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Introduction: Recruiting organizations (i.e., health plans, health systems, or clinical practices) is important for implementation science, yet limited research explores effective strategies for engaging organizations in pragmatic studies. We explore the effort required to meet recruitment targets for a pragmatic implementation trial, characteristics of engaged and non-engaged clinical practices, and reasons health plans and rural clinical practices chose to participate., Methods: We explored recruitment activities and factors associated with organizational enrollment in SMARTER CRC, a randomized pragmatic trial to increase rates of CRC screening in rural populations. We sought to recruit 30 rural primary care practices within participating Medicaid health plans. We tracked recruitment outreach contacts, meeting content, and outcomes using tracking logs. Informed by the Consolidated Framework for Implementation Research, we analyzed interviews, surveys, and publicly available clinical practice data to identify facilitators of participation., Results: Overall recruitment activities spanned January 2020 to April 2021. Five of the 9 health plans approached agreed to participate (55%). Three of the health plans chose to operate centrally as 1 site based on network structure, resulting in 3 recruited health plan sites. Of the 101 identified practices, 76 met study eligibility criteria; 51% (n = 39) enrolled. Between recruitment and randomization, 1 practice was excluded, 5 withdrew, and 7 practices were collapsed into 3 sites for randomization purposes based on clinical practice structure, leaving 29 randomized sites. Successful recruitment required iterative outreach across time, with a range of 2 to 17 encounters per clinical practice. Facilitators to recruitment included multi-modal outreach, prior relationships, effective messaging, flexibility, and good timing., Conclusion: Recruiting health plans and rural clinical practices was complex and iterative. Leveraging existing relationships and allocating time and resources to engage clinical practices in pragmatic implementation research may facilitate more diverse representation in future trials and generalizability of research findings., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: From 2021 to 2023, Dr. Coronado served as PI on a contract through the Center for Health Research funded by Guardant Health that assessed adherence to a commercially available blood test for colorectal cancer.

Background: Colorectal cancer (CRC) incidence and mortality are disproportionately high among rural residents and Medicaid enrollees., Objectives: To address disparities, we used a modified community engagement approach, Boot Camp Translation (BCT). Research partners, an advisory board, and the rural community informed messaging about CRC outreach and a mailed fecal immunochemical test program., Methods: Eligible rural patients (English-speaking and ages 50-74) and clinic staff involved in patient outreach participated in a BCT conducted virtually over two months. We applied qualitative analysis to BCT transcripts and field notes., Results: Key themes included: the importance of directly communicating about the seriousness of cancer, leveraging close clinic-patient relationships, and communicating the test safety, ease, and low cost., Conclusions: Using a modified version of BCT delivered in a virtual format, we were able to successfully capture community input to adapt a CRC outreach program for use in rural settings. Program materials will be tested during a pragmatic trial to address rural CRC screening disparities.

Introduction: Colorectal cancer (CRC) incidence and mortality are disproportionately high among rural residents despite the availability of effective screening methods. Outreach activities can improve CRC screening rates but rely on accurate identification of patients due for screening. We report on data challenges in rural clinics and Medicaid health plans in Oregon in identifying patients eligible for CRC screening, in a large project implementing mailed fecal immunochemical tests (FIT) and patient navigation., Methods: We analyzed data from clinic intake surveys and administrative claims. Clinics were asked to identify total population numbers relevant to CRC screening and follow-up. Health plans also identified enrollees eligible for CRC screening in Spring, 2021. Clinic staff validated patient lists for eligibility using their electronic health records (EHR)., Results: EHR features varied across the 29 participating and 28 responding clinics. Among the 28 responding clinics, 21 were able to report their Medicaid population (75%), 19 reported the number of patients aged 50 to 75 (68%) and the number screened for CRC in the last year (68%). Only 8 (29%) were able to report screening details such as number screened by FIT and 9 were able to report on patients with an abnormal FIT or colonoscopy completed after FIT (32%). Health plans had challenges properly identifying where enrollees received care and had missing data for race and ethnicity (range 22 to 34% unknown race, <1% to 24% unknown ethnicity)., Discussion: Most participating rural primary care clinics and Medicaid health plans experienced challenges identifying the population due for a CRC screening outreach program. Better EHR functionality and data reporting capabilities could help rural clinics apply population-based strategies and ultimately attenuate disparities in cancer screening and follow-up., Competing Interests: Conflict of interest: Since 2020, Dr. Coronado has served as a scientific advisory for Exact Sciences and Guardant Health through a contract with Kaiser Permanente Center for Health Research. All other authors declare no conflicts of interest., (© Copyright by the American Board of Family Medicine.)

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., (© 2019 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.)

Background: The Plan-Do-Study-Act (PDSA) cycle is a commonly used improvement process in health care settings, although its documented use in pragmatic clinical research is rare. A recent pragmatic clinical research study, called the Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), used this process to optimize the research implementation of an automated colon cancer screening outreach program in intervention clinics. We describe the process of using this PDSA approach, the selection of PDSA topics by clinic leaders, and project leaders' reactions to using PDSA in pragmatic research., Methods: STOP CRC is a cluster-randomized pragmatic study that aims to test the effectiveness of a direct-mail fecal immunochemical testing (FIT) program involving eight Federally Qualified Health Centers in Oregon and California. We and a practice improvement specialist trained in the PDSA process delivered structured presentations to leaders of these centers; the presentations addressed how to apply the PDSA process to improve implementation of a mailed outreach program offering colorectal cancer screening through FIT tests. Center leaders submitted PDSA plans and delivered reports via webinar at quarterly meetings of the project's advisory board. Project staff conducted one-on-one, 45-min interviews with project leads from each health center to assess the reaction to and value of the PDSA process in supporting the implementation of STOP CRC., Results: Clinic-selected PDSA activities included refining the intervention staffing model, improving outreach materials, and changing workflow steps. Common benefits of using PDSA cycles in pragmatic research were that it provided a structure for staff to focus on improving the program and it allowed staff to test the change they wanted to see. A commonly reported challenge was measuring the success of the PDSA process with the available electronic medical record tools., Conclusion: Understanding how the PDSA process can be applied to pragmatic trials and the reaction of clinic staff to their use may help clinics integrate evidence-based interventions into their everyday care processes., Trial Registration: Clinicaltrials.gov NCT01742065 . Registered October 31, 2013.

Purpose: Colonoscopy can prevent morbidity and mortality from colorectal cancer (CRC) and is the most commonly used screening method in the United States. Barriers to colonoscopy at multiple levels can contribute to disparities. Yet, in rural settings, little is known about who delivers colonoscopy and facilitators and barriers to colonoscopy access through screening completion. Methods: We conducted a qualitative study with providers in rural Oregon who worked in endoscopy centers or primary care clinics. Semistructured interviews, conducted in July and August, 2021, focused on clinician experiences providing colonoscopy to rural Medicaid patients, including workflows, barriers, and access. We used thematic analysis, through immersion crystallization, to analyze interview transcripts and develop emergent themes. Findings: We interviewed 19 providers. We found two categories of colonoscopy providers: primary care providers (PCPs) doing colonoscopy on their own patients (n = 9; 47%) and general surgeons providing colonoscopy to patients referred to their services (n = 10; 53%). Providers described barriers to colonoscopy at the provider, community, and patient levels and suggested patient supports could help overcome them. Providers found current colonoscopy capacity sufficient, but noted PCPs trained to perform colonoscopy would be key to continued accessibility. Finally, providers shared concerns about the shrinking number of PCP endoscopists, especially with anticipated increased screening demand related to the CRC screening guideline shift. Conclusions: These themes reflect opportunities to address multilevel barriers to improve access, colonoscopy capacity, and patient education approaches. Our results highlight that PCPs are an essential part of the workforce that provides colonoscopy in rural areas. [ABSTRACT FROM AUTHOR]

Background: Mailed 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. Methods: SMARTER 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. Discussion: Findings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings. Trial registration: Registered at ClinicalTrials.gov (NCT04890054) and at the NCI's Clinical Trials Reporting Program (CTRP no.: NCI-2021–01032) on May 11, 2021. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer (CRC) screening can improve health outcomes, but screening rates remain low across the US. Mailed fecal immunochemical tests (FIT) are an effective way to increase CRC screening rates, but is still underutilized. In particular, cost of FIT has not been explored in relation to practice characteristics, FIT selection, and screening outreach approaches.Methods: We administered a cross-sectional survey drawing from prior validated measures to 252 primary care practices to assess characteristics and context that could affect the implementation of direct mail fecal testing programs, including the cost, source of test, and types of FIT used. We analyzed the range of costs for the tests, and identified practice and test procurement factors. We examined the distributions of practice characteristics for FIT use and costs answers using the non-parametric Wilcoxon rank-sum test. We used Pearson's chi-squared test of association and interpreted a low p-value (e.g. < 0.05) as evidence of association between a given practice characteristic and knowing the cost of FIT or fecal occult blood test (FOBT).Results: Among the 84 viable practice survey responses, more than 10 different types of FIT/FOBTs were in use; 76% of practices used one of the five most common FIT types. Only 40 practices (48%) provided information on FIT costs. Thirteen (32%) of these practices received the tests for free while 27 (68%) paid for their tests; median reported cost of a FIT was $3.04, with a range from $0.83 to $6.41 per test. Costs were not statistically significantly different by FIT type. However, practices who received FITs from manufacturer's vendors were more likely to know the cost (p = 0.0002) and, if known, report a higher cost (p = 0.0002).Conclusions: Our findings indicate that most practices without lab or health system supplied FITs are spending more to procure tests. Cost of FIT may impact the willingness of practices to distribute FITs through population outreach strategies, such as mailed FIT. Differences in the ability to obtain FIT tests in a cost-effective manner could have consequences for implementation of outreach programs that address colorectal cancer screening disparities in primary care practices. [ABSTRACT FROM AUTHOR]

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 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Promoting uptake of evidence-based innovations in healthcare systems requires attention to how innovations are adapted to enhance their fit with a given setting. Little is known about real-world variation in how programs are delivered over time and across multiple populations and contexts, and what motivates adaptations.Methods: As part of the BeneFIT study of mailed fecal immunochemical tests (FIT) to increase colorectal cancer screening, we interviewed 9 leaders from two participating Medicaid/Medicare health insurance plans to examine adaptations to their health plan-initiated mailed FIT outreach programs in the second year of implementation. We applied an adaptation and modification model developed by Stirman and colleagues to document content and context modifications made to the two programs.Results: Both health plans made substantial changes to their programs in the second year; adaptations differed substantially across health plans. In Health Plan Oregon, adaptations generally targeted health centers and member populations, most content adaptations involved tailoring program components, and the program was expanded to four additional health centers. In contrast, Health Plan Washington's second-year content adaptations were primarily at the level of members, and generally involved adding program components. Moreover, Health Plan Washington undertook large-scale context adaptations to the setting where the program was led (local vs. national), the personnel who administered the program (vendor and staffing), and the population selected for outreach (limiting outreach to dual-eligible members).Conclusions: Both programs implemented a variety of adaptations that reflected the values and incentives of the broader health plan contexts. Financial incentives for screening allowed Health Plan Oregon to expand but led Health Plan Washington to offer more targeted outreach to a subset of eligible enrollees. The breadth of changes made by each health system reflects the necessity of evaluating programs in context and adjusting to specific challenges as they are identified. Further research is needed to understand the effects of these types of adaptations on program efficiency and enrollee and health system outcomes. [ABSTRACT FROM AUTHOR]

This document is a correction notice for an article titled "Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas." The correction addresses an error in the Competing Interest statement made by the authors. The corrected statement clarifies the involvement of Dr. Coronado with Exact Sciences and Guardant Health in relation to the study. The original article has been updated accordingly. [Extracted from the article]

Objective: Variations in processes for different clinics and health systems can dramatically change the way preventive interventions are implemented. We present a method for documenting these variations using workflow diagrams and demonstrate how understanding workflow aided an electronic health record (EHR) embedded colorectal cancer screening intervention. Materials and Methods: We mapped variation in processes for ordering and documenting fecal testing, current colonoscopy, prior colonoscopies, and pathology results. This work was part of a multi-site cluster-randomized pragmatic trial to test a mailed approach to offering fecal testing at 26 safety net clinics (in eight organizations) in Oregon and Northern California. We created clinic-specific workflow diagrams and then distilled them into consolidated diagrams that captured the variations. Results: Clinics had varied practices for storing and using information about colorectal cancer screening. Developing workflow diagrams of key processes enabled clinics to find optimal ways to send fecal test kits to patients due for screening. The workflows informed the rollout of new EHR tools and identified best practices for data capture. Discussion: Diagramming workflows can have great utility when implementing and refining EHR tools for clinical practice, especially when doing so across multiple clinical sites. The process of developing the workflows uncovered successful practice recommendations and revealed limitations and potential effects of a research intervention. Conclusion: Our method of documenting clinical process variation might inform other EHR-powered, multi-site research and can improve data feedback from EHR systems to clinical caregivers. [ABSTRACT FROM AUTHOR]