Clinical Decision Support for Surgery: A Mixed Methods Study on Design and Implementation Perspectives from Urologists.

OBJECTIVES: To assess urologist attitudes toward clinical decision support embedded into the electronic health record and define design needs to facilitate implementation and impact. With recent advances in big data and artificial intelligence, enthusiasm for personalized, data-driven tools to improve surgical decision-making has grown, but the impact of current tools remains limited. METHODS: A sequential explanatory mixed methods study from 2019-2020 was performed. First, survey responses from the 2019 American Urological Association annual census evaluated attitudes toward an automatic clinical decision support tool that would display risk/benefit data. This was followed by the purposeful sampling of 25 urologists and qualitative interviews assessing perspectives on clinical decision support impact and design needs. Bivariable, multivariable, and coding-based thematic analysis were applied and integrated. RESULTS: Among a weighted sample of 12,366 practicing urologists, the majority agreed clinical decision support would help decision-making (70.9%, 95% CI 68.7-73.2%), aid patient counseling (78.5%, 95% CI 76.5-80.5%), save time (58.1%, 95% CI 55.7-60.5%), and improve patient outcomes (42.9%, 95% CI 40.5-45.4%). More years in practice was negatively associated with agreement (p<0.001). Urologists described how clinical decision support could bolster evidence-based care, personalized medicine, resource utilization, and patient experience. They also identified multiple implementation barriers and provided suggestions on form, functionality, and visual design to improve usefulness and ease of use. CONCLUSIONS: Urologists have favorable attitudes toward the potential for clinical decision support in the electronic health record. Smart design will be critical to ensure effective implementation and impact.

Prevalence of Lung Cancer Screening in the US, 2022.

This cross-sectional study compares lung cancer screening prevalence in 2022 among individuals eligible by 2021 vs 2013 criteria by sociodemographics and state.

Perceived vs Actual Shared Decision-Making Behavior Among Urologists: A Convergent, Parallel, Mixed-Methods Study of Self-Reported Practice.

OBJECTIVE: To evaluate the association between self-perceived use of shared decision-making among urologists with use of validated prediction tools and self-described surgical decision-making. METHODS: This is a convergent mixed methods study of these parallel data from two modules (Shared Decision Making and Validated Prediction tools) within the 2019 American Urological Association (AUA) Annual Census. The shared decision-making (SDM) module queried aspects of SDM that urologists regularly used. The validated prediction tools module queried whether urologists regularly used, trusted, and found prediction tools helpful. Selected respondents to the 2019 AUA Annual Census underwent qualitative interviews on their surgical decision-making. RESULTS: In the weight sampled of 12,312 practicing urologists, most (77%) reported routine use of SDM, whereas only 30% noted regular use of validated prediction tools. On multivariable analysis, users of prediction tools were not associated with regular SDM use (31% vs 28%, P = .006) though was associated with use of decision aids f (32% vs 26%, P < .001). Shared decision-making emerged thematically with respect to matching treatment options, prioritizing goals, and navigating challenging decisions. However, the six specific components of shared decision-making ranged in their mentions within qualitative interviews. CONCLUSION: Most urologists report performing SDM as supported by its thematic presence in surgical decision-making. However, only a minority use validated prediction tools and urologists infrequently mention specific SDM components. This discrepancy provides an opportunity to explore how urologists perform SDM and can be used to support integrated strategies to implement SDM more effectively in clinical practice.

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.

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

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 as to implementation practitioners seeking exemplars for operationalizing strategies in early phases of implementation in healthcare.

Optimizing process flow diagrams to guide implementation of a colorectal cancer screening intervention in new settings.

PURPOSE: The goal of this study was to assess acceptability of using process flow diagrams (or process maps) depicting a previously implemented evidence-based intervention (EBI) to inform the implementation of similar interventions in new settings. METHODS: We developed three different versions of process maps, each visualizing the implementation of the same multicomponent colorectal cancer (CRC) screening EBI in community health centers but including varying levels of detail about how it was implemented. Interviews with community health professionals and practitioners at other sites not affiliated with this intervention were conducted. We assessed their preferences related to the map designs, their potential utility for guiding EBI implementation, and the feasibility of implementing a similar intervention in their local setting given the information available in the process maps. RESULTS: Eleven community health representatives were interviewed. Participants were able to understand how the intervention was implemented and engage in discussions around the feasibility of implementing this type of complex intervention in their local system. Potential uses of the maps for supporting implementation included staff training, role delineation, monitoring and quality control, and adapting the components and implementation activities of the existing intervention. CONCLUSION: Process maps can potentially support decision-making about the adoption, implementation, and adaptation of existing EBIs in new contexts. Given the complexities involved in deciding whether and how to implement EBIs, these diagrams serve as visual, easily understood tools to inform potential future adopters of the EBI about the activities, resources, and staffing needed for implementation.

Values Assessment Tools in Advanced Cancer: A Clinical Literature Review.

BACKGROUND: Patients with advanced cancer may receive cancer treatment that does not reflect their values because they may not be completely aware of what is important to them regarding treatment-related decisions when they are diagnosed. OBJECTIVES: The purpose of this review was to determine whether existing values assessment tools can improve awareness of treatment-related decisional values in patients with advanced cancer. METHODS: PubMed®, CINAHL®, and PsycINFO® databases were searched for original English-language articles evaluating values assessment tools that could be used to assess patients with advanced cancer. The quality of the identified tools was evaluated using selected International Patient Decision Aid Standards instrument, version 3.0, criteria. FINDINGS: All tools identified are appropriate for use in patients with advanced cancer. Two scored at least 80% on the selected International Patient Decision Aid Standards criteria. The Short Graphic Values History Tool was developed with patient and clinician input and may be particularly useful for low-literacy patient populations with advanced cancer. No values assessment tools have been identified specifically for use in patients with advanced cancer.

Primary care provider perspectives on the role of community pharmacy in colorectal cancer screening: a qualitative study.

BACKGROUND: The United States Preventive Services Task Force (USPSTF) lists 32 grade A or B recommended preventive services for non-pregnant United States (US) adults, including colorectal cancer screening (CRC). Little guidance is given on how to implement these services with consistency and fidelity in primary care. Given limited patient visit time and competing demands, primary care providers (PCPs) tend to prioritize a small subset of these recommendations. Completion rates of some of these services, including CRC screening, are suboptimal. Expanding delivery of preventive services to other healthcare providers, where possible, can improve access and uptake, particularly in medically underserved areas or populations. Fecal immunochemical testing (FIT) (at-home, stool-based testing) for CRC screening can be distributed and resulted without PCP involvement. Pharmacists have long delivered preventive services (e.g., influenza vaccination) and may be a good option for expanding CRC screening delivery using FIT, but it is not clear how PCPs would perceive this expansion. METHODS: We used semi-structured interviews with PCPs in North Carolina and Washington state to assess perceptions and recommendations for a potential pharmacy-based FIT distribution program (PharmFIT™). Transcripts were coded and analyzed using a hybrid inductive-deductive content analysis guided by the Consolidated Framework for Implementation Research (CFIR) to elucidate potential multi-level facilitators of and barriers to implementation of PharmFIT™. RESULTS: We completed 30 interviews with PCPs in North Carolina (N = 12) and Washington state (N = 18). PCPs in both states were largely accepting of PharmFIT™, with several important considerations. First, PCPs felt that pharmacists should receive appropriate training for identifying patients eligible and due for FIT screening. Second, a clear understanding of responsibility for tracking tests, communication, and, particularly, follow-up of positive test results should be established and followed. Finally, clear electronic workflows should be established for relay of test result information between the pharmacy and the primary care clinic. CONCLUSION: If the conditions are met regarding pharmacist training, follow-up for positive FITs, and transfer of documentation, PCPs are likely to support PharmFIT™ as a way for their patients to obtain and complete CRC screening using FIT.

Uptake of colorectal cancer screening after mailed fecal immunochemical test (FIT) outreach in a newly eligible 45-49-year-old community health center population.

PURPOSE: We assessed fecal immunochemical test (FIT) uptake following a mailed FIT intervention among 45-49-year-olds newly eligible for colorectal cancer (CRC) screening based on 2021 United States Preventive Services Task Force screening recommendations. We also tested the effect of an enhanced versus plain mailing envelope on FIT uptake. METHODS: In February 2022 we mailed FITs to eligible 45-49-year-olds at one Federally Qualified Health Center (FQHC) clinic. We determined the proportion who completed FITs within 60 days. We also conducted a nested randomized trial comparing uptake using an enhanced envelope (padded with tracking label and colored messaging sticker) versus plain envelope. Finally, we determined the change in CRC screening by any modality (e.g., FIT, colonoscopy) among all clinic patients in this age group (i.e., clinic-level screening) between baseline and 6 months post-intervention. RESULTS: We mailed FITs to 316 patients. Sample characteristics: 57% female, 58% non-Hispanic Black, and 50% commercially insured. Overall, 54/316 (17.1%) returned a FIT within 60 days, including 34/158 (21.5%) patients in the enhanced envelope arm versus 20/158 (12.7%) in the plain envelope arm (difference 8.9 percentage points, 95% CI: 0.6-17.2). Clinic-level screening among all 45-49-year-olds increased 16.6 percentage points (95% CI: 10.9-22.3), from 26.7% at baseline to 43.3% at 6 months. CONCLUSION: CRC screening appeared to increase following a mailed FIT intervention among diverse FQHC patients aged 45-49. Larger studies are needed to assess acceptability and completion of CRC screening in this younger population. Visually appealing mailers may improve uptake when implementing mailed interventions. Trial registration The trial was registered on May 28, 2020 at ClinicalTrials.gov (identifier NCT04406714).

Exploring the Acceptability of Text Messages to Inform and Support Shared Decision-making for Colorectal Cancer Screening: Online Panel Survey.

BACKGROUND: While online portals may be helpful to engage patients in shared decision-making at the time of cancer screening, because of known disparities in patient portal use, sole reliance on portals to support cancer screening decision-making could exacerbate well-known disparities in this health care area. Innovative approaches are needed to engage patients in health care decision-making and to support equitable shared decision-making. OBJECTIVE: We assessed the acceptability of text messages to engage sociodemographically diverse individuals in colorectal cancer (CRC) screening decisions and support shared decision-making in practice. METHODS: We developed a brief text message program offering educational information consisting of components of shared decision-making regarding CRC screening (eg, for whom screening is recommended, screening test options, and pros/cons of options). The program and postprogram survey were offered to members of an online panel. The outcome of interest was program acceptability measured by observed program engagement, participant-reported acceptability, and willingness to use similar programs (behavioral intent). We evaluated acceptability among historically marginalized categories of people defined by income, literacy, and race. RESULTS: Of the 289 participants, 115 reported having a low income, 146 were Black/African American, and 102 had less than extreme confidence in their health literacy. With one exception, we found equal or greater acceptability, regardless of measure, within each of the marginalized categories of people compared to their counterparts. The exception was that participants reporting an income below US $50,000 were less likely to engage with sufficient content of the program to learn that there was a choice among different CRC screening tests (difference -10.4%, 95% CI -20.1 to -0.8). Of note, Black/African American participants reported being more likely to sign up to receive text messages from their doctor's office compared to white participants (difference 18.7%, 95% CI 7.0-30.3). CONCLUSIONS: Study findings demonstrate general acceptance of text messages to inform and support CRC screening shared decision-making.

Engaging stakeholders in the use of an interactive simulation tool to support decision-making about the implementation of colorectal cancer screening interventions.

PURPOSE: We aimed to understand how an interactive, web-based simulation tool can be optimized to support decision-making about the implementation of evidence-based interventions (EBIs) for improving colorectal cancer (CRC) screening. METHODS: Interviews were conducted with decision-makers, including health administrators, advocates, and researchers, with a strong foundation in CRC prevention. Following a demonstration of the microsimulation modeling tool, participants reflected on the tool's potential impact for informing the selection and implementation of strategies for improving CRC screening and outcomes. The interviews assessed participants' preferences regarding the tool's design and content, comprehension of the model results, and recommendations for improving the tool. RESULTS: Seventeen decision-makers completed interviews. Themes regarding the tool's utility included building a case for EBI implementation, selecting EBIs to adopt, setting implementation goals, and understanding the evidence base. Reported barriers to guiding EBI implementation included the tool being too research-focused, contextual differences between the simulated and local contexts, and lack of specificity regarding the design of simulated EBIs. Recommendations to address these challenges included making the data more actionable, allowing users to enter their own model inputs, and providing a how-to guide for implementing the simulated EBIs. CONCLUSION: Diverse decision-makers found the simulation tool to be most useful for supporting early implementation phases, especially deciding which EBI(s) to implement. To increase the tool's utility, providing detailed guidance on how to implement the selected EBIs, and the extent to which users can expect similar CRC screening gains in their contexts, should be prioritized.

Reach and effectiveness of a centralized navigation program for patients with positive fecal immunochemical tests requiring follow-up colonoscopy.

Completion rates for follow-up colonoscopies after an abnormal fecal immunochemical test (FIT) are suboptimal in federally qualified health center (FQHC) settings. We implemented a screening intervention that included mailed FIT outreach to North Carolina FQHC patients from June 2020 to September 2021 and centralized patient navigation to support patients with abnormal FITs in completing follow-up colonoscopy. We evaluated the reach and effectiveness of navigation using electronic medical record data and navigator call logs detailing interactions with patients. Reach assessments included the proportion of patients successfully contacted by phone and who agreed to participate in navigation, intensity of navigation provided (including types of barriers to colonoscopy identified and total navigation time), and differences in these measures by socio-demographic characteristics. Effectiveness outcomes included colonoscopy completion, timeliness of follow-up colonoscopy (i.e., within 9 months), and bowel prep adequacy. Among 514 patients who completed a mailed FIT, 38 patients had an abnormal result and were eligible for navigation. Of these, 26 (68%) accepted navigation, 7 (18%) declined, and 5 (13%) could not be contacted. Among navigated patients, 81% had informational needs, 38% had emotional barriers, 35% had financial barriers, 12% had transportation barriers, and 42% had multiple barriers to colonoscopy. Median navigation time was 48.5 min (range: 24-277 min). Colonoscopy completion differed across groups - 92% of those accepting navigation completed colonoscopy within 9 months, versus 43% for those declining navigation. We found that centralized navigation was widely accepted in FQHC patients with abnormal FIT, and was an effective strategy, resulting in high colonoscopy completion rates.

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.

The Prevalence of Low-Value Prostate Cancer Screening in Primary Care Clinics: A Study Using the National Ambulatory Medical Care Survey.

INTRODUCTION: There has been an increasing focus on improving value in health care and deimplementing the use of low-value services, such as prostate cancer (PC) screening for men aged >70 years. The objectives of this study are to (1) identify the proportion of primary care visits at which low-value PC screening is ordered, and (2) identify predisposing, enabling, and health care need characteristics associated with low-value PC screening in the United States. METHODS: This was a secondary analysis of the National Ambulatory Medicare Care Survey datasets from 2013 to 2016 and 2018. Andersen's Behavioral Model of Health Services Use guided independent variable selection. Weighted multivariable logit models were used to analyze data. RESULTS: There were 6.71 low-value prostate-specific antigens (PSAs) per 100 visits and 1.65 low-value digital rectal exams (DREs) per 100 visits. For each additional service ordered by primary care providers, the odds of ordering a low-value PSA increased by 49%, and the odds of performing a low-value DRE increased by 37%. CONCLUSIONS: The use of low-value PSAs and DREs was sizable during the observed time period. Organizations who want to reduce low-value PSAs and DREs may want to focus interventions on providers who order a high number of tests.

Adolescent asthma management self-efficacy and responsibility: impact on asthma control and quality-of-life.

OBJECTIVE: The purpose of this study was to investigate the extent to which adolescent asthma management self-efficacy, outcome expectations, and asthma responsibility were associated with asthma control and quality-of-life. Adolescent self-efficacy and outcome expectations are important components of social cognitive theory, which guided this research. METHODS: English- and Spanish-speaking adolescents ages 11-17 with persistent asthma were recruited at four pediatric clinics. Adolescents were interviewed and parents completed questionnaires. Multiple linear regression was used to analyze the data. RESULTS: Three hundred and fifty-nine adolescents were recruited. Older adolescent age, male gender, and higher adolescent asthma management self-efficacy were significantly associated with higher adolescent responsibility; outcome expectations were not significantly associated with responsibility. Adolescent ratings of their own responsibility were higher than parent ratings of their child's responsibility for almost all asthma management tasks. Adolescents with higher reported asthma management self-efficacy were significantly more likely to have better quality-of-life and controlled asthma. Adolescents with more positive outcome expectations were significantly more likely to have controlled asthma. Being Native American was associated with worse quality-of-life and asthma not being controlled. Being Black was associated with asthma not being controlled. CONCLUSIONS: Parents and providers should work to improve adolescent self-efficacy in managing their asthma because it is associated with asthma responsibility, asthma control, and quality-of-life. Providers need to especially work with Native American and Black adolescents to improve quality-of-life and asthma control.

Sociodemographic correlates of colorectal cancer screening completion among women adherent to mammography screening guidelines by place of birth.

INTRODUCTION: Colorectal cancer screening rates in the U.S. still fall short of national goals, while screening rates for other cancer sites, such as breast, remain high. Understanding characteristics associated with colorectal cancer screening among different groups of women adherent to breast cancer screening guidelines can shed light on the facilitators of colorectal cancer screening among those already engaged in cancer prevention behaviors. The purpose of this study was to explore which demographic characteristics, healthcare access factors, and cancer-related beliefs were associated with colorectal cancer screening completion among U.S. and foreign-born women adherent to mammography screening recommendations. METHODS: Analyses of the 2015 National Health Interview Survey were conducted in 2019. A sample of 1206 women aged 50-74 who had a mammogram in the past 2 years and were of average risk for colorectal cancer was examined. Logistic regression was used to determine demographic, health service, and health belief characteristics associated with colorectal cancer screening completion. RESULTS: Fifty-five percent of the sample were adherent to colorectal cancer screening recommendations. Women over the age of 65 (AOR = 1.76, 95% CI 1.06-2.91), with any type of health insurance, and who were bilingual (AOR = 3.84, 95% CI 1.83-8.09) were more likely to complete screening, while foreign-born women (AOR = 0.53, 95% CI 0.34-0.83) were less likely. Cancer-related beliefs did not influence adherence. Stratified analyses by nativity revealed additional associations. CONCLUSIONS: Demographic and health service factors interact to influence colorectal cancer screening among women completing breast cancer screening. Colorectal cancer screening interventions targeting specific underserved groups and financing reforms may enhance women's colorectal cancer screening rates.

Extending analytic methods for economic evaluation in implementation science.

BACKGROUND: Economic evaluations of the implementation of health-related evidence-based interventions (EBIs) are conducted infrequently and, when performed, often use a limited set of quantitative methods to estimate the cost and effectiveness of EBIs. These studies often underestimate the resources required to implement and sustain EBIs in diverse populations and settings, in part due to inadequate scoping of EBI boundaries and underutilization of methods designed to understand the local context. We call for increased use of diverse methods, especially the integration of quantitative and qualitative approaches, for conducting and better using economic evaluations and related insights across all phases of implementation. MAIN BODY: We describe methodological opportunities by implementation phase to develop more comprehensive and context-specific estimates of implementation costs and downstream impacts of EBI implementation, using the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. We focus specifically on the implementation of complex interventions, which are often multi-level, resource-intensive, multicomponent, heterogeneous across sites and populations, involve many stakeholders and implementation agents, and change over time with respect to costs and outcomes. Using colorectal cancer (CRC) screening EBIs as examples, we outline several approaches to specifying the "boundaries" of EBI implementation and analyzing implementation costs by phase of implementation. We describe how systems mapping and stakeholder engagement methods can be used to clarify EBI implementation costs and guide data collection-particularly important when EBIs are complex. In addition, we discuss the use of simulation modeling with sensitivity/uncertainty analyses within implementation studies for projecting the health and economic impacts of investment in EBIs. Finally, we describe how these results, enhanced by careful data visualization, can inform selection, adoption, adaptation, and sustainment of EBIs. CONCLUSION: Health economists and implementation scientists alike should draw from a larger menu of methods for estimating the costs and outcomes associated with complex EBI implementation and employ these methods across the EPIS phases. Our prior experiences using qualitative and systems approaches in addition to traditional quantitative methods provided rich data for informing decision-making about the value of investing in CRC screening EBIs and long-term planning for these health programs. Future work should consider additional opportunities for mixed-method approaches to economic evaluations.

Effect of Incidental Findings Information on Lung Cancer Screening Intent: a Randomized Controlled Trial.

BACKGROUND: The Centers for Medicare & Medicaid Services requires decision aid use for lung cancer screening (LCS) shared decision-making. However, it does not require information about incidental findings, a potential harm of screening. OBJECTIVE: To assess the effect of incidental findings information in an LCS decision aid on screening intent as well as knowledge and valuing of screening benefits and harms. DESIGN: Randomized controlled trial conducted online between July 16, 2020, and August 22, 2020. PARTICIPANTS: Adults 55-80 years, eligible for LCS. INTERVENTION: LCS video decision aid including information on incidental findings or a control video decision aid. MAIN MEASURES: Intent to undergo LCS; knowledge regarding the benefit and harms of LCS using six knowledge questions; and valuing of six benefits and harms using rating (1-5 scale, 5 most important) and ranking (ranked 1-6) exercises. KEY RESULTS: Of 427 eligible individuals approached, 348 (83.1%) completed the study (173 intervention, 175 control). Mean age was 64.5 years, 48.6% were male, 73.0% white, 76.3% with less than a college degree, and 64.1% with income < $50,000. There was no difference between the intervention and controls in percentage intending to pursue screening (70/173, 40.5% vs 73/175, 41.7%, diff 1.2%, 95% CI - 9.1 to 11.5%, p = 0.81). Intervention participants had a higher percentage of correct answers for the incidental findings knowledge than controls (164/173, 94.8% vs 129/175, 73.7%, 95% CI - 28.4 to - 13.8%, p < 0.01). Incidental findings had the fifth highest mean importance rating (4.0 ± 1.1) and the third highest mean ranking (3.6 ± 1.5). There was no difference in mean rating or ranking of incidental findings between intervention and control groups (rating 4.0 vs 3.9, diff 0.1, 95% CI - 0.2, 0.3, p = 0.51; ranking 3.6 vs 3.6, diff 0.02, 95% CI - 0.3, 0.3, p = 0.89). CONCLUSIONS: Incidental findings information in a LCS decision aid did not affect LCS intent, but it resulted in more informed individuals regarding these findings. In formulating screening preferences, incidental findings were less important than other benefits and harms. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04432753.

Centralized colorectal cancer screening outreach and patient navigation for vulnerable populations in North Carolina: study protocol for the SCORE randomized controlled trial.

BACKGROUND: Although colorectal cancer (CRC) screening is effective in reducing CRC mortality, screening rates in vulnerable populations served by community health centers (CHCs) remain below national targets. CHCs in North Carolina are challenged to reach CRC screening targets as they tend to be under-resourced, have limited capacity to implement and sustain population health interventions, and typically operate independently from one another and from regional colonoscopy providers. The Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) project is designed to address barriers to CRC screening in partnership with CHCs by implementing a multilevel intervention that includes centralized support infrastructure for mailed fecal immunochemical test (FIT) outreach and patient navigation to follow-up colonoscopy. This paper describes protocols for the SCORE implementation trial. METHODS: We will conduct a type 2 hybrid effectiveness-implementation trial that will assess effectiveness at increasing CRC screening and follow-up rates while also assessing implementation outcomes. The planned trial sample will include 4000 CHC patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or a multilevel intervention that includes mailed FIT outreach and patient navigation support to follow-up colonoscopy for those with abnormal FIT. The primary effectiveness outcome is completion of any CRC screening test at six months after randomization. We will also conduct a multilevel assessment of implementation outcomes and determinants. DISCUSSION: This hybrid effectiveness-implementation trial will evaluate the effectiveness and implementation of an intervention that provides centralized infrastructure for mailed FIT screening and patient navigation for CHCs that operate independently of other healthcare facilities. Findings from this research will enhance understanding of the effectiveness of a centralized approach and factors that determine successful implementation in vulnerable patient populations. TRIAL REGISTRATION: The trial was registered on May 28, 2020, at ClinicalTrials.gov (identifier NCT04406714).