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

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]

Background: Colorectal-cancer is a leading cause of cancer death in the United States, and Latinos have particularly low rates of screening. Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) is a partnership among two research institutions and a network of safety net clinics to promote colorectal cancer screening among populations served by these clinics. This paper reports on results of a pilot study conducted in a safety net organization that serves primarily Latinos. Methods: The study assessed two clinic-based approaches to raise rates of colorectal-cancer screening among selected age-eligible patients not up-to-date with colorectal-cancer screening guidelines. One clinic each was assigned to: (1) an automated data-driven Electronic Health Record (EHR)-embedded program for mailing Fecal Immunochemical Test (FIT) kits (Auto Intervention); or (2) a higher-intensity program consisting of a mailed FIT kit plus linguistically and culturally tailored interventions delivered at the clinic level (Auto Plus Intervention). A third clinic within the safety-net organization was selected to serve as a passive control (Usual Care). Two simple measurements of feasibility were: 1) ability to use real-time EHR data to identify patients eligible for each intervention step, and 2) ability to offer affordable testing and follow-up care for uninsured patients. Results: The study was successful at both measurements of feasibility. A total of 112 patients in the Auto clinic and 101 in the Auto Plus clinic met study inclusion criteria and were mailed an introductory letter. Reach was high for the mailed component (92.5% of kits were successfully mailed), and moderate for the telephone component (53% of calls were successful completed). After exclusions for invalid address and other factors, 206 (109 in the Auto clinic and 97 in the Auto Plus clinic) were mailed a FIT kit. At 6 months, fecal test completion rates were higher in the Auto (39.3%) and Auto Plus (36.6%) clinics compared to the usual-care clinic (1.1%). Conclusions: Findings showed that the trial interventions delivered in a safety-net setting were both feasible and raised rates of colorectal-cancer screening, compared to usual care. Findings from this pilot will inform a larger pragmatic study involving multiple clinics. Trial registration: ClinicalTrial.gov: NCT01742065 [ABSTRACT FROM AUTHOR]

Background: Colorectal-cancer is a leading cause of cancer death in the United States, and Latinos have particularly low rates of screening. Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) is a partnership among two research institutions and a network of safety net clinics to promote colorectal cancer screening among populations served by these clinics. This paper reports on results of a pilot study conducted in a safety net organization that serves primarily Latinos.Methods: The study assessed two clinic-based approaches to raise rates of colorectal-cancer screening among selected age-eligible patients not up-to-date with colorectal-cancer screening guidelines. One clinic each was assigned to: (1) an automated data-driven Electronic Health Record (EHR)-embedded program for mailing Fecal Immunochemical Test (FIT) kits (Auto Intervention); or (2) a higher-intensity program consisting of a mailed FIT kit plus linguistically and culturally tailored interventions delivered at the clinic level (Auto Plus Intervention). A third clinic within the safety-net organization was selected to serve as a passive control (Usual Care). Two simple measurements of feasibility were: 1) ability to use real-time EHR data to identify patients eligible for each intervention step, and 2) ability to offer affordable testing and follow-up care for uninsured patients.Results: The study was successful at both measurements of feasibility. A total of 112 patients in the Auto clinic and 101 in the Auto Plus clinic met study inclusion criteria and were mailed an introductory letter. Reach was high for the mailed component (92.5% of kits were successfully mailed), and moderate for the telephone component (53% of calls were successful completed). After exclusions for invalid address and other factors, 206 (109 in the Auto clinic and 97 in the Auto Plus clinic) were mailed a FIT kit. At 6 months, fecal test completion rates were higher in the Auto (39.3%) and Auto Plus (36.6%) clinics compared to the usual-care clinic (1.1%).Conclusions: Findings showed that the trial interventions delivered in a safety-net setting were both feasible and raised rates of colorectal-cancer screening, compared to usual care. Findings from this pilot will inform a larger pragmatic study involving multiple clinics.Trial Registration: ClinicalTrial.gov: NCT01742065. [ABSTRACT FROM AUTHOR]