Innovative Tools to Improve Colorectal Cancer Screening Rates in Manitoba

Primary care providers (PCP) will be recruited within the Winnipeg Regional Health Authority (WRHA) community areas of St. James Assiniboia, Assiniboine South, Downtown, River Heights, Fort Garry, St. Vital and St. Boniface. The first step in recruiting PCP within the WRHA will involve a pre-collaboration call to PCP/clinics to make them aware that the study coordinator will be dropping off a a PCP Collaboration Letter that briefly outlines the proposed research study and requests the participation of PCP. The letter will inquire as to whether the PCP/clinic would be interested in collaborating on the study as well as the best date, time and method of contacting the office. Based on this information, the study coordinator will contact each clinic in the preferred manner to set a date and time to determine their interest in study collaboration and, if so, to set a date and time for a site visit to discuss the study protocol and PCP/clinic involvement and responsibilities.

Once a PCP/clinic has agreed to collaborate on the study, a PCP/Clinic Characterization Form will be completed by the study coordinator. The purpose of this form is to document the routine standard of care provided by each PCP in regards to CRC screening practices with the FOBT and to ensure minimal obtrusiveness of the study protocol in the daily functioning of the PCP/clinic. It is believed that, in Winnipeg, two standard methods of having patients complete an FOBT exist; laboratory requisition filled out by the PCP or direct distribution of the FOBT kit by the PCP to the patient. By filling out the PCP/Clinic Characterization Form, the preferred method of FOBT screening by each PCP/clinic will be documented. This factor will be taken into account as a covariate in the statistical analysis of the data. All PCP within a medical clinic will be randomly allocated to one of two study groups (control or intervention). In the case of medical clinics where there are sub-groupings of PCP/staff that function as a single/separate unit/entity, each sub-group of PCPs will be randomized separately. The objective of customizing this portion of the study protocol to each PCP/clinic is to optimize collaboration with PCPs as well as simulate "real world" PCP practices resulting in evidence-based findings that are able to be integrated into practice.

Collaborating PCP/clinics will be randomly allocated into providing their average risk male and female patients (50-74 years) with either the control or the intervention protocol for FOBT screening for CRC. As there is one type of control group and one study intervention (provision of a magnet with contact information for a Provincial Health Contact Center (PHCC) and Colorectal Cancer Information and FOBT Screening Website) there are a total of two study groups: (1) FOBT recommendation based on usual PCP practice, and (2) FOBT recommendation based on usual PCP practice + magnet. Once a PCP/Clinic is randomized into a group, all their patients will participate in that study group.

Upon arrival for their periodic health examination (PHE) appointment, eligible patients in all study groups will be asked by a front desk clinic support staff employee to complete an In-Clinic Patient Survey/Consent Form related to their exposure to Provincial CRC Screening initiatives (CancerCare Manitoba; ColonCheck) and whether they have completed an FOBT in conjunction with the CancerCare Manitoba Screening Program in the last two years.

During their PHE, the PCP will determine patient eligibility according to the criteria outlined by the study coordinator during the site visit. PCPs in the control group will provide patients with a laboratory requisition indicating an FOBT or directly provide the FOBT kit to patients. Those patients who have a lab requisition indicating FOBT will receive the FOBT kit from the laboratory. PCP in the control and intervention groups will be provided with Patient Tracking Forms (one per patient) on which the PCP will indicate the patient name and date of FOBT requisition/distribution. Each Patient Tracking Form will have a removable sticker with a unique patient study identification number. The PCP will remove the sticker from the Patient Tracking Form and place it on the patient's In-Clinic Survey which will allow researchers to link the data. Study identification numbers that will facilitate patient tracking as well as allow the study coordinator to determine for each PCP/clinic, the number of patients requested by the PCP/clinic to complete an FOBT. It will also facilitate tracking patients that complete their FOBT. The study coordinator will follow-up with PCP/clinic support staff to determine the patients completing their FOBT. Patients are given four months in which to complete their FOBT. After this time, if the FOBT is not completed, they will be assigned an incomplete according to the intention to treat model. In this way, personal health identification is protected. The study coordinator will contact the PCP/clinics regularly for Patient Tracking Form updates and to foster collaborative relationships between researchers and PCP.