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.
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.
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.
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.
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.
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.
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configurational comparative methods
qualitative comparative analysis
fecal immunochemical test
federally qualified health center
- STOP CRC:
Strategies and Opportunities to Stop Colon Cancer in Priority Populations
electronic health record
plan-do-study-act improvement process
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Research reported in this publication was supported by the National Institutes of Health Common Fund and the National Cancer Institute under award numbers UH2AT007782 and 4UH3CA188640-02, awarded to the second and seventh authors (Green and Coronado).
Conflict of Interest
The authors declare that they do not have a conflict of interest.
Dr. Coronado: From November 2014 to August 2015, Dr. Coronado served as a co-investigator on an industry-funded study to evaluate patient adherence to an experimental blood test for colorectal cancer. The study was funded by EpiGenomics. From September 2017 to June 2018, Dr. Coronado served as the Principal Investigator on an industry-funded study to compare the clinical performance of an experimental FIT to an FDA-approved FIT. This study is funded by Quidel Corporation. Dr. Coronado has served as a scientific advisor for Exact Sciences and Guardant Health. All other authors declare no conflicts of interest.
Ethics Approval and Consent to Participate
The study was approved by the Institutional Review Board of Kaiser Permanente Northwest on December 6, 2013. The project received a waiver of informed consent; however, all interview participants provided verbal assent. All staff have been trained in ethical conduct of human subject research.
Consent for Publication
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The study sponsor had no role in study design; collection, analysis, and interpretation of data; writing the report; or the decision to submit the report for publication.
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Contributions to the Literature
• This study identifies what clinical setting factors lead to different levels of implementation of an evidence-based colorectal cancer screening program. High levels of implementation were directly linked to having centralized staff devoted to implementation and the ability to carry out the program as designed.
• Configurational comparative methods are well-suited to assess combinations of conditions linked to successful implementation. Understanding how combinations of conditions lead to successful implementation can inform efforts to optimize the delivery of evidence-based interventions in practice.
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Petrik, A.F., Green, B., Schneider, J. et al. Factors Influencing Implementation of a Colorectal Cancer Screening Improvement Program in Community Health Centers: an Applied Use of Configurational Comparative Methods. J GEN INTERN MED 35, 815–822 (2020). https://doi.org/10.1007/s11606-020-06186-2
- colorectal cancer
- fecal immunochemical tests
- FIT tests
- configurational comparative methods
- Consolidated Framework for Implementation Research