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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: 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. [ABSTRACT FROM AUTHOR]

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. [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]

Background: Challenges of recruiting participants into pragmatic trials, particularly at the level of the health system, remain largely unexplored. As part of Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), we recruited eight separate community health centers (consisting of 26 individual safety net clinics) into a large comparative effectiveness pragmatic study to evaluate methods of raising the rates of colorectal cancer screening. Methods: In partnership with STOP CRC’s advisory board, we defined criteria to identify eligible health centers and applied these criteria to a list of health centers in Washington, Oregon, and California affiliated with Oregon Community Health Information Network, a 16-state practice-based research network of federally sponsored health centers. Project staff contacted centers that met eligibility criteria and arranged in-person meetings of key study investigators with health center leadership teams. We used the Consolidated Framework for Implementation Research to thematically analyze the content of discussions during these meetings to identify major facilitators of and barriers to health center participation. Results: From an initial list of 41 health centers, 11 met the initial inclusion criteria. Of these, leaders at three centers declined and at eight centers (26 clinic sites) agreed to participate (73%). Participating and nonparticipating health centers were similar with respect to clinic size, percent Hispanic patients, and percent uninsured patients. Participating health centers had higher proportions of Medicaid patients and higher baseline colorectal cancer screening rates. Common facilitators of participation were perception by center leadership that the project was an opportunity to increase colorectal cancer screening rates and to use electronic health record tools for population management. Barriers to participation were concerns of center leaders about ability to provide fecal testing to and assure follow-up of uninsured patients, limited clinic capacity to prepare mailings required by the study protocol, discomfort with randomization, and concerns about delaying program implementation at some clinics due to the research requirements. Conclusion: Our findings address an important research gap and may inform future efforts to recruit community health centers into pragmatic research. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Follow-up colonoscopy after a positive fecal immunochemical test (FIT) is necessary for colorectal cancer (CRC) screening to be effective. We report colonoscopy follow-up rates after a positive FIT overall and by population characteristics in the BeneFIT demonstration pilot, a Medicaid health insurance plan-delivered mailed FIT outreach program., Methods: In 2016, 2 health insurance plans in Oregon and in Washington state mailed FIT kits to Medicaid patients who, based on claims data, were overdue for CRC screening. We report follow-up colonoscopy completion rates after positive FIT, and differences in completion rates by age, sex, race, ethnicity, preferred language, and number of primary care visits in the prior year. This research was human subjects approved with a waiver of consent for data collection., Results: The FIT positivity rates in Health Plan Oregon and Health Plan Washington were 7.9% (39/488) and 14.6% (125/857), respectively. Colonoscopy completion rates within 12 months of the positive test were 35.9% (14/41) in Health Plan Oregon and 32.8% (41/125) in Health Plan Washington. Colonoscopy completion rates were higher among individuals who preferred a language other than English (Non-English speakers 70.0%, English speakers 31.3%, P  = .04)., Conclusion: In a health plan-delivered mailed FIT outreach program, follow-up colonoscopy rates after a positive test were low. Additional interventions are needed to assure colonoscopy after a positive FIT test and to reap the benefits of screening.