Faculty Bibliography

LEARNINGOBJECTIVES 1: Interpersonal /Communication Skill: 1) Identify communication skills needed to recruit older adults LEARNING OBJECTIVES 2: 2) Assess feasibility of GOSCEs to enhance recruitment skills in RAs. SETTING AND PARTICIPANTS: Convenience sample of 18 (5 male, 13 female) Research Assistants (RAs) at an urban hospital who recruit older adults for clinical trials. DESCRIPTION: Increasing older adults' participation in clinical trials is urgently needed. We developed a remote, three station simulation (Group Objective Structured Clinical Exam - GOSCE) to teach RAs communication skills. This 2-hour course included a discussion of challenges in recruiting older adults; skills practice with Standardized Participants (SPs); and a debrief to review experiences, highlight best practices. After discussion, RAs rotated (3 per group) through the stations, each with SP and faculty observer who provided immediate feedback. Thus, learners had opportunities for active and observational learning.Scenarios were: 1) an older white woman with hearing impairment; 2) an older white woman and family member together; and 3) an older Black man mistrustful due to history of racism in medical research. SPs completed behaviorally anchored checklists (11 communication skills across all cases, and 5-7 case-specific questions). Learners completed a 36- item survey of self-assessed change in skill after the workshop; insights on recruitment practice; and educational value. EVALUATION: The communication checklist across all cases included: relationship development (5 items, mean of 58% well done (range: 50-75%), patient education (3 items, 44% (42-58%)), patient satisfaction (2 items, 54% (50-58%)), and information gathering (1 item, 92%). Seventeen RAs completed the survey, 100% felt the workshop provided valuable feedback and taught relevant material, 88% would participate again and 52%reported that the workshop improved their recruitment skills. All RAs reported encountering situations similar to hearing impairment and family member cases, and the majority rated the cases as high in educational value. Just 45% reported experiencing a case similar to the Black male case, and 100% rate it as high in educational value. Key points identified by RAs included the value of building a trusting relationship with potential subjects, recognizing possible barriers to communication early on and addressing these directly in a supportive and respectful style. DISCUSSION / REFLECTION / LESSONS LEARNED: Remote GOSCEs are a feasible mechanism for training RAs in subject recruitment focused on the unique needs of older adults. Responses to the RA survey suggest that GOSCEs are feasible for training RAs in simulated clinical scenarios with which participants are familiar and unfamiliar. SP assessment of RAs identified areas for further reinforcement to improve recruitment skills. This innovation is a feasible, high yield strategy for training research staff. It is highly adaptable to the specific recruitment needs and skills of a clinical trials and will add to the literature on educating RAs

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/OBJECTIVE: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.

The COVID-19 pandemic has magnified the importance of clinical trials for finding a safe and effective vaccine to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. Although communication about vaccines and vaccine hesitancy were challenges long before COVID-19, the twin facts of a pandemic and an "infodemic" of health information, misinformation, and disinformation have raised new challenges for vaccine-related communication and decision-making. The goal of this commentary is to highlight strategies to improve communication and decision-making for adults considering participation in COVID-19 vaccine clinical trials. First, I present a general conceptual model for clinical trial participation that can be applied to various vaccine and other clinical trial contexts. Next, I introduce the ASK (Assume, Seek, Know) approach for enhancing clinical trial participation: (1) assume that all patients will want to know their options, (2) seek the counsel of stakeholders, and (3) know your numbers. The ideas presented in this commentary are intended to enhance vaccine-specific clinical trial communication, decision-making, and literacy, while dually offering strategies and resources that may help reduce vaccine hesitancy and increase vaccine uptake over time.

Resistant hypertension, defined as blood pressure levels above goal while taking ≥3 classes of antihypertensive medication or ≥4 classes regardless of blood pressure level, is associated with increased cardiovascular disease risk. The 2018 American Heart Association Scientific Statement on Resistant Hypertension recommends healthy lifestyle habits and thiazide-like diuretics and mineralocorticoid receptor antagonists for adults with resistant hypertension. The term apparent treatment-resistant hypertension (aTRH) is used when pseudoresistance cannot be excluded. We estimated the use of healthy lifestyle factors and recommended antihypertensive medication classes among US Black adults with aTRH. Data were pooled for Black participants in the JHS (Jackson Heart Study) in 2009 to 2013 (n=2496) and the REGARDS study (Reasons for Geographic and Racial Differences in Stroke) in 2013 to 2016 (n=3786). Outcomes included lifestyle factors (not smoking, not consuming alcohol, ≥75 minutes of vigorous-intensity or ≥150 minutes of moderate or vigorous physical activity per week, and body mass index <25 kg/m²) and recommended antihypertensive medications (thiazide-like diuretics and mineralocorticoid receptor antagonists). Overall, 28.3% of participants who reported taking antihypertensive medication had aTRH. Among participants with aTRH, 14.5% and 1.2% had ideal levels of 3 and 4 of the lifestyle factors, respectively. Also, 5.9% of participants with aTRH reported taking a thiazide-like diuretic, and 9.8% reported taking a mineralocorticoid receptor antagonist. In conclusion, evidence-based lifestyle factors and recommended pharmacological treatment are underutilized in Black adults with aTRH. Increased use of lifestyle recommendations and antihypertensive medication classes specifically recommended for aTRH may improve blood pressure control and reduce cardiovascular disease-related morbidity and mortality among US Black adults.

BACKGROUND:It is important to monitor the scope of clinical research of all types, to involve participants of all ages and subgroups in studies that are appropriate to their condition, and to ensure equal access and broad validity of the findings. OBJECTIVE:We conducted a review of clinical research performed at New York University with the following objectives: (1) to determine the utility of institutional administrative data to characterize clinical research activity; (2) to assess the inclusion of special populations; and (3) to determine if the type, initiation, and completion of the study differed by age. METHODS:Data for all studies that were institutional review board-approved between January 1, 2014, and November 2, 2016, were obtained from the research navigator system, which was launched in November 2013. One module provided details about the study protocol, and another module provided the characteristics of individual participants. Research studies were classified as observational or interventional. Descriptive statistics were used to assess the characteristics of clinical studies across the lifespan, by type, and over time. RESULTS:A total of 22%-24% of studies included children (minimum age <18 years) and 4%-5% focused exclusively on pediatrics. Similarly, 64%-72% of studies included older patients (maximum age >65 years) but only 5%-12% focused exclusively on geriatrics. Approximately 85% of the studies included both male and female participants. Of the remaining studies, those open only to girls or women were approximately 3 times as common as those confined to boys or men. A total of 56%-58% of projects focused on nonvulnerable patients. Among the special populations studied, children (12%-15%) were the most common. Noninterventional trial types included research on human data sets (24%), observational research (22%), survey research (16%), and biospecimen research (8%). The percentage of projects designed to test an intervention in a vulnerable population increased from 17% in 2014 to 21% in 2015. CONCLUSIONS:Pediatric participants were the special population that was most often studied based on the number of registered projects that included children and adolescents. However, they were much less likely to be successfully enrolled in research studies compared with adults older than 65 years. Only 20% of the studies were interventional, and 20%-35% of participants in this category were from vulnerable populations. More studies are exclusively devoted to women's health issues compared with men's health issues.

BACKGROUND:Tablet and smartphone ownership have increased among US adults over the past decade. However, the degree to which people use mobile devices to help them make medical decisions remains unclear. OBJECTIVE:The objective of this study is to explore factors associated with self-reported use of tablets or smartphones to support medical decision making in a nationally representative sample of US adults. METHODS:Cross-sectional data from participants in the 2018 Health Information National Trends Survey (HINTS 5, Cycle 2) were evaluated. There were 3504 responses in the full HINTS 5 Cycle 2 data set; 2321 remained after eliminating respondents who did not have complete data for all the variables of interest. The primary outcome was use of a tablet or smartphone to help make a decision about how to treat an illness or condition. Sociodemographic factors including gender, race/ethnicity, and education were evaluated. Additionally, mobile health (mHealth)- and electronic health (eHealth)-related factors were evaluated including (1) the presence of health and wellness apps on a tablet or smartphone, (2) use of electronic devices other than tablets and smartphones to monitor health (eg, Fitbit, blood glucose monitor, and blood pressure monitor), and (3) whether people shared health information from an electronic monitoring device or smartphone with a health professional within the last 12 months. Descriptive and inferential statistics were conducted using SAS version 9.4. Weighted population estimates and standard errors, univariate odds ratios, and 95% CIs were calculated, comparing respondents who used tablets or smartphones to help make medical decisions (n=944) with those who did not (n=1377), separately for each factor. Factors of interest with a P value of <.10 were included in a subsequent multivariable logistic regression model. RESULTS:Compared with women, men had lower odds of reporting that a tablet or smartphone helped them make a medical decision. Respondents aged 75 and older also had lower odds of using a tablet or smartphone compared with younger respondents aged 18-34. By contrast, those who had health and wellness apps on tablets or smartphones, used other electronic devices to monitor health, and shared information from devices or smartphones with health care professionals had higher odds of reporting that tablets or smartphones helped them make a medical decision, compared with those who did not. CONCLUSIONS:A limitation of this research is that information was not available regarding the specific health condition for which a tablet or smartphone helped people make a decision or the type of decision made (eg, surgery, medication changes). In US adults, mHealth and eHealth use, and also certain sociodemographic factors are associated with using tablets or smartphones to support medical decision making. Findings from this study may inform future mHealth and other digital health interventions designed to support medical decision making.

OBJECTIVE:To determine whether racial differences exist in patient preferences for prostate cancer treatment after being informed about options using a patient-centered vs. a standard decision aid (DA). METHODS:This article reports secondary analyses of a large study of men diagnosed with early stage prostate cancer. Men were recruited from 4 VA Health Systems and randomized to receive a patient-centered or standard DA about prostate cancer treatment options. Data were collected at 1) baseline, 2) after reading the DA but prior to diagnosis, and 3) after receiving a cancer diagnosis and meeting with a urologist. RESULTS:grade reading level were more likely to prefer active surveillance and less likely to prefer radiation compared to those who received the standard DA written at >9th grade reading level. African American patients' treatment preferences did not differ as a function of DA. CONCLUSIONS:When informed about prostate cancer treatment options through a patient-centered DA, White patients changed their treatment preferences but African American patients did not. PRACTICE IMPLICATIONS/CONCLUSIONS:As DAs are increasingly being used in clinical practice, more research is needed regarding the efficacy, relevance, and receptivity of DAs for African Americans.

Despite the promise of clinical trials for improving cancer care, less than 5% of all cancer patients participate. Racial/ethnic minorities continue to be underrepresented in cancer clinical trials (CCTs). To address this gap, we developed a plain language, web-based decision support tool (CHOICES DST) in English and Spanish to support decision-making about CCTs among Blacks and Hispanics. In phase 1 (information collection), we conducted qualitative interviews with 45 cancer patients, completed a thorough literature review, and reviewed results from a telephone survey of 1100 cancer patients. In phase 2 (content generation), we created the first iteration of the CHOICES DST. In phase 3 (usability testing), we gathered user experience and acceptability data from a small sample of cancer survivors (n = 9). The Knowledge, Empowerment, and Values Clarification (KEV) model of decision-making was developed based on data from phase 1. The KEV model and other phase 1 data allowed us to create the CHOICES DST platform. Usability testing of the CHOICES DST showed highly favorable responses from users, satisfaction with content, ease of navigation, and a desire to use the tool. Qualitative results identified addressable points that would benefit from content and navigation-related alterations. The final version of the CHOICES DST was well received and understood by Black and Hispanic participants, and adheres to the mandates for plain language communication. This research provides preliminary data that CHOICES DST holds promise for improving knowledge of CCTs and potentially improving informed decision-making about participation in trials.

Data from the Health Information National Trends Survey (HINTS) show that the Internet is the first place people go to when they need information about health or medical topics. Searches for online health information have both benefits and challenges for patient-physician communication. To fully appreciate these issues, it is important to understand the following: (1) who is going online; (2) why are they going; (3) where are they going; (4) what needs are being met; and (5) how, if at all, do they discuss health information found online with their doctors. The objective of this mini-review is to highlight contemporary issues regarding the impact of the internet on patient-physician communication and to present directions for future research. PATIENT SUMMARY: The growing use of the Internet has implications for people seeking information on health matters. Our review shows that the Internet can be helpful for patient-physician communication, but this depends on the quality of health information found and whether the information is discussed during medical visits.

Although there is a large amount of user-generated content about urological health issues on social media, much of this content has not been vetted for information accuracy. In this article, we review the literature on the quality and balance of information on urological health conditions on social networks. Across a wide range of benign and malignant urological conditions, studies show a substantial amount of commercial, biased and/or inaccurate information present on popular social networking sites. The healthcare community should take proactive steps to improve the quality of medical information on social networks. PATIENT SUMMARY: In this review, we examined the spread of misinformation about urological health conditions on social media. We found that a significant amount of the circulating information is commercial, biased or misinformative.