decision-making tool via multiple NCI-funded

studies. It addresses the “when,” “where” and “how” details of screening via stool sample tests or colonoscopy. In this study, we will conduct a parallel cluster-randomized trial in 20 clinics participating in the American Academy of Family Physicians National Research Network, serving communities in which at least 25% of the

patient population's preferred language is Spanish. Specific aims for the project will be: (Aim 1) To compare CRC screening outcomes at 6 months between two implementation approaches for our “I2 tool” : (1) implementation through a Normalization Process Theory-guided Participatory Learning in Action (NPT-PLA

arm) process versus (2) implementation with a usual quality improvement process (control arm) in primary care practices using a parallel cluster randomized trial; and (Aim 2) to evaluate the facilitators and barriers of the implementation approach in each study arm using the Normalization Process Theory (NPT) framework.

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 the I2 tool into routine primary care delivery, using the NPT-PLA intervention or control approach. 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 enroll all patients in each clinic eligible for CRC screening (a minimum of 100 per clinic). 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 initial exposure to the I2 tool. A secondary aim will be to determine whether completion of the I2 screening tool varies between study arms. For Aim 2, in all clinics at baseline and after 6 months of clinic participation we will administer a survey based on the NPT

constructs (the “NOMAD”) to assess implementation team members' comprehension of their role in the project, the salience of our intervention approach, their buy-in, the feasibility of altering workflows, and the potential sustainability of the intervention in their clinical setting. We will also conduct summative qualitative focus group

discussions in all clinics with the implementation team after 6 months of clinic participation, and at 12 months with team leaders to assess maintenance. Key personnel include the Multiple-PIs (KA Greiner, J LeMaster, C Hester), KUMC Biostatistician B Gajewski and an international NPT expert, A MacFarlane. The study will

provide important information on barriers and facilitators of embedding NPT-PLA interventions in “real-world” primary care clinical settings to promote cancer screening successfully.