Abnormal Fecal Immunochemical Test Result Research Articles

Performance of OC-Auto Micro 80 Fecal Immunochemical Test in an Integrated Academic-Community Health System.

We aimed to determine the performance of the OC-Auto Micro 80 fecal immunochemical test (FIT) in an average-risk population receiving care in an integrated, academic-community health system. The FIT is the most used colorectal cancer (CRC) screening test worldwide. However, many Food and Drug Administration-cleared FIT products have not been evaluated in clinical settings. We performed a retrospective cohort study of patients (50 to 75y old) in the University of Washington Medicine health care system who were screened for CRC by OC-Auto Micro 80 FIT between March 2016 and September 2021. We used electronic health records to extract patient-level and clinic-level factors, FIT use, colonoscopy, and pathology findings. The primary outcomes were the FIT positivity rate and neoplasms detected at colonoscopy. Secondary outcomes were FIT positivity by sex and safety-net versus non-safety-net clinical settings. We identified 39,984 FITs completed by 26,384 patients; 2411 (6.0%) had a positive FIT result (>100 ng/mL of hemoglobin in buffer), and 1246 (51.7%) completed a follow-up colonoscopy. The FIT positive rate was 7.0% in men and 5.2% in women ( P <0.01). Among those who completed a colonoscopy after an abnormal FIT result, the positive predictive value for CRC, advanced adenoma, and advanced neoplasia was 3.0%, 20.9%, and 23.9%, respectively. In a retrospective analysis of a large heterogeneous population, the OC-Auto Micro 80 FIT for CRC screening demonstrated a positivity rate of 6.0% and a positive predictive value for CRC of 3.0%.

Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas

BackgroundMailed fecal immunochemical test (FIT) outreach and patient navigation are evidence-based practices shown to improve rates of colorectal cancer (CRC) and follow-up in various settings, yet these programs have not been broadly adopted by health systems and organizations that serve diverse populations. Reasons for low adoption rates are multifactorial, and little research explores approaches for scaling up a complex, multi-level CRC screening outreach intervention to advance equity in rural settings.MethodsSMARTER CRC, a National Cancer Institute Cancer Moonshot project, is a cluster-randomized controlled trial of a mailed FIT and patient navigation program involving 3 Medicaid health plans and 28 rural primary care practices in Oregon and Idaho followed by a national scale-up trial. The SMARTER CRC intervention combines mailed FIT outreach supported by clinics, health plans, and vendors and patient navigation for colonoscopy following an abnormal FIT result. We applied the framework from Perez and colleagues to identify the intervention’s components (including functions and forms) and scale-up dissemination strategies and worked with a national advisory board to support scale-up to additional organizations. The team is recruiting health plans, primary care clinics, and regional and national organizations in the USA that serve a rural population. To teach organizations about the intervention, activities include Extension for Community Healthcare Outcomes (ECHO) tele-mentoring learning collaboratives, a facilitation guide and other materials, a patient navigation workshop, webinars, and individualized technical assistance. Our primary outcome is program adoption (by component), measured 6 months after participation in an ECHO learning collaborative. We also assess engagement and adaptations (implemented and desired) to learn how the multicomponent intervention might be modified to best support broad scale-up.DiscussionFindings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings.Trial registrationRegistered at ClinicalTrials.gov (NCT04890054) and at the NCI’s Clinical Trials Reporting Program (CTRP no.: NCI-2021–01032) on May 11, 2021.

Implementing an Organized Colorectal Cancer Screening Program: Lessons Learned From an Academic–Community Practice

IntroductionThe effectiveness of mailed fecal immunochemical test (FIT) outreach might be enhanced through an organized colorectal cancer (CRC) screening program, yet published real-world experiences are limited. We synthesized the process of implementing a CRC screening program which used mailed FIT outreach in a large integrated academic-community practice. Materials and MethodsData from a pilot mailed FIT program were shared with healthcare system leadership which inspired the creation of a cross-institutional organized CRC Screening Program. In partnership with a centralized Population Health Team and Primary Care, we defined: 1) the institutional approach to CRC screening, 2) the target population and method for screening, 3) the team responsible for implementation, 4) the healthcare team responsible for decisions and care, 5) a quality assurance structure, and 6) a method for identifying cancer occurrence. ResultsThe Fred Hutch/UW Medicine Population Health CRC Screening Program began in September 2021. The workflow for mailed FIT outreach included a mailed postcard, a MyChart message from the patient's primary care provider (PCP), a FIT kit with a letter signed by the PCP and program director, and up to three bi-weekly reminders. Patients without a colonoscopy 3 months after an abnormal FIT result received navigation through the program. In the first program year, we identified 9,719 patients eligible for outreach and in an intention to treat analysis, 32% of patients completed CRC screening by FIT or colonoscopy. ConclusionsReal-world experiences detailing how to implement organized CRC screening programs might increase adoption. In our experience, broadly disseminating pilot data, early institutional support, robust data management and strong cross-departmental relationships were critical to successfully implementing a CRC screening program that benefits all patients.

S388 Patient Navigation Increases Follow-Up After Abnormal Fecal Immunochemical Test Results but Reveals Persistent Barriers to Colonoscopy

S388 Patient Navigation Increases Follow-Up After Abnormal Fecal Immunochemical Test Results but Reveals Persistent Barriers to Colonoscopy

Abstract A019: Impact of COVID-19 on patient navigation services for follow-up colonoscopy after abnormal fecal testing in community health centers

Abstract Introductory sentence about purpose of the study: The PRECISE study tests the effectiveness of a targeted patient navigation program for follow-up colonoscopy after abnormal fecal testing in community health centers. We present adaptations of the patient navigation program resulting from the impact of the COVID-19 pandemic. Brief description of pertinent experimental procedures: Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after an abnormal FIT result to prevent CRC or find it in early, treatable forms. Unfortunately, almost half of patients with an abnormal FIT result fail to complete this essential screening component. Patient navigation can provide needed support for patients to complete a follow-up colonoscopy. PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients were aged 50-75, had an abnormal FIT result in the past month, and were due for a follow-up colonoscopy. Patients were randomized to patient navigation or usual care. Patient navigation was delivered by a bilingual (English and Spanish) patient navigator using a six-topic phone-based protocol, adapted from the New Hampshire Colorectal Cancer Screening Program. Summary of new, unpublished data: A total of 985 patients were enrolled in the PRECISE study, 489 randomized to the intervention arm and 496 to the control arm. Due to the COVID-19 pandemic, we made adaptations to the navigator training program and navigation delivery. We converted our in-person training program to a virtual navigation training series combining pre-recorded videos and live webinars. Additionally, we strengthened relationships with GI practices to expedite referrals, improve scheduling processes, and better understand COVID-related policy changes including the conversion of some pre-procedure consultations to a phone-based platform and COVID-19 testing requirements prior to the colonoscopy. Finally, we adapted patient navigator messages to address fear and anxiety about getting medical care during the peak COVID-19 pandemic. Preliminary patient navigation outcomes will be available in September 2022. Statement of conclusions: This innovative clinical trial highlights the importance of patient navigation to improve CRC screening in community health centers. Rapid response to COVID-19 provided the opportunity to adapt our navigator program for a virtual setting allowing for 1) the sustainability of patient navigation during the pandemic and 2) the broadening of training resources for patient navigators and community health workers. Citation Format: Jamie H. Thompson, Jennifer Rivelli, Jennifer Schneider, Amanda F. Petrik, Gloria D. Coronado. Impact of COVID-19 on patient navigation services for follow-up colonoscopy after abnormal fecal testing in community health centers [abstract]. In: Proceedings of the AACR Special Conference on Colorectal Cancer; 2022 Oct 1-4; Portland, OR. Philadelphia (PA): AACR; Cancer Res 2022;82(23 Suppl_1):Abstract nr A019.

Barriers associated with inadequate follow-up of abnormal fecal immunochemical test results in a safety-net system: A mixed-methods analysis

In safety-net healthcare systems, colonoscopy completion within 1-year of an abnormal fecal immunochemical test (FIT) result rarely exceeds 50%. Understanding how electronic health records (EHR) documented reasons for missed colonoscopy match or differ from patient-reported reasons, is critical to optimize effective interventions to address this challenge. We conducted a convergent mixed-methods study which included a retrospective analysis of EHR data and semi-structured interviews of adults 50–75 years old, with abnormal FIT results between 2014 and 2020 in a large safety-net healthcare system. Of the 299 patients identified, 59.2% (n = 177) did not complete a colonoscopy within one year of their abnormal result. EHR abstraction revealed a documented reason for lack of follow-up colonoscopy in 49.2% (n = 87/177); patient-level (e.g., declined colonoscopy; 51.5%) and multi-factorial reasons (e.g., lost to follow-up; 37.9%) were most common. In 18 patient interviews, patient (e.g., fear of colonoscopy), provider (e.g., lack of result awareness), and system-level reasons (e.g., scheduling challenges) were most common. Only three reasons for lack of colonoscopy overlapped between EHR data and patient interviews (competing health issues, lack of transportation, and abnormal FIT result attributed to another cause). In a cohort of safety-net patients with abnormal FIT results, the most common reasons for lack of follow-up were patient-related. Our analysis revealed a discordance between EHR documented and patient-reported reasons for lack of colonoscopy after an abnormal FIT result. Mixed-methods analyses, as in the present study, may give us the greatest insight into modifiable determinants to develop effective interventions beyond quantitative and qualitative data analysis alone.

Colonoscopy Following an Abnormal Fecal Test Result from an Annual Colorectal Cancer Screening Program in a Federally Qualified Health Center.

Individuals with an abnormal fecal immunochemical test (FIT) result have an elevated risk of colorectal cancer, and the risk increases if the follow-up colonoscopy is delayed. Of note, rates of follow-up colonoscopy are alarmingly low in federally qualified health centers (FQHCs), US health care settings that serve a majority racial and ethnic minority patient population. We assessed factors associated with colonoscopy after an abnormal FIT result and used chart-abstracted data to assess reasons (including process measures) for lack of follow-up as part of an annual, mailed-FIT outreach program within a large, Latino-serving FQHC. As part of the National Institutes of Health-funded PROMPT study, we identified patients with an abnormal FIT result and used logistic regression to assess associations between patient demographics and receipt of follow-up colonoscopy, controlling for patients' preferred language. We report on time (days) to referral and time to colonoscopy. For charts with an abnormal FIT result but no evidence of colonoscopy, we performed a manual abstraction and obtained the reason for the absence of colonoscopy. When there was no evidence of colonoscopy in a patient's electronic health record (EHR), we performed an automated query of the administrative claims database to identify colonoscopy outcomes. We identified 324 patients with abnormal FIT results from July to October 2018. These patients were mostly publicly insured (Medicaid 53.1%, Medicare 14.5%), 81.8% were aged 50 to 64 years, 55.3% were female, 80.3% were Hispanic/Latino, and 67.3% preferred to speak Spanish. We found that 108/324 (33.3%) patients completed colonoscopy within 12 months, and the median time to colonoscopy was 94 days (IQR: 68-176). Common barriers to colonoscopy completion, obtained from chart-abstracted data, were: no documentation following referral to gastrointestinal (GI) specialist or GI consultation (41.6%), no referral to GI specialist following abnormal fecal test (34.2%), and absence of a valid insurance authorization (6.5%). Multi-level strategies are needed to provide optimal care across the cancer continuum for FQHC patients. In order to reduce the risk of CRC and realize the return on fecal testing investment, concerted system-level efforts are urgently needed to improve rates of follow-up colonoscopy among FQHC patients and redress racial and ethnic disparities in CRC screening outcomes.

Abstract PO-042: Incorporating Latino patient input in messaging for follow-up colonoscopy after abnormal fecal testing

Abstract Introductory sentences indicating the purposes of the study: We used boot camp translation (BCT), a validated community based participatory strategy, to elicit input from diverse stakeholders (i.e., patients and clinic staff) to develop messaging and patient education materials for follow-up colonoscopy after abnormal fecal testing. BCT is a process that engages participants in translating health information into ideas, messages, and materials that are understandable and relevant to patients. Brief description of pertinent experimental procedures: Colorectal cancer is the second-leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinos. Mailed fecal immunochemical test (FIT) outreach programs have been shown to improve colorectal cancer screening rates in federally qualified health centers (FQHCs), with improvements ranging from 22% – 45%. Patients with an abnormal FIT result have an increased risk of having colorectal cancer, and the risk increases if the necessary follow-up colonoscopy is delayed. Unfortunately, rates of follow-up colonoscopy among adults with an abnormal FIT result are low in FQHCs. As part of the Participatory Research to Advance Colon Cancer Prevention (PROMPT) study, a partnership with a Los Angeles-based FQHC that provides medical services to over 300,000 patients annually (82% Latino), we used BCT to gather input from patients and staff to develop messaging and materials for patients in need of a follow-up colonoscopy after abnormal FIT. Due to the COVID-19 pandemic, we conducted BCT using a digital platform. Eligible patient participants were Latino, ages 50 to 75 years, Spanish-speaking, and willing to participate in three virtual sessions. Recruitment and BCT materials were developed in English and Spanish, but all three sessions were held in Spanish consistent with patient preferences. The sessions included presentations on colorectal cancer screening, effective messaging to improve Latino screening participation, and brainstorming sessions to obtain feedback on messaging and materials. Summary of the new unpublished data: A total of 10 adults (7 patients and 3 clinic staff) participated in the BCT sessions. Key themes learned were 1) increasing awareness about the colonoscopy procedure (why it is important, what the procedure is, how to prepare), 2) using simple and clear wording, including statistics, and using family as a motivator, and 3) providing different patient outreach modalities to broaden reach, such as patient-facing fact sheets, videos in clinic or sent by text. Statement of the conclusions: Using BCT, we successfully incorporated feedback from Spanish-speaking Latino patients to design culturally relevant materials to promote follow-up colonoscopy after abnormal FIT results. Targeted efforts are needed to improve rates of follow-up colonoscopy among patients with abnormal FIT results in FQHC settings. (Final materials, including patient-facing fact sheets and screenshots from short videos, will be showcased in the poster.) Citation Format: Jamie H. Thompson, Jennifer Rivelli, Anne Escaron, Joanna Garcia, Esmeralda Ruiz, Evelyn Torres-Ozadali, Dawn Richardson, Priyanka Gautom, Gloria Coronado. Incorporating Latino patient input in messaging for follow-up colonoscopy after abnormal fecal testing [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-042.

Follow-up colonoscopy after an abnormal stool-based colorectal cancer screening result: analysis of steps in the colonoscopy completion process

BackgroundDelays in receiving follow-up colonoscopy after an abnormal fecal immunochemical test (FIT) result are associated with increased colorectal cancer incidence and mortality. Little is known about patterns of follow-up colonoscopy completion in federally qualified health centers.MethodsWe abstracted the medical records of health center patients, aged 50–75 years, who had an abnormal FIT result between August 5, 2017 and August 4, 2018 (N = 711). We assessed one-year rates of colonoscopy referral, pre-procedure visit completion, colonoscopy completion, and time to colonoscopy; associations between these outcomes and patient characteristics; and reasons for non-completion found in the medical record.ResultsOf the 711 patients with an abnormal FIT result, 90% were referred to colonoscopy, but only 52% completed a pre-procedure visit, and 43% completed a colonoscopy within 1 year. Median time to colonoscopy was 83 days (interquartile range: 52–131 days). Pre-procedure visit and colonoscopy completion rates were relatively low in patients aged 65–75 (vs. 50–64), who were uninsured (vs. insured) or had no clinic visit in the prior year (vs. ≥ 1 clinic visit). Common reasons listed for non-completion were that the patient declined, or the provider could not reach the patient.DiscussionEfforts to improve follow-up colonoscopy rates in health centers might focus on supporting the care transition from primary to specialty gastroenterology care and emphasize care for older uninsured patients and those having no recent clinic visits. Our findings can inform efforts to improve follow-up colonoscopy uptake, reduce time to colonoscopy receipt, and save lives from colorectal cancer.Trial registration: National Clinical Trial (NCT) Identifier: NCT03925883.

Precision Patient Navigation to Improve Rates of Follow-up Colonoscopy, An Individual Randomized Effectiveness Trial.

Colorectal cancer screening by annual fecal immunochemical test (FIT) with follow-up on abnormal results is a cost-effective strategy to reduce colorectal cancer incidence and mortality. Unfortunately, many patients with abnormal results do not complete a follow-up colonoscopy. We tested whether navigation targeted to patients who are unlikely to complete the procedure may improve adherence and long-term outcomes. Study participants were patients at a large, integrated health system (Kaiser Permanente Northwest) who were ages 50 to 75 and were due for a follow-up colonoscopy after a recent abnormal FIT result. Probability of adherence to follow-up was estimated at baseline using a predictive risk model. Patients whose probability was 70% or lower were randomized to receive patient navigation or usual care, with randomization stratified by probability category (<50%, 50% < 60%, 60% < 65%, 65% ≤ 70%). We compared colonoscopy completion within 6 months between the navigation and usual care groups using Cox proportional hazards regression. Participants (n = 415; 200 assigned to patient navigation, 215 to usual care) had a mean age of 62 years, 54% were female, and 87% were non-Hispanic white. By 6 months, 76% of the patient navigation group had completed a colonoscopy, compared with 65% of the usual care group (HR = 1.35; 95% confidence interval, 1.07-1.72; log-rank P value = 0.027). In this randomized trial, patient navigation led to improvements in follow-up colonoscopy adherence. More research is needed to assess the value of precision-directed navigation programs.

Perceptions on Barriers and Facilitators to Colonoscopy Completion After Abnormal Fecal Immunochemical Test Results in a Safety Net System

The effectiveness of stool-based colorectal cancer (CRC) screening, including fecal immunochemical tests (FITs), relies on colonoscopy completion among patients with abnormal results, but in safety net systems and federally qualified health centers, in which FIT is frequently used, colonoscopy completion within 1 year of an abnormal result rarely exceeds 50%. Clinician-identified factors in follow-up of abnormal FIT results are understudied and could lead to more effective interventions to address this issue. To describe clinician-identified barriers and facilitators to colonoscopy completion among patients with abnormal FIT results in a safety net health care system. This qualitative study was conducted using semistructured key informant interviews with primary care physicians (PCPs) and staff members in a large safety net health care system in Washington state. Eligible clinicians were recruited through all-staff meetings and clinic medical directors. Interviews were conducted from February to December 2020 through face-to-face interactions or digital meeting platforms. Interview transcripts were analyzed deductively and inductively using a content analysis approach. Data were analyzed from September through December 2020. Barriers and facilitators to colonoscopy completion after an abnormal FIT result were identified by PCPs and staff members. Among 21 participants, there were 10 PCPs and 11 staff members; 20 participants provided demographic information. The median (interquartile range) age was 38.5 (33.0-51.5) years, 17 (85.0%) were women, and 9 participants (45.0%) spent more than 75% of their working time engaging in patient care. All participants identified social determinants of health, organizational factors, and patient cognitive factors as barriers to colonoscopy completion. Participants suggested that existing resources that addressed these factors facilitated colonoscopy completion but were insufficient to meet national follow-up colonoscopy goals. In this qualitative study, responses of interviewed PCPs and staff members suggested that the barriers to colonoscopy completion in a safety net health system may be modifiable. These findings suggest that interventions to improve follow-up of abnormal FIT results should be informed by clinician-identified factors to address multilevel challenges to colonoscopy completion.

Estimating the Backlog of Colonoscopy due to Coronavirus Disease 2019 and Comparing Strategies to Recover in Ontario, Canada

Estimating the Backlog of Colonoscopy due to Coronavirus Disease 2019 and Comparing Strategies to Recover in Ontario, Canada

Development of a multivariable prediction model to identify patients unlikely to complete a colonoscopy following an abnormal FIT test in community clinics

BackgroundColorectal cancer (CRC) is the 3rd leading cancer killer among men and women in the US. The Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) project aimed to increase CRC screening among patients in Federally Qualified Health Centers (FQHCs) through a mailed fecal immunochemical test (FIT) outreach program. However, rates of completion of the follow-up colonoscopy following an abnormal FIT remain low. We developed a multivariable prediction model using data available in the electronic health record to assess the probability of patients obtaining a colonoscopy following an abnormal FIT test.MethodsTo assess the probability of obtaining a colonoscopy, we used Cox regression to develop a risk prediction model among a retrospective cohort of patients with an abnormal FIT result.ResultsOf 1596 patients with an abnormal FIT result, 556 (34.8%) had a recorded colonoscopy within 6 months. The model shows an adequate separation of patients across risk levels for non-adherence to follow-up colonoscopy (bootstrap-corrected C-statistic > 0.63). The refined model included 8 variables: age, race, insurance, GINI income inequality, long-term anticoagulant use, receipt of a flu vaccine in the past year, frequency of missed clinic appointments, and clinic site. The probability of obtaining a follow-up colonoscopy within 6 months varied across quintiles; patients in the lowest quintile had an estimated 18% chance, whereas patients in the top quintile had a greater than 55% chance of obtaining a follow-up colonoscopy.ConclusionsKnowing who is unlikely to follow-up on an abnormal FIT test could help identify patients who need an early intervention aimed at completing a follow-up colonoscopy.Trial registrationThis trial was registered at ClinicalTrials.gov (NCT01742065) on December 5, 2012. The protocol is available.

Patients without colonoscopic follow-up after abnormal fecal immunochemical tests are often unaware of the abnormal result and report several barriers to colonoscopy

BackgroundThe fecal immunochemical test (FIT) is the second most commonly used colorectal cancer (CRC) screening modality in the United States; yet, follow-up of abnormal FIT results with diagnostic colonoscopy is underutilized. Our objective was to determine patient-reported barriers to diagnostic colonoscopy following abnormal FIT in an academic healthcare setting.MethodsWe included patients age 50–75 with an abnormal FIT result between 1/1/2015 and 10/31/2017 and no documented follow-up diagnostic colonoscopy. We abstracted demographic data from the electronic health record (EHR). Study personnel conducted telephone surveys with patients to confirm colonoscopy completion and elicit data on notification of FIT results and barriers to colonoscopy. We also provided brief verbal education about diagnostic colonoscopy. We calculated frequencies of demographic data and survey responses and compared survey responses by interest in colonoscopy after education.ResultsWe surveyed 67 patients. Fifty-one were aware of the abnormal FIT result, and a majority learned of the abnormal FIT result by direct communication with providers (19, 37.3%) or EHR messaging (11, 21.6%). Overall, fifty-three patients (79.1%) confirmed lack of colonoscopy, citing provider-related (19, 35.8%), patient-related (16, 30.2%), system-related (1, 1.9%), or multifactorial (17, 32.1%) reasons. Lack of knowledge of FIT result (14, 26.4%) was most common. After brief education, 20 (37.7%) patients requested colonoscopy.ConclusionPatients with an abnormal FIT reported various multi-level barriers to diagnostic colonoscopy after abnormal FIT, including knowledge of FIT results. When provided with brief education, participants expressed interest in diagnostic colonoscopy. Future efforts will evaluate interventions to improve colonoscopy follow-up.

Standardized Workflows Improve Colonoscopy Follow-Up After Abnormal Fecal Immunochemical Tests in a Safety-Net System.

How clinical teams function varies across sites and may affect follow-up of abnormal fecal immunochemical test (FIT) results. This study aimed to identify the characteristics of clinical practices associated with higher diagnostic colonoscopy completion after an abnormal FIT result in a multi-site integrated safety-net system. We distributed survey questionnaires about tracking and follow-up of abnormal FIT results to primary care team members across 11 safety-net clinics from January 2017 to April 2017. Surveys were distributed at all-staff clinic meetings and electronic surveys sent to those not in attendance. Participants received up to three reminders to complete the survey. Of the 501 primary care team members identified, 343 (68.5%) completed the survey. In the four highest-performing clinics, nurse managers identified at least two team members who were responsible for communicating abnormal FIT results to patients. Additionally, team members used a clinic-based registry to track patients with abnormal FIT results until colonoscopy completion. Compared to higher-performing clinics, lower-performing clinics more frequently cited competing health issues (56% vs. 40%, p = 0.03) and lack of patient priority (59% vs. 37%, p < 0.01) as barriers and were also more likely to discuss abnormal results at a clinic visit (83% vs. 61%, p < 0.01). Our findings suggest organized and dedicated efforts to communicate abnormal FIT results and track patients until colonoscopy completion through registries is associated with improved follow-up. Increased utilization of electronic health record platforms to coordinate communication and navigation may improve diagnostic colonoscopy rates in patients with abnormal FIT results.

Prospective Cohort study of Predictors of Follow-Up Diagnostic Colonoscopy from a Pragmatic Trial of FIT Screening

The goal of this study was to explore diagnostic colonoscopy completion in adults with abnormal screening fecal immunochemical test (FIT) results. This was 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 federally qualified community health clinics. Diagnostic colonoscopy completion and reasons for non-completion were ascertained through a manual review of electronic health records, and completion was compared across a wide range of individual patient health and sociodemographic characteristics. Among 2,018 adults with an abnormal FIT result, 1066 (52.8%) completed a follow-up colonoscopy within 12 months. Completion was generally similar across a wide range of participant subpopulations; however, completion was higher for participants who were younger, Hispanic, Spanish-speaking, and had zero or one of the Charlson medical comorbidities, compared to their counterparts. Neighborhood-level predictors were not associated with diagnostic colonoscopy completion. Thus, completion of a diagnostic colonoscopy was relatively low in a large sample of community health clinic adults who had an abnormal screening FIT result. While completion was generally similar across a wide range of characteristics, younger, healthier, Hispanic participants tended to have a higher likelihood of completion.

Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers

BackgroundColorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own. ObjectivesThe Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention). MethodsPRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50–75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum. DiscussionThis innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers. Trial RegistrationNational Clinical Trial (NCT) Identifier: NCT03925883.

243 An Interim Analysis of a Patient Navigation Program (PNP) to Improve Colonoscopy Access After Abnormal FIT

INTRODUCTION: Colorectal cancer (CRC) is a leading cause of cancer mortality despite being largely preventable. The fecal immunochemical test (FIT) is a recommended screening method, but timely evaluation of abnormal results is critical to the effectiveness of CRC screening. Recent studies indicate low rates of follow up colonoscopy after abnormal FIT within safety net health systems. A patient navigator program (PNP) is an evidence based strategy that has been shown to improve colonoscopy completion. The aim of this study was to evaluate the effectiveness of a PNP to encourage follow up colonoscopy after abnormal FIT within a large safety net hospital system. METHODS: We established an enterprise-wide PNP at five tertiary care hospitals within the Los Angeles County Department of Health Services (LAC-DHS) system. Patients 50–75 years of age with an abnormal FIT result were assisted by the PNP to complete their follow up colonoscopy within 6 months. Here we perform an interim analysis of a prospective cohort of patients from June 1, 2018 to December 31, 2018 assisted by the PNP. We compare the effectiveness of the PNP intervention by comparing colonoscopy rates to a period prior to the intervention. We also summarize the endoscopic findings of patients undergoing colonoscopy. RESULTS: Among 1217 patients with abnormal FIT results, 43% (n = 546) were men with a mean age of 60.3 ± 6.2 years. From a previous baseline of 167 days (SD 118), the mean time from abnormal FIT to colonoscopy improved to 117 days (SD 53) with navigation. The frequency of colonoscopy completion increased in patients who received navigation (53%, n = 642) as compared to patients who did not receive navigation (40.5%, 492/1213). Among PNP patients undergoing colonoscopy (N = 642), 50.2% (n = 322) had adenomatous polyps, 24% (n = 156) had “high risk” adenomas, and 2% (n = 12) had CRC. CONCLUSION: After the introduction of a patient navigator program, there was an overall increase in patients undergoing follow-up colonoscopy after abnormal FIT within a shorter time interval. Over half of the patients undergoing colonoscopy were found to have clinically significant findings including high risk adenomas and CRC. In this interim analysis, we demonstrate that the integration of a patient navigator program for CRC screening may be instrumental in increasing adherence to recommended screening guidelines across a large safety net health system.

326 Implementation of Patient Navigators Reveals Barriers to and Increases Uptake of Colonoscopy After Positive Fecal Immunochemical Tests

INTRODUCTION: Patients with abnormal fecal immunochemical test (FIT) results require diagnostic colonoscopy to reduce mortality from colorectal cancer (CRC). Barriers to follow-up are multifactorial and include patient-, provider-, and system-level factors. Patient navigators (PN) can be effective in improving follow-up by helping patients overcome these barriers. We aimed to assess the impact of PN on clinical care processes required for colonoscopy completion after positive FIT in a large, academic health care system. METHODS: We included all UCLA Health outpatients with an abnormal FIT result between 12/1/2016 and 12/01/2018 without documentation of a colonoscopy. Two PN underwent training with a gastroenterologist and quality officer. For all FIT positive patients, PN 1) conducted a chart review to confirm lack of colonoscopy completion, 2) contacted the primary care provider when there was an inappropriate reason for lack of colonoscopy, and 3) called patients to review FIT results, encourage follow-up, address barriers, and schedule a colonoscopy. Intervention endpoints were 1) colonoscopy completion, 2) patient refusal, 3) provider felt colonoscopy inappropriate, and 4) patient left the health system. We determined the proportion of patients that reached each endpoint at 4 months and reasons providers reported that colonoscopy was not indicated after positive FIT. RESULTS: Our cohort included 131 subjects. Mean age was 62.8 (±7.3), 50.3% were female, and 49.6% were White. In all, 87 (66.4%) reached an intervention endpoint at 4 months (Figure 1). Twenty-seven (31.0%) received diagnostic follow-up: 12 (44.5%) had colonoscopy, 3 (11.1%) had CT colonography, 1 (3.7%) had sigmoidoscopy, and 11 (40.7%) reported colonoscopies outside the health system. Primary care providers that were contacted by the PN often did not feel colonoscopy was indicated (25, 19.1%), and many (10, 40.0%) cited recent colonoscopy (Table 1). There were 19 (21.8%) patients that refused follow-up colonoscopy. CONCLUSION: PN was effective in increasing diagnostic follow-up after positive FIT and revealed persistent challenges to appropriate resolution of positive FIT. Future efforts will improve provider education about appropriate use of FIT and evaluate if PN can improve timely diagnostic follow-up when tracking positive FIT patients prospectively.

Lower Abnormal Fecal Immunochemical Test Cut-Off Values Improve Detection of Colorectal Cancer in System-Level Screens

BACKGROUND & AIMS:Noninvasive tests used in colorectal cancer screening, such as the fecal immunochemical test (FIT), are more acceptable but detect neoplasias with lower levels of sensitivity than colonoscopy. We investigated whether lowering the cut-off concentration of hemoglobin for designation as an abnormal FIT result increased the detection of advanced neoplasia in a mailed outreach program.METHODS:We performed a prospective study of 17,017 uninsured patients, age 50 to 64 years, who were not current with screening and enrolled in a safety-net system in Texas. We reduced the cut-off value for an abnormal FIT result from 20 or more to 10 or more μg hemoglobin/g feces a priori. All patients with abnormal FIT results were offered no-cost diagnostic colonoscopy. We compared proportions of patients with abnormal FIT results and neoplasia yield for standard vs lower cut-off values, as well as absolute hemoglobin concentration distribution among 5838 persons who completed the FIT. Our primary aim was to determine the effects of implementing a lower hemoglobin concentration cut-off value on colonoscopy demand and yield, specifically colorectal cancer (CRC) and advanced neoplasia detection, compared with the standard, higher, hemoglobin concentration cut-off value.RESULTS:The proportions of patients with abnormal FIT results were 12.3% at the 10 or more μg hemoglobin/g feces and 6.6% at the standard 20 or more μg hemoglobin/g feces cut-off value (P = .0013). Detection rates for the lower vs the standard threshold were 10.2% vs 12.7% for advanced neoplasia (P = .12) and 0.9% vs 1.2% for CRC (P = .718). The positive predictive values were 18.9% for the lower threshold vs 24.4% for the standard threshold for advanced neoplasia (P = .053), and 1.7% vs 2.4% for CRC (P = .659). The number needed to screen to detect 1 case with advanced neoplasia was 45 at the lower threshold compared with 58 at the standard threshold; the number needed to scope to detect 1 case with advanced neoplasia increased from 4 to 5. Most patients with CRC (72.7%) or advanced adenoma (67.3%) had hemoglobin concentrations of 20 or more μg/g feces. In the group with 10 to 19 μg hemoglobin/g feces, there were 3 patients with CRC (3 of 11; 27.3%) and 36 with advanced adenoma (36 of 110; 32.7%) who would not have been detected at the standard positive threshold (advanced neoplasia Pcomparison < .001). The proportion of patients found to have no neoplasia after an abnormal FIT result (false positives) was not significantly higher with the lower cut-off value (44.4%) than the standard cut-off value (39.1%) (P = .1103).CONCLUSIONS:In a prospective study of 17,017 uninsured patients, we found that reducing the abnormal FIT result cut-off value (to ≥10 μg hemoglobin/g feces) might increase detection of advanced neoplasia, but doubled the proportion of patients requiring a diagnostic colonoscopy. If colonoscopy capacity permits, health systems that use quantitative FITs should consider lowering the abnormal cut-off value to optimize CRC detection and prevention. (ClinicalTrials.gov no: NCT01946282.)