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

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. Cancer 2020;126:540-548.

Screening rates for colorectal cancer (CRC) remain low, especially among certain populations. Mailed fecal immunochemical testing (FIT) outreach initiated by U.S. health plans could reach underserved individuals, while solving CRC screening data and implementation challenges faced by health clinics. We report the models and motivations of two health insurance plans implementing a mailed FIT program for age-eligible U.S. Medicaid and Medicare populations. One health plan operates in a single state with ~220,000 enrollees; the other operates in multiple states with ~2 million enrollees. We conducted in-depth qualitative interviews with key stakeholders and observed leadership and clinic staff planning during program development and implementation. Interviews were transcribed and coded using a content analysis approach; coded interview reports and meeting minutes were iteratively reviewed and summarized for themes. Between June and September 2016, nine participants were identified, and all agreed to the interview. Interviews revealed that organizational context was important to both organizations and helped shape program design. Both organizations were hoping this program would address barriers to their prior CRC screening improvement efforts and saw CRC screening as a priority. Despite similar motivations to participate in a mailed FIT intervention, contextual features of the health plans led them to develop distinct implementation models: a collaborative model using some health clinic staffing versus a centralized model operationalizing outreach primarily at the health plan. Data are not yet available on the models’ effectiveness. Our findings might help inform the design of programs to deliver mailed FIT outreach.

Background: Mailed fecal immunochemical testing (FIT) programs can improve colorectal cancer (CRC) screening rates, but health systems often vary implementation (i.e., adapt) these programs for their organizations. A health insurance plan implemented a mailed FIT program (named BeneFIT) and allowed participating health systems to adapt the program. This mixed-methods study explored which program adaptations might have achieved higher screening rates.Methods: We used a multi-method approach. First, we conducted a descriptive analysis of CRC screening rates by key health system characteristics and program adaptations. Second, we applied Configurational Comparative Methods (CCMs) to determine potential explanatory factors consistent with higher screening rates. The main outcome measure was CRC screening rates.Results: Seventeen health systems took part in at least one year of BeneFIT. The overall screening completion rate was 20% (4%–28%) in Year 1, and 25% (12%–35%) in Year 2 of the program. Health systems that used two or more adaptations had higher screening rates, and no single adaptation clearly led to higher screening rates. In Year 1, smaller systems (having <2 clinics) with phone reminders (n=2) met the implementation success threshold (≥19% screening rate) while larger systems were successful when offering a patient incentive (n=4), scrubbing mailing lists (n=4), or allowing mailed FIT returns with no other adaptations (n=1). In Year 2, large systems (>2 clinics) were successful with a phone reminder (n=4) or a patient incentive (n=3). Of the 10 systems that implemented BeneFIT in both years, seven improved in Year 2.Conclusions: Health systems can choose between many adaptations and successfully implement a health plan’s mailed FIT program. Screening completion rates are positively associated with the number of adaptations implemented by a health system. Health system size emerged as an important contextual factor, with different solutions for larger than smaller health systems.