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Background: In real-world settings, low adherence to lung cancer screening (LCS) diminishes population-level benefits of reducing lung cancer mortality. We describe the Larch Study protocol, which tests the effectiveness of two patient-centered interventions (Patient Voices Video and Stepped Reminders) designed to address barriers and improve annual LCS adherence., Methods: The Larch Study is a pragmatic randomized clinical trial conducted within Kaiser Permanente Washington. Eligible patients (target n = 1606) are aged 50-78 years with an index low-dose CT (LDCT) of the chest with negative or benign findings. With a 2 × 2 factorial-design, patients are individually randomized to 1 of 4 arms: video only, reminders only, both video and reminders, or usual care. The Patient Voices video addresses patient education needs by normalizing LCS, reminding patients when LCS is due, and encouraging social support. Stepped Reminders prompts primary care physicians to order patient's repeat screening LDCT and patients to schedule their scan. Intervention delivery is embedded within routine healthcare, facilitated by shared electronic health record components. Primary outcome is adherence to national LCS clinical guidelines, defined as repeat LDCT within 9-15 months. Patient-reported outcomes are measured via survey (knowledge of LCS, perception of stigma) approximately 8 weeks after index LDCT. Our mixed-methods formative evaluation includes process data, collected during the trial, and interviews with trial participants and stakeholders., Discussion: Results will fill an important scientific gap on multilevel interventions to increase annual LCS adherence and provide opportunities for spread and scale to other healthcare settings., Registration: Trial is registered at clinicaltrials.gov (#NCT05747443)., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Fecal immunochemical test (FIT) is an effective colorectal cancer screening modality. Little is known about prevalence, reasons, and testing after unsatisfactory FIT, or a FIT that cannot be processed by the laboratory due to inadequate stool specimen or incomplete labeling., Methods: Our retrospective cohort study examined unsatisfactory FIT among average-risk individuals aged 50-74 years in a large, integrated, safety-net health system who completed an index FIT from 2010 to 2019. We determined prevalence of unsatisfactory FIT and categorized reasons hierarchically. We used multivariable logistic regression models to identify factors associated with: (i) unsatisfactory FIT; and (ii) subsequent testing within 15 months of the unsatisfactory FIT., Results: Of 56,980 individuals completing an index FIT, 10.2% had an unsatisfactory FIT. Reasons included inadequate specimen (51%), incomplete labeling (27%), old specimen (13%), and broken/leaking container (8%). Unsatisfactory FIT was associated with being male [OR, 1.10; confidence interval (CI), 1.03-1.16], Black (OR, 1.46; CI, 1.33-1.61), Spanish speaking (OR, 1.12; CI, 1.01-1.24), on Medicaid (OR, 1.42; CI, 1.28-1.58), and received FIT by mail (OR, 2.66; CI, 2.35-3.01). Among those with an unsatisfactory FIT, fewer than half (41%) completed a subsequent test within 15 months (median, 4.4 months). Adults aged 50-54 years (OR, 1.16; CI, 1.01-1.39) and those who received FIT by mail (OR, 1.92; CI, 1.49-2.09) were more likely to complete a subsequent test., Conclusions: One in ten returned a FIT that could not be processed, mostly due to patient-related reasons. Fewer than half completed a subsequent test after unsatisfactory FIT., Impact: Screening programs should address these breakdowns such as specimen collection and labeling to improve real-world effectiveness. See related In the Spotlight, p. 183., (©2023 American Association for Cancer Research.)

Importance: Optimal strategies for increasing cervical cancer screening may differ by patient screening history and health care setting. Mailing human papillomavirus (HPV) self-sampling kits to individuals who are overdue for screening increases adherence; however, offering self-sampling kits to screening-adherent individuals has not been evaluated in the US., Objective: To evaluate the effectiveness of direct-mail and opt-in approaches for offering HPV self-sampling kits to individuals by cervical cancer screening history (screening-adherent and currently due, overdue, or unknown)., Design, Setting, and Participants: Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Individuals aged 30 to 64 years with female sex, a primary care clinician, and no hysterectomy were identified through electronic health records (EHRs) and enrolled between November 20, 2020, and January 28, 2022, with follow-up through July 29, 2022., Interventions: Individuals stratified as due (eg, at the time of randomization, these individuals have been previously screened and are due for their next screening in ≤3 months) were randomized to receive usual care (patient reminders and clinician EHR alerts [n = 3671]), education (usual care plus educational materials about screening [n = 3960]), direct mail (usual care plus educational materials and a mailed self-sampling kit [n = 1482]), or to opt in (usual care plus educational materials and the option to request a kit [n = 3956]). Individuals who were overdue for screening were randomized to receive usual care (n = 5488), education (n = 1408), or direct mail (n = 1415). Individuals with unknown history for screening were randomized to receive usual care (n = 2983), education (n = 3486), or to opt in (n = 3506)., Main Outcomes and Measures: The primary outcome was screening completion within 6 months. Primary analyses compared direct-mail or opt-in participants with individuals randomized to the education group., Results: The intention-to-treat analyses included 31 355 randomized individuals (mean [SD] age, 45.9 [10.4] years). Among those who were due for screening, compared with receiving education alone (1885 [47.6%]), screening completion was 14.1% (95% CI, 11.2%-16.9%) higher in the direct-mail group (914 [61.7%]) and 3.5% (95% CI, 1.2%-5.7%) higher in the opt-in group (2020 [51.1%]). Among individuals who were overdue, screening completion was 16.9% (95% CI, 13.8%-20.0%) higher in the direct-mail group (505 [35.7%]) compared with education alone (264 [18.8%]). Among those with unknown history, screening was 2.2% (95% CI, 0.5%-3.9%) higher in the opt-in group (634 [18.1%]) compared with education alone (555 [15.9%])., Conclusions and Relevance: Within a US health care system, direct-mail self-sampling increased cervical cancer screening by more than 14% in individuals who were due or overdue for cervical cancer screening. The opt-in approach minimally increased screening. To increase screening adherence, systems implementing HPV self-sampling should prioritize direct-mail outreach for individuals who are due or overdue for screening. For individuals with unknown screening history, testing alternative outreach approaches and additional efforts to document screening history are warranted., Trial Registration: ClinicalTrials.gov Identifier: NCT04679675.

Background: Screening over many years is required to optimize colorectal cancer (CRC) outcomes., Objective: To evaluate the effect of a CRC screening intervention on adherence to CRC screening over 9 years., Design: Randomized trial., Setting: Integrated health care system in Washington state., Participants: Between August 2008 and November 2009, 4653 adults in a Washington state integrated health care system aged 50-74 due for CRC screening were randomized to usual care (UC; N =1163) or UC plus study interventions (interventions: N = 3490)., Interventions: Years 1 and 2: (arm 1) UC or this plus study interventions; (arm 2) mailed fecal tests or information on scheduling colonoscopy; (arm 3) mailings plus brief telephone assistance; or (arm 4) mailings and assistance plus nurse navigation. In year 3, stepped-intensity participants (arms 2, 3, and 4 combined) still eligible for screening were randomized to either stopped or continued interventions in years 3 and 5-9., Main Measures: Time in adherence to CRC testing over 9 years (covered time, primary outcome), and percent with no CRC testing in participants assigned to any intervention compared to UC only. Poisson regression models estimated incidence rate ratios for covered time, adjusting for patient characteristics and accounting for variable follow-up time., Key Results: Compared to UC, intervention participants had 21% more covered time over 9 years (57.5% vs. 69.1%; adjusted incidence rate ratio 1.21, 95% confidence interval 1.16-1.25, P<0.001). Fecal testing accounted for almost all additional covered time among intervention patients. Compared to UC, intervention participants were also more likely to have completed at least one CRC screening test over 9 years or until censorship (88.6% vs. 80.6%, P<0.001)., Conclusions: An outreach program that included mailed fecal tests and phone follow-up led to increased adherence to CRC testing and fewer age-eligible individuals without any CRC testing over 9 years., Trial Registration: Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up (SOS), NCT00697047, clinicaltrials.gov/ct2/show/NCT00697047., (© 2021. Society of General Internal Medicine.)

Screening reduces colorectal cancer mortality; however, this remains the second leading cause of cancer deaths in the United States and adherence to colorectal cancer screening falls far short of the National Colorectal Cancer Roundtable goal of 80%. Numerous studies have examined the effectiveness of interventions to increase colorectal cancer screening uptake. Outreach is the active dissemination of screening outside of the primary care setting, such as mailing fecal blood tests to individuals' homes. Navigation uses trained personnel to assist individuals through the screening process. Patient education may take the form of brochures, videos, or websites. Provider education can include feedback about screening rates of patient panels. Reminders to healthcare providers can be provided by dashboards of patients due for screening. Financial incentives provide monetary compensation to individuals when they complete screening tests, either as fixed payments or via a lottery. Individual preference for specific screening strategies has also been examined in several trials, with a choice of screening strategies yielding higher adherence than recommendation of a single strategy., (Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Primary care provider's (PCP) perceptions of colorectal cancer screening test effectiveness and their recommendations for testing intervals influence patient screening uptake. Few large studies have examined providers' perceptions and recommendations, including their alignment with evidence suggesting comparable test effectiveness and guideline recommendations for screening frequency. Providers ( n = 1,281) within four healthcare systems completed a survey in 2017-2018 regarding their perceptions of test effectiveness and recommended intervals for colonoscopy and fecal immunochemical testing (FIT) for patients ages 40-49, 50-74, and ≥75 years. For patients 50-74 (screening eligible), 82.9% of providers rated colonoscopy as very effective versus 59.6% for FIT, and 26.3% rated colonoscopy as more effective than FIT. Also, for this age group, 77.9% recommended colonoscopy every 10 years and 92.4% recommended FIT annually. For patients ages 40-49 and ≥75, more than one-third of providers believed the tests were somewhat or very effective, although >80% did not routinely recommend screening by either test for these age groups. Provider screening test interval recommendations generally aligned with colorectal cancer guidelines; however, 25% of providers believed colonoscopy was more effective than FIT for mortality reduction, which differs from some modeling studies that suggest comparable effectiveness. The latter finding may have implications for health systems where FIT is the dominant screening strategy. Only one-third of providers reported believing these screening tests were effective in younger and older patients (i.e., <50 and ≥75 years). Evidence addressing these beliefs may be relevant if cancer screening recommendations are modified to include older and/or younger patients., (©2020 American Association for Cancer Research.)

Objectives: In this study, we conducted telephone interviews with patients in community clinics who had abnormal fecal immunochemical test (FIT) results to identify follow-up colonoscopy challenges. The FIT is an effective colorectal cancer screening method, but its value is contingent on follow-up diagnostic colonoscopy. Methods: We explored barriers at 3 timepoints: (1) abnormal FIT-result communication, (2) scheduling/completion of colonoscopy, and (3) receipt of results. We sought to understand variation in experience by both Spanish and English language patients. Results: We interviewed 32 patients (16 English; 16 Spanish), 66% of whom were women. There were 13 early completers (≤ 2 months after FIT result), 14 later completers (> 2 months after FIT result), and 5 non-completers of the colonoscopy. The greatest challenge was fear of the procedure, expressed more often by Spanish language (SL) participants and later completers. SL participants also cited cost and lack of clear communication about the need for a colonoscopy. English language (EL) participants experienced lack of reliable transportation. Conclusions: Barriers to timely colonoscopy completion following an abnormal FIT can occur at different transitions in care and vary by patient characteristics. Our findings may inform the design of programs to improve colonoscopy completion in safety net clinics.

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.

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.)

Importance: Colorectal cancer screening rates are suboptimal, particularly among sociodemographically disadvantaged groups., Objective: To examine whether guaranteed money or probabilistic lottery financial incentives conditional on completion of colorectal cancer screening increase screening uptake, particularly among groups with lower screening rates., Design, Setting, and Participants: This parallel, 3-arm randomized clinical trial was conducted from March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington. A total of 838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled., Interventions: Interventions were (1) mail only (n = 284; up to 3 mailings that included information on the importance of colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n = 270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n = 284; mailings plus a 1 in 10 chance of receiving $50 on screening completion)., Main Outcomes and Measures: The primary outcome was completion of any colorectal cancer screening within 6 months of randomization. Secondary outcomes were FIT or colonoscopy completion within 6 months of randomization. Intervention effects were compared across sociodemographic subgroups and self-reported psychosocial measures., Results: A total of 838 participants (mean [SD] age, 59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity) were included in the study. Completion of any colorectal screening was not significantly higher for the mail and monetary group (207 of 270 [76.7%]) or the mail and lottery group (212 of 284 [74.6%]) than for the mail only group (203 of 284 [71.5%]) (P = .11). For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group. For patients with Medicaid insurance, the net increase compared with mail only in FIT completion for the mail and monetary or the mail and lottery group was 37.7% (95% CI, 11.0%-64.3%) (34.2% for the mail and monetary group and 40.4% for the mail and lottery group) compared with a net increase of only 5.6% (95% CI, -0.9% to 12.2%) among those not Medicaid insured (test for interaction P = .03)., Conclusions and Relevance: Financial incentives increased FIT uptake but not overall colorectal cancer screening. Financial incentives may decrease screening disparities among some sociodemographically disadvantaged groups., Trial Registration: ClinicalTrials.gov identifier: NCT00697047.

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.

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

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., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Importance: Approximately 24 million US individuals receive care at federally qualified health centers, which historically have low rates of colorectal cancer screening. The US Preventive Services Task Force recommends routine colorectal cancer screening for individuals aged 50 to 75 years., Objective: To determine the effectiveness of an electronic health record (EHR)-embedded mailed fecal immunochemical test (FIT) outreach program implemented in health centers as part of standard care., Design, Setting, and Participants: This cluster randomized pragmatic clinical trial was conducted in 26 federally qualified health center clinics, representing 8 health centers in Oregon and California, randomized to intervention (n = 13) or usual care (n = 13). All participants were overdue for colorectal cancer screening during the accrual interval (February 4, 2014 to February 3, 2015)., Interventions: Electronic health record-embedded tools to identify eligible adults and to facilitate implementation of a stepwise mailed intervention involving (1) an introductory letter, (2) a mailed FIT, and (3) a reminder letter; training, collaborative learning, and facilitation through a practice improvement process., Main Outcomes and Measures: Effectiveness was measured as clinic-level proportions of adults who completed a FIT, and secondarily, any colorectal cancer screening within 12 months of accrual or by August 3, 2015. Implementation was measured as clinic-level proportions of adults who were mailed an introductory letter and ordered a FIT., Results: Twenty-six clinics with 41 193 adults (mean [SD] age, 58.5 [6.3] years; 22 994 women) were randomized to receive the direct mail colorectal screening intervention (13 clinics; 21 134 patients) or usual care (13 clinics; 20 059 patients). Compared with usual care clinics, intervention clinics had significantly higher adjusted clinic-level proportion of participants who completed a FIT (13.9% vs 10.4%; difference, 3.4 percentage points; 95% CI, 0.1%-6.8%) and any colorectal cancer screening (18.3% vs 14.5%; difference, 3.8 percentage points; 95% CI, 0.6%-7.0%). We observed large variation across health centers in effectiveness (FIT completion differences range, -7.4 percentage points to 17.6 percentage points) and implementation (proportion who were mailed a FIT range, 6.5% to 68.2%). The number needed to mail to achieve a completed FIT was 4.8 overall, and 4.0 in clinics that mailed a FIT reminder., Conclusions and Relevance: An EHR-embedded mailed FIT outreach intervention significantly improved rates of FIT completion and rates of any colorectal cancer screening. Higher rates of colorectal cancer screening occurred in clinics that successfully implemented the mailed outreach program., Trial Registration: ClinicalTrials.gov identifier: NCT01742065.

Background: Screening over many years is required to optimize reductions in colorectal cancer (CRC) mortality. However, no prior trials have compared strategies for obtaining long-term adherence., Methods: Systems of Support to Increase Colorectal Cancer Screening and Follow-Up was implemented in an integrated health care organization in Washington State. Between 2008 and 2009, 4675 individuals aged 50 to 74 years were randomized to receive the usual care (UC), which included clinic-based strategies to increase CRC screening (arm 1), or, in years 1 and 2, mailings with a call-in number for colonoscopy and mailed fecal tests (arm 2), mailings plus brief telephone assistance (arm 3), or mailings and assistance plus nurse navigation (arm 4). Active-intervention subjects (those in arms 2, 3, and 4 combined) who were still eligible for CRC screening were randomized to mailings being stopped or continued in years 3 and 5. The time in compliance with CRC screening over 5 years was compared for persons assigned to any intervention and persons assigned to UC. Screening tests contributed time on the basis of national guidelines for screening intervals (fecal tests annually, sigmoidoscopy every 5 years, and colonoscopy every 10 years)., Results: All participants contributed data, but they were censored at disenrollment, death, the age of 76 years, or a diagnosis of CRC. Compared with UC participants, intervention participants had 31% more adjusted covered time over 5 years (incidence rate ratio, 1.31; 95% confidence interval, 1.25-1.37; covered time, 47.5% vs 62.1%). Fecal testing accounted for almost all additional covered time., Conclusions: In a health care organization with clinic-based activities to increase CRC screening, a centralized program led to increased CRC screening adherence over 5 years. Longer term data on screening adherence and its impact on CRC outcomes are needed. Cancer 2017;123:4472-80. © 2017 American Cancer Society., (© 2017 American Cancer Society.)

Little is known about the challenges faced by community clinics who must address clinical priorities first when participating in pragmatic studies. We report on implementation challenges faced by the eight community health centers that participated in Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), a large comparative effectiveness cluster-randomized trial to evaluate a direct-mail program to increase the rate of colorectal cancer (CRC) screening. We conducted interviews, at the onset of implementation and 1 year later, with center leaders to identify challenges with implementing and sustaining an electronic medical record (EMR)-driven mailed program to increase CRC screening rates. We used the Consolidated Framework for Implementation Research to thematically analyze the content of meeting discussions and identify anticipated and experienced challenges. Common early concerns were patients' access to colonoscopy, patients' low awareness of CRC screening, time burden on clinic staff to carry out the STOP CRC program, inability to accurately identify eligible patients, and incompatibility of the program's approach with the patient population or organizational culture. Once the program was rolled out, time burden remained a primary concern and new organizational capacity and EMR issues were raised (e.g., EMR staffing resources and turnover in key leadership positions). Cited program successes were improved CRC screening processes and rates, more patients reached, reduced costs, and improved patient awareness, engagement, or satisfaction. These findings may inform any clinic considering mailed fecal testing programs and future pragmatic research efforts in community health centers.

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.

Background: Long-term adherence to colorectal cancer (CRC) screening is particularly important for fecal testing. Some U.S. studies report that only 25% of individuals repeat fecal testing annually. The purpose of this qualitative study was to identify barriers and facilitators reported by patients with suboptimal screening adherence to refine interventions for starting ongoing adherence to CRC screening. We also explored whether participants, particularly never screeners, would be willing to do a CRC screening blood test., Methods: Forty-one patients who previously enrolled in the Systems of Support to Increase CRC Screening (SOS) trial were interviewed 4-5 years later. Participants were purposively selected to include men and women with diverse race/ethnicities who had either been inconsistent screeners or had never screened during the first three years of SOS despite receiving at least two rounds of mailed fecal tests. Two interviewers conducted 30-min telephone interviews using a semi-structured interview guide. An iterative thematic analysis approach was used., Results: Themes related to screening barriers were more pervasive among never screeners including: (1) Avoidance (inattention, procrastination) (2) Concerns about handling stool; (3) Health concerns; (4) Fear of a cancer diagnosis or positive test results. Themes related to screening facilitators were more often mentioned by participants who screened at least once including: (1) Use of a simpler 1-sample fecal test; (2) Convenience of mailings and doing the test at home; (3) Salience of prevention, especially as one got older; and (4) Influence of recommendations from providers, family and friends. Participants had diverse preferences for the number (3 on average) and types (phone, mail, text) of screening reminders. Some participants did not prefer e-mail links to the patient shared electronic health record because of difficulties remembering their password. It was acceptable for a nurse or medical assistant not from their clinic to call them as long as that person was knowledgeable about their records and could communicate with their physician. Participants, especially never screeners, were generally very enthusiastic about the potential option of a CRC screening blood test., Conclusion: Future CRC screening programs should be designed to minimize these barriers and maximize facilitators to improve long-term screening adherence., Trial Registration: Primary Funding Agency: The National Cancer Institute of the National Institutes of Health (R01CA121125). Registered at clinicaltrials.gov NCT00697047 .

Background: While electronic health records (EHRs) play a key role in increasing colorectal cancer (CRC) screening by identifying individuals who are overdue, important shortfalls remain., Objectives: As part of the Strategies and Opportunities to STOP Colon Cancer (STOP CRC) study, we assessed the accuracy of EHR codes in identifying patients eligible for CRC screening., Methods: We selected a stratified random sample of 800 study participants from 26 participating clinics, in the Pacific Northwest region of the USA. We compared data obtained through codes in the EHR to conduct a manual chart audit. A trained chart abstractor completed the abstraction of eligible and ineligible patients., Results: Of 520 individuals in need of CRC screening, identified via the EHR, 459 were confirmed through chart review (positive predictive value = 88%). Of 280 individuals flagged as up-to-date in their screening per EHR data, 269 were confirmed through chart review (negative predictive value = 96%). Among the 61 patients incorrectly classified as eligible, 83.6% of disagreements were due to evidence of a prior colonoscopy or referral that was not captured in recognizable fields in the EHR., Conclusions: Our findings highlight importance of better capture of past screening events in the EHR. While the need for better population-based data is not unique to CRC screening, it provides an important example of the use of population-based data not only for tracking care, but also for delivering interventions., (© The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: The patient-centered medical home (PCMH) includes comprehensive chronic illness and preventive services, including identifying patients who are overdue for colorectal cancer screening (CRCS). The association between PCMH implementation and CRCS during the Systems of Support to Increase Colorectal Cancer Screening Trial (SOS) is described., Methods: The SOS enrolled 4664 patients from 21 clinics from August 2008 to November 2009. Patients were randomized to usual care, mailed fecal kits, kits plus brief assistance, or kits plus assistance and navigation. A PCMH model that included a workflow for facilitating CRCS was implemented at all study clinics in late 2009. Patients enrolled early had little exposure to the PCMH, whereas patients enrolled later were exposed during most of their first year in the trial. Logistic regression models were used to assess the association between PCMH exposure and CRCS., Results: Usual care patients with ≥8 months in the PCMH had higher CRCS rates than those with ≤4 months in the PCMH (adjusted difference, 10.1%; 95% confidence interval, 5.7-14.6). SOS interventions led to significant increases in CRCS, but the magnitude of effect was attenuated by exposure to the PCMH (P for interaction = .01)., Conclusion: Exposure to a PCMH was associated with higher CRCS rates. Automated mailed and centrally delivered stepped interventions increased CRCS rates, even in the presence of a PCMH., (© Copyright 2016 by the American Board of Family Medicine.)

Background: The current study was conducted to determine the effect of continuing a centralized fecal occult blood test (FOBT) mailed program on screening adherence., Methods: A patient-level randomized controlled trial was conducted in 21 patient-centered medical home primary care clinics between January 2010 and November 2012. A total of 2208 patients ranging in age from 52 to 75 years in a substudy of the Systems of Support to Increase Colon Cancer Screening and Follow-Up (SOS) trial were randomized at year 3 to continued automated interventions (Continued group), which included mailed information regarding colorectal cancer (CRC) screening choices, and were mailed stool kit tests or to a group in which interventions were stopped (Stopped group). The main outcomes and measures were the completion of CRC screening in year 3 and by subgroup characteristics, respectively., Results: Adherence to CRC screening in year 3 was found to be significantly higher in patients in the Continued group compared with those in the Stopped group (53.3% vs 37.3%; adjusted net difference, 15.6% [P<.001]). This difference was entirely due to greater completion of FOBT (adjusted net difference, 18.0% [P<.001]). Year 3 CRC screening rates were highest in patients in the Continued group completing FOBT in both years 1 and 2 (77.2%), followed by patients completing only 1 FOBT in 1 of the 2 years (44.6%), with low rates of CRC testing reported among patients not completing any FOBT within the first 2 years (18.1%)., Conclusions: A centralized mailed FOBT CRC screening program continued to be more effective than patient-centered medical home usual-care interventions, but only for those patients who had previously completed FOBT testing. Research is needed regarding how to engage patients not completing CRC testing after being mailed at least 2 rounds of FOBT tests. Cancer 2016;122:312-321. © 2015 American Cancer Society., (© 2015 American Cancer Society.)

Background: The one-sample fecal immunochemical test (FIT) is gaining popularity for colorectal cancer (CRC) screening of average-risk people. However, uptake and annual use remain suboptimal., Methods: In 2013, we mailed questionnaires to three groups of nonHispanic White, Black, and Latino Kaiser Permanente Northern California (KPNC) members ages 52-76 who received FIT kits in 2010-2012: Continuers did the FIT all 3 years; Converts in 2012, but not 2010 or 2011; and Nonusers in none of the 3 years. The questionnaires covered social influences, perceived CRC risk, reasons for using (Continuers, Converts) or avoiding using (Nonusers) the FIT, and recommendations for improving the kit., Results: Continuers (n = 607, response rate 67.5%), Converts (n = 317, response rate 35.6%), and Nonusers (n = 215, response rate 21.1%) did not differ in perceived risk or family history of CRC, but Nonusers were less likely than Continuers and Converts to know someone who had polyps or CRC. Continuers, Converts, and Nonusers did not differ in social network encouragement of CRC screening, but did differ in believing that it was very important that they be screened (88.3%, 68.4%, 47.7%) and that their medical team thought it very important that they be screened (88.6%, 79.9%, 53.9%). Approximately half of Continuers and Converts completed the FIT to please their doctor. Converts were less likely than Continuers to use the FIT to "make sure they were OK" (53.7% vs. 72.6%) or "protect their health" (46.1% vs. 76.4%). Nearly half of Converts completed the FIT out of guilt. Approximately half of FIT kit users suggested adding a disposable glove, extra paper, and wider-mouth tube to the kit. Nonusers' reasons for not using the FIT included discomfort, disgust, or embarrassment (59.6%); thinking it unnecessary (32.9%); fatalism/fear (15.5%); and thinking it too difficult to use (14.5%), but <10% did not want CRC screening at all., Conclusions: Nonusers and irregular users of the FIT are less intrinsically motivated to get CRC screening than long-term users and more averse to preparing their stool sample. Changes to the FIT kit to address discomfort and difficulty factors might improve uptake and continued use.

Introduction: Recent colorectal cancer screening studies focus on optimizing adherence. This study evaluated the cost effectiveness of interventions using electronic health records (EHRs); automated mailings; and stepped support increases to improve 2-year colorectal cancer screening adherence., Methods: Analyses were based on a parallel-design, randomized trial in which three stepped interventions (EHR-linked mailings ["automated"]; automated plus telephone assistance ["assisted"]; or automated and assisted plus nurse navigation to testing completion or refusal [navigated"]) were compared to usual care. Data were from August 2008 to November 2011, with analyses performed during 2012-2013. Implementation resources were micro-costed; research and registry development costs were excluded. Incremental cost-effectiveness ratios (ICERs) were based on number of participants current for screening per guidelines over 2 years. Bootstrapping examined robustness of results., Results: Intervention delivery cost per participant current for screening ranged from $21 (automated) to $27 (navigated). Inclusion of induced testing costs (e.g., screening colonoscopy) lowered expenditures for automated (ICER=-$159) and assisted (ICER=-$36) relative to usual care over 2 years. Savings arose from increased fecal occult blood testing, substituting for more expensive colonoscopies in usual care. Results were broadly consistent across demographic subgroups. More intensive interventions were consistently likely to be cost effective relative to less intensive interventions, with willingness to pay values of $600-$1,200 for an additional person current for screening yielding ≥80% probability of cost effectiveness., Conclusions: Two-year cost effectiveness of a stepped approach to colorectal cancer screening promotion based on EHR data is indicated, but longer-term cost effectiveness requires further study., (Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: Few studies use longitudinal data to identify predictors of colorectal cancer screening (CRCS). We examined predictors of (1) initial CRCS during the first year of a randomized trial, and (2) repeat CRCS during the second year of the trial among those that completed FOBT in Year 1., Methods: The sample comprised 1247 participants of the Systems of Support to Increase Colorectal Cancer Screening (SOS) Trial (Group Health Cooperative, August 2008 to November 2011). Potential predictors of CRCS were identified with logistic regression and included sociodemographics, health history, and validated scales of psychosocial constructs., Results: Prior CRCS (OR 2.64, 95% CI 1.99-3.52) and intervention group (Automated: OR 2.06 95% CI 1.43-2.95; Assisted: OR 4.03, 95% CI 2.69-6.03; Navigated: OR 5.64, 95% CI 3.74-8.49) were predictors of CRCS completion at Year 1. For repeat CRCS at Year 2, prior CRCS at baseline (OR 1.97, 95% CI 1.25-3.11), intervention group (Automated: OR 9.27, 95% CI 4.56-18.82; Assisted: OR 11.17, 95% CI 5.44-22.94; Navigated: OR 13.10, 95% CI 6.33-27.08), and self-efficacy (OR 1.32, 95% CI 1.00-1.73) were significant predictors., Conclusion: Self-efficacy and prior CRCS are important predictors of future screening behavior. CRCS completion increased when access barriers were removed through interventions., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Understanding how interventions affect time to completion of colorectal cancer screening might assist in planning and delivering population-based screening interventions. The Systems of Support to Increase Colorectal Cancer Screening (SOS) study was conducted between 2008 and 2011 at 21 primary care medical centers in Western Washington. Participants in the study, ages 50 to 73 years, were eligible if they were enrolled in Group Health (Seattle, WA) and were due for colorectal cancer screening. Of note, 4,675 recruited participants were randomized to usual care or one of three interventions with incremental levels of systems of support for completion of colorectal cancer screening. We conducted time to screening analyses of the SOS data in years 1 and 2. We investigated whether these effects were time-varying. For year 1, the intervention effects on the time to completion of colorectal cancer screening were the strongest during the first two post-randomization months and then decreased, with no significant effect after the fifth month. For year 2, the intervention effects on the time to colorectal cancer screening increased from the first to the third month and then decreased, with no significant effect after the fifth month. Hence, each of the interventions to increase colorectal cancer screening had its greatest effect within the first 3 months after being offered to participants. Future studies should test whether booster interventions offered later could increase screening rate among those who remain unscreened. Additional research is needed to develop intervention strategies for colorectal cancer screening that focus on sustained behavior over time., (©2014 American Association for Cancer Research.)

Background: Colorectal cancer is the second-leading cause of cancer deaths in the United States. The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics. The study will assess the effectiveness of a system-based intervention designed to improve the rates of colorectal-cancer screening using fecal immunochemical testing (FIT) in federally qualified health centers in Oregon and Northern California., Material and Methods: STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics. Clinics will be randomized to one of two arms. Clinics in the intervention arm (1) will use an automated, data-driven, electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits (with pictographic instructions) to them; (2) will conduct an improvement process (e.g. Plan-Do-Study-Act) to enhance the adoption, reach, and effectiveness of the program. Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits. The primary outcomes are: proportion of age- and screening-eligible patients completing a FIT within 12months; and cost, cost-effectiveness, and return on investment of the intervention., Conclusions: This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients, including many with historically low colorectal-cancer screening rates. If successful, the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: We describe patterns of colorectal cancer screening uptake in a U.S. insured population as individuals become newly eligible for screening at age 50 and assess temporal trends and patient characteristics with screening uptake., Methods: We identified a cohort of 81,223 men and women who were members of Group Health and turned 50 years old from 1996 to 2010. We ascertained receipt of colorectal cancer screening within five years. Time to screening was estimated by year of cohort entry using cumulative incidence curves and Cox proportional hazards models-estimated patient characteristics associated with screening uptake., Results: Stool-based screening tests were the most common, 72% of first screening tests. The proportion of individuals initiating colorectal cancer screening via colonoscopy increased from 8% in 1996 to 1998 to 33% in 2008 to 2010. Patient factors associated with increased colorectal cancer screening were: turning 50 more recently (2008-2010; Ptrend < 0.0001) or Asian race [HR, 1.14; 95% confidence interval (CI), 1.10-1.19]. Patient factors associated with decreased screening were: being a woman (HR, 0.70; 95% CI, 0.68-0.72), Native American (HR, 0.68; 95% CI, 0.60-0.78), or Pacific Islander race (HR, 0.82; 95% CI, 0.72-0.95), and having prevalent diabetes (HR, 0.78; 95% CI, 0.75-0.82) and higher body mass index (Ptrend < 0.0001)., Conclusions: Patient characteristics associated with initiation of colorectal cancer screening in a newly eligible population are similar to characteristics associated with overall screening participation in all age-eligible adults. Our results identify patient populations to target in outreach programs., Impact: Disparities in receipt of colorectal cancer screening are evident from onset of an age-eligible cohort, identifying key groups for future interventions for screening., (©2014 American Association for Cancer Research.)

The Affordable Care Act (ACA) mandates that both Medicaid and insurance plans cover life-saving preventive services recommended by the US Preventive Services Task Force, including colorectal cancer (CRC) screening and choice between colonoscopy, flexible sigmoidoscopy, and fecal occult blood testing (FOBT). People who choose FOBT or sigmoidoscopy as their initial test could face high, unexpected, out-of-pocket costs because the mandate does not cover needed follow-up colonoscopies after positive tests. Some people will have no coverage for any CRC screening because of lack of state participation in the ACA or because they do not qualify (e.g., immigrant workers). Existing disparities in CRC screening and mortality will worsen if policies are not corrected to fully cover both initial and follow-up testing.

Colorectal cancer (CRC) is a leading cause of cancer mortality worldwide. CRC incidence and mortality can be reduced through screening. However, in the United States, screening participation remains suboptimal, particularly among underserved populations such as the uninsured, recent immigrants, and racial/ethnic minority groups. Increasing screening rates among underserved populations will reduce the US burden of CRC. In this commentary focusing on underserved populations, we highlight the public health impact of CRC screening, list key challenges to screening the underserved, and review promising approaches to boost screening rates. We identify four key policy and research priorities to increase screening among underserved populations: 1) actively promote the message, "the best test is the one that gets done"; 2) develop and implement methods to identify unscreened individuals within underserved population groups for screening interventions; 3) develop and implement approaches for organized screening delivery; and 4) fund and enhance programs and policies that provide access to screening, diagnostic follow-up, and CRC treatment for underserved populations. This commentary represents the consensus of a diverse group of experts in cancer control and prevention, epidemiology, gastroenterology, and primary care from across the country who formed the Coalition to Boost Screening among the Underserved in the United States. The group was organized and held its first annual working group meeting in conjunction with the World Endoscopy Organization's annual Colorectal Cancer Screening Committee meeting during Digestive Disease Week 2012 in San Diego, California.

Background: Colorectal cancer screening (CRCS) reduces morbidity and mortality; however, the positive benefits might be partially offset by long-term distress following positive screening results. We examined relationships among colorectal cancer-specific worry and situational anxiety after positive fecal occult blood tests [FOBT (+)] compared with receipt of negative results., Methods: Of note, 2,260 eligible members of Group Health, an integrated healthcare delivery system, completed baseline surveys and received FOBT screening kits, with 1,467 members returning the kits. We matched FOBT (+) patients (n = 55) 1:2 on age and sex with FOBT (-) respondents (n = 110). Both groups completed follow-up surveys at 7 to 14 days and 4 months after screening. We assessed situational anxiety (State-Trait Anxiety Inventory, STAI), colorectal cancer worry frequency, and mood disturbance., Results: Mean age was 59 years, and majority were women (62%) and White (89%). After adjusting for age, sex, and baseline worry, at 7 to 14 days after screening, the FOBT (+) group was 3.82 [95% confidence interval (CI), 1.09-13.43] times more likely to report colorectal cancer-related mood disturbances and significantly higher mean STAI scores than the FOBT (-) group (mean = 38.8 vs. 30.9; P = 0.007). At 4-month posttest, mood disturbances and situational anxiety seemed to drop to baseline levels for FOBT (+). No colon cancer worry frequency was observed., Conclusions: FOBT (+) results are associated with short-term situational anxiety and colorectal cancer-specific mood disturbances., Impact: Distress from FOBT (+) results declined to near-baseline levels by 4 months. Additional studies are needed to clarify the relationship between long-term distress and follow-up colonoscopy.

Objective: The aim of this study is to compare the uptake of three mailed high-sensitivity fecal occult blood tests (FOBTs)., Methods: We conducted a parallel 3-arm randomized controlled trial in an integrated healthcare delivery system in Washington State. From January 2010 through February 2011, automated data were used to identify potentially eligible patients aged 50-74 due for colorectal cancer screening. Participants were mailed one of three FOBT kits (1-sample OC-Auto® fecal immunochemical test [FIT], 2-sample InSure® FIT, or 3-sample guaiac Hemoccult SENSA®), instructions, and a postage-paid return envelope. We performed a modified intent-to-treat analysis with return of any FOBT within 6 months of randomization as the primary outcome., Results: Of the 9922 people invited, 2873 returned surveys, 2263 were randomized, and 2234 were analyzed. FOBTs were returned by 1431 participants. At 6 months post-randomization, the proportions screened by any FOBT were 0.69 (95% confidence interval [CI] 0.66-0.72) for the OC-Auto arm, 0.64 (95% CI: 0.61-0.68) for the InSure arm, and 0.61 (95% CI: 0.58-0.65) for the Hemoccult SENSA arm (P<0.001 for any difference). Pairwise comparisons showed significant differences between the OC-Auto group and each of the other groups after correction for multiple comparisons., Conclusion: Uptake of mailed FOBT kits varies by kit type., (© 2013.)

Background: Screening decreases colorectal cancer (CRC) incidence and mortality, yet almost half of age-eligible patients are not screened at recommended intervals., Objective: To determine whether interventions using electronic health records (EHRs), automated mailings, and stepped increases in support improve CRC screening adherence over 2 years., Design: 4-group, parallel-design, randomized, controlled comparative effectiveness trial with concealed allocation and blinded outcome assessments. (ClinicalTrials.gov: NCT00697047), Setting: 21 primary care medical centers., Patients: 4675 adults aged 50 to 73 years not current for CRC screening., Intervention: Usual care, EHR-linked mailings ("automated"), automated plus telephone assistance ("assisted"), or automated and assisted plus nurse navigation to testing completion or refusal ("navigated"). Interventions were repeated in year 2., Measurements: The proportion of participants current for screening in both years, defined as colonoscopy or sigmoidoscopy (year 1) or fecal occult blood testing (FOBT) in year 1 and FOBT, colonoscopy, or sigmoidoscopy (year 2)., Results: Compared with those in the usual care group, participants in the intervention groups were more likely to be current for CRC screening for both years with significant increases by intensity (usual care, 26.3% [95% CI, 23.4% to 29.2%]; automated, 50.8% [CI, 47.3% to 54.4%]; assisted, 57.5% [CI, 54.5% to 60.6%]; and navigated, 64.7% [CI, 62.5% to 67.0%]; P < 0.001 for all pair-wise comparisons). Increases in screening were primarily due to increased uptake of FOBT being completed in both years (usual care, 3.9% [CI, 2.8% to 5.1%]; automated, 27.5% [CI, 24.9% to 30.0%]; assisted, 30.5% [CI, 27.9% to 33.2%]; and navigated, 35.8% [CI, 33.1% to 38.6%])., Limitation: Participants were required to provide verbal consent and were more likely to be white and to participate in other types of cancer screening, limiting generalizability., Conclusion: Compared with usual care, a centralized, EHR-linked, mailed CRC screening program led to twice as many persons being current for screening over 2 years. Assisted and navigated interventions led to smaller but significant stepped increases compared with the automated intervention only. The rapid growth of EHRs provides opportunities for spreading this model broadly.

Background: Most physicians report routinely recommending colorectal cancer (CRC) screening, but many eligible patients are not screened. To better understand this finding, we explored the relationship between the content of hypothetical patient-physician CRC screening discussions and CRC screening rates in physicians' practices., Methods: Semistructured interviews, including role-playing, with 24 primary care physicians explored their CRC screening approach with average-risk patients. Qualitative analysis examined physician-reported components of the CRC screening discussion, then compared findings between physicians with high (≥60%, n = 16) and low (≤45%, n = 8) CRC screening rates (based on HEDIS criteria). We conducted no statistical tests because of the small sample size and its exploratory aims., Results: High screeners used dramatic language (eg, patient stories) and mentioned risk of death, disability, or surgery from CRC in screening discussion role-plays more often than low screeners. High screeners frequently offered fecal occult blood testing, flexible sigmoidoscopy, and colonoscopy as equally acceptable screening options. High screeners more commonly described solutions for overcoming CRC screening barriers., Conclusions: Encouraging providers to use risk-specific messaging about the consequences of CRC, offering screening option choices, and promoting a problem-solving approach to surmount barriers are potential strategies for increasing CRC screening rates.

Background: Screening over many years is required to optimize colorectal cancer (CRC) outcomes. Objective: To evaluate the effect of a CRC screening intervention on adherence to CRC screening over 9 years. Design: Randomized trial. Setting: Integrated health care system in Washington state. Participants: Between August 2008 and November 2009, 4653 adults in a Washington state integrated health care system aged 50–74 due for CRC screening were randomized to usual care (UC; N =1163) or UC plus study interventions (interventions: N = 3490). Interventions: Years 1 and 2: (arm 1) UC or this plus study interventions; (arm 2) mailed fecal tests or information on scheduling colonoscopy; (arm 3) mailings plus brief telephone assistance; or (arm 4) mailings and assistance plus nurse navigation. In year 3, stepped-intensity participants (arms 2, 3, and 4 combined) still eligible for screening were randomized to either stopped or continued interventions in years 3 and 5–9. Main Measures: Time in adherence to CRC testing over 9 years (covered time, primary outcome), and percent with no CRC testing in participants assigned to any intervention compared to UC only. Poisson regression models estimated incidence rate ratios for covered time, adjusting for patient characteristics and accounting for variable follow-up time. Key Results: Compared to UC, intervention participants had 21% more covered time over 9 years (57.5% vs. 69.1%; adjusted incidence rate ratio 1.21, 95% confidence interval 1.16–1.25, P<0.001). Fecal testing accounted for almost all additional covered time among intervention patients. Compared to UC, intervention participants were also more likely to have completed at least one CRC screening test over 9 years or until censorship (88.6% vs. 80.6%, P<0.001). Conclusions: An outreach program that included mailed fecal tests and phone follow-up led to increased adherence to CRC testing and fewer age-eligible individuals without any CRC testing over 9 years. Trial Registration: Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up (SOS), NCT00697047, clinicaltrials.gov/ct2/show/NCT00697047 [ABSTRACT FROM AUTHOR]

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. In this study, a health insurance plan demonstrates its ability to deliver 2 different mailed fecal immunochemical test (FIT) program models, with vendors used to manage some program elements. These mailed FIT programs began to close gaps in colorectal cancer screening rates in the health plan's dual‐eligible Medicaid/Medicare population. [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]

Mailed fecal immunochemical testing (FIT) kits for colorectal cancer screening at home can contribute to reaching national goals of 80% colorectal cancer screening in communities. Policies that support cost‐effective colorectal cancer screening programs would decrease colorectal cancer disparities. [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]

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

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]

Purpose: To explore financial incentives as an intervention to improve colorectal cancer screening (CRCS) adherence among traditionally disadvantaged patients who have never been screened or are overdue for screening. Approach: We used qualitative methods to describe patients' attitudes toward the offer of incentives, plans for future screening, and additional barriers and facilitators to CRCS. Setting: Kaiser Permanente Washington (KPWA). Participants: KPWA patients who were due or overdue for CRCS. Method: We conducted semi-structured qualitative interviews with 37 patients who were randomized to 1 of 2 incentives (guaranteed $10 or a lottery for $50) to complete CRCS. Interview transcripts were analyzed using a qualitative content approach. Results: Patients generally had positive attitudes toward both types of incentives, however, half did not recall the incentive offer at the time of the interview. Among those who recalled the offer, 95% were screened compared to only 25% among those who did not remember the offer. Most screeners stated that staying healthy was their primary motivator for screening, but many suggested that the incentive helped them prioritize and complete screening. Conclusions: Incentives to complete CRCS may help motivate patients who would like to screen but have previously procrastinated. Future studies should ensure that the incentive offer is noticeable and shorten the deadline for completion of FIT screening. [ABSTRACT FROM AUTHOR]

Objective: To derive a taxonomy for colorectal cancer screening that advances Randomized Controlled Trials (RCTs) and screening uptake.Design: Detailed publication review, multiple interviews with principal investigators (PIs) and collaboration with PIs as co-authors produced a CRCS intervention taxonomy. Semi-structured interview questions with PIs (Drs. Inadomi, Myers, Green, Gupta, Jerant and Ritvo) yielded details about trial conduct. Interview comparisons led to an iterative process informing serial interviews until a consensus was obtained on final taxonomy structure.Results: These taxonomy headings (Engagement Sponsor, Population Targeted, Alternative Screening Tests, Delivery Methods, and Support for Test Performance (EPADS)) were used to compare studies. Exemplary insights emphasized: 1) direct test delivery to patients; 2) linguistic-ethnic matching of staff to minority subjects; and 3) authorization of navigators to schedule or refer for colonoscopies and/or distribute stool blood tests during screening promotion.Conclusion: PIs of key RCTs (2012-2015) derived a CRCS taxonomy useful in detailed examination of CRCS promotion and design of future RCTs. [ABSTRACT FROM AUTHOR]

Mailing HPV self-sampling kits to overdue individuals increases cervical cancer screening adherence; offering self-sampling to previously adherent individuals has not been evaluated in the U.S. Given heterogeneity of the U.S. health system and population, data are needed to optimize how HPV self-sampling is offered to individuals who are overdue, due after successful past screening, or have an unknown screening history. STEP is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system, designed to compare different outreach approaches for offering HPV self-sampling in populations defined by prior screening behavior (previously-adherent, overdue, or unknown screening history). Over 14 months, eligible individuals were identified through electronic medical record (EMR) data and randomized to Usual Care (UC), Education (UC + educational materials about cervical cancer screening), Direct-Mail (UC + Education + a mailed self-sampling kit) or Opt-In (UC + Education + option to request a kit), depending on screening history. The primary objective is to compare screening completion by outreach approach and screening history. Secondary objectives include evaluating incremental cost-effectiveness of outreach approaches, and identifying patient preference for, and satisfaction with, HPV self-screening, and barriers to abnormal results follow-up (measured through interviews and focus groups). The trial was designed to generate data that U.S. health systems can use to inform primary HPV screening implementation strategies that incorporate HPV self-sampling options to improve screening access, adherence, and patient satisfaction. The objective of this report is to describe the rationale and design of this pragmatic trial. [ABSTRACT FROM AUTHOR]