Faculty Bibliography

IMPORTANCE:Black men have a higher risk of prostate cancer compared with White men, but Black adults are underrepresented in online content about prostate cancer. Across racial groups, the internet is a popular source of health information; Black adults are more likely to trust online health information, yet have more medical mistrust than White adults. OBJECTIVE:To evaluate the association between racial representation in online content about prostate cancer and trust in the content and identify factors that influence trust. DESIGN, SETTING, AND PARTICIPANTS:A randomized clinical trial was conducted from August 18, 2021, to January 7, 2022, consisting of a 1-time online survey. Participants included US men and women aged 40 years and older. Data were analyzed from January 2022 to June 2023. INTERVENTIONS:Participants were randomized to watch the same video script about either prostate cancer screening or clinical trials presented by 1 of 4 speakers: a Black physician, a Black patient, a White physician, or a White patient, followed by a questionnaire. MAIN OUTCOMES AND MEASURES:The primary outcome was a published scale for trust in the information. χ2 tests and multivariable logistic regression were used to compare trust according to the video's speaker and topic. RESULTS:Among 2904 participants, 1801 (62%) were men, and the median (IQR) age was 59 (47-69) years. Among 1703 Black adults, a greater proportion had high trust in videos with Black speakers vs White speakers (72.7% vs 64.3%; adjusted odds ratio [aOR], 1.62; 95% CI, 1.28-2.05; P < .001); less trust with patient vs physician presenter (64.6% vs 72.5%; aOR, 0.63; 95% CI, 0.49-0.80; P < .001) and about clinical trials vs screening (66.3% vs 70.7%; aOR, 0.78; 95% CI, 0.62-0.99; P = .04). Among White adults, a lower proportion had high trust in videos featuring a patient vs physician (72.0% vs 78.6%; aOR, 0.71; 95% CI, 0.54-0.95; P = .02) and clinical trials vs screening (71.4% vs 79.1%; aOR, 0.57; 95% CI, 0.42-0.76; P < .001), but no difference for Black vs White presenters (76.8% vs 73.7%; aOR, 1.11; 95% CI, 0.83-1.48; P = .49). CONCLUSIONS AND RELEVANCE:In this randomized clinical trial, prostate cancer information was considered more trustworthy when delivered by a physician, but racial concordance was significantly associated with trust only among Black adults. These results highlight the importance of physician participation and increasing racial diversity in public dissemination of health information and an ongoing need for public education about clinical trials. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT05886751.

OBJECTIVE:There are substantial disparities in clinical trial participation, which is problematic in diseases such as lupus that disproportionately affect racial/ethnic minority populations. We examined the effectiveness of an online educational course aiming to train medical providers to refer Black and Latino patients to lupus clinical trials (LCTs). METHODS:The American College of Rheumatology's Materials to Increase Minority Involvement in Clinical Trials (MIMICT) study uses an online, randomized, two-group, pretest/posttest design with medical and nursing providers of multiple specialties. We exposed intervention group participants to an education course, while the control group participants received no intervention. Controlling for the effects of participant characteristics, including specialty, and professional experience with lupus, we modeled relationships among exposure to the education course and changes in knowledge, attitudes, self-efficacy, and intentions to refer Black and Latino patients to LCTs. We also examined education course satisfaction. RESULTS:Compared to the control group, the intervention group had significantly higher posttest scores for knowledge, self-efficacy, and intentions to refer Black and Latino patients to LCTs. Both medical and nursing trained intervention group participants had significantly higher mean posttest scores for knowledge and intentions to refer compared to the medical and nursing trained control group participants. Attitude was insignificant in analysis. The online education course, which received a favorable summary score, indicated that satisfaction and intentions to refer were strongly and positively correlated. CONCLUSION/CONCLUSIONS:The MIMICT education course is an effective method to educate medical providers about LCTs and improve their intentions to refer Black and Latino patients.

Electronic health records (EHRs) are often used for recruitment into research studies, as they efficiently facilitate targeted outreach. While studies increasingly are reaching out to potential participants through the EHR patient portal, there is little available information about which approaches are most effective. We surveyed all investigators at one academic medical center who had used the Epic MyChart patient portal for recruitment. We found that messages were typically adapted for a large group, but not tailored further for individual subgroups. The vast majority of studies sent a message only once. Recruitment costs were modest, averaging $431/study. The results show some promise for recruiting through the patient portal but also identified ways in which messages could be optimized.

BACKGROUND:Social determinants of health (SDOH) refer to the social, economic, and psychosocial conditions that influence health. Lower levels of SDOH factors including income, education, and employment are associated with a higher prevalence of diabetes, poorer glycemic control, and increased diabetes-related mortality. Few studies have conducted a comprehensive evaluation of multiple SDOH factors in a population with type 2 diabetes mellitus (T2DM). OBJECTIVE:This study aimed to identify the range of SDOH challenges-including diabetes-related distress-that impact patients with insulin-dependent diabetes at an urban safety-net clinic using the 5-domain SDOH framework developed by the Healthy People 2020 initiative. METHODS:The pilot study used a cross-sectional, mixed methods approach. Participants were recruited from 3 programs within a general internal medicine clinic that provides ambulatory care for patients with uncontrolled T2DM. We administered an investigator-developed SDOH survey based on the Healthy People 2020 framework and the validated Diabetes Distress Scale (DDS), which assesses 4 domains of diabetes-related distress. One-on-one interviews were conducted to gain in-depth information about challenges. RESULTS:level of 11.0% (SD 2.6%). Overall, 92% (52/57) of participants had a barrier in at least one SDOH domain. SDOH challenges were most commonly reported in the domain of Health and Health Care (84%, 48/57), followed by Economic Stability (54%, n=31), Neighborhood and Built Environment (53%, n=30), Education and Health Literacy (47%, n=27), and Social and Community context (37%, n=21). The mean overall DDS score was 2.09 (SD 0.84), where scores of ≥2 indicate distress. Further, 79% (45/57) of participants had at least moderate diabetes-related distress in one of the 4 DDS domains. General themes that emerged from participant interviews included job interference with healthy behaviors, concerns about burdening others, challenges communicating with providers, and difficulty getting appointments in a timely manner. CONCLUSIONS:We found high levels of SDOH barriers across all 5 domains of the Center for Disease Control and Prevention's Healthy People 2020 framework, including significant levels of diabetes-related distress. Future programs to address SDOH barriers in patients with uncontrolled insulin-dependent diabetes should consider screening for and focusing on a wide range of challenges.

BACKGROUND:Surgery is the most common treatment for localized small kidney masses (SKMs) up to 4 cm, despite a lack of evidence for improved overall survival. Nonsurgical management options are gaining recognition, as evidence supports the indolence of most SKMs. Decision aids (DAs) have been shown to improve patient comprehension of the trade-offs of treatment options and overall decision quality, and may improve consideration of all major options according to individual health priorities and preferences. OBJECTIVE:This pilot randomized controlled trial (RCT) primarily aims to evaluate the impact of a new web-based DA on treatment decisions for patients with SKM; that is, selection of surgical versus nonsurgical treatment options. Secondary objectives include an assessment of decision-making outcomes: decisional conflict, decision satisfaction, and an understanding of individual preferences for treatment that incorporate the trade-offs associated with surgical versus nonsurgical interventions. METHODS:Three phases comprise the construction and evaluation of a new web-based DA on SKM treatment. In phase 1, this DA was developed in print format through a multidisciplinary design committee incorporating patient focus groups. Phase 2 was an observational study on patient knowledge and decision-making measures after randomization to receive the printed DA or institutional educational materials, which identified further educational needs applied to a web-based DA. Phase 3 will preliminarily evaluate the web-based DA: in a pilot RCT, 50 adults diagnosed with SKMs will receive the web-based DA or an existing web-based institutional website at urology clinics at a large academic medical center. The web-based DA applies risk communication and information about diagnosis and treatment options, elicits preferences regarding treatment options, and provides a set of options to consider with their doctor based on a decision-analytic model of benefits/harm analysis that accounts for comorbidity, age group, and tumor features. Questionnaires and treatment decision data will be gathered before and after viewing the educational material. RESULTS:This phase will consist of a pilot RCT from August 2022 to January 2023 to establish feasibility and preliminarily evaluate decision outcomes. Previous study phases from 2018 to 2020 supported the feasibility of providing the printed DA in urology clinics before clinical consultation and demonstrated increased patient knowledge about the diagnosis and treatment options and greater likelihood of favoring nonsurgical treatment just before consultation. This study was funded by the National Cancer Institute. Recruitment will begin in August 2022. CONCLUSIONS:A web-based DA has been designed to address educational needs for patients making treatment decisions for SKM, accounting for comorbidities and treatment-related benefits and risks. Outcomes from the pilot trial will evaluate the potential of a web-based DA in personalizing treatment decisions and in helping patients weigh attributes of surgical versus nonsurgical treatment options for their SKMs. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05387863; https://clinicaltrials.gov/ct2/show/NCT05387863. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:PRR1-10.2196/41451.

OBJECTIVE:To develop and pilot test a patient decision aid (DA) describing small kidney masses and risks and benefits of treatment for the masses. METHODS:An expert committee iteratively designed a small kidney mass DA, incorporating evidence-based risk communication and informational needs for treatment options and shared decision making. After literature review and drafting content with the feedback of urologists, radiologists, and an internist, a rapid qualitative assessment was conducted using two patient focus groups to inform user-centered design. In a pilot study, 30 patients were randomized at the initial urologic consultation to receive the DA or existing institutional patient educational material (PEM). Preconsultation questionnaires captured patient knowledge and shared decision-making preferences. After review of the DA and subsequent clinician consultation, patients completed questionnaires on discussion content and satisfaction. Proportions between arms were compared using Fisher exact tests, and decision measures were compared using Mann-Whitney tests. RESULTS:Patient informational needs included risk of tumor growth during active surveillance and ablation, significance of comorbidities, and posttreatment recovery. For the DA, 84% of patients viewed all content, and mean viewing time was 20 min. Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, P < .001). DA use also increased the proportion of patients discussing ablation (66.7% DA versus 18.2% PEM, P = .02). Decision satisfaction measures were similar in both arms. DISCUSSION/CONCLUSIONS:Patients receiving a small kidney mass DA are likely to gain knowledge and preparedness to discuss all treatment options over standard educational materials.

BACKGROUND:The need to engage adults, age 65 and older, in clinical trials of conditions typical in older populations, (e.g. hypertension, diabetes mellitus, Alzheimer's disease and related dementia) is exponentially increasing. Older adults have been markedly underrepresented in clinical trials, often exacerbated by exclusionary study criteria as well as functional dependencies that preclude participation. Such dependencies may further exacerbate communication challenges. Consequently, the evidence of what works in subject recruitment is less generalizable to older populations, even more so for those from racial and ethnic minority and low-income communities. METHODS:To support capacity of research staff, we developed a virtual, three station simulation (Group Objective Structured Clinical Experience-GOSCE) to teach research staff communication skills. This 2-h course included a discussion of challenges in recruiting older adults; skills practice with Standardized Participants (SPs) and faculty observer who provided immediate feedback; and debrief to highlight best practices. Each learner had opportunities for active learning and observational learning. Learners completed a retrospective pre-post survey about the experience. SP completed an 11-item communication checklist evaluating the learner on a series of established behaviorally anchored communication skills (29). RESULTS:In the research staff survey, 92% reported the overall activity taught them something new; 98% reported it provided valuable feedback; 100% said they would like to participate again. In the SP evaluation there was significant variation: the percent well-done of items by case ranged from 25-85%. CONCLUSIONS:Results from this pilot suggest that GOSCEs are a (1) acceptable; (2) low cost; and (3) differentiating mechanism for training and assessing research staff in communication skills and structural competency necessary for participant research recruitment.

Randomized controlled trials (RCTs) remain the gold standard to evaluate clinical interventions, producing the highest level of evidence while minimizing potential bias. Inadequate recruitment is a commonly encountered problem that undermines the completion and generalizability of RCTs-and is even more challenging when enrolling amidst a pandemic. Here, we reflect on our experiences with virtual recruitment of non-hospitalized patients in the United States for ColCorona, an international, multicenter, randomized, placebo-controlled coronavirus disease 2019 (COVID-19) drug trial. Recruitment challenges during a pandemic include constraints created by shelter-in-place policies and targeting enrollment according to national and local fluctuations in infection rate. Presenting a study to potential participants who are sick with COVID-19 and may be frightened, overwhelmed, or mistrusting of clinical research remains a challenge. Strategies previously reported to improve recruitment include transparency, patient and site education, financial incentives, and person-to-person outreach. Active measures taken during ColCorona to optimize United States recruitment involved rapid expansion of sites, adjustment of recruitment scripts, assessing telephone calls versus text messages for initial contact with participants, institutional review board-approved financial compensation, creating an infrastructure to systematically identify potentially eligible patients, partnering with testing sites, appealing to both self-interest and altruism, and large-scale media efforts with varying degrees of success.