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Implementation strategies in the Exploration and Preparation phases of a colorectal cancer screening intervention in community health centers

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Renée M. Ferrari, Jennifer Leeman, Alison T. Brenner, Sara Y. Correa, Teri L. Malo, Alexis Moore, Meghan C. O’Leary, Connor M. Randolph, Shana Ratner, Leah Frerichs, Deeonna E. Farr, Seth D. Crockett, Stephanie B. Wheeler, Kristen Hassmiller Lich, Evan Beasley, Michelle Hogsed, Ashley Bland, Claudia Richardson, Mike Newcomer, Daniel S. Reuland

Colorectal cancer screening can save lives, yet it remains especially underused in underserved communities. This project’s surprising solution was not simply a better test—it was redesigning who does the work and how the pieces connect.

Abstract

Background Adoption of colorectal cancer (CRC) screening has lagged in community health center (CHC) populations in the USA. To address this implementation gap, we developed a multilevel intervention to improve screening in CHCs in our region. We used the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to guide this effort. Here, we describe the use of implementation strategies outlined in the Expert Recommendations for Implementing Change (ERIC) compilation in both the Exploration and Preparation phases of this project. During these two EPIS phases, we aimed to answer three primary questions: (1) What factors in the inner and outer contexts may support or hinder colorectal cancer screening in North Carolina CHCs?; (2) What evidence-based practices (EBPs) best fit the needs of North Carolina CHCs?; and (3) How can we best integrate the selected EBPs into North Carolina CHC systems? Methods During the Exploration phase, we conducted local needs assessments, built a coalition, and conducted local consensus discussions. In the Preparation phase, we formed workgroups corresponding to the intervention’s core functional components. Workgroups used cyclical small tests of change and process mapping to identify implementation barriers and facilitators and to adapt intervention components to fit inner and outer contexts. Results Exploration activities yielded a coalition of stakeholders, including two rural CHCs, who identified barriers and facilitators and reached consensus on two EBPs: mailed FIT and navigation to colonoscopy. Stakeholders further agreed that the delivery of those two EBPs should be centralized to an outreach center. During Preparation, workgroups developed and refined protocols for the following centrally-delivered intervention components: a registry to identify and track eligible patients, a centralized system for mailing at-home stool tests, and a process to navigate patients to colonoscopy after an abnormal stool test. Conclusions This description may be useful both to implementation scientists, who can draw lessons from applied implementation studies such as this to refine their implementation strategy typologies and frameworks, as well

Transcript

Colorectal cancer screening can save lives, yet it remains especially underused in underserved communities. This project’s surprising solution was not simply a better test—it was redesigning who does the work and how the pieces connect. Despite strong evidence that colorectal cancer screening reduces mortality, screening remains underused in the USA.

Screening rates are especially low in people who are medically underserved and those without health insurance. North Carolina community health centers serve diverse populations, including many with lower incomes and or who lack health insurance. Although screening rates have increased in recent years, they remain below state and national averages.

To address this colorectal cancer screening implementation gap, the Scaling Colorectal Cancer Screening through Outreach, Referral, and Engagement project was initiated. The project was grounded in the Institute for Healthcare Improvement’s Improvement Model, a widely used model familiar to the community health center partners.

The Improvement Model provides process maps and Plan-Do-Study-Act cycles to iteratively plan and test improvements in care delivery, while the EPIS framework guides planning and implementation of a complex, multilevel intervention. The project describes implementation strategies used during the Exploration and Preparation phases of EPIS and the multilevel determinants that guided their design.

Exploration involves engaging stakeholders, selecting evidence-based practices, and identifying needs, opportunities, and challenges in the practice setting and wider context. Preparation entails identifying and planning for barriers and facilitators related to the selected practices.

EPIS identifies outer context, inner context, bridging factors, and the innovation being implemented as levels where implementation may be impeded or facilitated. Early needs assessment included review of existing data and literature on colorectal cancer burden in North Carolina, as well as literature on colorectal cancer screening interventions.

To identify evidence-based practices likely to have the most impact in this setting, the team assessed evidence regarding intervention effectiveness. That assessment included a systematic review and meta-analysis of randomized trials evaluating evidence-based interventions to increase colorectal cancer screening.

The team engaged the three community health centers in identifying and prioritizing inner and outer contextual factors relevant to colorectal cancer screening in North Carolina. In this early phase, engagement involved relationship-building and exploration rather than formal engagement methods.

Engagement occurred through site visits, attendance at standing community health center meetings, and ongoing discussions. The research team built a coalition of stakeholders that served as a primary bridging factor linking outer and inner contexts. Early in Exploration and before study funding, relationships with key stakeholders working to improve colorectal cancer screening were developed and expanded.

The coalition included the North Carolina Society for Gastroenterology, the state Division of Public Health’s Cancer Prevention and Control Branch, the North Carolina Colorectal Cancer Roundtable, the North Carolina Community Health Center Association, and regional programs and providers.

Because colonoscopy is required after an abnormal FIT-based screening test and community health centers do not provide colonoscopy services, endoscopy providers were also identified and engaged. Review of the literature and ongoing discussions during stakeholder meetings helped identify colorectal cancer screening barriers and facilitators.

Outer-context barriers included a large number of uninsured people, lack of Medicaid expansion, racial, income, and rural inequities in screening rates, and forty independently operated community health centers with diverse electronic health records. Facilitators included a university comprehensive cancer center serving the entire state and active community health center and endoscopy-provider partners.

Inner-context barriers included mixed quality of patient data in the electronic health record and constraints on clinic staff time. Figure two adapts the EPIS framework for the SCORE project, placing implementation within a cycle of exploration, preparation, implementation, and sustainment.

It organizes influences into outer context, inner context, bridging factors, and innovation factors, including centralized registry functions, mailed FIT outreach, and patient navigation. This matters because the framework connects statewide and organizational barriers with the relationships and centralized supports intended to coordinate screening across community health centers with diverse electronic health records.

Based on prior review of the colorectal cancer screening literature, mailed FIT and patient navigation were identified as evidence-based practices that aligned with the selection criteria. Mailed FIT has potential to reach patients outside the clinic visit, while patient navigation addresses barriers to accessing colonoscopies after a positive FIT.

Combining the two practices reaches patients across the screening care continuum. To address staff time constraints and replicability across community health centers, delivery of mailed FIT and navigation was centralized within an intermediary organization rather than within individual community health centers.

This decision enabled the project to address constraints on the time staff had available to implement mailed outreach. Centralization also had potential to address screening service fragmentation, including poor integration among primary care clinics and endoscopy centers that sometimes led to poor follow-up on endoscopy referrals.

Figure three maps the SCORE intervention across three linked workgroups: the Registry Workgroup identifies patients due for screening, the Mailed FIT Workgroup sends kits and reminders and reports results, and the FIT-plus-to-Colonoscopy Workgroup supports patients through navigation, colonoscopy, and follow-up.

The arrows show how information and patients move between these functions, while the footnote notes that chart review to confirm eligibility occurs only at Community Health Center two. This structure matters because each workgroup bridges research staff, health centers, and other stakeholders around a core intervention function.

Because the planned intervention was complex, Preparation work was divided among three workgroups corresponding to the intervention’s core functions. Each workgroup served as a bridging factor and included research team members, key personnel from each community health center, and other stakeholders such as endoscopy providers.

The Registry Workgroup focused on identifying and tracking patients due for screening, the Mailed FIT Workgroup focused on mailed FIT outreach, and the FIT-positive to Colonoscopy Workgroup focused on facilitating follow-up colonoscopy. Each workgroup established a charter and held regular, often weekly, task-oriented meetings focused on collaborative problem-solving.

Workgroups developed intervention processes, explored inner and outer contexts of potential impact, and identified barriers and facilitators specific to their core function. Two specific tools included process mapping and electronic health record chart review.

Process mapping clarified starting and stopping points, current processes, and barriers and facilitators affecting specific process steps. Interactive diagramming used sticky notes on a large wall diagram to revise steps and branching points in screening workflows.

Because community health centers operate independently, use different electronic health record systems, and vary in endoscopy access, process maps helped identify points of variation for adaptation to different contexts. Cyclical small tests of change, also known as rapid Plan-Do-Study-Act cycles, are a quality improvement strategy using small-scale tests of change to iteratively improve care processes.

In this project, workgroups used Plan-Do-Study-Act cycles to refine multiple intervention processes within each core function before implementation. The Registry Workgroup used iterative electronic health record data queries for each community health center, paired with manual electronic health record review, to test and refine the accuracy of queries identifying patients eligible for mailed FIT kits.

The Mailed FIT Workgroup conducted multiple waves of pilot FIT kit mailings, with twenty-nine to one hundred mailings per wave, to test and refine tracking, notification, and referral processes. Figure four maps the SCORE intervention across six swimlanes, showing which entities perform each step, from identifying eligible patients and mailing FIT kits through laboratory processing, colonoscopy referral, follow-up, and electronic health record updates.

Diamonds mark decisions such as whether a patient returns the FIT and whether colonoscopy is complete, while arrows show the process order. Stars identify steps performed by the centralized outreach team, making the workflow and division of responsibility explicit for implementation in small, independent community health centers.

The Registry Workgroup developed a secure, integrated database of patient-level data from community health centers, endoscopy centers, navigator calls, and the centralized outreach center. The registry was designed to facilitate efficient and accurate tracking of patients throughout the intervention.

In addition to tracking patients, the registry was designed to support monitoring and reporting of effectiveness and implementation outcomes. The Registry Workgroup built the registry in REDCap, a secure, HIPPA compliant electronic data capture system hosted at the academic cancer center.

Preparation activities and findings were integrated into a comprehensive implementation blueprint for SCORE. The blueprint included an overall project description, standard operating procedures with context-driven tailoring for each community health center site, patient-facing materials, timelines, and refined process maps.

The implementation blueprint also included a published protocol for effectiveness evaluation. Because the intervention was centralized, the standard operating procedure was targeted to and used by the outreach center team performing centralized functions rather than community health center staff.

The strategies used during Exploration led to consensus on selecting the evidence-based practices needed to fill a screening gap, while Preparation strategies culminated in a comprehensive implementation blueprint. A recent systematic review of EPIS found that most published implementation studies focused on the Implementation phase, with little empirical research addressing Exploration or Preparation.

Other literature suggested that in-depth planning during Exploration and Preparation was infrequent although critical. This study adds to a limited body of in-depth empirical description of an approach to these early phases of implementing a multilevel outreach intervention in health care.

Centralization was found to be critical to developing the SCORE intervention in this context. Centralization may be particularly appropriate in rural community health centers with limited staff resources, limited control over external organizations, and low patient volume.

Those conditions can result in high transaction costs and motivate outsourcing implementation activities to a centralized entity with dedicated and specialized resources. The implementation strategies used during the first two phases yielded a comprehensive blueprint for the third phase, Implementation.

Through coalition building and workgroups, stakeholder partners developed consensus about and ownership of the intervention and its implementation. Two implementation strategies were identified as candidates for addition to the ERIC compilation: reviewing and appraising current evidence regarding effective interventions and using systems.

The big lesson is that careful Exploration and Preparation turned local barriers into a centralized, adaptable screening system: mailed FIT, navigation to colonoscopy, and a registry developed with the people who would use it.

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