PB-iCRC: Multi-site Practice-Based Implementation of a ColoRectal Cancer Screening Intervention

The study is a Type 3 Hybrid cluster-randomized trial to be conducted in 20 practices that are members of the DARTNet Institute/American Academy of Family Physicians National Research Network. Investigators will use this approach because the implementation Intervention they are testing is delivered at the clinic level; and because they have already tested the I2- tool that they are implementing and found it is effective. Clinics will be randomly assigned to 1 of the 2 study arms (NPT-PLA or usual QI 'control'), so that neither clinic staff nor DARTNet/AAFP NRNstudy staff know in advance the arm to which a clinic will be assigned. Clinics will each participate for one year. Clinics will enter the study over the first 3 years of the study in a rolling fashion, starting in the 4th quarter of year 1 (2 clinics randomized 1:1 every 3 months thereafter until all have been enrolled), with a maximum of 8 clinics simultaneously participating at any one time.

Individual patients needing CRC screening will be enrolled in the first 6 months ("active intervention" period) of a clinic's participation and followed for 6 months after they are provided access to the I2 screening tool (between inception and 6 months during the period of clinic participation), to monitor if they used the tool, and if CRC screening was ordered and completed.

During the active intervention period (first 6 months of participation), all clinics in both arms will form clinic-based 'implementation teams' that will meet monthly to plan how they will implement the I2 tool. On entry to the study, each clinic will work with DARTNet staff in both arms of the study to produce a workflow map that describes how they currently conduct CRC screening. Control clinics will be provided a prespecified workflow (the "pilot protocol") that follows the approach that the investigators developed in our 2019-22 pilot study; and asked to integrate the I2 tool into their existing clinic workflow. NPT-PLA clinics will also be given the pilot protocol, but they will also use a survey-based assessments of their clinic's capacity to implement the I2 tool using the NPT based NOMAD tool. Control clinics will also complete this, but will not use the results to guide 'usual QI' processes in their clinic. Thereafter, intervention teams will meet monthly to adapt the pilot protocol using NPT-PLA methods and use their adapted approach to implement the I2 tool in their clinical context. Finally, the investigators will use NPT (2022) informed qualitative interviews at the end of the active intervention in all participating clinics to conduct a summative evaluation of the implementation process.

Study arms and interventions are further described in that section of this Record

Twenty clinics will be randomly assigned 1:1 to treatment group (NPT-PLA -10 clinics) or 'usual QI' (10 clinics) at the time of the clinic's study entry (which will take place during the first 4 years of the study), based on random numbers generated by study biostatisticians and delivered to DARNet/AAFP NRN study staff responsible for recruitment and enrollment. We will use stratified randomization,with 3 strata: a) federally qualified health clinics or other free clinics, b) academic medical centers or other large health systems and c) other physician owned practices. Study biostatisticians who analyze the study data will not be told which clinics are in which treatment group. Each clinic will participate for a total of 12 months. Clinics will be recruited via email and a one-page description of the project.