Fecal Immunochemical Test Kit Research Articles

Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial

BackgroundColorectal cancer (CRC) screening rates remain suboptimal, particularly in low-income and underserved populations. Mailed fecal immunochemical testing (FIT) may overcome common barriers to screening; however, the effect of mailed FIT kits may differ across important subpopulations. The goal of the current study was to examine sociodemographic and health-related factors that moderate the effect of an intervention of automated direct mail of FIT kits at health clinics serving low-income populations.MethodsThis study is a secondary analysis of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study, a cluster-randomized pragmatic trial to increase uptake of CRC screening in patients seen at federally qualified health centers. The intervention involved tools embedded in the electronic medical records to enable participating clinics to mail FIT kits and related materials to eligible participants. We examined the rate of FIT completion by potential moderating characteristics using electronic health record data supplemented by the American Community Survey and the Centers for Medicare & Medicaid Services Geographic Variation datasets, linked via geocoding to patients’ addresses. All patients aged 50–75 seen in participating health clinics who were eligible for CRC screening were included.ResultsAlthough not always statistically significant, we saw a consistent pattern of increased FIT return rates among intervention participants compared to control participants across all subgroups studied, with incidence rate ratios (IRRs) generally ranging from 1.25 to 1.50. FIT completion in the intervention group ranged from 15 and 20% across subpopulations, typically three to six percentage points higher than the control group participants. The only moderator with a statistically significant interaction was race: persons of Asian descent showed a twofold response to the intervention (adjusted incidence rate ratio [aIRR] = 2.06, 95% confidence interval 1.41 to 3.00).ConclusionsResponse to a mailed FIT intervention was generally consistent across a wide range of individual and neighborhood-level patient characteristics, including typically underserved patients and those in low-resource communities.Trial registrationClinicalTrials.gov, NCT01742065. Registered on 5 December 2012.

Effectiveness of a mailed fecal immunochemical test outreach: a Medicare Advantage pilot study.

Background:Mailed fecal immunochemical test (FIT) outreach effectively increases colorectal cancer (CRC) screening but is underutilized. This pilot aimed to determine the use of FIT for CRC screening among Medicare Advantage enrollees when offered via mailed outreach and the factors associated with FIT return.Methods:Our pilot study included Medicare Advantage enrollees who were 50–75-years old, not up to date with CRC screening, and had a billable primary care encounter in the prior 3 years. Eligible patients received a letter containing information about CRC screening and a FIT kit, screening status by FIT was then assessed using the electronic health record.Results:Of the 1142 patients identified, 945 were eligible for outreach. On 12-month follow up, 29% of patients (n = 276) completed CRC screening via FIT, with a median return time of 140 days [interquartile range (IQR) 52–257]; 6% (n = 17) of the completed tests were positive, and 53% (n = 9) of patients have completed a diagnostic colonoscopy. Patients with primary encounter <12 months prior to mailed outreach were most likely to complete a FIT. Over the 12-month study period, CRC screening rates increased by 5% (63–68%).Conclusions:Mailed FIT outreach in a Medicare Advantage population was feasible and led to a 5% increase in CRC screening completion. Our pilot revealed rare incorrect patient addresses and high lab discard rate; both important factors that were addressed prior to larger-scale implementation of a mailed FIT program. Further research is needed to understand the potential impact of multilevel interventions on CRC screening in this healthcare system.

Low Rates of Colonoscopy Follow-up After a Positive Fecal Immunochemical Test in a Medicaid Health Plan Delivered Mailed Colorectal Cancer Screening Program.

BackgroundFollow-up colonoscopy after a positive fecal immunochemical test (FIT) is necessary for colorectal cancer (CRC) screening to be effective. We report colonoscopy follow-up rates after a positive FIT overall and by population characteristics in the BeneFIT demonstration pilot, a Medicaid health insurance plan-delivered mailed FIT outreach program.MethodsIn 2016, 2 health insurance plans in Oregon and in Washington state mailed FIT kits to Medicaid patients who, based on claims data, were overdue for CRC screening. We report follow-up colonoscopy completion rates after positive FIT, and differences in completion rates by age, sex, race, ethnicity, preferred language, and number of primary care visits in the prior year. This research was human subjects approved with a waiver of consent for data collection.ResultsThe FIT positivity rates in Health Plan Oregon and Health Plan Washington were 7.9% (39/488) and 14.6% (125/857), respectively. Colonoscopy completion rates within 12 months of the positive test were 35.9% (14/41) in Health Plan Oregon and 32.8% (41/125) in Health Plan Washington. Colonoscopy completion rates were higher among individuals who preferred a language other than English (Non-English speakers 70.0%, English speakers 31.3%, P = .04).ConclusionIn a health plan-delivered mailed FIT outreach program, follow-up colonoscopy rates after a positive test were low. Additional interventions are needed to assure colonoscopy after a positive FIT test and to reap the benefits of screening.

Individual and Geospatial Characteristics Associated With Use and Nonuse of the Fecal Immunochemical Test (FIT) for Colorectal Cancer Screening in an Urban Minority Population.

Initiatives by the Centers for Disease Control and Prevention as well as the National Colorectal Cancer Roundtable aim to increase the rate of colorectal cancer (CRC) screening. We assess individual and geographic characteristics associated fecal immunochemical test (FIT) CRC screening over 3 years. This is a retrospective study of 1500 FIT kits which were mailed or opportunistically handed to eligible participants in Brooklyn, New York from January 2014 to December 2016. Eligibility criteria included increased risk for colon cancer, uninsured or underinsured, and a minimum age of 50 years to warrant CRC screening. We looked at the association of individual demographic characteristics and FIT screening by logistic regression using SPPS version 23 software. In addition, using ArcGIS, we coded patients address and layered census tract population information to find associations. In total, 1367 Cancer Services Participants met our study criteria. The study sample was predominantly female (95.2%) and minority (46% African American, 24.7% Hispanic, 17.3% Caucasian, 11.4% Asian) and on average 59 years old (SD, 5.7). A large majority (73%) had household incomes below $20,000/year. Approximately half (49.9%) of all Cancer Services Participants returned their FIT kit. In participants who did not return their FIT kit, the majority were African American (41%), followed by Hispanics (26.5%), Caucasians (20.6%), and Asians (11.8%). Multivariable logistic regression showed that a screening history of prior colonoscopy or FIT, gender, ethnicity, and educational attainment were significantly associated with FIT CRC screening uptake (P<0.05). Geospatial mapping showed clusters of low screening uptake in areas of high poverty. Hot-spot analysis identified areas of significant vulnerability. FIT uptake remains suboptimal. Individual predictors as well as area poverty is associated with low screening uptake. Geospatial mapping is an effective tool for evaluating CRC screening uptake.

Direct-to-member mailed colorectal cancer screening outreach for Medicaid and Medicare enrollees: Implementation and effectiveness outcomes from the BeneFIT study.

BackgroundColorectal cancer screening uptake is low, particularly among individuals enrolled in Medicaid. To the authors' knowledge, little is known regarding the effectiveness of direct‐to‐member outreach by Medicaid health insurance plans to raise colorectal cancer screening use, nor how best to deliver such outreach.MethodsBeneFIT is a hybrid implementation‐effectiveness study of 2 program models that health plans developed for a mailed fecal immunochemical test (FIT) intervention. The programs differed with regard to whether they used a centralized approach (Health Plan Washington) or collaborated with health centers (Health Plan Oregon). The primary implementation outcome of the current study was the percentage of eligible enrollees to whom the plans delivered each intervention component. The primary effectiveness outcome was the rate of FIT completion within 6 months of mailing of the introductory letter.ResultsThe health plans identified 12,000 eligible enrollees (8551 in Health Plan Washington and 3449 in Health Plan Oregon). Health Plan Washington mailed an introductory letter and FIT kit to 8551 enrollees (100%) and delivered a reminder call to 839 (10.3% of the 8132 attempted). Health Plan Oregon mailed an introductory letter, and a letter and FIT kit plus a reminder postcard to 2812 enrollees (81.5%) and 2650 enrollees (76.8%), respectively. FIT completion rates were 18.2% (1557 of 8551 enrollees) in Health Plan Washington. In Health Plan Oregon, completion rates were 17.4% (488 of 2812 enrollees) among enrollees who were mailed an introductory letter and 18.3% (484 of 2650 enrollees) among enrollees who also were mailed a FIT kit plus reminder postcard.ConclusionsThe implementation of mailed FIT outreach by health plans may be effective and could reach many individuals at risk of developing colorectal cancer.

2847 Outside the Scope a Better FIT for Some Patients

INTRODUCTION: Colorectal cancer is the 3rd most common cancer in American adults and is the 2nd most common cause of cancer death. Colorectal cancer screening (CRCS) is unique because it not only detects but also prevents cancer from ever developing, something no other cancer screening accomplishes. Despite this advantage, in 2015 the national average for CRCS compliance was only 63%, below the National Colorectal Cancer Roundtable (NCCR) goal of 80%. The reason for the low rate of CRCS is multifactorial including the fear of having a colonoscopy. At the Baylor Scott &amp; White Primary Care Clinic in Round Rock, TX, CRCS compliance in 2019 was 54% for commercial insurance and 73% for Medicare patients. Our goal was to increase our CRCS compliance and provide better preventative care for our patients. METHODS: We reviewed the charts of 200 randomly selected patients who were considered non-compliant with CRCS between September 2017 to September 2018. Non-compliance was defined as a patient who was eligible for CRCS in this one-year time frame but failed to have CRCS. This helped identify causes for why CRCS was not performed. In our review, 0% of these patients were offered alternative methods of CRCS besides colonoscopy. This information led us to educate attending and resident physicians with oral presentations on the availability of alternative testing modalities for CRCS. In addition, one of these modalities, fecal immunochemical test (FIT) kits, were placed in patient rooms in our primary care clinic. Providers were asked to offer patients a colonoscopy for CRCS, and if a patient refused, to then offer FIT testing. RESULTS: Among noncompliant patients, no modalities aside from colonoscopy were mentioned by providers for CRCS to non-compliant patients. With the implementation of FIT kits, patients were more inclined to undergo CRCS. From January to March 2019, there was a 12% CRCS compliance rate. After our intervention in April 2019, CRCS compliance was 18% in April 2019, with the entire 6% increase in compliance coming from FIT test kits. CONCLUSION: Despite its benefit, CRCS remains below compliance goals set by NCCR. By having FIT kits placed in all the clinic rooms, it was more convenient for patients to have CRCS. There will be continued education on the benefits and modalities of CRCS to more health care providers. We plan to implement this project at other Baylor Scott &amp; White Primary Care Clinics in the region.

Repeat Annual Colorectal Cancer Screening in Rural Community Clinics: A Randomized Clinical Trial to Evaluate Outreach Strategies to Sustain Screening

The majority of colorectal cancer (CRC) research using the fecal immunochemical test (FIT) has studied short-term screening results in predominantly urban areas. The purpose of this study was to evaluate the effectiveness of 2 outreach strategies embedded in a health literacy intervention on repeat CRC screening in rural community clinics. A 2-arm randomized controlled trial was conducted in 4 rural clinics in Louisiana. During a regularly scheduled clinic visit, participants ages 50-75 received a FIT kit and brief educational intervention. Participants were randomized to receive an automated call or a personal call by a prevention counselor after 4 weeks and 8 weeks if FIT kits were not returned. In year 2, materials were mailed, and follow-up calls were conducted as in year 1. The primary outcome was repeat FIT-the return of the FIT kit in both years. Of 568 eligible participants, 55% were female, 67% were African American, and 39% had low health literacy. Repeat FIT rates were 36.5% for those receiving the automated call and 33.6% for those receiving a personal call (P = .30). No annual FITs were returned in 30% of participants, while only 1 FIT was returned by 35% of participants (31% only year 1 and 4% only year 2). Sustaining CRC screening with FIT is challenging in rural clinics. A lower cost automated call was just as effective as the personal call in promoting repeat annual screening. However, more intensive strategies are needed to improve long-term FIT screening among rural participants.

Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach

Colonoscopy and fecal immunochemical testing (FIT) are considered top-tier tests for colorectal cancer (CRC) screening. Behavioral economic insights about "choice architecture" suggest that participation could be influenced by how people are presented test options. To investigate response rates for offering colonoscopy only compared with sequential choice (colonoscopy and then FIT) or active choice (colonoscopy or FIT) through mailed outreach. Three-arm pragmatic randomized clinical trial conducted between November 14, 2017, and May 14, 2018. The setting was primary care practices at an academic health system. Patients aged 50 to 74 years with at least 2 primary care visits in the 2-year preenrollment period were included if they were eligible but not up to date on CRC screening. Eligible patients received mailed outreach about CRC screening. Equal numbers of eligible patients were randomly assigned to 3 outreach groups to receive mailings about CRC screening with the following options: (1) direct phone number to call for scheduling colonoscopy (colonoscopy only), (2) direct phone number to call for colonoscopy and a mailed FIT kit if no response within 4 weeks (sequential choice), or (3) direct phone number to call for colonoscopy and a mailed FIT kit offered at the same time (active choice). The primary outcome was CRC screening completion (FIT or colonoscopy) within 4 months of initial outreach. The secondary outcomes were CRC screening completion within 6 months of outreach and the choice of colonoscopy as a screening test. In total, 438 patients were included in the intent-to-treat analysis, with a median age of 56 years (interquartile range, 52-63 years); 55.0% were women. At 4 months, the CRC screening completion rates were 14.4% (95% CI, 8.7%-20.1%) in the colonoscopy-only arm, 17.1% (95% CI, 11.0%-23.2%) in the sequential choice arm, and 19.9% (95% CI, 13.4%-26.4%) in the active choice arm. Neither choice arm achieved a screening rate statistically greater than that in the colonoscopy-alone arm. Among those who completed CRC screening at 4 months, 90.5% (95% CI, 78.0%-103.0%) chose colonoscopy in the colonoscopy-only arm, which was significantly higher than the 52.0% (95% CI, 32.4%-71.6%; P = .005) and 37.9% (95% CI, 20.2%-55.6%; P < .001) in the sequential choice and active choice arms, respectively. There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm. Subtle changes in sequencing or defaults can alter patient decision making related to preventive health. ClinicalTrials.gov identifier: NCT03246438.

Follow-up approaches to a health literacy intervention to increase colorectal cancer screening in rural community clinics: A randomized controlled trial.

Significant disparities exist in colorectal cancer (CRC) screening rates among those of low socioeconomic status, with fewer years of education, lacking health insurance, or living in rural areas. A randomized controlled trial was conducted to compare the effectiveness of 2 follow-up approaches to a health literacy intervention to improve CRC screening: automated telephone call or personal call. Patients aged 50 to 75years residing in 4 rural community clinics in Louisiana were given a structured interview that assessed demographic, health literacy and CRC screening barriers, knowledge, and attitudes. All were given health literacy-informed CRC education, a patient-friendly CRC screening pamphlet, simplified fecal immunochemical test (FIT) instructions, and a FIT kit, and a "teach-back" method was used to confirm understanding. Patients were randomized to 1 of 2 telephone follow-up arms. If they did not mail their FIT kit within 4weeks, they received a reminder call and were called again at 8weeks if the test still was not received. A total of 620 patients were enrolled. Approximately 55% were female, 66% were African American, and 40% had limited literacy. The overall FIT completion rate was 68%: 69.2% in the automated telephone call arm and 67% in the personal call arm. Greater than one-half of the patients (range, 58%-60%) returned the FIT kit without receiving a telephone call. There was no difference noted with regard to the effectiveness of the follow-up calls; each increased the return rate by 9%. Providing FIT kits and literacy-appropriate education at regularly scheduled clinic visits with a follow-up telephone call when needed was found to increase CRC screening among low-income, rural patients. The lower cost automated call was just as effective as the personal call.

Colorectal Cancer Screening in African American HOPE VI Public Housing Residents.

This study explores whether colorectal cancer screening outreach via home visits and follow-up calls is effective among public housing African American residents. It reports on the proportion of returned Fecal Immunochemical Test kits, on the characteristics of study participants, and on their primary reasons for returning the kit. By conducting home visits and follow-up calls, our colorectal cancer-screening outreach resulted in a higher Fecal Immunochemical Test kit return rate than anticipated. Findings suggest that a more personalized outreach approach can yield higher colorectal cancer-screening rates among urban minority populations, which are at higher risk to be diagnosed with late-stage colorectal cancer.

Patient-Reported Barriers to Completing a Diagnostic Colonoscopy Following Abnormal Fecal Immunochemical Test Among Uninsured Patients.

For colorectal cancer (CRC) screening to improve survival, patients with an abnormal fecal immunochemical test (FIT) must follow-up with a diagnostic colonoscopy. Adherence to follow-up is low and patient-level barriers for suboptimal adherence have yet to be explored. To characterize barriers for non-completion of diagnostic colonoscopy after an abnormal FIT reported by under- and uninsured patients receiving care in a safety-net health system. A longitudinal, cohort study of CRC screening outreach to 8565 patients using mailed FIT kits. Patients with abnormal FIT results received telephonic navigation to arrange for a no-cost diagnostic colonoscopy. Adults aged 50-64years receiving care at a North Texas safety-net health system. Descriptive analyses characterized the patient sample and reasons for lack of follow-up after abnormal FIT over the 3-year outreach program. Thematic qualitative analyses characterized reasons for lack of follow-up with a colonoscopy after the abnormal FIT. Of 689 patients with an abnormal FIT, 45% (n = 314) did not complete a follow-up colonoscopy. Among the 314 non-completers, 184 patients reported reasons for not completing a follow-up colonoscopy included health insurance-related challenges (38%), comorbid conditions (37%), social barriers such as transportation difficulties and lack of social support (29%), concerns about FIT/colonoscopy process (12%), competing life priorities (12%), adverse effects of bowel preparation (3%), and poor health literacy (3%). Among the 314 non-completers, 131 patients did not report a barrier, as 51% reported that that had completed a previous colonoscopy in the past 10years, 10% refused with no reason, and 10% were never reached by phone. Future studies aimed at improving FIT screening and subsequent colonoscopy rates need to address the unique needs of patients for effective and sustainable screening programs. NCT01946282.

Effectiveness and Cost of Organized Outreach for Colorectal Cancer Screening: A Randomized, Controlled Trial

Colorectal cancer (CRC) screening remains underused, especially in safety-net systems. The objective of this study was to determine the effectiveness, costs, and cost-effectiveness of organized outreach using fecal immunochemical tests (FITs) compared with usual care. Patients age 50-75 years eligible for CRC screening from eight participating primary care safety-net clinics were randomlyassigned to outreach intervention with usual care vs usual care alone. The intervention included a mailed postcard and call, followed by a mailed FIT kit, and a reminder phone call if the FIT kit was not returned. The primary outcome was screening participation at 1 year and a microcosting analysis of the outreach activities with embedded long-term cost-effectiveness of outreach. All statistical tests were two-sided. A total of 5386 patients were randomly assigned to the intervention group and 5434 to usual care. FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs 37.4%, P < .001; difference = 20.5%, 95% confidence interval = 18.6% to 22.4%). In the intervention group, FIT completion rate was higher in patients who had previously completed a FIT vs those who had not (71.9% vs 35.7%, P < .001). There was evidence of effect modification of the intervention by language, and clinic. Outreach cost approximately $23 per patient and $112 per additional patient screened. Projecting long-term outcomes, outreach was estimated to cost $9200 per quality-adjusted life-year gained vs usual care. Population-based management with organized FIT outreach statistically significantly increased CRC screening and was cost-effective in a safety-net system. The sustainability of the program and any impact of economies of scale remain to be determined.

Using a continuum of hybrid effectiveness-implementation studies to put research-tested colorectal screening interventions into practice

BackgroundFew previous studies have applied the hybrid effectiveness-implementation design framework to illustrate the way in which an intervention was progressively implemented and evaluated across multiple studies in diverse settings.MethodsWe describe the design components and methodologies of three studies that sought to improve rates of colorectal cancer (CRC) screening using mailed outreach, and apply domains put forth by Curran et al.: research aims, research questions, comparison conditions, sample, evaluation methods, measures, and potential challenges.The Hybrid 1 study (emphasis on effectiveness) was a patient-level randomized trial of a mailed fecal test and stepped phone-outreach intervention program delivered in an integrated healthcare system (21 clinics, 4673 patients). The primary outcome was effectiveness (CRC screening uptake). Implementation outcomes included cost-effectiveness and acceptability.The Hybrid 2 study (shared emphasis on effectiveness and implementation) was a pragmatic cluster-randomized trial of mailed fecal immunochemical test (FIT) outreach implemented at safety net clinics (26 clinics, 41,000 patients). The intervention used electronic health record tools (adapted from Hybrid 1) and clinic personnel to deliver the intervention. Outcomes included effectiveness (FIT completion) and implementation (FIT kits delivered, clinic barriers and facilitators, cost-effectiveness).Hybrid 3 study (emphasis on implementation) is a demonstration project being conducted by two Medicaid/Medicare insurance plans (2 states, 12,000 patients) comparing two strategies for implementing mailed FIT programs that addressed Hybrid 2 implementation barriers. Outcomes include implementation (activities delivered, barriers) and effectiveness (FIT completion).ResultsThe effectiveness-implementation typology successfully identified a number of distinguishing features between the three studies. Two additional features, program design and program delivery, varied across our studies, and we propose adding them to the current typology. Program design and program delivery reflect the process by which and by whom a program is designed and delivered (e.g., research staff vs. clinic/health plan staff).ConclusionsWe describe three studies that demonstrate the hybrid effectiveness to implementation continuum and make recommendations for expanding the hybrid typology to include new descriptive features. Additional comparisons of Hybrid 1, 2, and 3 studies may help confirm whether our hybrid typology refinements are generalizable markers of the pipeline from research to practice.

Developing Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program in a Latino-Based Community Health Center.

Colon cancer is the second leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinos. One factor thought to contribute to the low screening rate is the difficulty Latinos encounter in understanding health information, and therefore in taking appropriate health action. Therefore, we used Boot Camp Translation (BCT), a patient engagement approach, to engage Latino stakeholders (ie, patients, clinic staff) in refining the messages and format of colon cancer screening reminders for a clinic-based direct mail fecal immunochemical testing (FIT) program. Patient participants were Latino, ages 50 to 75 years, able to speak English or Spanish, and willing to participate in the in-person kickoff meeting and follow-up phone calls over a 3-month period. We held separate BCT sessions for English- and Spanish-speaking participants. As part of the in-person meetings, a bilingual colon cancer expert presented on colon health and screening messages and BCT facilitators led interactive sessions where participants reviewed materials and reminder messages in various modalities (eg, letter, text). Participants considered what information about colon cancer screening was important, the best methods to share these messages, and the timing and frequency with which these messages should be delivered to patients to encourage FIT completion. We used follow-up phone calls to iteratively refine materials developed based on key learnings from the in-person meeting. Twenty-five adults participated in the in-person sessions (English [n = 12]; Spanish [n = 13]). Patient participants were primarily enrolled in Medicaid/uninsured (76%) and had annual household incomes less than $20,000 (67%). Key themes distilled from the sessions included increasing awareness that screening can prevent colon cancer, stressing the urgency of screening, emphasizing the motivating influence of family, and using personalized messages from the practice such as 'I' or 'we' statements in letters or automated phone call reminders delivered by humans. Participants in both sessions noted the importance of receiving an automated or live alert before a FIT kit is mailed and a reminder within 2 weeks of FIT kit mailing. Using BCT, we successfully incorporated participant feedback to adapt culturally relevant health messages to promote FIT testing among Latino patients served by community clinics. Materials will be tested in the larger Participatory Research to Advance Colon Cancer Prevention (PROMPT) trial.

Effect of Financial Incentives on Patient Use of Mailed Colorectal Cancer Screening Tests

Mailing fecal immunochemical test (FIT) kits to patients' homes has been shown to boost colorectal cancer screening rates, but response rates remain limited, and organized programs typically require repeated outreach attempts. Behavioral economics has shown that offering salient financial incentives to patients may increase participation in preventive health. To compare the impact of different financial incentives for mailed FIT outreach. This 4-parallel-arm randomized clinical trial included patients aged 50 to 75 years who had an established primary care clinician, at least 2 visits in the prior 2 years, and were eligible for colorectal cancer screening and not up-to-date. This study was conducted at urban primary care practices at an academic health system from December 2015 to February 2018. Data analysis was conducted from March 2018 to September 2018. Eligible patients received a letter from their primary care clinician that included a mailed FIT kit and instructions for use. They were randomized in a 1:1:1:1 ratio to receive (1) no financial incentive; (2) an unconditional $10 incentive included with the mailing; (3) a $10 incentive conditional on FIT completion; or (4) a conditional lottery with a 1-in-10 chance of winning $100 after FIT completion. Fecal immunochemical test completion within 2 and 6 months of initial outreach. A total of 897 participants were randomized, with a median age of 57 years (interquartile range, 52-62 years); 56% were women, and 69% were black. The overall completion rate across all arms was 23.5% at 2 months. The completion rate at 2 months was 26.0% (95% CI, 20.4%-32.3%) in the no incentive arm, 27.2% (95% CI, 21.5%-33.6%) in the unconditional incentive arm, 23.2% (95% CI, 17.9%-29.3%) in the conditional incentive arm, and 17.7% (95% CI, 13.0%-23.3%) in the lottery incentive arm. None of the arms with an incentive were statistically superior to the arm without incentive. The overall FIT completion rate across all arms was 28.9% at 6 months, and there was also no difference by arm. The completion rate at 6 months was 32.7% (95% CI, 26.6%-39.3%) in the no incentive arm, 31.7% (95% CI, 25.7%-38.2%) in the unconditional incentive arm, 26.8% (95% CI, 21.1%-33.1%) in the conditional incentive arm, and 24.3% (95% CI, 18.9%-30.5%) in the lottery incentive arm. Mailed FIT resulted in high colorectal cancer screening response rates in this population, but different forms of financial incentives of the same expected value ($10) did not incrementally increase FIT completion rates. The incentive value may have been too small or financial incentives may not be effective in this context. ClinicalTrials.gov Identifier: NCT02594150.

Barriers and Facilitators of Colorectal Cancer Screening in a Federally Qualified Health Center (FQHC).

Colorectal cancer is a leading cause of cancer-related mortality in the United States. Current screening recommendations for individuals aged 50 to 75 years include colonoscopy every 10 years, flexible sigmoidoscopy every 5 years, or annual stool-based testing. Stool-based testing, including fecal immunochemical tests (FITs), are cost effective, easy to perform at home, and noninvasive, yet many patients fail to return testing kits and go unscreened. The purpose of the study was to identify patient characteristics and perceived barriers and facilitators of FIT return. Patients in a large, federally qualified health center who received a FIT kit order between January 1 and July 1, 2017 were identified. We compared sociodemographic and health characteristics between patients who returned and did not return FITs. We used telephone surveys to nonreturners to identify potential barriers (cost, knowledge, psychosocial factors) and facilitators (prepaid postage, outreach) of FIT kit return. An online survey of clinicians assessed perceived patient barriers and facilitators of colorectal cancer screening. Of the 875 patients who received a FIT order, 435 (49.7%) did not return the kit and 121 of the nonreturners completed a telephone survey. Current smokers had an increased risk of FIT nonreturn compared with never smokers (RR = 1.32; 95% CI, 1.13-1.54). Forgetfulness and lack of motivation were the most common FIT return barriers perceived by both patients and clinicians. Prepaid postage with return address on FIT return envelopes and live call reminders were the most commonly reported facilitators. Barriers and facilitators varied greatest between English- and Spanish-speaking patients. In this study, the most common perceived barriers to return of screening fecal test kits were forgetfulness and lack of motivation. The most common perceived facilitators were live call reminders and postage-paid return envelopes. Understanding barriers and facilitators to FITs may be necessary to enhance cancer screening rates in underserved patient populations.

A Survey of Provider Attitudes, Beliefs, and Perceived Barriers Regarding a Centralized Direct-Mail Colorectal Cancer Screening Approach at Community Health Centers.

Background: Colorectal cancer screening (CRC) rates are low, particularly among individuals with low socioeconomic status. Organized CRC screening programs have demonstrated success in increasing screening rates. Little is known about provider attitudes, beliefs, and practices related to CRC screening or how they are influenced by an organized CRC screening program. Methods: In 2014 and 2016, providers from 26 safety net clinics in Oregon and Northern California were invited to complete baseline and follow-up online surveys for the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study. The provider survey link was sent electronically to primary care providers serving adult patients. Providers were sent reminders every 2 weeks via email to complete the survey, up to 3 reminders total. In this article, we describe learnings about provider attitudes, beliefs, and practices related to CRC screening after implementation of the STOP CRC program. Results: A total of 166 unique providers completed baseline and/or follow-up surveys, representing 228 responses. Main themes included (1) favorable shifts in attitude toward fecal immunochemical test (FIT) and direct-mail cancer screening programs, (2) changes in provider perception of key barriers, and (3) growing interest in centralized automated systems for identifying patients due for CRC screening and eligible for population-based outreach. Discussion: Providers are interested in improved information systems for identifying patients due for CRC screening and delivering population-based outreach (ie, to distribute FIT kits outside of the clinic visit) to help reduce health system- and patient-level barriers to screening. Trial Registration: National Clinical Trial (NCT) Identifier NCT01742065.

Effectiveness and cost of multilayered colorectal cancer screening promotion interventions at federally qualified health centers in Washington State.

It has been demonstrated that fecal immunochemical test (FIT) mailing programs are effective for increasing colorectal cancer (CRC) screening. The objectives of the current study were to assess the magnitude of uptake that could be achieved with a mailed FIT program in a federally qualified health center and whether such a program can be implemented at a reasonable cost to support sustainability. The Washington State Department of Health's partner HealthPoint implemented a direct-mail FIT program at 9 medical clinics, along with a follow-up reminder letter and automated telephone calls to those not up-to-date with recommended screening. Supplemental outreach events at selected medical clinics and a 50th birthday card screening reminder program also were implemented. The authors collected and analyzed process, effectiveness, and cost measures and conducted a systematic assessment of the short-term cost effectiveness of the interventions. Overall, 5178 FIT kits were mailed with 4009 follow-up reminder letters, and 8454 automated reminder telephone calls were made over 12 months. In total, 1607 FIT kits were returned within 3 months of the end of the implementation period: an overall return rate of 31% for the mailed FIT program. The average total intervention cost per FIT kit returned was $39.81, and the intervention implementation cost per kit returned was $18.76. The mailed FIT intervention improved CRC screening uptake among HealthPoint's patient population. This intervention was implemented for less than $40 per individual successfully screened. The findings and lessons learned can assist other clinics that serve disadvantaged populations to increase their CRC screening adherence.

Annual colorectal cancer screening in rural community clinics using the fecal immunochemical test (FIT): Second and third year screening.

35 Background: Colorectal cancer (CRC), the second leading cause of cancer death in the US, can be significantly reduced if it is detected early. Although overall CRC screening rates have increased significantly, disparities persist among low income individuals, adults with low literacy and those living in rural areas. Methods: Randomized controlled trial to assess the effectiveness of 2 health literacy informed phone follow-up strategies to improve annual screening with Fecal Immunochemical Test (FIT) in 4 rural community clinics. Eligible patients, age 50-75, were recruited. After consenting, a research assistant (RA) recommended screening and gave literacy and culturally appropriate education using a pamphlet, the FIT kit, simplified instructions and a demonstration of how to use it, At 4 weeks patients who had not returned their kit receive either 1) a personal follow-up call (PC) from a central RA using motivational interviewing skills and reminding them to complete FIT kits; or 2) an automated follow-up call (AC) using plain language and motivational messages encourages patients to complete the FIT. During years 2 and 3, FIT kits were mailed to patients. Follow-up call procedures previously used were followed. Results: 620 patients not up-to-date were enrolled: 308/AC &amp; 306/PC; 66% were African American, 55% women; 40% had limited literacy. During Year 1, 69% completed screening in AC arm versus 67% in PC arm. During Year 2, percentage screened decreased: 40% screened in AC arm and 37% in PC arm. Number of patients that needed at least one follow-up called increased: 74% in both arms needed at least 1 reminder call. Among those called, 19% in the AC arm completed their kit versus 15% in the PC arm. To date in Year 3, 32% screened in AC and 34% in PC. Conclusions: Simplified instructions accompanied by a face-to-face demonstration of FIT, use of “teach back” to confirm understanding with a follow-up call if needed, facilitated completion rates of all patients, particularly those with limited literacy. The less costly and time consuming automated call was equally effective as a personal call. Screening rates in years 2 and 3 declined. CRC screening with FIT is only effective when completed annually. Clinical trial information: RSG-13-021-01 - CPPB.

Qualitative Investigation of FIT Colorectal Cancer Screening Uptake in an Uninsured Urban Minority Population

Introduction: Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the USA. Screening and prevention of CRC with stool testing and colonoscopy is cost effective and greatly reduces the risk for CRC and death. Fecal immunochemical testing (FIT) has been shown to be more accurate than guaiac testing for CRC and advanced adenoma detection. Our post-intervention analysis aims to identify barriers to FIT in patients who were provided with free FIT as part of a comprehensive cancer screening program. Methods: Validated standardized surveys were mailed to 100 patients who ‘returned' FIT kits and 100 patients who ‘refused to return' FIT kits (Image 1). Patients received a $5 gift card if they completed the questionnaire. Postage-paid return envelopes were included. Patients had two months to return the completed questionnaires. Results: A total of 17 ‘returned' questionnaires and 8 of ‘refused' questionnaires were completed. Of the 17 ‘returned' questionnaires, 13 were female and 4 were male. 8 of the ‘returned' respondents were African American, while 3 were Caucasian, 4 were Hispanic and 2 were Asian. Further demographics are shown in Image 2.2763_A Figure 1. Mailed Surveys2763_B Figure 2. Study DemographicsConclusion: We report low response rates for both questionnaires. This suggests that identifying barriers to FIT/colonoscopy screening remains challenging in an uninsured urban minority population. African American females with income <$10,000 were the predominant respondents from the ‘returned' cohort, which may indicate better screening uptake among this subpopulation. Six (35%) of ‘returned' respondents reported previous FIT, while none of the ‘refused' cohort had previous FIT. This may represent an unfamiliarity factor among ‘refused' respondents. Among the ‘returned' respondents, some of the identified reasons that influenced use of the FIT kit included lack of insurance, family history of colon polyps, interest in preventative screening and physician recommendation during an encounter for screening mammogram. ‘Difficult instructions' was listed as a reason for not using the FIT kit by 12.5% of the ‘refused' respondents while others from this cohort reported not receiving the kit or not having time to perform the testing. Although eliciting information regarding barriers to FIT kit use remains challenging, more study into this area is warranted to increase CRC screening rates.