Trial Information

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.

PCP/clinics allocated to the intervention groups will be utilize the same Patient Tracking
Forms as described above. Each of the Patient Tracking Form sheets will have a sequentially
numbered study magnet attached that the PCP will provide to their patient. The refrigerator
magnet contains a study specific PHCC telephone number and Website address as well as a
brief message about the importance of the FOBT in early detection of CRC.

The sheets of sequential study identification numbers and the Patient Tracking Forms will
facilitate determining the number of patients for which an FOBT was requested and the number
of patients provided with a magnet. Patients provided with a magnet will use the number
assigned to their magnet to identify themselves with the PHCC nurse at the beginning of
every call they make as well as to login to the website. This will allow us to determine
how many patients provided with the magnet call the PHCC/use the website as well as the
number of times they call/login and their most common questions. The number on the magnet
will allow us to determine of those who call/login to the PHCC, the number that complete the
FOBT.

A four month follow-up patient survey will be conducted by the PHCC to evaluate patient
experience with the PHCC and/or CRC Information and Screening Website as well as possible
barriers to FOBT compliance. We will also conduct a survey of PCPs involved in the study to
determine their experience with the study protocol and how to better facilitate PCP
collaboration in research.

The study has been designed to be two-tailed with an alpha error of 0.05%, a beta error of
10% and a power index of 90%. Current FOBT screening rates in Manitoba are approximately
41.9% (Statistics Canada, 2009). It is believed that an intervention leading to an increase
in FOBT screening rates of 15% would be clinically significant as it has been predicted that
if approximately 70 % of Canadians aged 50 to 74 had a biennial FOBT, followed up by
colonoscopy for positive FOBTs, the CRC mortality rate could be reduced by an estimated 17%
(Statistics Canada, 2009). A logistic regression of a binary response variable (Y) on a
binary independent variable (X) with a sample size of 716 observations [of which 80% are in
the group that does not utilize the supplied intervention/magnet PHCC or Website (X=0) and
20% are in the group that does utilize the intervention/magnet PHCC or Website (X=1)]
achieves 90% power at a 0.05 significance level to detect a change in Prob(Y=1) from the
baseline value of 0.400 to 0.550. This change corresponds to an odds ratio of 1.833.

A biostatistician will be involved in the statistical analysis of results. Analysis of
results will be based on the Intention to Treat Model. Therefore, patients not returning
their FOBT test within a period of four months will be scored as failing to complete the
FOBT test. Categorical variables will be compared using the Chi-square test or Fisher's
exact test. The time taken to return FOBT cards will be estimated using Kaplan-Meier
analysis. Statistical analysis will be performed using SAS or SPSS Software.

All forms provided to the PCP/Clinics will be collected by the study coordinator at the end
of the study.