Implementing Mailed Colorectal Cancer Fecal Screening Tests in Real-World Primary Care Settings: Promising Implementation Practices and Opportunities for Improvement.

Colorectal cancer (CRC) screening reduces morbidity and mortality, but screening rates in the USA remain suboptimal. The Colorectal Cancer Control Program (CRCCP) was established in 2009 to increase screening among groups disproportionately affected. The CRCCP utilizes implementation science to support health system change as a strategy to reduce disparities in CRC screening by directing resources to primary care clinics to implement evidence-based interventions (EBIs) proven to increase CRC screening. As COVID-19 continues to impede in-person healthcare visits and compel the unpredictable redirection of clinic priorities, understanding clinics' adoption and implementation of EBIs into routine care is crucial. Mailed fecal testing is an evidence-based screening approach that offers an alternative to in-person screening tests and represents a promising approach to reduce CRC screening disparities. However, little is known about how mailed fecal testing is implemented in real-world settings. In this retrospective, cross-sectional analysis, we assessed practices around mailed fecal testing implementation in 185 clinics across 62 US health systems. We sought to (1) determine whether clinics that do and do not implement mailed fecal testing differ with respect to characteristics (e.g., type, location, and proportion of uninsured patients) and (2) identify implementation practices among clinics that offer mailed fecal testing. Our findings revealed that over half (58%) of clinics implemented mailed fecal testing. These clinics were more likely to have a CRC screening policy than clinics that did not implement mailed fecal testing (p = 0.007) and to serve a larger patient population (p = 0.004), but less likely to have a large proportion of uninsured patients (p = 0.01). Clinics that implemented mailed fecal testing offered it in combination with EBIs, including patient reminders (92%), provider reminders (94%), and other activities to reduce structural barriers (95%). However, fewer clinics reported having the leadership support (58%) or funding stability (29%) to sustain mailed fecal testing. Mailed fecal testing was widely implemented alongside other EBIs in primary care clinics participating in the CRCCP, but multiple opportunities for enhancing its implementation exist. These include increasing the proportion of community health centers/federally qualified health centers offering mailed screening; increasing the proportion that provide pre-paid return mail supplies with the screening kit; increasing the proportion of clinics monitoring both screening kit distribution and return; ensuring patients with abnormal tests can obtain colonoscopy; and increasing sustainability planning and support.

Supply and quality of colonoscopy according to the characteristics of gastroenterologists in the French population-based colorectal-cancer screening program.

BACKGROUND: Since its complete roll-out in 2009, the French colorectal cancer screening program (CRCSP) experienced 3 major constraints [use of a less efficient Guaiac-test (gFOBT), stopping the supply of Fecal-Immunochemical-Test kits (FIT), and suspension of the program due to the coronavirus disease 2019 (COVID-19)] affecting its effectiveness. AIM: To describe the impact of the constraints in terms of changes in the quality of screening-colonoscopy (Quali-Colo). METHODS: This retrospective cohort study included screening-colonoscopies performed by gastroenterologists between Jan-2010 and Dec-2020 in people aged 50-74 living in Ile-de-France (France). The changes in Quali-colo (Proportion of colonoscopies performed beyond 7 mo (Colo_7 mo), Frequency of serious adverse events (SAE) and Colonoscopy detection rate) were described in a cohort of Gastroenterologists who performed at least one colonoscopy over each of the four periods defined according to the chronology of the constraints [gFOBT: Normal progress of the CRCSP using gFOBT (2010-2014); FIT: Normal progress of the CRCSP using FIT (2015-2018); STOP-FIT: Year (2019) during which the CRCSP experienced the cessation of the supply of test kits; COVID: Program suspension due to the COVID-19 health crisis (2020)]. The link between each dependent variable (Colo_7 mo; SAE occurrence, neoplasm detection rate) and the predictive factors was analyzed in a two-level multivariate hierarchical model. RESULTS: The 533 gastroenterologists (cohort) achieved 21509 screening colonoscopies over gFOBT period, 38352 over FIT, 7342 over STOP-FIT and 7995 over COVID period. The frequency of SAE did not change between periods (gFOBT: 0.3%; FIT: 0.3%; STOP-FIT: 0.3%; and COVID: 0.2%; P = 0.10). The risk of Colo_7 mo doubled between FIT [adjusted odds ratio (aOR): 1.2 (1.1; 1.2)] and STOP-FIT [aOR: 2.4 (2.1; 2.6)]; then, decreased by 40% between STOP-FIT and COVID [aOR: 2.0 (1.8; 2.2)]. Regardless of the period, this Colo_7 mo's risk was twice as high for screening colonoscopy performed in a public hospital [aOR: 2.1 (1.3; 3.6)] compared to screening-colonoscopy performed in a private clinic. The neoplasm detection, which increased by 60% between gFOBT and FIT [aOR: 1.6 (1.5; 1.7)], decreased by 40% between FIT and COVID [aOR: 1.1 (1.0; 1.3)]. CONCLUSION: The constraints likely affected the time-to-colonoscopy as well as the colonoscopy detection rate without impacting the SAE's occurrence, highlighting the need for a respectable reference time-to-colonoscopy in CRCSP.

The Use of the Faecal Immunochemical Test during the Covid-19 Pandemic to Triage Urgent Colorectal Cancer Referrals

Aim: During the first wave of the Covid19 pandemic in 2020, elective GI endoscopy services were abbreviated for fear of viral transmission. However, primary care continued to refer patients on the NG12 pathway. Serendipitously, a national study suggested that a new Faecal Immunochemical Test might be helpful in triaging patients with colorectal alarm symptoms. Method(s): A single centre observational study of patients referred using NG12 referral criteria between March and August [pb1] 2020. Patients were triaged to the urgent cancer pathway if FIT >= 10 mg/ml and investigated using latest NHS England guidance. Demographic data, method of investigations, cancer and polyp detection rates were compared to those observed in a cohort of patients who had been referred in the previous six months prior when FIT was not used as the triage tool (September 2019 to February 2020) when Covid 19 was not prevalent. Result(s): A total of 1192 patients with a median age of 70 years (IQ range 58-79) of which 53.9% were male, were referred using NG12 guidelines during the pandemic period compared with 1592 patients with a median age of 72 years (IQ range 59.5-91) of which 49.2% were male, in the prior six months. Colorectal cancer was detected in 45 patients, (3.2%) compared with 38 patients (2.8%) in the pre pandemic period (NS). There were two patients who turned out to have CRC despite a negative FIT. After the introduction of FIT as a triage tool, there was a significant reduction in the use of endoscopy (n = 463, 42.3% vs. n = 1186, 74.5%, P = 0.035) with a significant increase in CT scanning (n = 677, 61.2% vs. n = 750, 47.1%, P = 0.035). Conclusion(s): The use of FIT in NG12 patients triaged during the first wave of the Covid 19 pandemic reduced endoscopy but not CT scanning and did not compromise CRC detection rates. The use of FIT triage for endoscopic investigation is a safe method that aids in reducing the burden on services greatly. A negative FIT test does not absolutely exclude CRC.

Alleviating the click fatigue on clinicians to improve referrals for colorectal cancer screening

Background: The impact of clinician burnout on patient care is pervasive across medical delivery systems. The effects are also felt in preventive care where cancer screening efforts rely on clinician referrals through the electronic medical records (EMRs). Though designed to support healthcare, EMRs are a significant source of clinician burnout given the number of clicks or navigation time needed to refer a patient. This is a barrier to Patient Navigation (PN) when ordered tests do not materialize into screenings or when clinicians order labs/imaging and the pending orders are not created. This causes frustration for all clinical staff involved, delays the workflow processes, and leads to missed opportunities for PN. We implemented an 'order set' intervention to reduce the click burden linked to colorectal cancer (CRC) screening referral among clinicians in South Georgia. Methods: The 'order set' intervention was developed to facilitate PN for a Colorectal Cancer Control Program (CRCCP) aimed at implementing Evidence- Based Interventions to increase CRC screening rates in Georgia. The 'order set' was designed to address workflow issues by consolidating steps associated with CRC screening. This reduced typing input and the need to click between multiple windows within the EMR while making a referral to PN. The intervention was piloted in the Albany Area Primary Health Care (AAPHC) system after modifications were made to the EMR and clinician workflows. The monthly CRC screening rates continue to be generated and tracked post-implementation. Results: The use of the 'order set' reduced the click burden from 78 to 7 inputs and clinician EMR interaction time from 110 seconds to 29 seconds. Providers from 4/7 clinics have adopted the 'order sets' when making referrals for CRC screening. Two clinics provided post-implementation screening data. The pre-implementation screening rates for one clinic were comparable (August = 59.3%, September = 57.6%) to post-implementation (October = 56.3%, November = 56.6%, December = 57.2%), while the second clinic showed some increase (August = 58.6%, September = 60%) vs. (October = 61%, November = 62.1%, December = 62.8%). Conclusions: The 'order sets' intervention reduced the time clinicians spent creating referrals for CRC screening, including fecal immunochemical tests (FIT) and colonoscopies. Additional follow-up and rollout to clinics participating in the program is underway to evaluate further the impact of the order sets on CRC screening outcome and process measures, including qualitative interviews with clinicians. There is significant potential in the application of order sets to various workflow processes to aid in preventative health efforts. Challenges linked to the COVID-19 pandemic and staff turnover affected acquisition of patient referral data.

Risk-stratified FIT for urgent colonoscopy in Lynch syndrome: A clinical service throughout the COVID-19 pandemic

Background: Lynch syndrome (LS) is an inherited disorder characterized by pathogenic variants within mismatch repair genes resulting in an increased risk of colorectal cancer (CRC). In England, the fecal immunochemical test for Haemoglobin (FIT) is currently used in non-LS symptomatic and screening populations to guide subsequent colonoscopy. Herein, we report results from a national emergency clinical service implemented during the COVID-19 pandemic which used FIT to prioritize colonoscopy in LS patients while endoscopy services were limited. Methods: Regional genetic and endoscopy services across England were invited to participate. Patient eligibility was determined by 1) Diagnosis of Lynch Syndrome 2) Planned colonoscopic surveillance between 1 March 2020 and 31 March 2021. Requests for FIT testing from participating NHS Trusts were sent to the NHS Bowel Cancer Screening South of England Hub's Research Laboratory in Surrey. The Hub sent patients a FIT kit (OC-Sensor? (Eiken, Japan)), instructions for use, a questionnaire, and a pre-paid return envelope. Lab reports with feecal haemoglobin (f-Hb) results were returned electronically for clinical action. LS patients were risk-stratified for colonoscopy based upon the following f-Hb thresholds: (1) f-Hb ≥10mg of Haemoglobin (Hb)/g (mg/g) faeces: triaged for colonoscopy via an urgent two-week wait (2WW) pathway, (2) f-Hb ≤10mg/g: schedule patients for colonoscopy within 6-12 weeks, where local endoscopy service availability permits. Results: Fifteen centers across England participated in the clinical service from 9th June 2020 to 31st March 2021. An uptake rate of 64% was observed from this cohort (375/588 invites), though 21 cases were removed from analysis due to repeat FITs, insufficient sample, missing clinical data, or FIT completed after colonoscopy. Of the remaining 354 patients analyzed, 269 patients (76%) had a f-Hb of <6mg/g. 6% (n=23) of patients had a f-Hb that was at or between greater than the limit of detection of the assay (≥6mg/g) yet below 10mg/g.18% (n=62) had FIT results of ≥10mg/g and met criteria for urgent colonoscopy triage via the 2WW pathway. Of the 62 urgently triaged patients, 22 had detectable adenomas, 6 had advanced adenomas (AAs), and 4 were diagnosed with CRC (table). Conclusions: The utility of FIT during the pandemic has demonstrated clinical value for LS patients requiring CRC surveillance. Further longitudinal investigation on the efficacy of FIT in people with LS is warranted and will be examined as part of the multi-center prospective research study “FIT for Lynch Syndrome” (ISRCTN15740250) which is presently recruiting patients in the UK.

FAECAL IMMUNOCHEMICAL TEST CHARACTERISTICS IN A 2 WEEK REFERRAL PATHWAY: A RELIABLE GATEKEEPER

Introduction Faecal Immunochemical testing (FIT) has become an important part of colorectal cancer referral pathways over the last few years. Implementation has been expediated by the Covid pandemic. FIT is increasingly used in primary care in conjunction with high risk symptoms and anaemia to direct referral for further investigation. This investigates the outcomes of patients referred to a large NHS Trust on a lower GI two week wait pathway and compares outcomes in those with and without an initial FIT test. Methods A total of 363 patients were from 1st to 28th February 2021, with information and result gathered from clinic letters and Trust IT systems. The FIT test result was recorded where it had been performed. Positive predictive value (PPV) and negative predictive value (NPV) were calculated to asses FIT performance and outcomes were stratified by FIT positivity. Results The majority of patients referred (275 of 363 patients or 75.54%) underwent FIT as part of their lower GI pathway referral. More than half had a positive FIT result of 10 7ug/ ml or greater (176/275, 64%). 14 out of 275 patients (5.09%) were found to have colorectal cancer. The overall PPV of FIT was 7.8%. PPV was higher in those with FIT >400 (38.5%). The PPV in those with FIT 10-49 was relatively low at 6.5% (5/91). Among 99 patients with negative FIT, 2 patients (2.0%) were found to have colorectal cancer, giving FIT a high NPV of 98.88%. Both patients presented with symptoms including weight loss (but no anaemia) and were diagnosed on CT imaging. Both had extensive metastatic disease at diagnosis. In the group who had not undergone FIT testing, 7 out of 88 (8.0%) were found to have cancer. Conclusions The majority of the patients referred had FIT initially, although continuous improvement is still needed to achieve the aim of all patients undergoing FIT prior to referral. The considerably higher PPV of FIT >400 compared to 10-49 demonstrates how the FIT value can be used to prioritise appropriate investigations and urgency to those with the highest diagnostic yield. As part of a lower GI pathway, there were two FIT negative cancers but these were both picked up on CT scans due to the associated presence of weight loss at presentation. This should reassure referrers that FIT negative patients without anaemia or weight loss do not need urgent referral.

ROLE OF FIT AND CT ABDOMEN-PELVIS IN PRIORITISING DIAGNOSTIC COLONOSCOPY FOR COLORECTAL CANCER

Introduction COVID-19 has resulted in many new challenges for healthcare services. Colonoscopy, which is the gold standard investigation for diagnosis of colorectal cancer (CRC), has been significantly impacted with cessation of services during peak corona virus outbreaks with significant backlog. Several strategies have been proposed to address this. One of the main approaches is to risk stratify patients using a quantitative faecal immunochemical test (qFIT) alone or in combination with CT scan. Our study assessed the adherence of Bedford Hospital NHS Foundation Trust in performing both qFIT and CTAP with Iv contrast prior to colonoscopy referral. This study also evaluated the sensitivity of qFIT and CTAP both individually and in combination of missing a cancer when used as a triage service for prioritisation of colonoscopy. Methodology Data was collected retrospectively from all colonoscopies performed in Bedford hospital, from June to August 2020, totalling 470 patients. Results Average patient age was 59.9 years, with an age range of 19 to 90 years old. 55% were males and 45% were females. 45% (210) patients had a FIT performed pre colonoscopy. 129 patients had positive FIT. Overall, 35% (164) of patients underwent CTAP prior to colonoscopy. 125 patients underwent both FIT and CTAP prior to colonoscopy. Individually, FIT had a positive predictive value (PPV) and negative predictive value (NPV) of 6.2% and 98.7% with respect to diagnosing CRC. CTAP had a PPV and NPV of 42.9% and 100%. Performing FIT and CTAP in combination had a PPV and NPV of 28.6% and 100% respectively. Conclusion Sensitivity of single qFIT is low and can miss cancers if used alone. Therefore, it should not be utilised as a single test for triage in community for prioritising colonoscopy in symptomatic patients. The risk of missing a cancer can be reduced by CTAP with Iv contrast as an add on test with negative predictive value of 100%.

IMPROVING COLORECTAL CANCER SCREENING IN A SAFETY NET CLINIC THROUGH A RETURN- BY-MAIL FECAL IMMUNOCHEMICAL TEST PROGRAM

STATEMENT OF PROBLEM/QUESTION: Can establishing a return-bymail fecal immunochemical test (FIT) program increase the colorectal cancer screening rate in a safety net primary care clinic? DESCRIPTION OF PROGRAM/INTERVENTION: Colorectal cancer (CRC) screening rates are typically lower in safety net health systems. This trend has been exacerbated by the COVID-19 pandemic, which has limited access to colonoscopy for screening. There is evidence that FITs are costeffective and mailed FIT programs can increase screening rates for vulnerable patients. We implemented a return-by-mail FIT program in the adult primary care clinic of New York City Health + Hospitals/Bellevue, a public safety net hospital. We evaluated adults aged 50-75 who were not up to date with CRC screening. All patients due for CRC screening were only offered FIT as a screening modality. We implemented a partial mailed FIT program, in which FIT tests picked up in clinic could be returned by mail directly to the lab. Prior to our intervention, patients were required to return FITs to the clinic in person. MEASURES OF SUCCESS: We evaluated FIT completion rates within our clinic 30 days before and after the introduction of return-by-mail FIT kits in July 2021. We also evaluated our clinic's pre- and post-intervention performance relative to other clinics within the New York City Health + Hospitals system using claims data. Additionally, we randomly surveyed patients who received a FIT and did not complete it in the period prior to our intervention to assess reasons for incompletion. FINDINGS TO DATE: A total of 5,153 and 5,180 patients aged 50-75 were seen in clinic 30 days before and 30 days after the implementation of a mailed FIT program. 571 patients were provided a return-in-person FIT kit 30 days prior to our intervention. Of these patients, 289 (50.6%) completed a FIT. By contrast, 781 patients were provided a return- by-mail FIT kit 30 days following our intervention. Of these patients, 464 (59.4%) completed a FIT (p < 0.01). Additionally, the proportion of patients who completed annual CRC screening prior to our intervention was lower in our clinic (48.2%) compared to the average across the New York City public hospital system (51.4%) according to managed care Medicaid claims data (MetroPlus, June 2021). Four months following our intervention, our clinic's year-to-date CRC screening rate exceeded the average system-wide rate (59.3% vs. 57.6%, November 2021). We also called 45 patients who were provided a FIT test prior to our intervention and did not complete it. 12 patients were reached, and 2 of these patients cited difficulty dropping off the test as the primary barrier to FIT completion (16.7%). KEY LESSONS FOR DISSEMINATION: By implementing a return-bymail FIT program, we were able to increase our clinic's CRC screening rate by 8.8%. Our data are similar to previous programs implementing mailed FIT programs in safety net patient populations. Future aims are to implement a mail-to-patient FIT program in addition to our initial return-by-mail program.

CHANGING PERFORMANCE OF COLORECTAL CANCER SCREENING FOLLOWING A COVID-19 PANDEMIC IN KOREA

Background/Aim: It is easy to predict that the actual COVID-19 pandemic would have had a negative impact on cancer screening activities and the outcomes of screenings, but to date, real-time population-based evidence to substantiate this concern is very scarce. In this study, to understand the changes in the behavior and performance of CRC screening following the COVID-19 pandemic, the indicators of CRC screening processes and outcome measures were compared with both monthly data in 2019 and monthly changes focusing on the peaks that appeared in 2020. Method: This population-based nationwide study used fecal immunochemical test (FIT) and colonoscopy claims data from the Korean National Health Insurance System (NHIS) from 2019 to 2020. Data were analyzed from 15,867,759 subjects in 2019 and 16,155,930 subjects in 2020. We compared the data of CRC screening (FIT/ colonoscopy) of the COVID-19 pandemic period (2020) with those of the same period of 2019. Result: In the COVID-19 period, 3,445,660 (21.3%) subjects underwent FIT, whereas in 2019, 6,490,707 (40.9%) subjects performed FIT (almost 2-fold). Participation rate in colonoscopy after FIT positive fell in 2020 by 36.0% compared with the average rate recorded in 2019 (44.5%). In particular, it was confirmed that the participation rate of the CRC screening further decreased immediately after the COVID-19 peak periods (first and second wave: March 2020 and August 2020). Conclusion: The overall adherences to CRC screening tests decreased substantially during COVID-19 pandemic. Therefore, urgent modulation for not only easier access but also planning a restart for CRC screening is needed to address the growing burden of under-detected CRC in Korea.

DIAGNOSTIC YIELD OF FIT IN COLO-RECTAL CANCER AND INFLAMMATORY BOWEL DISEASE WITHIN A LONDON DISTRICT GENERAL HOSPITAL

Introduction Faecal immunochemical test (FIT) has been introduced as an effective screening test for colorectal cancer in the general population and colonoscopy is the gold standard test for confirmation of colon cancer. Due to the emergence of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pandemic, endoscopy services were severely reduced to emergency only in order to minimise COVID-19 infection spread throughout the world. Subsequently, FIT has been used as a triage tool to refer urgently (2 week wait cancer pathway) along with other alarm symptoms, e.g. anaemia, weight loss and change in bowel habit;to endoscopy services in the UK. The aim of this study was to determine the diagnostic efficacy of FIT in colorectal disease within a London based district general hospital. Secondary aims including assessing whether FIT has any diagnostic efficacy in inflammatory bowel disease (IBD). Methods From March to December 2020 all cases referred to the 2 week wait cancer pathway were analysed. The FIT score as well as well as presenting alarm symptoms were recorded prior to further investigation. The post colonoscopy outcome was also recorded to assess which patients were diagnosed with Colo-rectal cancer. Results There were 386 cases referred under 2 weeks wait cancer pathway. Of them 137 had positive FIT (>10 microgram/gram). Only 12 of those had colorectal cancer diagnosed on colonoscopy (8.8%). Median age of 68.5 (the range 44- 90 years), 58 % female and 42% were male respectively. The sensitivity of FIT in colorectal cancer diagnosis was 90% with a specificity of 48%, positive predictive value (PPV) was 6% and negative predictive value (NPV) 99%, However, out of 137 FIT positivity, there were 14 cases diagnosed inflammatory bowel disease (IBD, 13 Ulcerative colitis and 1 Crohn's disease). The sensitivity of FIT in diagnosing IBD was 93%, and specificity was 49% The PPV is 8% and NPV 99%. The Median age 56 (range 25-82 years), 57% were male and 43% were female. Those with a positive FIT and new IBD diagnosis appeared to be a younger, male dominant group. Conclusion FIT is a useful Colo-rectal cancer screening tool within the general population though its diagnostic yield is low. Its use has dramatically increased throughout the pandemic allowing a release of pressure off 2 week wait services with fewer referrals in FIT negative patients. Using FIT as a rule out method should be approached with caution as it is clear some Colo-rectal malignancies can present as FIT negative. FIT may also have a potential in assisting the diagnosis of IBD, in particular ulcerative colitis, within a younger group of the population though remains inferior to faecal calprotectin. Judicious use of the FIT in specific age groups is recommended in order to minimise both patient and practitioner anxiety and unnecessary referral.

IDENTIFYING OPPORTUNITIES IN A TIME OF CRISIS: THE IMPACT OF COVID-19 ON AN ORGANIZED COLORECTAL CANCER SCREENING PROGRAM IN ONTARIO, CANADA

Background: Ontario Health (Cancer Care Ontario) oversees ColonCancerCheck (CCC), Ontario's population-based organized colorectal cancer (CRC) screening program. CCC recommends average risk screening with the fecal immunochemical test (FIT), but colonoscopy is available opportunistically. A central lab mails FIT kits directly to people upon request from care providers. CCC's recommendations are promoted centrally with Regional Cancer Programs and regional clinical leaders. At the start of the COVID-19 pandemic, FIT kit mailing and mailed letters to invite/remind people to screen were paused. Colonoscopy capacity varied with the waves of the pandemic depending on local factors. Subsequently, CCC gradually implemented recovery activities, such as resuming FIT kit and letter mailing, and provided guidance on screening prioritization, which included conversion of low yield colonoscopy to FIT. Aim: To understand the impact of COVID-19 on CRC screening in Ontario across four periods: pre-, early-, mid- and late-COVID-19. Methods: We compared key performance indicators over time: percent overdue for CRC screening, FIT requisition volumes, FIT requisition rejection rates, FIT kit return rates, colonoscopy volumes and colonoscopy wait times. Results: Comparing pre- to late-COVID-19 periods, the percent of people overdue for CRC screening increased (39.5% vs. 43.1%). An increase in FIT participation was observed, with greater volumes of FIT kits being requested (101,925 vs. 119,113 per month) and improved FIT kit return rates (54.7% vs. 60.8%). However, FIT requisition rejection rates also increased (5.7% vs. 15.0%). Overall colonoscopy volumes declined (24,432 vs. 21,317 per month), with decreases in average risk screening colonoscopy (15.5% vs. 9.9%). The proportion of people getting a colonoscopy within 8 weeks of an abnormal FIT result improved (81.2% vs. 83.5%). Interpretation: While screening performance declined at the start of the pandemic, as screening activities resumed, it has improved in key areas, even exceeding pre-COVID metrics: greater FIT participation, a reduction in average risk screening colonoscopies, and improved colonoscopy wait times for abnormal FIT. Fewer patient-provider interactions and participant reluctance to seek healthcare may have led to an increase in the number of people overdue for CRC screening. CCC's centralized approach to FIT distribution and its pandemic response, including consistent messaging and a regional infrastructure, facilitated the uptake of pandemic guidance and may have led to improved performance. Conclusions: These results suggest that there are opportunities for organized screening programs to improve performance during times of crisis. Sustaining these program performance improvements post-pandemic is essential if CRC screening participation is to return to pre-pandemic levels. (Table Presented)

CHANGE IN COLORECTAL CANCER SCREENING PATTERNS IN A SAFETY-NET HOSPITAL AND A PRIVATE HEALTH SYSTEM DURING THE COVID-19 PANDEMIC

Background The COVID-19 pandemic led to significant alterations in the delivery of cancer screening. The resulting decrease in outpatient visits and cancellations of non-urgent procedures have negatively affected colorectal cancer (CRC) screening, though the impact on different types of healthcare systems remains unclear. We aimed to quantify and compare the effect of the first wave of the pandemic on CRC screening uptake at a safety-net hospital and a private health system based in New York City (NYC). Methods In this retrospective study, we identified individuals aged 50 to 75 years presenting for outpatient care at a safety-net public hospital (Bellevue Hospital) and private health system (NYU Langone Health) in March through September of 2019 and 2020 (first wave of the pandemic in NYC). We excluded those who were up-to-date with CRC screening before each study period or had a prior diagnosis of CRC, hereditary cancer syndrome, inflammatory bowel disease, or colectomy. The primary outcome was the proportion of screening-eligible patients seen in the outpatient setting who underwent CRC screening. Results The safety-net hospital had a total of 9,569 outpatient visits in 2019 and 7,280 in 2020. Overall, 552 (5.8%) and 289 (4.0%) screening tests were completed in 2019 and 2020, respectively (p < 0.01). Of these, there were 382 (69.2%) fecal immunochemical tests (FIT) in 2019 and 256 (88.6%) in 2020 (p < 0.01). For individuals who had positive FIT results, 17.2% in 2019 and 25.0% in 2020 had colonoscopy follow-up within 6 months (p = 0.62). A total of 5 and 3 cases of CRC were diagnosed in 2019 and 2020, respectively. In the private health system, there were 99,889 visits in 2019 and 33,849 in 2020. Overall, 658 (0.66%) and 250 (0.74%) completed screening tests in 2019 and 2020, respectively (p = 0.13). Of the screening tests, 518 (78.7%) were FIT in 2019 and 206 (82.4%) were in 2020 (p = 0.22). Of the positive FIT results, 29.4% in 2019 and 27.0% in 2020 had colonoscopy follow-up within 6 months (p = 0.80). A total of 97 and 43 CRC cases were diagnosed in 2019 and 2020, respectively. Conclusion In our study of a safety-net hospital and a private health system in NYC, outpatient volume and absolute numbers of screening tests and CRC diagnoses decreased for both institutions during the COVID-19 pandemic. We observed a decrease in screening rate and increase in proportional FIT use in the public hospital but not the private health system. Although colonoscopy follow-up rate after positive FIT results were low for both institutions, which may reflect incomplete capture of colonoscopy examinations, there were no differences before and during the pandemic. (Table Presented) (Table Presented)

OPTIMIZATION OF A PROGRAMMATIC MAILED FECAL IMMUNOCHEMICAL TEST INITIATIVE FOR COLORECTAL CANCER SCREENING IN THE ERA OF COVID-19

Introduction The COVID-19 pandemic led to a sharp decrease in colorectal cancer screening rates as all non-urgent procedures, including average-risk screening colonoscopies, were suspended for infection control and resource conservation. In response to pandemic restrictions, many organizations have turned to alternative strategies such as fecal immunochemical test (FIT) outreach programs. Though prior randomized controlled trials have demonstrated success of mailed programmatic stool test initiatives, there are few studies examining specific strategies for delivering such programs. Methods Baseline pre-intervention FIT completion data was obtained between March 2020 and July 2020 at the Providence VA Medical Center. We then implemented a programmatic mailed FIT initiative at a single community-based outpatient clinic between February 2021 and August 2021 by 1) identifying all patients due for average risk colorectal cancer screening through a VA database, 2) sending primer letters and a brief survey to confirm average risk, 3) mailing FIT kits and 4) sending reminder letters 4 weeks after mailed FIT kits. The primary endpoint was overall FIT completion rate. Secondary endpoints included survey response rate, completed FIT after initial mailing and reminder letter, positive FIT rate, and rate of colonoscopy completion for positive FIT. Results Baseline FIT completion rate prior to the intervention was 29.8% (148/497). A total of 378 patients were identified through the database as being due for average risk colorectal cancer screening and were sent primer letters with surveys. 36.5% (138/378) of patients responded to the survey and 23.3% of those who responded (32/138) were found to be at increased risk and were removed from the FIT mailing list. 36.9% (126/347) of patients completed their FIT within 4 weeks of initial kit mailing. An additional 6.7% (15/221) returned their FIT after a reminder letter. The overall FIT completion rate after our interventions was 40.6% (141/347) which was a statistically significant improvement compared with the pre-intervention group (p=0.0012 using Fisher's exact test). 8.5% (12/141) of patients who completed their FIT had a positive result. Of these patients, 58.3% (7/12) had documented colonoscopy completion within 6 months of positive FIT and 41.6% (5/12) either declined the procedure or were unresponsive to scheduling attempts. Conclusion Programmatic mailed FIT outreach is an effective strategy to enhance colorectal cancer screening. Primer and reminder letters are a simple yet effective steps for improving mailed FIT completion rates. Further studies are needed to validate these methods to optimize averagerisk colorectal cancer screening, particularly in the era of COVID-19 where colonoscopy capability is limited at many centers. (Figure Presented)

IMPACT OF THE COVID-19 PANDEMIC ON FECAL IMMUNOCHEMICAL TESTING, COLONOSCOPY SERVICES, AND COLORECTAL NEOPLASIA DETECTION IN A LARGE UNITED STATES COMMUNITY-BASED POPULATION

Background and Aims: The COVID-19 pandemic profoundly impacted clinical services globally, including colorectal cancer (CRC) testing such as fecal immunochemical test (FIT) screening and colonoscopy. We investigated the impact of the pandemic on FIT and colonoscopy utilization, and colorectal neoplasia detection in a large community-based population in the United States. Methods: We performed a retrospective cohort study of patients ages 18-89 years undergoing FIT screening or colonoscopy in 2019 and 2020 within Kaiser Permanente Northern California (KPNC), a large integrated healthcare organization. We calculated percentage changes in FIT kits mailed, FITs completed, positive FITs, colonoscopies performed overall and by indication, and colorectal neoplasia detection (advanced adenoma and CRC) in 2020 compared to 2019. Results: FIT kit mailings ceased in mid- March through April 2020 but rebounded thereafter leading to an 8.7% increase in total FIT kits mailed in 2020 compared to 2019. However, with the later mailing of FIT kits, there were 9.0% fewer FITs completed and 10.1% fewer positive tests in 2020 compared to 2019. Colonoscopy volumes nadired in April 2020, with a 79.4% reduction compared with April 2019, but recovered to near pre-pandemic monthly volumes in September through December 2020. However, overall, there was a 26.9% decline in colonoscopies performed in 2020 compared to 2019. Declines of 41.5%, 38,3%, 19.9%, and 20.0% were seen for screening, surveillance, diagnostic, and FIT positive colonoscopies, respectively, in 2020 compared to 2019. With the gradual recovery of colonoscopy volumes after the initial pandemic lockdown, by November and December 2020 the numbers of patients with advanced adenomas or CRC detected by colonoscopy were comparable to those same months in 2019. However, the total number of patients with advanced adenomas or CRC detected by colonoscopy declined by 26.9% and 8.7%, respectively, in 2020 compared to 2019. Conclusions: The COVID-19 pandemic led to fewer FIT screenings and colonoscopies performed in 2020 compared with 2019. However, after the lifting of regional lockdowns, FIT screenings exceeded, and colonoscopy volumes nearly reached numbers from those same months in 2019. Overall, the pandemic led to 27% and 9% reductions in advanced adenoma and CRC detection, respectively, in 2020 compared to 2019, validating concerns about the potential for stage progression for cancers that went undetected due to the pandemic. Strategies to identify high-risk patients for expedited colonoscopy procedure scheduling and resolve remaining colonoscopy procedure backlogs are needed to mitigate this risk.(Figure Presented)Figure 1. Number of FIT kits mailed, completed, and positive in 2019 and 2020(Figure Presented)Figure 2. Number of colonoscopies and advanced adenomas and colorectal cancers detected by colonoscopy in 2019 and 2020

INCREASE IN COLORECTAL CANCER SCREENING IN A SAFETY-NET HOSPITAL AFTER IMPLEMENTING MAIL-ABLE FECAL IMMUNOCHEMICAL TESTS

Background Colorectal cancer (CRC) screening rates are typically lower in public safety-net hospital systems, and optimal screening modalities have yet to be determined in this population. There is evidence that fecal immunochemical test (FIT) is a cost-effective approach in this setting, especially as the COVID-19 pandemic decreased the accessibility of colonoscopy. Mailed FIT outreach programs have been shown to markedly increased CRC screening for vulnerable patients. However, there is limited evidence regarding individual facets of these programs, such as returning FIT by mail. In the process of establishing a complete mailed FIT program during the pandemic, we evaluate the effect of allowing patients to mail back a completed FIT they received in person. Methods Patients at a safety-net hospital in New York City aged 50-75 who were not up to date with CRC screening were evaluated. We included patients 30 days before and after the implementation of mail-able FIT kits in July 2021. All patients due for CRC screening were only offered FIT as a screening modality, and prior to the intervention were required to visit the clinic to both obtain and return the FIT. We implemented a partial mailed FIT program, in which FITs picked up in clinic can be mailed directly to the lab after completion. We also randomly surveyed patients who received a FIT and did not complete it in the period prior to our intervention to assess reasons for incompletion. Results A total of 5,153 and 5,180 patients aged 50-75 were seen in clinic 30 days prior and 30 days after the implementation of the mail-able FIT kit respectively. A total of 571 patients were provided a FIT kit that required a return trip to the clinic for completion. Of these patients, 289 (50.6%) completed a FIT. In comparison, there were a total of 781 patients who were provided a FIT kit allowed to be mailed back for completion. Of these patients, 464 (59.4%) completed a FIT (p < 0.01). A total of 45 patients with an incomplete FIT prior to the intervention were called, and 12 patients were reached. Of these patients, 10 endorsed forgetting about the test, and 2 endorsed difficulty scheduling time to drop off the test. Conclusion Organized mailed FIT outreach was previously shown to improve CRC screening in a safety-net setting. We have further shown that implementing a program with FIT kits that can be mailed back significantly improves screening. While our mail-able kits would improve screening in patients with difficulty returning to clinic, many in our population would potentially benefit from reminders to complete. Future work could assess long-term completion rates of our program, and compare it with a full mailed FIT outreach program to quantify the potential increased benefit of also mailing kits to patients.

EFFECTIVENESS OF OPT-IN VERSUS OPT-OUT TEXT MESSAGE-BASED OUTREACH FOR COLORECTAL CANCER SCREENING

Background and Aims: Reliance on in-visit, opt-in screening for colorectal cancer (CRC) may be an obstacle to screening, especially during the COVID-19 pandemic and among low income and vulnerable populations. We aim to describe and evaluate the effectiveness of a CRC screening outreach campaign in a safety-net health system testing opt-out and opt-in text message outreach followed by mailed fecal immunochemical test (FIT) kits. Methods: From November 2020 to April 2021, the outreach campaign targeted patients ages 50-75 from 11 primary care clinics within the San Francisco Health Network who had previously completed a FIT test and were overdue for CRC screening. Patients were assigned to receive a language-concordant, pre-alert text message notifying that they would be mailed a FIT kit 1) unless they opted out of receiving a kit or 2) if they opted in to receiving a kit. The primary outcome was screening participation at 3 months after outreach. Results: A total of 371 patients were assigned to receive opt-out text messages and 522 received opt-in text messages. FIT kits were mailed to 96.5% (n = 358) of the opt-out group and 19.3% (n = 101) of the opt-in group. Screening uptake at 3 months was significantly higher in the optout group than in the opt-in group (58.8% vs. 18.0%, P < 0.001;difference = 40.8%, 95% confidence interval 34.8%-46.8%). Black/African American patients had lower screening rates (33.3% in opt-out group and 9.4% in opt-in group) compared to Hispanic/Latino (53.3% in opt-out group and 26.7% in opt-in group) and Asian (66.7% in opt-out group and 26.7% in opt-in group) patients. Conclusions: During the COVID-19 pandemic, optout text messaging followed by mailed FIT kits improved population-level CRC screening rates in a safety-net health system. Tailored initiatives are needed to address low screening rates for Black/African American patients.

Participation in a government-subsidised colorectal cancer screening programme for asymptomatic individuals in Hong Kong.

BACKGROUND: A Government-subsidised colorectal cancer screening programme (CRCSP) was launched in Hong Kong. This study aimed to assess the participation rate in CRCSP among Chinese individuals between the ages of 50 and 75 years and to survey individuals' reasons for declining to participate in the CRCSP. METHODS: A cross-sectional study was performed. Asymptomatic Chinese individuals aged 50-75 years in Hong Kong who did not have a history of colorectal cancer were recruited. A survey was used to collect information about individuals' participation in the CRCSP. RESULTS: The survey was completed by 1317 participants. Of these, 432 (32.8%) joined the CRCSP and the remaining 885 participants (67.2%) did not join the CRCSP. The most common reason that participants provided for not joining the CRCSP was thinking that the screening was not necessary because they had no health problems (29.3%). Some (14.4%) of the participants claimed to lack information about the CRCSP and screening procedures. Some (12.5%) of them completed the screening before the CRCSP was launched, and the cost was covered by other sources. CONCLUSION: The participation in CRCSP for a screening among the Hong Kong population has generally increased, but obstacles to participating in screening programme remain.

Implementing evidence-based interventions (EBI) to increase uptake of fecal immunochemical test (FIT) colorectal cancer (CRC) screening in Vulnerable Populations

Purpose: We partnered with a local Federally Qualified Health Center (FQHC) to test implementation of evidence-based interventions (EBI) promoting Fecal Immunochemical Test (FIT) CRC screening in an environment in which colonoscopy has been the prevailing screening strategy. We report on implementation adaptations and preliminary results. Background: Sociocultural and medical concerns are barriers to colonoscopy uptake in some populations. An additional barrier to CRC screening is system level capacity for colonoscopy that results in a back log of cases and long wait times. With Covid-19, the additional backlog in overdue CRC screening has underscored the need to expand FIT testing capacity to address screening needs and to pre-empt further racial/ethnic and SES disparities in CRC outcomes. This trial tests the unique and additive value of multiple EBIs for increasing CRC screening (primarily through FIT testing, but also colonoscopy when indicated) while evaluating the success of implementing these approaches. EBIs include the use of medical reminders, addressing the structural barriers (social determinants of health [SDOH]), and assistance from community health workers. Methods: Participants (3500), ages 45-75, were identified from a large FQHC in New Haven, CT and determined to be overdue for CRC screening. Participants were randomly assigned to one of the four arms of the study: 1) Provider reminder (overdue for CRC screening) only;2) Provider Reminder + SDOH short message and one-size-fits all link to resources;3) Provider Reminder + SDOH short message and offer for individualized navigation (trained navigators from local community) to address SDOH and other barriers;4) Provider Reminder + offer to participate in a CRC educational program as phase 2 of the NCI's Screen to Save program (not an EBI). Preliminary data on uptake of CRC screening will be presented. Results: With input from stakeholders, we have: 1) lowered age eligibility from 50 to 45 to align with new guidelines;2) expanded the target population to 2 additional satellite clinics, more than doubling the proposed study enrollment;3) incorporated design changes in the patient reminders. The collaboration between research team and clinician stakeholders has been critical in minimizing disruptions to clinical workflow while assuring fidelity to the evidence-based interventions. Preliminary outcomes (within one month of intervention) on uptake of intervention across the 4 arms of the study, i.e., referral for CRC screening and test completion will be presented. Conclusion: The unique challenges of this urban community of primarily African American/Black, Hispanic/Latinx and/or low socioeconomic status individuals stem from the disproportionate burden of SDOH barriers. Findings will inform primary care setting implementation of EBIs to address the anticipated increase in disparities in CRC screening, exacerbated by COVID-19 changes in health care access and utilization, as well as the increased demand associated with the change in guidelines.