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 . However, rates of CRC screening remain inadequate [2, 3]. In 2006, only 60.8% of adults 50 or older reported recent CRC screening . Screening rates are even lower among Black and Hispanic populations [4–10] and in areas with higher poverty rates .
Community health centers (CHCs) frequently use FOBT as their only form of CRC screening due to limited access and high cost of endoscopy. However, FOBT should be done every 1–2 years to optimize detection of polyps and early cancer. 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. Individuals in vulnerable groups often face multiple barriers to annual FOBT screening, including lack of regular source of care, less frequent routine medical visits, frequent changes in residence, and lack of awareness of the need for annual FOBT 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. However, there is currently inadequate financing and an inadequate number of endoscopists available for CHCs to use endoscopy as a primary screening modality.
Few studies have examined the rate of repeat CRC screening with FOBT [11, 12]. To our knowledge, none have been conducted in populations with high prevalence of barriers to screening (e.g., low literacy, varied cultural norms, transportation difficulties). The assumption that FOBT is an effective CRC screening strategy presumes it will be done at least biennially, and cost-effectiveness studies of CRC screening strategies have found that the results are sensitive to the rate of adherence . Therefore, studies are needed to develop and test strategies to increase adherence to FOBT over multiple years. It is important to evaluate a) whether these strategies improve adherence compared to high-quality usual care, and b) whether multifaceted interventions can achieve the consistently high adherence rates year after year that are required to reduce late-stage CRC and CRC 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 CHC who complete a repeat FOBT within six months of becoming due for CRC screening. We first describe the CHC’s efforts to improve CRC screening rates prior to the start of this study. We then 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. Finally, we discuss the significance of the study and some of the potential implications.
Previous efforts to improve CRC screening rates at Erie Family Health Center
This study is being conducted at Erie Family Health Center (EFHC), a federally-qualified health center network in Chicago, Illinois that serves an overwhelmingly Latino population; 66% are best served in Spanish; 36% are uninsured; and 91% come from households with incomes below the Federal Poverty Line. EFHC uses the General Electric Centricity electronic health record (EHR), which is supported by the Alliance of Chicago Community Health Services. The EHR has clinical reminders for chronic disease management and clinical preventive services and allows EFHC to routinely gather data for quality of care measures.
In December, 2007, 16% of all eligible patients were up to date on CRC screening based on USPSTF guidelines. This rate had been stable over the previous six months and was similar to many other CHCs in Chicago. Between December, 2007 and October, 2009, EFHC implemented several system-level changes designed to improve CRC screening rates. These efforts are best viewed as a single quality improvement initiative with multiple components: a) performance measurement, feedback, and financial incentives, b) implementation of a team-based care approach empowering medical assistants (MAs) to recommend CRC screening, and c) development of strategies to improve access to diagnostic colonoscopy.
Performance measurement, feedback, and financial incentives
EFHC uses performance measures to determine provider incentive payments. These measures are chosen every year by the providers themselves to reflect their priorities, rather than being imposed by EFHC’s management team. In 2007, providers chose CRC screening as a performance measure. As a result, adult medicine providers were routinely told what percent of their patient panel was up to date on CRC screening. Along with their individual performance, providers are also shown how their screening rates rank among other adult providers within the organization. Performance on the CRC measure was also used to allocate performance-based incentive bonuses. Each quarter, providers receive a bonus for falling in the top and middle terciles of similar providers in each measure. Along with their individual performance, providers are also shown how their screening rates rank among other adult providers within the organization.
Empowerment of medical assistants to offer CRC screening if overdue
EFHC also implemented a standing order that allowed MAs to recommend guaiac card FOBT screening during pre-appointment triage and vital signs measurement to patients who were age 50 or older and not up to date on CRC screening. If the patients agreed to take the FOBT cards home, the MA showed them how to use it and answered basic questions about the test. If patients had questions beyond the MA’s scope of practice, patients were told to discuss this during the provider visit. The provider also had a chance to reinforce the MA’s recommendation to perform the test or to attempt to change a patient’s decision if the patient did not agree to the screening when the MA offered the test.
Improved access to diagnostic colonoscopy
Before August, 2009, uninsured EFHC patients had access to diagnostic colonoscopies only through self-pay, charity programs, or care at public hospitals. Each of those modes has limitations. Most uninsured EFHC patients would find the cost of self-financing a colonoscopy not feasible. Charity care applications’ bureaucratic and documentation requirements can be challenging for all patients, especially those with low literacy. Furthermore, public hospitals in the Chicago area tend to have long waitlists for services, especially procedural tests like colonoscopy. These challenges may have caused some providers to be unwilling to use FOBT for CRC screening if they believed a patient could not get a timely diagnostic colonoscopy if the FOBT result was positive.
In August, 2009, EFHC and Northwestern Memorial Hospital implemented an agreement to provide free diagnostic colonoscopies to uninsured patients who met EFHC’s sliding scale fee criteria. Further eligibility requirements included that the patient not be insulin-dependent, be older than age 50 (or 40 if they have a first-degree relative who had colorectal cancer), and have some indicator for being high risk (i.e., have a positive FOBT, first degree family member, history of rectal bleeding, or tubular adenoma on prior colonoscopy). More than just making colonoscopies affordable, the program eased access by allowing EFHC to directly schedule patients into dedicated appointment slots, thereby reducing the scheduling complexity for the patient. Further, pre-procedure preparation instructions and materials were given at EFHC to reduce literacy barriers and increase compliance. Patients for whom transportation was a barrier were given the option of being chaperoned to and from the appointment by an EFHC staff member.
Improvements in CRC screening rate
By October, 2009, the screening rate at EFHC had more than doubled to 43%. Because the changes above were implemented concurrently, it is not known which of these system changes was most responsible for the increase in the CRC screening rate. The multiple strategies employed at EFHC and the relatively high rate of CRC screening achieved by these interventions means that the “usual care” group in this study is a strong comparator.