Systems of Support to Increase Colorectal Cancer Screening and Follow-Up Rates (SOS): Design, Challenges, and Baseline Characteristics of Trial ParticipantsContemporary Clinical Trials
AbstractBackground Screening decreases colorectal cancer (CRC) morbidity and mortality, yet remains underutilized. Screening breakdowns arise from lack of uptake and failure to follow-up after a positive screening test. Objectives Systems of support to increase colorectal cancer screening and follow-up (SOS) is a randomized trial designed to increase: (1) CRC screening and (2) follow-up of positive screening tests. The Chronic Care Model and the Preventive Health Model inform study design. Methods The setting is a large nonprofit healthcare organization. In part-1 study, patients age 50-75 due for CRC screening are randomized to one of 4 study conditions. Arm 1 receives usual care. Arm 2 receives automated support (mailed information about screening choices and fecal occult blood tests (FOBT)). Arm 3 receives automated and assisted support (a medical assistant telephone call). Arm 4 receives automated, assisted, and care management support (a registered nurse provides behavioral activation and coordination of care). In part-2, study patients with a positive FOBT or adenomas on flexible sigmoidoscopy are randomized to receive either usual care or nurse care management. Primary outcomes are: 1) the proportion with CRC screening, 2) the proportion with a complete diagnostic evaluation after a positive screening test. Results We sent recruitment letters to 15,414 patients and 4675 were randomized. Randomly assigned treatment groups were similar in age, sex, race, education, self-reported health, and CRC screening history. Conclusions We will determine the effectiveness and cost effectiveness of stepped increases in systems of support to increase CRC screening and follow-up after a positive screening test over 2 years.
Citation InformationBeverly B. Green, C. Y. Wang, Kathryn Horner, Sheryl Catz, et al.. "Systems of Support to Increase Colorectal Cancer Screening and Follow-Up Rates (SOS): Design, Challenges, and Baseline Characteristics of Trial Participants" Contemporary Clinical Trials Vol. 31 Iss. 6 (2010) p. 589 - 603
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