Abstract
BackgroundColorectal cancer (CRC) is common and leads to significant morbidity and mortality. Although screening with fecal occult blood testing (FOBT) or endoscopy has been shown to decrease CRC mortality, screening rates remain suboptimal. Screening rates are particularly low for people with low incomes and members of underrepresented minority groups. FOBT should be done annually to detect CRC early and to reduce CRC mortality, but this often does not occur. This paper describes the design of a multifaceted intervention to increase long-term adherence to FOBT among poor, predominantly Latino patients, and the design of a randomized controlled trial (RCT) to test the efficacy of this intervention compared to usual care.MethodsIn this RCT, patients who are due for repeat FOBT are identified in the electronic health record (EHR) and randomized to receive either usual care or a multifaceted intervention. The usual care group includes multiple point-of-care interventions (e.g., standing orders, EHR reminders), performance measurement, and financial incentives to improve CRC screening rates. The intervention augments usual care through mailed CRC screening test kits, low literacy patient education materials, automated phone and text message reminders, in-person follow up calls from a CRC Screening Coordinator, and communication of results to patients along with a reminder card highlighting when the patient is next due for screening. The primary outcome is completion of FOBT within 6 months of becoming due.DiscussionThe main goal of the study is to determine the comparative effectiveness of the intervention compared to usual care. Additionally, we want to assess whether or not it is possible to achieve high rates of adherence to CRC screening with annual FOBT, which is necessary for reducing CRC mortality. The intervention relies on technology that is increasingly widespread and declining in cost, including EHR systems, automated phone and text messaging, and FOBTs for CRC screening. We took this approach to ensure generalizability and allow us to rapidly disseminate the intervention through networks of community health centers (CHCs) if the RCT shows the intervention to be superior to usual care.Trial registrationClinicalTrials.gov NCT01453894
Highlights
Colorectal cancer (CRC) is common and leads to significant morbidity and mortality
This paper describes the design of a comparative effectiveness study of an intervention to maximize the number of poor, predominantly Latino patients cared for at a Community health centers (CHCs) who complete a repeat fecal occult blood testing (FOBT) within six months of becoming due for CRC screening
We review critical aspects of the study design and intervention, including a) the use of an IRB-approved waiver of informed consent to randomize all eligible patients and achieve a fully representative study population, b) the conceptual framework for the multifaceted intervention, c) the outreach tools developed for each component of the intervention, d) separation of the intervention into two discrete phases to allow assessment of the marginal benefit of outreach by a CRC Screening Coordinator compared to lower-cost outreach strategies, e) the patient educational tools developed to provide feedback to patients with negative FOBTs and to improve successful completion of diagnostic colonoscopy among patients with positive FOBTs, and f ) the outcome assessment
Summary
Screening with fecal occult blood testing (FOBT) or endoscopy has been shown to decrease CRC mortality, screening rates remain suboptimal. The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC) screening using fecal occult blood test (FOBT), sigmoidoscopy, or colonoscopy in adults, beginning at age 50 and continuing until age 75 [1]. Community health centers (CHCs) frequently use FOBT as their only form of CRC screening due to limited access and high cost of endoscopy. Performing the test less often may result in many aggressive cancers being missed until an advanced stage, markedly reducing the health benefits of population screening. If FOBT cannot be conducted annually or biennially with high reliability, it may be necessary to expand the use of alternative screening modalities, such as endoscopy (i.e., sigmoidoscopy or colonoscopy), to reduce CRC mortality. There is currently inadequate financing and an inadequate number of endoscopists available for CHCs to use endoscopy as a primary screening modality
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