Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) in Appalachia: protocol for a group randomized, delayed intervention trial.

Appalachian regions of Kentucky and Ohio are hotspots for colorectal cancer (CRC) mortality in the USA. Screening reduces CRC incidence and mortality; however, screening uptake is needed, especially in these underserved geographic areas. Implementation science offers strategies to address this challenge. The aim of the current study was to conduct multi-site, transdisciplinary research to evaluate and improve CRC screening processes using implementation science strategies. The study consists of two phases (Planning and Implementation). In the Planning Phase, a multilevel assessment of 12 health centers (HC) (one HC from each of the 12 Appalachian counties) was conducted by interviewing key informants, creating community profiles, identifying HC and community champions, and performing HC data inventories. Two designated pilot HCs chose CRC evidence-based interventions to adapt and implement at each level (i.e., patient, provider, HC, and community) with evaluation relative to two matched control HCs. During the Implementation Phase, study staff will repeat the rollout process in HC and community settings in a randomized, staggered fashion in the remaining eight counties/HCs. Evaluation will include analyses of electronic health record data and provider and county surveys. Rural HCs have been reluctant to participate in research because of concerns about capacity; however, this project should demonstrate that research does not need to be burdensome and can adapt to local needs and HC abilities. If effective, this approach could be disseminated to HC and community partners throughout Appalachia to encourage the uptake of effective interventions to reduce the burden of CRC.

We conducted a multi-site study to evaluate and improve CRC screening processes using implementation science strategies at multiple levels including the patient, provider, health center, and community. Our goals were to increase rates of guideline-recommended CRC screening, follow-up, and referral-to-care in an Appalachian, medically underserved population.

Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative.

BACKGROUND: Although patient navigation has shown promise for increasing participation in colorectal cancer screening and follow-up, little evidence is available to guide implementation of patient navigation in clinical practice. We characterize 8 patient navigation programs being implemented as part of multi-component interventions of the National Cancer Institute's Cancer Moonshot Accelerating Colorectal Cancer Screening and Follow-Up Through Implementation Science (ACCSIS) initiative. METHODS: We developed a data collection template organized by ACCSIS framework domains. The template was populated by a representative from each of the 8 ACCSIS research projects. We report standardized descriptions of 1) the socio-ecological context in which the navigation program was being conducted, 2) navigation program characteristics, 3) activities undertaken to facilitate program implementation (eg, training), and 4) outcomes used in program evaluation. RESULTS: ACCSIS patient navigation programs varied broadly in their socio-ecological context and settings, the populations they served, and how they were implemented in practice. Six research projects adapted and implemented evidence-based patient navigation programs; the remaining projects developed new programs. Five projects began navigation when patients were due for initial colorectal cancer screening; 3 projects began navigation later in the screening process, when patients were due for follow-up colonoscopy after an abnormal stool-test result. Seven projects relied on existing clinical staff to deliver the navigation; 1 hired a centralized research navigator. All project researchers plan to evaluate the effectiveness and implementation of their programs. CONCLUSIONS: Our detailed program descriptions may facilitate cross-project comparisons and guide future implementation and evaluation of patient navigation programs in clinical practice.

Development and Evaluation of Patient Navigation Training for Rural and Appalachian Populations.

The Appalachian region of the USA includes 423 counties in 13 states positioned along the spine of the Appalachian Mountains stretching from New York to Mississippi. Approximately 42% of Appalachia is rural, and while the economy of Appalachia has diversified over the past two decades from reliance on agriculture and coal mining, 176 (41.6%) of the 423 counties are classified as economically distressed or at-risk. Patient navigation (PN) has been shown to be effective as an approach to address multiple barriers and enhance access to healthcare services, and yet there are no known PN programs focusing on the Appalachian population. This project was designed to develop, implement, and evaluate a curriculum and training program for PN for cancer prevention and control in Appalachia. The training program was developed through formative evaluation and offered daylong workshops that provided instruction in 60-90-min modules. Workshop topics included an introduction to PN, Appalachian culture, community needs assessment, communication, financial navigation, and navigation for screening and diagnostic follow-up for breast, cervical, and colorectal cancers. A total of 20 workshops were conducted with 334 attendees. The workshops were evaluated using a mixed-method approach using pre- and posttests and participant evaluations. The overall mean posttest scores increased by 4% from pretest (p < 0.05). Evaluation also showed that attendees valued the focus on Appalachian culture and judged the content relevant and useful. Attendees also expressed interest in additional opportunities for similar workshops that expanded upon current topics and allowed for exploration of Appalachian health-related issues.

Facilitators and Barriers to Implementing a Digital Informed Decision Making Tool in Primary Care: A Qualitative Study.

BACKGROUND: Informed decision aids provide information in the context of the patient's values and improve informed decision making (IDM). To overcome barriers that interfere with IDM, our team developed an innovative iPad-based application (aka "app") to help patients make informed decisions about colorectal cancer screening. The app assesses patients' eligibility for screening, educates them about their options, and empowers them to request a test via the interactive decision aid. OBJECTIVE: The aim of the study is to explore how informed decision aids can be implemented successfully in primary care clinics, including the facilitators and barriers to implementation; strategies for minimizing barriers; adequacy of draft training materials; and any additional support or training desired by clinics. DESIGN: This work deals with a multicenter qualitative study in rural and urban settings. PARTICIPANTS: A total of 48 individuals participated including primary care practice managers, clinicians, nurses, and front desk staff. APPROACH: Focus groups and semi-structured interviews, with data analysis were guided by thematic analysis. KEY RESULTS: Salient emergent themes were time, workflow, patient age, literacy, and electronic health record (EHR) integration. Saving time was important to most participants. Patient flow was a concern for all clinic staff, and they expressed that any slowdown due to patients using the iPad module or perceived additional work to clinic staff would make staff less motivated to use the program. Participants voiced concern about older patients being unwilling or unable to utilize the iPad and patients with low literacy ability being able to read or comprehend the information. CONCLUSION: Integrating new IDM apps into the current clinic workflow with minimal disruptions would increase the probability of long-term adoption and ultimate sustainability. NIH TRIAL REGISTRY NUMBER: R01CA218416-A1.

Building Cancer Prevention and Control Research Capacity in Rural Appalachian Kentucky Primary Care Clinics During COVID-19: Development and Adaptation of a Multilevel Colorectal Cancer Screening Project.

This study describes the development of a colorectal cancer (CRC) screening multilevel intervention with four primary care clinics in rural Appalachian Kentucky. We also discuss barriers experienced by the clinics during COVID-19 and how clinic limitations and needs informed project modifications. Four primary care clinics were recruited, key informant interviews with clinic providers were conducted, electronic health record (EHR) capacity to collect data related to CRC screening and follow-up was assessed, and a series of meetings were held with clinic champions to discuss implementation of strategies to impact clinic CRC screening rates. Analysis of interviews revealed multilevel barriers to CRC screening. Patient-level barriers included fatalism, competing priorities, and financial and literacy concerns. The main provider- and clinic-level barriers were provider preference for colonoscopy over stool-based testing and EHR tracking concerns. Clinics selected strategies to address barriers, but the onset of COVID-19 necessitated modifications to these strategies. Due to COVID-19, changes in clinic staffing and workflow occurred, including provider furloughs, a state-mandated pause in elective procedures, and an increase in telehealth. Clinics adapted screening strategies to match changing needs, including shifting from paper to digital educational tools and using telehealth to increase annual wellness visits for screening promotion. While significant delays persist for scheduling colonoscopies, clinics were encouraged to promote stool-based tests as a primary screening modality for average-risk patients.

Development of a multilevel intervention to increase colorectal cancer screening in Appalachia.

BACKGROUND: Colorectal cancer (CRC) screening rates are lower in Appalachian regions of the United States than in non-Appalachian regions. Given the availability of various screening modalities, there is critical need for culturally relevant interventions addressing multiple socioecological levels to reduce the regional CRC burden. In this report, we describe the development and baseline findings from year 1 of "Accelerating Colorectal Cancer Screening through Implementation Science (ACCSIS) in Appalachia," a 5-year, National Cancer Institute Cancer MoonshotSM-funded multilevel intervention (MLI) project to increase screening in Appalachian Kentucky and Ohio primary care clinics. METHODS: Project development was theory-driven and included the establishment of both an external Scientific Advisory Board and a Community Advisory Board to provide guidance in conducting formative activities in two Appalachian counties: one in Kentucky and one in Ohio. Activities included identifying and describing the study communities and primary care clinics, selecting appropriate evidence-based interventions (EBIs), and conducting a pilot test of MLI strategies addressing patient, provider, clinic, and community needs. RESULTS: Key informant interviews identified multiple barriers to CRC screening, including fear of screening, test results, and financial concerns (patient level); lack of time and competing priorities (provider level); lack of reminder or tracking systems and staff burden (clinic level); and cultural issues, societal norms, and transportation (community level). With this information, investigators then offered clinics a menu of EBIs and strategies to address barriers at each level. Clinics selected individually tailored MLIs, including improvement of patient education materials, provision of provider education (resulting in increased knowledge, p = .003), enhancement of electronic health record (EHR) systems and development of clinic screening protocols, and implementation of community CRC awareness events, all of which promoted stool-based screening (i.e., FIT or FIT-DNA). Variability among clinics, including differences in EHR systems, was the most salient barrier to EBI implementation, particularly in terms of tracking follow-up of positive screening results, whereas the development of clinic-wide screening protocols was found to promote fidelity to EBI components. CONCLUSIONS: Lessons learned from year 1 included increased recognition of variability among the clinics and how they function, appreciation for clinic staff and provider workload, and development of strategies to utilize EHR systems. These findings necessitated a modification of study design for subsequent years. TRIAL REGISTRATION: Trial NCT04427527 is registered at https://clinicaltrials.gov and was registered on June 11, 2020.