A Canadian community pilot comparing primary care physician recruitment to public health unit program recruitment for colorectal screening by fecal occult blood testing in Ontario

T Sullivan PhD^a, L Paszat MD^a,b, MD Mai^a, L Rabanek MD^a,b,c, P Ritvo PhD^a, A Hudson MD^a

^aCancer Care Ontario, ^bInstitute for Clinical Evaluative Sciences, , ^cDivision of Gastroenterology, University of Toronto, Toronto

AIMS: Building on the promising results of several large RCTs on FOBT, this implementation study will compare the rate of participation of eligible individuals in FOBT screening between a supported usual care arm and a public health strategy arm. This project will run through 2004. The specific objectives are: 1) to compare participation rates, as measured by the submission of a completed FOBT kit to the laboratory, between two different recruitment approaches. 2) to describe variation in these rates among the diverse geographic, sociodemographic, and linguistic communities of Ontario, including the North and among non-English speakers. 3)to describe attitudes about screening with FOBT compared to other approaches among primary care physicians, public health units, and persons eligible for screening METHODS: Six Primary care sites and six public health sites have been selected through a simple randomization process based on counties in Ontario. Designed to simulate optimal practice situations, each arm will have an eligible screening population of 220,000. One population will consist of eligible patients of approximately 450 participating primary care physicians who will see them during routine office visits. The other population will consist of eligible Ontarians residing within six public health units. We assume that 34% (74,800 in each arm) of eligibles will receive standard educational information plus a study FOBT requisition and consent form during the one-year period. We assume that 23% (50,600 in each arm) of eligibles will pick up a FOBT kit. We assume that 17% (37,500 in each arm) of eligibles will return completed FOBT kits to the laboratory (recruitment rate). We assume that 2% of the 75,000 tests (both arms) will be positive (1500), and that, among those, the baseline compliance with follow-up medical investigations is 50%. The study will have 90% power (two-sided alpha = 0.01) to detect a 20% difference in the rate of compliance with follow-up medical investigations following a positive FOBT between the two strategies. We will have 90% power (two-sided alpha = 0.01) to detect a 6% difference in the recruitment rate. RESULTS: For each arm of the project we will compare screening participation rates; compliance with follow-up procedures in those individuals with positive FOBT results; relative frequency of use of each of the diagnostic medical procedures that are utilized in the follow-up of a positive FOBT result; time period to complete a diagnostic procedure from the time of the positive FOBT result; perceptions and experiences of participating physicians with regard to FOBT, other screening modalities and access to diagnostic procedures; perceptions and attitudes of individuals about FOBT before and after they have completed the test. CONCLUSIONS: Early experience in the recruitment efforts will be presented. The results of this pilot will inform provincial level planning for a full provincial program model for a jurisdiction of 11 million inhabitants.

Paper presented at the International Symposium on Predictive Oncology and Intervention Strategies; Nice, France; February 7 - 10, 2004; in oral session 992 (Screening & detection - Part I).