Mailed fecal immunochemical test outreach for colorectal cancer screening: Summary of a Centers for Disease Control and Prevention-sponsored Summit.

Uptake of colorectal cancer screening remains suboptimal. Mailed fecal immunochemical testing (FIT) offers promise for increasing screening rates, but optimal strategies for implementation have not been well synthesized. In June 2019, the Centers for Disease Control and Prevention convened a meeting of subject matter experts and stakeholders to answer key questions regarding mailed FIT implementation in the United States. Points of agreement included: 1) primers, such as texts, telephone calls, and printed mailings before mailed FIT, appear to contribute to effectiveness; 2) invitation letters should be brief and easy to read, and the signatory should be tailored based on setting; 3) instructions for FIT completion should be simple and address challenges that may lead to failed laboratory processing, such as notation of collection date; 4) reminders delivered to initial noncompleters should be used to increase the FIT return rate; 5) data infrastructure should identify eligible patients and track each step in the outreach process, from primer delivery through abnormal FIT follow-up; 6) protocols and procedures such as navigation should be in place to promote colonoscopy after abnormal FIT; 7) a high-quality, 1-sample FIT should be used; 8) sustainability requires a program champion and organizational support for the work, including sufficient funding and external policies (such as quality reporting requirements) to drive commitment to program investment; and 9) the cost effectiveness of mailed FIT has been established. Participants concluded that mailed FIT is an effective and efficient strategy with great potential for increasing colorectal cancer screening in diverse health care settings if more widely implemented.

Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence.

OBJECTIVE: We evaluated whether people who had not completed a faecal immunochemical test (FIT) for colorectal cancer (CRC) screening would complete a blood-based testing option if offered one during health encounters. Blood-based screening tests for CRC could add to the total number of people screened for CRC by providing another testing alternative. DESIGN: Study participants were patients aged 45-75 years at a large, integrated health system who were offered but did not complete an FIT in the prior 3-9 months and were scheduled for a clinical encounter. Individuals were randomised (1:1) to be offered a commercially available CRC blood test (Shield, Guardant Health) versus usual care. We compared 3-month CRC screening proportions in the two groups. RESULTS: We randomised 2026 patients; 2004 remained eligible following postrandomisation exclusions (1003 to usual care and 1001 to blood draw offer; mean age: 60, 62% female, 80% non-Hispanic white). Of the 1001 allocated to the blood test group, 924 were recruited following chart-review exclusions; 548 (59.3%) were reached via phone, of which 280 (51.1%) scheduled an appointment with the research team. CRC screening proportions were 17.5 percentage points higher in the blood test group versus usual care (30.5% vs 13.0%; OR 2.94, 95% CI 2.34 to 3.70; p<0.001). CONCLUSION: Among adults who had declined prior CRC screening, the offer of a blood-based screening test boosted CRC screening by 17.5 percentage points over usual care. Further research is needed on how to balance the favourable adherence with lower advanced adenoma detection compared with other available tests. TRIAL REGISTRATION NUMBER: NCT05987709.

Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Developing patient-refined colorectal cancer screening materials: application of a virtual community engagement approach.

INTRODUCTION: In partnership with a federally qualified health center (FQHC), an adapted virtual version of boot camp translation (BCT) was used to elicit input from Spanish-speaking Latino patients and staff to develop messaging and patient education materials for follow-up colonoscopy after abnormal fecal testing. We describe how we adapted an existing in-person BCT process to be delivered virtually and present evaluations from participants on the virtual format. METHODS: Three virtual BCT sessions were facilitated by bilingual staff and conducted via Zoom. These sessions included introductions and discussions on colorectal cancer (CRC), CRC screening, and gathered feedback from participants on draft materials. Ten adults were recruited from the FQHC. A research team member from the FQHC served as the point of contact (POC) for all participants and offered Zoom introductory sessions and/or technology support before and during the sessions. Following the third session, participants were invited to complete an evaluation form about their virtual BCT experience. Using a 5-point Likert Scale (where 5 = strongly agree), questions focused on session utility, group comfort level, session pacing, and overall sense of accomplishment. RESULTS: Average scores ranged from 4.3 to 5.0 indicating strong support towards the virtual BCT sessions. Additionally, our study emphasized the importance of a POC to provide technical support to participants throughout the process. Using this approach, we successfully incorporated feedback from participants to design culturally relevant materials to promote follow-up colonoscopy. CONCLUSION: We recommend ongoing public health emphasis on the use of virtual platforms for community engaged work.

Mail-Based Self-Sampling to Complete Colorectal Cancer Screening: Accelerating Colorectal Cancer Screening and Follow-up Through Implementation Science.

Introduction: Leveraging cancer screening tests, such as the fecal immunochemical test (FIT), that allow for self-sampling and postal mail for screening invitations, test delivery, and return can increase participation in colorectal cancer (CRC) screening. The range of approaches that use self-sampling and mail for promoting CRC screening, including use of recommended best practices, has not been widely investigated. Methods: We characterized self-sampling and mail strategies used for implementing CRC screening across a consortium of 8 National Cancer Institute Cancer Moonshot Initiative Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) research projects. These projects serve diverse rural, urban, and tribal populations in the US. Results: All 8 ACCSIS projects leveraged self-sampling and mail to promote screening. Strategies included organized mailed FIT outreach with mailed invitations, including FIT kits, reminders, and mailed return (n = 7); organized FIT-DNA outreach with mailed kit return (n = 1); organized on-demand FIT outreach with mailed offers to request a kit for mailed return (n = 1); and opportunistic FIT-DNA with in-clinic offers to be mailed a test for mailed return (n = 2). We found differences in patient identification strategies, outreach delivery approaches, and test return options. We also observed consistent use of Centers for Disease Control and Prevention Summit consensus best practice recommendations by the 7 projects that used mailed FIT outreach. Conclusion: In research projects reaching diverse populations in the US, we observed multiple strategies that leverage self-sampling and mail to promote CRC screening. Mail and self-sampling, including mailed FIT outreach, could be more broadly leveraged to optimize cancer screening.

Health plan-based mailed fecal testing for colorectal cancer screening among dual-eligible Medicaid/Medicare enrollees: Outcomes of 2 program models.

BACKGROUND: Health insurance plans are increasingly offering mailed fecal immunochemical test (FIT) programs for colorectal cancer (CRC) screening, but few studies have compared the outcomes of different program models (eg, invitation strategies). METHODS: This study compares the outcomes of 2 health plan-based mailed FIT program models. In the first program (2016), FIT kits were mailed to all eligible enrollees; in the second program (2018), FIT kits were mailed only to enrollees who opted in after an outreach phone call. Participants in this observational study included dual-eligible Medicaid/Medicare enrollees who were aged 50 to 75 years and were due for CRC screening (1799 in 2016 and 1906 in 2018). Six-month FIT completion rates, implementation outcomes (eg, mailed FITs sent and reminders attempted), and program-related health plan costs for each program are described. RESULTS: All 1799 individuals in 2016 were sent an introductory letter and a FIT kit. In 2018, all 1906 were sent an introductory letter, and 1905 received at least 1 opt-in call attempt, with 410 (21.5%) sent a FIT. The FIT completion rate was 16.2% (292 of 1799 [95% CI, 14.5%-17.9%]) in 2016 and 14.6% (278 of 1906 [95% CI, 13.0%-16.2%]) in 2018 (P = .36). The overall implementation costs were higher in 2016 ($40,156) than 2018 ($34,899), with the cost per completed FIT slightly higher in 2016 ($138) than 2018 ($126). CONCLUSIONS: An opt-in mailed FIT program achieved FIT completion rates similar to those of a program mailing to all dual-eligible Medicaid/Medicare enrollees. LAY SUMMARY: Health insurance plans can use different program models to successfully mail fecal test kits for colorectal cancer screening to dual-eligible Medicaid/Medicare enrollees, with nearly 1 in 6 enrollees completing fecal testing.

Clinic Factors Associated With Mailed Fecal Immunochemical Test (FIT) Completion: The Difference-Making Role of Support Staff.

PURPOSE: Mailed fecal immunochemical test (FIT) programs can facilitate colorectal cancer (CRC) screening. We sought to identify modifiable, clinic-level factors that distinguish primary care clinics with higher vs lower FIT completion rates in response to a centralized mailed FIT program. METHODS: We used baseline observational data from 15 clinics within a single urban federally qualified health center participating in a pragmatic trial to optimize a mailed FIT program. Clinic-level data included interviews with leadership using a guide informed by the Consolidated Framework for Implementation Research (CFIR) and FIT completion rates. We used template analysis to identify explanatory factors and configurational comparative methods to identify specific combinations of clinic-level conditions that uniquely distinguished clinics with higher and lower FIT completion rates. RESULTS: We interviewed 39 clinic leaders and identified 58 potential explanatory factors representing clinic workflows and the CFIR inner setting domain. Clinic-level FIT completion rates ranged from 30% to 56%. The configurational model for clinics with higher rates (≥37%) featured any 1 of the following 3 factors related to support staff: (1) adding back- or front-office staff in past 12 months, (2) having staff help patients resolve barriers to CRC screening, and (3) having staff hand out FITs/educate patients. The model for clinics with lower rates involved the combined absence of these same 3 factors. CONCLUSIONS: Three factors related to support staff differentiated clinics with higher and lower FIT completion rates. Adding nonphysician support staff and having those staff provide enabling services might help clinics optimize mailed FIT screening programs.

Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach.

BACKGROUND & AIMS: Mailing fecal immunochemical test (FITs) to individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening. Little is known about how phone-based advance notifications (primers) affect the effectiveness of mailed FIT outreach programs. METHODS: We performed a prospective study of patients at a large urban health center, 50-75 years old and due for screening, with no record of a prior FIT. Participants were randomly assigned to groups that received a live phone call primer (n = 1203) or a text message primer (n = 1622), from June through December 2018. The participants were then mailed a FIT kit, followed by 2 automated calls, and live reminder calls delivered by the care team. The main outcome was completion of FIT within 3 months of assignment to the live phone call or text message group. RESULTS: Participants had a FIT completion rate of 16.8%, a mean age of 58 years, and 80% were Latino. In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%). Between-group differences increased to 7.3% points (95% CI, 3.6%-11.0%) in the per-protocol analysis of 2144 participants reached by the text message (1320/1622, 81%), live call (438/1203, 36%), or voice message (386/1203, 32%). This rate increased to 14.9% points (95% CI; 9.6%-20.1%) in the per-protocol analysis of 1758 participants reached by the text message or reached by the live call. CONCLUSIONS: In a randomized trial, advance notification live phone calls outperformed text messages in prompting health center patients who had not previously completed a FIT to complete a mailed FIT. Clinicaltrials.gov no: NCT03167125.

The influence of multi-morbidities on colorectal cancer screening recommendations and completion.

PURPOSE: Patients' chronic disease burden can influence the likelihood that providers will recommend cancer screening and that patients will participate in it. Using data from the STOP CRC pragmatic study, we examined associations between chronic disease burden and colorectal cancer screening recommendation and use. METHODS: Participating STOP CRC clinics (n = 26) received either usual care or training to implement a mailed fecal immunochemical test (FIT) outreach program. Selected clinic patients (n = 60,187 patients) were aged 50-74 and overdue for colorectal cancer screening. We used logistic regression to examine the associations between FIT recommendations and completion and patients' chronic disease burden, calculated using the Charlson Comorbidity Index and the Chronic Illness and Disability Payment System. RESULTS: For each index, FIT recommendation odds were 8-9% higher among individuals with minimal chronic disease burden and 13-23% lower among individuals with high chronic disease burden (inverted U-shaped association). Among adults who were ordered a FIT, FIT completion odds were 20% lower for individuals with any, versus no, chronic condition and diminished with increasing disease burden (inverse linear association). CONCLUSIONS: Analysis showed an inverted U-shaped association between patients' chronic disease burden and providers' recommendation of a FIT and an inverse linear association between patients' chronic disease burden and FIT completion. ClinicalTrials.gov registration: NCT01742065.

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

BACKGROUND: Delays 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. METHODS: We 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. RESULTS: Of 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. DISCUSSION: Efforts 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.

A Promotor-Led Pilot Study to Increase Colorectal Cancer Screening in Latinos: The Juntos Contra El Cáncer Program.

Background. Latinos have lower colorectal cancer (CRC) screening rates compared to other racial/ethnic groups in the United States, despite an overall increase in CRC screening over the past 10 years. To address this disparity, we implemented a promotor-led intervention to increase CRC screening test adherence in community-based settings, connecting community members with a partnering federally qualified health center. Purpose. To evaluate the Juntos Contra el Cáncer/Together Against Cancer (JUNTOS) intervention, by assessing pre-post changes in (1) CRC screening test adherence and (2) CRC knowledge and perceived barriers to CRC screening. We also assessed the feasibility and acceptability of program activities. Method. JUNTOS was a group-based intervention, delivered by promotores (community health workers), to promote CRC screening test adherence among Latino adults. The intervention consisted of a culturally tailored 2½-hour interactive workshop followed by an appointment scheduling assistance from a promotor. Workshop participants were Latino adults (males and females) aged 50 to 75 years who were not up-to-date with CRC screening guidelines. We conducted interviews before and 6 to 9 months after the workshop to assess program outcomes. Results. Of the 177 participants included, 118 reported completing the CRC screening test (66.7%) by 6 to 9 months postintervention. We observed baseline to 6- to 9-month increase in CRC knowledge and lower perceived barriers to obtaining CRC screening. Furthermore, the intervention was found to be feasible and acceptable. Conclusion. Results suggest that JUNTOS can be feasibly implemented in partnership with a federally qualified health center. The current study supports group-based CRC interventions in community and clinic settings.

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

BACKGROUND: Colorectal 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. METHODS: BeneFIT 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. RESULTS: The 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. CONCLUSIONS: The implementation of mailed FIT outreach by health plans may be effective and could reach many individuals at risk of developing colorectal cancer.

Factors Influencing Implementation of a Colorectal Cancer Screening Improvement Program in Community Health Centers: an Applied Use of Configurational Comparative Methods.

BACKGROUND: Evidence-based programs such as mailed fecal immunochemical test (FIT) outreach can only affect health outcomes if they can be successfully implemented. However, attempts to implement programs are often limited by organizational-level factors. OBJECTIVES: As part of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) pragmatic trial, we evaluated how organizational factors impacted the extent to which health centers implemented a mailed FIT outreach program. DESIGN: Eight health centers participated in STOP CRC. The intervention consisted of customized electronic health record tools and clinical staff training to facilitate mailing of an introduction letter, FIT kit, and reminder letter. Health centers had flexibility in how they delivered the program. MAIN MEASURES: We categorized the health centers' level of implementation based on the proportion of eligible patients who were mailed a FIT kit, and applied configurational comparative methods to identify combinations of relevant organizational-level and program-level factors that distinguished among high, medium, and low implementing health centers. The factors were categorized according to the Consolidated Framework for Implementation Research model. KEY RESULTS: FIT tests were mailed to 21.0-81.7% of eligible participants at each health center. We identified a two-factor solution that distinguished among levels of implementation with 100% consistency and 100% coverage. The factors were having a centralized implementation team (inner setting) and mailing the introduction letter in advance of the FIT kit (intervention characteristics). Health centers with high levels of implementation had the joint presence of both factors. In health centers with medium levels of implementation, only one factor was present. Health centers with low levels of implementation had neither factor present. CONCLUSIONS: Full implementation of the STOP CRC intervention relied on a centralized implementation team with dedicated staffing time, and the advance mailing of an introduction letter. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01742065 Registered 05 December 2012-Prospectively registered.

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

BACKGROUND: Colorectal 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. METHODS: To 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. RESULTS: Of 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. CONCLUSIONS: Knowing 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 REGISTRATION: This trial was registered at ClinicalTrials.gov ( NCT01742065 ) on December 5, 2012. The protocol is available.

First-year implementation of mailed FIT colorectal cancer screening programs in two Medicaid/Medicare health insurance plans: qualitative learnings from health plan quality improvement staff and leaders.

BACKGROUND: Colorectal cancer screening rates remain low, especially among certain racial and ethnic groups and the uninsured and Medicaid insured. Clinics and health care systems have adopted population-based mailed fecal immunochemical testing (FIT) programs to increase screening, and now health insurance plans are beginning to implement mailed FIT programs. We report on challenges to and successes of mailed FIT programs during their first year of implementation in two health plans serving Medicaid and dual eligible Medicaid/Medicare enrollees. METHODS: This qualitative descriptive study gathered data through in-depth interviews with staff and leaders at each health plan (n = 10). The Consolidated Framework for Implementation Research, field notes from program planning meetings between the research team and the health plans, and internal research team debriefs informed interview guide development. Qualitative research staff used Atlas.ti to code the health plan interviews and develop summary themes through an iterative content analysis approach. RESULTS: We identified first-year implementation challenges in five thematic areas: 1) program design, 2) vendor experience, 3) engagement/communication, 4) reaction/satisfaction of stakeholders, and 5) processing/returning of mailed kits. Commonly experienced challenges by both health plans related to the time-consuming nature of the programs to set up, and complexities and delays in working with vendors. We found implementation successes in the same five thematic areas as well as four additional areas of: 1) leadership support, 2) compatibility with the health plan, 3) broader impacts, and 4) collaboration with researchers. Commonly experienced successes included the ability to adapt the mailed FIT program to the individual health plan culture and needs, and the synchronicity between the programs and their organizational missions and goals. CONCLUSIONS: Both health plans successfully adapted mailed FIT programs to their own culture and resources and used their strong quality management resources to maximize success in overcoming the time demands of setting up the program and working with their vendors. Mailed FIT programs administered by health plans, especially those serving Medicaid- and dual eligible Medicaid/Medicare-insured populations, may be an important resource to support closing gaps in colorectal cancer screening among traditionally underserved populations.

Challenges in Reaching Medicaid and Medicare Enrollees in a Mailed Fecal Immunochemical Test Program.

BeneFIT was a demonstration project that worked with a Medicaid/Medicare health plan to implement a mailed fecal immunochemical test (FIT) program. The goal was to reach age-eligible enrollees who were due for colorectal cancer (CRC) screening and prompt them to complete a FIT. One health insurance plan collaborated with six federally qualified health centers (FQHCs) in Oregon. Reach was defined as the percent of eligible individuals overdue for CRC screening who were mailed a FIT in 2016. We examined patient-level factors associated with reach, using multivariable log binomial regression and FIT completion rates at 6 months. The health plan identified 3386 age-eligible members overdue for CRC screening. Of these, 2615 (77.2%) were reached (mailed FIT kits) and 771 (22.8%) were not; 478 (14.1%) because they were not considered to be clinic patients and 290 (8.6%) because of mailing issues. Patient-level factors associated with not being reached were: being male, being Medicaid-insured (vs. Medicare), and having no primary care visits (vs. 4+ visits) in the last year. Among all enrollees identified as overdue for CRC screening, FIT completion rates at 6 months were 14.8% overall and 18.5% in the subgroup reached. In a mailed FIT program, a health insurance plan attempted to reach as many enrollees overdue for CRC screening as possible, however 22.8% were not mailed a FIT. Additional efforts are needed to ensure that the hardest to reach enrollees can participate in CRC screening.

Factors Affecting Adherence in a Pragmatic Trial of Annual Fecal Immunochemical Testing for Colorectal Cancer.

BACKGROUND: Colorectal cancer screening by fecal immunochemical test (FIT) reduces the burden of colorectal cancer. However, effectiveness relies on annual adherence, which presents challenges for clinic staff and patients. OBJECTIVE: Describe FIT return rates and identify factors associated with FIT adherence over 2 years in a mailed FIT outreach program in federally qualified health centers. DESIGN: Observational study nested in the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) trial. Five thousand one hundred ninety-five patients had an initial FIT order and were followed for ≥ 2 years (3574 also had a FIT order in the second year). MAIN MEASURES: FIT return percent in each year and patient- and neighborhood-level characteristics associated with FIT adherence. KEY RESULTS: Overall, the proportion of FIT orders that were completed was 46% in the patients' first year and 41% in the patients' second year. Of the 5195 patients with a FIT order in year 1, 3574 (69%) also had a FIT order in year 2 (71% of year 1 adherers and 67% of year 1 non-adherers, p = 0.009). Among those with a FIT order in the second year, the FIT return rate was about twice as high among those who were adherent in the first year (952/1674, or 57%) as among those who were not (531/1900, or 28%, p < 0.0001). Patient-level characteristics associated with higher odds of FIT return were a history of FIT screening at baseline, age over 65 (vs 50-65), no current tobacco use, recent receipt of a mammogram or flu vaccine, Asian ancestry (compared to non-Hispanic white), and non-English preference. The only neighborhood factor associated with lower FIT return rate was patient's larger residential city size. CONCLUSION: Our findings can inform the customization of programs to promote FIT return among patients who receive care at federally qualified health centers. TRIAL REGISTRATION: http://www.clinicaltrials.gov.

A cost-effectiveness analysis of a colorectal cancer screening program in safety net clinics.

STOP CRC is a cluster-randomized pragmatic study of a colorectal cancer (CRC) screening program within eight federally-qualified health centers (FQHCs) in Oregon and California promoting fecal immunochemical testing (FIT) with appropriate colonoscopy follow-up. Results are presented of a cost-effectiveness analysis of STOP CRC. Organization staff completed activity-based costing spreadsheets, assigning labor hours by intervention activity and job-specific wage rates. Non-labor costs were from study data. Data were collected over February 2014-February 2016; analyses were performed in 2016-2017. Incremental cost-effectiveness ratios (ICERs) using completed FITs adjusted for number of screening-eligible patients (SEPs), as the effectiveness measure were calculated overall and by organization. Intervention delivery costs totaled $305 K across eight organizations (range: $10.2 K-$110 K). Overall delivery cost per SEP was $14.43 (range: $10.37-$19.10). The largest cost category across organizations was implementation, specifically mailing preparation. The overall ICER was $483 per SEP-adjusted completed FIT (range: $96-$1021 among organizations with positive effectiveness). Lagged data accounting for implementation delay produced comparable results. The costs of colonoscopies following abnormal FITs decreased the overall ICER to S409 because usual care clinics generated more such colonoscopies than intervention clinics. Using lagged data, follow-up colonoscopies increase the ICER by 4.3% to $460. Results indicate the complex implications for cost-effectiveness of implementing standard CRC screening within a pragmatic setting involving FQHCs with varied patient populations, clinical structures, and resources. Performance variation across organizations emphasizes the need for future evaluations that inform the introduction of efficient CRC screening to underserved populations.

Does a transition to accountable care in Medicaid shift the modality of colorectal cancer testing?

BACKGROUND: Health care reform is changing preventive services delivery. This study explored trajectories in colorectal cancer (CRC) testing over a 5-year period that included implementation of 16 Medicaid Accountable Care Organizations (ACOs, 2012) and Medicaid expansion (2014) - two provisions of the Affordable Care Act (ACA) - within the state of Oregon, USA. METHODS: Retrospective analysis of Oregon's Medicaid claims for enrollee's eligible for CRC screening (50-64 years) spanning January 2010 through December 2014. Our analysis was conducted and refined April 2016 through June 2018. The analysis assessed the annual probability of patients receiving CRC testing and the modality used (e.g., colonoscopy, fecal testing) relative to a baseline year (2010). We hypothesized that CRC testing would increase following Medicaid ACO formation - called Coordinated Care Organizations (CCOs). RESULTS: A total of 132,424 unique Medicaid enrollees (representing 255,192 person-years) met inclusion criteria over the 5-year study. Controlling for demographic and regional factors, the predicted probability of CRC testing was significantly higher in 2014 (+ 1.4 percentage points, p < 0.001) compared to the 2010 baseline but not in 2012 or 2013. Increased fecal testing using Fecal Occult Blood Tests (FOBT) or Fecal Immunochemical Tests (FIT) played a prominent role in 2014. The uptick in statewide fecal testing appears driven primarily by a subset of CCOs. CONCLUSIONS: Observed CRC testing did not immediately increase following the transition to CCOs in 2012. However increased testing in 2014, may reflect a delay in implementation of interventions to increase CRC screening and/or a strong desire by newly insured Medicaid CCO members to receive preventive care.