Innovative Tools to Improve Colorectal Cancer Screening Rates in Manitoba
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The primary purpose of the study is to investigate the efficacy and effectiveness of a
      community-based nurse managed telephone support line (Provincial Health Contact Center; PHCC)
      and Colorectal Cancer Information and Screening Website in supporting Primary Care Providers
      (PCP) from Winnipeg, Manitoba (Canada) in their efforts to improve colorectal cancer (CRC)
      screening Fecal Occult Blood Test (FOBT) compliance in average risk men and women 50-74 years
      of age. Secondary outcomes of the study involve documenting and investigating common patient
      questions and comments about CRC and the FOBT during their PHCC communication(s)/Website
      visits as well as procuring feedback from PCP and patients related to their experiences with
      the study protocol (PCP), FOBT (patients) and PHCC/website (patients).
    

Detailed description: 
      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.
    

Intervention name(s): Refrigerator Magnet
Intervention type(s): Behavioral
Intervention description(s): The refrigerator magnet contains a telephone number for a Provincial Health Contact Centre and a URL for a colorectal cancer Website that patients can access to learn more about colorectal cancer, screening and the fecal occult blood test. Patients can also have their questions answered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: colorectal cancer; screening; fecal occult blood test; randomized control trial; primary care oncology; web site; provincial health contact center