Findings From a National Survey of Older US Adults on Patient Willingness to Use Telehealth Services: Cross-Sectional Survey.

BACKGROUND: Telehealth (telemedicine and telepharmacy) services increase access to patient services and ensure continuity of care. However, few studies have assessed factors that influence patients' willingness to use telehealth services, and we sought to investigate this. OBJECTIVE: This study aims to examine respondents' (aged between 45 and 75 years) willingness to use telehealth services (telepharmacy and telemedicine) and the correlates of the willingness to use telehealth services. METHODS: We administered a cross-sectional national survey of 1045 noninstitutionalized US adults aged between 45 and 75 years in March and April 2021. Multiple logistic regression analyses were used to identify demographic and health service use correlates of self-reported willingness to use telehealth services. RESULTS: Overall willingness to use telemedicine was high (674/1045, 64.5%). Adults aged 55 years and older were less willing to use telemedicine (aged between 55 and 64 years: odds ratio [OR] 0.61, 95% CI 0.42-0.86; aged 65 years or older: OR 0.33, 95% CI 0.22-0.49) than those younger than 55 years. Those with a regular provider (OR 1.01, 95% CI 1-1.02) and long travel times (OR 1.75, 95% CI 1.03-2.98) were more willing to use telemedicine compared to those without a regular provider and had shorter travel times, respectively. Willingness to use telemedicine services increased from 64.5% (674/1045) to 83% (867/1045) if the service was low-cost or insurance-covered, was with their existing health care provider, or was easy-to-use. Overall willingness to use telepharmacy was 76.7% (801/1045). Adults aged older than 55 years were less willing to use telepharmacy (aged between 55 and 64 years: OR 0.57, 95% CI 0.38-0.86; aged 65 years or older: OR 0.24, 95% CI 0.15-0.37) than those younger than 55 years. Those who rated pharmacy service quality higher were more willing to use telepharmacy (OR 1.06, 95% CI 1.03-1.09) than those who did not. CONCLUSIONS: Respondents were generally willing to use telehealth (telemedicine and telepharmacy) services, but the likelihood of their being willing to use telehealth decreased as they were older. For those initially unwilling (aged 55 years or older) to use telemedicine services, inexpensive or insurance-covered services were acceptable.

Paper Title: Colorectal cancer screening knowledge among community pharmacists: A national survey.

BACKGROUND: Colorectal cancer (CRC) screening can reduce CRC morbidity and mortality. Community pharmacies could be a viable option for delivering home-based CRC screening tests such as fecal immunochemical tests (FITs). However, little is known about community pharmacists' knowledge about CRC screening guidelines. OBJECTIVE: We assessed community pharmacists' knowledge about CRC screening to identify education and training needs for a pharmacy-based CRC screening program. METHODS: Between September 2022 and January 2023, we conducted an online national survey of community pharmacists practicing in the United States (US) (Responders were eligible if they were currently-licensed community pharmacists and currently practiced in the US. The survey assessed knowledge of national CRC screening guidelines, including recommended starting age, frequency of screening, different screening modalities, and follow-up care. Using multiple linear regression, we evaluated correlates of community pharmacists' level of CRC screening knowledge, defined as the total number of knowledge questions answered correctly from "0" (no questions correct) to "5" (all questions correct). RESULTS: 578 eligible community pharmacists completed the survey, with a response rate of 59%. Most community pharmacists correctly answered the question about the next steps following a positive FIT (87%) and the question about where a FIT can be done (84%). A minority of community pharmacists responded correctly to questions about the age to start screening with FIT (34%) and how often a FIT should be repeated (28%). Only 5% of pharmacists answered all knowledge questions correctly. Community pharmacists answered more CRC screening knowledge questions correctly as their years in practice increased. Board-certified community pharmacists answered more CRC screening knowledge questions correctly compared to those who were not board-certified. CONCLUSION: To ensure the successful implementation of a pharmacy-based CRC screening program, community pharmacists need to be educated about CRC screening and trained to ensure comprehensive patient counseling and preventive service delivery.

Patient Willingness to Use a Pharmacy-Based Colorectal Cancer Screening Service: A National Survey of U.S. Adults.

BACKGROUND: We aimed to understand U.S. adults' willingness to use a pharmacy-based fecal immunochemical test (FIT) distribution service for routine colorectal cancer screening called PharmFIT using Diffusion of Innovation Theory, evaluating patient's appraisals of the program's relative advantage, compatibility, and complexity. METHODS: From March to April 2021, we conducted a national online survey of 1,045 U.S. adults ages 45 to 75. We identified correlates of patient willingness to use PharmFIT using structural equation modeling. RESULTS: Most respondents (72%) were willing to get a FIT from their pharmacy for their regular colorectal cancer screening. Respondents were more willing to participate in PharmFIT if they perceived higher relative advantage ($\hat{\beta}$= 0.184; confidence interval, CI95%: 0.055-0.325) and perceived higher compatibility ($\hat{\beta}$ = 0.422; CI95%: 0.253-0.599) to get screened in a pharmacy, had longer travel times to their primary health care provider ($\hat{\beta}$ = 0.007; CI95%: 0.004-0.010). Respondents were less willing to participate in PharmFIT if they were 65 years or older ($\hat{\beta}$ = -0.220; CI95%: -0.362 to -0.070). CONCLUSIONS: Most U.S. adults would be willing to participate in PharmFIT for their routine colorectal cancer screening. Patient perceptions of the relative advantage and compatibility of PharmFIT were strongly associated with their willingness to use PharmFIT. Pharmacies should account for patient preferences for these two traits of PharmFIT to increase adoption and use. IMPACT: Pharmacy-based colorectal cancer screening may be a viable public health strategy to significantly increase equitable access to screening for U.S. residents.

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.

Patient perspectives on a proposed pharmacy-based colorectal cancer screening program.

Colorectal cancer (CRC) is a common and preventable cancer. CRC screening is underutilized, particularly within medically underserved communities. Most interventions aimed at increasing CRC screening are delivered through primary care clinics. Pharmacies are more accessible than traditional primary care settings and may be ideally suited for delivering CRC screening and increasing access. Fecal immunochemical test is an at-home, stool-based CRC screening test that could be distributed through pharmacies. The purpose of our study was to assess patient perspectives on receiving fecal immunochemical test-based CRC screening through pharmacies. We conducted semi-structured interviews with participants residing in North Carolina and Washington. Interviews explored acceptability and intervention design preferences for a pharmacy-based CRC screening program. The interview guide was informed by Andersen's Healthcare Utilization Model and the Theoretical Domains Framework. Interviews were conducted at the University of North Carolina at Chapel Hill and Fred Hutchinson Cancer Research Center, audio-recorded, and transcribed. Patients perceived a pharmacy-based CRC screening program to be highly acceptable, citing factors such as ease of pharmacy access and avoiding co-pays for an office visit. Some concerns about privacy and coordination with patients' primary care provider tempered acceptability. Trust and positive relationships with providers and pharmacists as well as seamless care across the CRC screening continuum also were viewed as important. Patients viewed pharmacy-based CRC screening as an acceptable option for CRC screening. To improve programmatic success, it will be important to ensure privacy, determine how communication between the pharmacy and the patient's provider will take place, and establish closed-loop care, particularly for patients with abnormal results.

Colon cancer is a common and preventable cancer in the USA and testing for colon cancer can be done at home with a simple test. Yet, many people remain unscreened. This is particularly true for people who may not have ready access to health care, such as those who have limited incomes or resources or who live in rural areas. Most people live close to a pharmacy and visit a pharmacy more frequently than a primary care office. Pharmacies commonly offer services beyond medication dispensing (e.g. flu shot, diabetes management), making them a potential avenue for increasing colon cancer screening. This study aimed to learn what patients think about receiving colon cancer screening through pharmacies. We interviewed 32 people who fit the age-range recommended for colon cancer screening. They were open to, even embracing of, getting screened for colon cancer through a pharmacy, primarily because of its convenience, accessibility, and because it would not require a co-pay. At the same time, they emphasized the need for privacy and coordination with their primary care provider. We concluded that colon cancer screening in pharmacies is potentially a good option for people, provided they have privacy and that their primary care providers are informed.

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.

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.

Patient preferences for the design of a pharmacy-based colorectal cancer screening program.

PURPOSE: To assess preferences for design of a pharmacy-based colorectal cancer (CRC) screening program (PharmFIT™) among screening-eligible adults in the United States (US) and explore the impact of rurality on pharmacy use patterns (e.g., pharmacy type, prescription pick-up preference, service quality rating). METHODS: We conducted a national online survey of non-institutionalized US adults through panels managed by Qualtrics, a survey research company. A total of 1,045 adults (response rate 62%) completed the survey between March and April 2021. Sampling quotas matched respondents to the 2010 US Census and oversampled rural residents. We assessed pharmacy use patterns by rurality and design preferences for learning about PharmFIT™; receiving a FIT kit from a pharmacy; and completing and returning the FIT kit. RESULTS: Pharmacy use patterns varied, with some notable differences across rurality. Rural respondents used local, independently owned pharmacies more than non-rural respondents (20.4%, 6.3%, p < 0.001) and rated pharmacy service quality higher than non-rural respondents. Non-rural respondents preferred digital communication to learn about PharmFIT™ (36% vs 47%; p < 0.001) as well as digital FIT counseling (41% vs 49%; p = 0.02) more frequently than rural participants. Preferences for receiving and returning FITs were associated with pharmacy use patterns: respondents who pick up prescriptions in-person preferred to get their FIT (OR 7.7; 5.3-11.2) and return it in-person at the pharmacy (OR 1.7; 1.1-2.4). CONCLUSION: Pharmacies are highly accessible and could be useful for expanding access to CRC screening services. Local context and pharmacy use patterns should be considered in the design and implementation of PharmFIT™.

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.

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).

What is the effect of a decision aid on knowledge, values and preferences for lung cancer screening? An online pre-post study.

OBJECTIVE: To examine if a decision aid improves knowledge of lung cancer screening benefits and harms and which benefits and harms are most valued. DESIGN: Pre-post study. SETTING: Online. PARTICIPANTS: 219 current or former (quit within the previous 15 years) smokers ages 55-80 with at least 30 pack-years of smoking. INTERVENTION: Lung cancer screening video decision aid. MAIN MEASURES: Screening knowledge tested by 10 pre-post questions and value of benefits and harms (reducing chance of death from lung cancer, risk of being diagnosed, false positives, biopsies, complications of biopsies and out-of-pocket costs) assessed through rating (1-5 scale) and ranking (top three ranked). RESULTS: Mean age was 64.7±6.1, 42.5% were male, 75.4% white, 48.4% married, 28.9% with less than a college degree and 67.6% with income

Screening for Lung Cancer With Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Lung cancer is the leading cause of cancer-related death in the US. Objective: To review the evidence on screening for lung cancer with low-dose computed tomography (LDCT) to inform the US Preventive Services Task Force (USPSTF). Data Sources: MEDLINE, Cochrane Library, and trial registries through May 2019; references; experts; and literature surveillance through November 20, 2020. Study Selection: English-language studies of screening with LDCT, accuracy of LDCT, risk prediction models, or treatment for early-stage lung cancer. Data Extraction and Synthesis: Dual review of abstracts, full-text articles, and study quality; qualitative synthesis of findings. Data were not pooled because of heterogeneity of populations and screening protocols. Main Outcomes and Measures: Lung cancer incidence, lung cancer mortality, all-cause mortality, test accuracy, and harms. Results: This review included 223 publications. Seven randomized clinical trials (RCTs) (N = 86 486) evaluated lung cancer screening with LDCT; the National Lung Screening Trial (NLST, N = 53 454) and Nederlands-Leuvens Longkanker Screenings Onderzoek (NELSON, N = 15 792) were the largest RCTs. Participants were more likely to benefit than the US screening-eligible population (eg, based on life expectancy). The NLST found a reduction in lung cancer mortality (incidence rate ratio [IRR], 0.85 [95% CI, 0.75-0.96]; number needed to screen [NNS] to prevent 1 lung cancer death, 323 over 6.5 years of follow-up) with 3 rounds of annual LDCT screening compared with chest radiograph for high-risk current and former smokers aged 55 to 74 years. NELSON found a reduction in lung cancer mortality (IRR, 0.75 [95% CI, 0.61-0.90]; NNS to prevent 1 lung cancer death of 130 over 10 years of follow-up) with 4 rounds of LDCT screening with increasing intervals compared with no screening for high-risk current and former smokers aged 50 to 74 years. Harms of screening included radiation-induced cancer, false-positive results leading to unnecessary tests and invasive procedures, overdiagnosis, incidental findings, and increases in distress. For every 1000 persons screened in the NLST, false-positive results led to 17 invasive procedures (number needed to harm, 59) and fewer than 1 person having a major complication. Overdiagnosis estimates varied greatly (0%-67% chance that a lung cancer was overdiagnosed). Incidental findings were common, and estimates varied widely (4.4%-40.7% of persons screened). Conclusions and Relevance: Screening high-risk persons with LDCT can reduce lung cancer mortality but also causes false-positive results leading to unnecessary tests and invasive procedures, overdiagnosis, incidental findings, increases in distress, and, rarely, radiation-induced cancers. Most studies reviewed did not use current nodule evaluation protocols, which might reduce false-positive results and invasive procedures for false-positive results.

What Works in Implementing Patient Decision Aids in Routine Clinical Settings? A Rapid Realist Review and Update from the International Patient Decision Aid Standards Collaboration.

BACKGROUND: Decades of effectiveness research has established the benefits of using patient decision aids (PtDAs), yet broad clinical implementation has not yet occurred. Evidence to date is mainly derived from highly controlled settings; if clinicians and health care organizations are expected to embed PtDAs as a means to support person-centered care, we need to better understand what this might look like outside of a research setting. AIM: This review was conducted in response to the IPDAS Collaboration's evidence update process, which informs their published standards for PtDA quality and effectiveness. The aim was to develop context-specific program theories that explain why and how PtDAs are successfully implemented in routine healthcare settings. METHODS: Rapid realist review methodology was used to identify articles that could contribute to theory development. We engaged key experts and stakeholders to identify key sources; this was supplemented by electronic database (Medline and CINAHL), gray literature, and forward/backward search strategies. Initial theories were refined to develop realist context-mechanism-outcome configurations, and these were mapped to the Consolidated Framework for Implementation Research. RESULTS: We developed 8 refined theories, using data from 23 implementation studies (29 articles), to describe the mechanisms by which PtDAs become successfully implemented into routine clinical settings. Recommended implementation strategies derived from the program theory include 1) co-production of PtDA content and processes (or local adaptation), 2) training the entire team, 3) preparing and prompting patients to engage, 4) senior-level buy-in, and 5) measuring to improve. CONCLUSIONS: We recommend key strategies that organizations and individuals intending to embed PtDAs routinely can use as a practical guide. Further work is needed to understand the importance of context in the success of different implementation studies.