Evaluating the Reach of a Patient Navigation Program for Follow-up Colonoscopy in a Large Federally Qualified Health Center.

Patient navigation (PN) has been shown to improve participation in cancer screening, including colorectal cancer screening, and the Community Preventive Services Task Force now recommends the practice. Despite the effectiveness of PN programs, little is known about the number of contacts needed to successfully reach patients or about the demographic and healthcare utilization factors associated with reach. PRECISE was an individual randomized study of PN vs. usual care conducted as a partnership between two large health systems in the Pacific Northwest. The navigation program was a six topic-area telephonic program designed to support patients with an abnormal fecal test result to obtain a follow-up colonoscopy. We report the number of contact attempts needed to successfully reach navigated patients. We used logistic regression to report the demographic and healthcare utilization characteristics associated with patients allocated to PN who were successfully reached. We identified 1200 patients with an abnormal FIT result, among whom 970 were randomized into the study (45.7% were female, 17.5% were Spanish-speaking, mean age was 60.8). Of the 479 patients allocated to the PN intervention, 382 (79.7%) were reached within 18 call attempts and nearly all (n = 356; 93.2%) were reached within six contact attempts. Patient characteristics associated with reach were race, county of residence, and body mass index. Our findings can guide future efforts to optimize the reach of PN programs.

A Community-Based Participatory Approach in Applying the Sociocultural Resilience Model in U.S-Mexico Border Communities.

BACKGROUND: Behavioral models play a key role in identifying pathways to better health and provide a foundation for health promotion interventions. However, behavioral models based in epidemiological research may be limited in relevance and utility in practice. OBJECTIVES: We describe a participatory approach within a community-based participatory research partnership for integrating epidemiological and community perspectives into the application of the sociocultural resilience model (SRM). The SRM posits that cultural processes have a symbiotic relationship with health-promoting social processes, which contribute to the health advantages among Mexicanorigin and other Latinx populations. METHODS: Community action board members engaged with academic partners to interpret and apply the SRM to a community-clinical linkages intervention implemented in the context of three U.S.-Mexico border communities. In a two-day workshop, partners engaged in a series of iterative discussions to reach common definitions and measures for SRM constructs. RESULTS: Partners described daily cultural processes as the food they eat, how they communicate, and a collectivist approach to getting things done. For intervention activities, the partners opted for intergenerational storytelling, sharing of food, and artistic forms of expression. Partners included measures of cultural nuances such as border identity and the complexities that often arise from navigating bicultural norms. CONCLUSIONS: Collaborative approaches within community-based participatory research partnerships can facilitate the adaptation and measurement of conceptual health behavior models in community practice.

Engaging with Rural Communities for Colorectal Cancer Screening Outreach Using Modified Boot Camp Translation.

BACKGROUND: Colorectal cancer (CRC) incidence and mortality are disproportionately high among rural residents and Medicaid enrollees. OBJECTIVES: To address disparities, we used a modified community engagement approach, Boot Camp Translation (BCT). Research partners, an advisory board, and the rural community informed messaging about CRC outreach and a mailed fecal immunochemical test program. METHODS: Eligible rural patients (English-speaking and ages 50-74) and clinic staff involved in patient outreach participated in a BCT conducted virtually over two months. We applied qualitative analysis to BCT transcripts and field notes. RESULTS: Key themes included: the importance of directly communicating about the seriousness of cancer, leveraging close clinic-patient relationships, and communicating the test safety, ease, and low cost. CONCLUSIONS: Using a modified version of BCT delivered in a virtual format, we were able to successfully capture community input to adapt a CRC outreach program for use in rural settings. Program materials will be tested during a pragmatic trial to address rural CRC screening disparities.

The Reach of Calls and Text Messages for Mailed FIT Outreach in the PROMPT Stepped-Wedge Colorectal Cancer Screening Trial.

BACKGROUND: Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening participation. We assessed the reach and effectiveness of adding notifications to mailed FIT programs. METHODS: We conducted secondary analyses of a stepped-wedge evaluation of an enhanced mailed FIT program (n = 15 clinics). Patients were stratified by prior FIT completion. Those with prior FIT were sent a text message (Group 1); those without were randomized 1:1 to receive a text message (Group 2) or live phone call (Group 3). All groups were sent automated phone call reminders. In stratified analysis, we measured reach and effectiveness (FIT completion within 6 months) and assessed patient-level associations using generalized estimating equations. RESULTS: Patients (n = 16,934; 83% Latino; 72% completed prior FIT) were reached most often by text messages (78%), followed by live phone calls (71%), then automated phone calls (56%). FIT completion was higher in patients with prior FIT completion versus without [44% (Group 1) vs. 19% (Group 2 + Group 3); P < 0.01]. For patients without prior FIT, effectiveness was higher in those allocated to a live phone call [20% (Group 3) vs. 18% (Group 2) for text message; P = 0.04] and in those who personally answered the live call (28% vs. 9% no call completed; P < 0.01). CONCLUSIONS: Text messages reached the most patients, yet effectiveness was highest in those who personally answered the live phone call. IMPACT: Despite the broad reach and low cost of text messages, personalized approaches may more successfully boost FIT completion.

Maximizing scarce colonoscopy resources: the crucial role of stool-based tests.

During the COVID-19 pandemic, health systems, including federally qualified health centers, experienced disruptions in colorectal cancer (CRC) screening. National organizations called for greater use of at-home stool-based testing followed by colonoscopy for those with abnormal test results to limit (in-person) colonoscopy exams to people with acute symptoms or who were high risk. This stool-test-first strategy may also be useful for adults with low-risk adenomas who are due for surveillance colonoscopy. We argue that colonoscopy is overused as a first-line screening method in low- and average-risk adults and as a surveillance tool among adults with small adenomas. Yet, simultaneously, many people do not receive much-needed colonoscopies. Delivering the right screening tests at intervals that reduce the risk of CRC, while minimizing patient inconvenience and procedural risks, can strengthen health-care systems. Risk stratification could improve efficiency of CRC screening, but because models that adequately predict risk are years away from clinical use, we need to optimize use of currently available technology-that is, low-cost fecal testing followed by colonoscopy for those with abnormal test results. The COVID-19 pandemic highlighted the urgent need to adapt to resource constraints around colonoscopies and showed that increased use of stool-based testing was possible. Learning how to adapt to such constraints without sacrificing patients' health, particularly for patients who receive care at federally qualified health centers, should be a priority for CRC prevention research.

Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence.

OBJECTIVE: We evaluated whether people who had not completed a faecal immunochemical test (FIT) for colorectal cancer (CRC) screening would complete a blood-based testing option if offered one during health encounters. Blood-based screening tests for CRC could add to the total number of people screened for CRC by providing another testing alternative. DESIGN: Study participants were patients aged 45-75 years at a large, integrated health system who were offered but did not complete an FIT in the prior 3-9 months and were scheduled for a clinical encounter. Individuals were randomised (1:1) to be offered a commercially available CRC blood test (Shield, Guardant Health) versus usual care. We compared 3-month CRC screening proportions in the two groups. RESULTS: We randomised 2026 patients; 2004 remained eligible following postrandomisation exclusions (1003 to usual care and 1001 to blood draw offer; mean age: 60, 62% female, 80% non-Hispanic white). Of the 1001 allocated to the blood test group, 924 were recruited following chart-review exclusions; 548 (59.3%) were reached via phone, of which 280 (51.1%) scheduled an appointment with the research team. CRC screening proportions were 17.5 percentage points higher in the blood test group versus usual care (30.5% vs 13.0%; OR 2.94, 95% CI 2.34 to 3.70; p<0.001). CONCLUSION: Among adults who had declined prior CRC screening, the offer of a blood-based screening test boosted CRC screening by 17.5 percentage points over usual care. Further research is needed on how to balance the favourable adherence with lower advanced adenoma detection compared with other available tests. TRIAL REGISTRATION NUMBER: NCT05987709.

Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas.

BACKGROUND: Mailed fecal immunochemical test (FIT) outreach and patient navigation are evidence-based practices shown to improve rates of colorectal cancer (CRC) and follow-up in various settings, yet these programs have not been broadly adopted by health systems and organizations that serve diverse populations. Reasons for low adoption rates are multifactorial, and little research explores approaches for scaling up a complex, multi-level CRC screening outreach intervention to advance equity in rural settings. METHODS: SMARTER CRC, a National Cancer Institute Cancer Moonshot project, is a cluster-randomized controlled trial of a mailed FIT and patient navigation program involving 3 Medicaid health plans and 28 rural primary care practices in Oregon and Idaho followed by a national scale-up trial. The SMARTER CRC intervention combines mailed FIT outreach supported by clinics, health plans, and vendors and patient navigation for colonoscopy following an abnormal FIT result. We applied the framework from Perez and colleagues to identify the intervention's components (including functions and forms) and scale-up dissemination strategies and worked with a national advisory board to support scale-up to additional organizations. The team is recruiting health plans, primary care clinics, and regional and national organizations in the USA that serve a rural population. To teach organizations about the intervention, activities include Extension for Community Healthcare Outcomes (ECHO) tele-mentoring learning collaboratives, a facilitation guide and other materials, a patient navigation workshop, webinars, and individualized technical assistance. Our primary outcome is program adoption (by component), measured 6 months after participation in an ECHO learning collaborative. We also assess engagement and adaptations (implemented and desired) to learn how the multicomponent intervention might be modified to best support broad scale-up. DISCUSSION: Findings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings. TRIAL REGISTRATION: Registered at ClinicalTrials.gov (NCT04890054) and at the NCI's Clinical Trials Reporting Program (CTRP no.: NCI-2021-01032) on May 11, 2021.

The recalibration and redevelopment of a model to calculate patients' probability of completing a colonoscopy following an abnormal fecal test.

OBJECTIVES: Fecal immunochemical testing (FIT) is an effective screening tool for colorectal cancer. If an FIT is abnormal, a follow-up colonoscopy is necessary to remove polyps or find cancers. We sought to develop a usable risk prediction model to identify patients unlikely to complete a colonoscopy following an abnormal FIT test. METHODS: We recalibrated and then redeveloped a prediction model in federally qualified health centers (FQHCs), using a retrospective cohort of patients aged 50-75 with an abnormal FIT test and clinical data. Logistic and Cox regressions were used to recalibrate and then redevelop the model. RESULTS: The initial risk model used data from eight FQHCs (26 clinics) including 1723 patients. When we applied the model to a single large FQHC (34 clinics, 884 eligible patients), the model did not recalibrate successfully (c-statistic dropped more than 0.05, from 0.66 to 0.61). The model was redeveloped in the same FQHC in a cohort of 1401 patients with a c-statistic of 0.65. CONCLUSIONS: The original model developed in a group of FQHCs did not adequately recalibrate in the single large FQHC. Health system, patient characteristics or data differences may have led to the inability to recalibrate the model. However, the redeveloped model provides an adequate model for the single FQHC.

Provision of colonoscopy in rural settings: A qualitative assessment of provider context, barriers, facilitators, and capacity.

PURPOSE: Colonoscopy can prevent morbidity and mortality from colorectal cancer (CRC) and is the most commonly used screening method in the United States. Barriers to colonoscopy at multiple levels can contribute to disparities. Yet, in rural settings, little is known about who delivers colonoscopy and facilitators and barriers to colonoscopy access through screening completion. METHODS: We conducted a qualitative study with providers in rural Oregon who worked in endoscopy centers or primary care clinics. Semistructured interviews, conducted in July and August, 2021, focused on clinician experiences providing colonoscopy to rural Medicaid patients, including workflows, barriers, and access. We used thematic analysis, through immersion crystallization, to analyze interview transcripts and develop emergent themes. FINDINGS: We interviewed 19 providers. We found two categories of colonoscopy providers: primary care providers (PCPs) doing colonoscopy on their own patients (n = 9; 47%) and general surgeons providing colonoscopy to patients referred to their services (n = 10; 53%). Providers described barriers to colonoscopy at the provider, community, and patient levels and suggested patient supports could help overcome them. Providers found current colonoscopy capacity sufficient, but noted PCPs trained to perform colonoscopy would be key to continued accessibility. Finally, providers shared concerns about the shrinking number of PCP endoscopists, especially with anticipated increased screening demand related to the CRC screening guideline shift. CONCLUSIONS: These themes reflect opportunities to address multilevel barriers to improve access, colonoscopy capacity, and patient education approaches. Our results highlight that PCPs are an essential part of the workforce that provides colonoscopy in rural areas.

Mail-Based Self-Sampling to Complete Colorectal Cancer Screening: Accelerating Colorectal Cancer Screening and Follow-up Through Implementation Science.

Introduction: Leveraging cancer screening tests, such as the fecal immunochemical test (FIT), that allow for self-sampling and postal mail for screening invitations, test delivery, and return can increase participation in colorectal cancer (CRC) screening. The range of approaches that use self-sampling and mail for promoting CRC screening, including use of recommended best practices, has not been widely investigated. Methods: We characterized self-sampling and mail strategies used for implementing CRC screening across a consortium of 8 National Cancer Institute Cancer Moonshot Initiative Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) research projects. These projects serve diverse rural, urban, and tribal populations in the US. Results: All 8 ACCSIS projects leveraged self-sampling and mail to promote screening. Strategies included organized mailed FIT outreach with mailed invitations, including FIT kits, reminders, and mailed return (n = 7); organized FIT-DNA outreach with mailed kit return (n = 1); organized on-demand FIT outreach with mailed offers to request a kit for mailed return (n = 1); and opportunistic FIT-DNA with in-clinic offers to be mailed a test for mailed return (n = 2). We found differences in patient identification strategies, outreach delivery approaches, and test return options. We also observed consistent use of Centers for Disease Control and Prevention Summit consensus best practice recommendations by the 7 projects that used mailed FIT outreach. Conclusion: In research projects reaching diverse populations in the US, we observed multiple strategies that leverage self-sampling and mail to promote CRC screening. Mail and self-sampling, including mailed FIT outreach, could be more broadly leveraged to optimize cancer screening.

System dynamics modeling for cancer prevention and control: A systematic review.

Cancer prevention and control requires consideration of complex interactions between multilevel factors. System dynamics modeling, which consists of diagramming and simulation approaches for understanding and managing such complexity, is being increasingly applied to cancer prevention and control, but the breadth, characteristics, and quality of these studies is not known. We searched PubMed, Scopus, APA PsycInfo, and eight peer-reviewed journals to identify cancer-related studies that used system dynamics modeling. A dual review process was used to determine eligibility. Included studies were assessed using quality criteria adapted from prior literature and mapped onto the cancer control continuum. Characteristics of studies and models were abstracted and qualitatively synthesized. 32 studies met our inclusion criteria. A mix of simulation and diagramming approaches were used to address diverse topics, including chemotherapy treatments (16%), interventions to reduce tobacco or e-cigarettes use (16%), and cancer risk from environmental contamination (13%). Models spanned all focus areas of the cancer control continuum, with treatment (44%), prevention (34%), and detection (31%) being the most common. The quality assessment of studies was low, particularly for simulation approaches. Diagramming-only studies more often used participatory approaches. Involvement of participants, description of model development processes, and proper calibration and validation of models showed the greatest room for improvement. System dynamics modeling can illustrate complex interactions and help identify potential interventions across the cancer control continuum. Prior efforts have been hampered by a lack of rigor and transparency regarding model development and testing. Supportive infrastructure for increasing awareness, accessibility, and further development of best practices of system dynamics for multidisciplinary cancer research is needed.

"I was screaming hallelujah": Patient and provider perceptions of blood-based testing for colorectal cancer screening.

BACKGROUND: Blood-based tests for colorectal cancer (CRC) screening can offer many advantages over stool-based tests such as FIT. Yet, we know little about patients' and providers' perceptions of this type of test. We report findings from a qualitative study comparing patient and provider perceptions of blood-based testing for CRC screening. METHODS: Patient participants were aged 45-75 years and members of a large, integrated health system. Participants were mailed, but did not complete, a FIT through an organized FIT-screening program and were scheduled for a health-care encounter at any of nine clinical sites. Participants were consented to complete a blood draw. We used purposive sampling to select and recruit patients (who did and did not complete the blood test) and providers/specialists who would be involved in offering the blood test to patients or explaining results. We administered telephone interviews using a semi-structured interview guide and recorded and transcribed all interviews, then coded and analyzed content. RESULTS: We interviewed 15 patients (11 completed and 4 did not complete the blood test) and 5 providers (3 primary care providers, one gastroenterologist (GI), and one GI medical assistant). Patients were enthusiastic about completing a blood test, citing the simplicity, ease, convenience, and high perceived accuracy of the test. Providers were also receptive to a blood-based option, if adequate test performance could be achieved and if they have information that informs patients about the pros and cons of blood-based screening versus other screening tests. CONCLUSIONS: Patients and providers were willing and enthusiastic about blood-based CRC screening tests. Future research focusing on performance and communication is needed.

Developing Patient-Refined Messaging for Follow-Up Colonoscopy After Abnormal Fecal Testing in Hispanic Communities: Key Learnings from Virtual Boot Camp Translation.

Colorectal cancer (CRC) is a leading cause of cancer death in the US. Screening by fecal immunochemical test (FIT) is a strategy to lower CRC rates. Unfortunately, only half of patients with an abnormal FIT result complete the follow-up colonoscopy, an essential component of screening. We used virtual Boot Camp Translation (BCT), to elicit input from partners to develop messaging/materials to motivate patients to complete a follow-up colonoscopy. Participants were Hispanic, ages 50 to 75 years, and Spanish-speaking. All materials were developed in English and Spanish. The first meeting included expert presentations that addressed colorectal health. The two follow-up sessions obtained feedback on messaging/materials developed based on themes from the first meeting. Ten participants attended the first meeting and eight attended the follow-up sessions. The two key barriers to follow-up colonoscopy after abnormal FIT noted by participants were (a) lack of colonoscopy awareness and (b) fear of the colonoscopy procedure. We learned that participants valued simple messaging to increase knowledge and alleviate concerns, patient-friendly outreach materials, and increased access to health information. Using virtual BCT, we included participant feedback to design culturally relevant health messages to promote follow-up colonoscopy after abnormal fecal testing among Hispanic patients served by community clinics.

The use of individual and multilevel data in the development of a risk prediction model to predict patients' likelihood of completing colorectal cancer screening.

Promotion of colorectal cancer (CRC) screening can be expensive and unnecessary for many patients. The use of predictive analytics promises to help health systems target the right services to the right patients at the right time while improving population health. Multilevel data at the interpersonal, organizational, community, and policy levels, is rarely considered in clinical decision making but may be used to improve CRC screening risk prediction. We compared the effectiveness of a CRC screening risk prediction model that uses multilevel data with a more conventional model that uses only individual patient data. We used a retrospective cohort to ascertain the one-year occurrence of CRC screening. The cohort was determined from a Health Maintenance Organization, in Oregon. Eligible patients were 50-75 years old, health plan members for at least one year before their birthday in 2018 and were due for screening. We created a risk model using logistic regression first with data available in the electronic health record (EHR), and then added multilevel data. In a cohort of 59,249 patients, 36.1% completed CRC screening. The individual level model included 14 demographic, clinical and encounter based characteristics, had a bootstrap-corrected C-statistic of 0.722 and sufficient calibration. The multilevel model added 9 variables from clinical setting and community characteristics, and the bootstrap-corrected C-statistic remained the same with continued sufficient calibration. The predictive power of the CRC screening model did not improve after adding multilevel data. Our findings suggest that multilevel data added no improvement to the prediction of the likelihood of CRC screening.

Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial.

BACKGROUND: Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening rates, yet little is known about how to optimize these programs for effectiveness and cost. METHODS: PROMPT was a pragmatic, stepped-wedge, cluster-randomized effectiveness trial of mailed FIT outreach. Participants in the standard condition were mailed a FIT and received live telephone reminders to return it. Participants in the enhanced condition also received a tailored advance notification (text message or live phone call) and two automated phone call reminders. The primary outcome was 6-month FIT completion; secondary outcomes were any colorectal cancer screening completion at 6 months, implementation, and program costs. RESULTS: The study included 27,585 participants (80% ages 50-64, 82% Hispanic/Latino; 68% preferred Spanish). A higher proportion of enhanced participants completed FIT at 6 months than standard participants, both in intention-to-treat [+2.8%, 95% confidence interval (CI; 0.4-5.2)] and per-protocol [limited to individuals who were reached; +16.9%, 95% CI (12.3-20.3)] analyses. Text messages and automated calls were successfully delivered to 91% to 100% of participants. The per-patient cost for standard mailed FIT was $10.84. The enhanced program's text message plus automated call reminder cost an additional $0.66; live phone calls plus an automated call reminder cost an additional $10.82 per patient. CONCLUSIONS: Adding advance notifications and automated calls to a standard mailed FIT program boosted 6-month FIT completion rates at a small additional per-patient cost. IMPACT: Enhancements to mailed FIT outreach can improve colorectal cancer screening participation. Future research might test the addition of educational video messaging for screening-naïve adults.

Strategies to Bridge Equitable Implementation of Telehealth.

During the COVID-19 pandemic, the rapid scaling of telehealth limited the extent to which proactive planning for equitable implementation was possible. The deployment of telehealth will persist in the postpandemic era, given patient preferences, advances in technologies, growing acceptance of telehealth, and the potential to overcome barriers to serve populations with limited access to high-quality in-person care. However, aspects and unintended consequences of telehealth may leave some groups underserved or unserved, and corrective implementation plans that address equitable access will be needed. The purposes of this paper are to (1) describe equitable implementation in telehealth and (2) integrate an equity lens into actionable equitable implementation.