Implicit Bias and Caring for Diverse Populations: Pediatric Trainee Attitudes and Gaps in Training

The objective of this study was to determine the attitudes, skill level, and preferred educational interventions of pediatric residents related to implicit bias and caring for diverse patient populations. A cross-sectional survey of pediatric residents at a single, large urban residency program was utilized. Surveys were completed by 88 (55%) residents who were 69% female and 35% non-White or mixed race. Almost all residents felt that it was very or extremely important to receive training on health disparities, diverse patient populations, and implicit bias. Self-assessment of skill level revealed that residents felt confident in areas often covered by cultural competency curricula, such as interpreter use, but were less confident in other areas. The top 3 areas identified for further training included implicit bias, working with transgender and gender nonconforming patients, and weight bias. For the majority of diversity and bias-related skills, prior training was significantly correlated with higher skill level ( P < .05).

A mHealth Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Design of mGlide RCT (Preprint)

BACKGROUND Sub-optimal treatment of hypertension remains a widespread problem particularly among minorities and socioeconomically disadvantaged groups. We present a health-system based intervention with diverse patient populations using readily available smart phone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control. OBJECTIVE mGlide RCT is a NIH-funded randomized controlled trial, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between health care teams and patients results in better hypertension control rates than a state-of-clinical care comparison. METHODS We are recruiting 450 participants including stroke survivors and primary care patients with elevated cardiovascular disease risk from diverse health systems. These systems include an acute stroke service (n=100), an academic medical center (n=150) and community medical centers including Federally Qualified Health Centers serving low income and minority (Latino, Hmong, African American, Somali) patients (n=200). The primary aim tests the clinical effectiveness of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained hypertension control rates at 12 months; describe provider experiences of system usability and satisfaction; examine patient experiences, including medication adherence and medication use self-efficacy, self-rated health and quality of life, and adverse event rates; and complete a cost-effectiveness analysis. RESULTS Enrollment. To date, we have randomized 104 participants (52 intervention; 52 control). CONCLUSIONS This study will provide evidence for whether a readily available mHealth-care model is better than state-of-clinical care for bridging the guideline-to-practice gap in hypertension treatment in health systems serving diverse patient populations. CLINICALTRIAL Clinicaltrials.gov NCT03612271

The Diversity Site Assessment Tool (DSAT), Reliability and Validity of the Industry Gold Standard for Establishing Investigator Site Ranking

Background: The purpose of this study was to evaluate the reliability and construct validity of the Diversity Site Assessment Tool (DSAT), a self-assessment instrument designed to self-report the extent to which best practices related to recruitment of diverse patient populations during clinical trials are used. Methods: A cross-sectional design was used. The convenience sample consisted of site representatives who are members of the Society for Clinical Research Sites and network site representatives that were approached via social media sites such as LinkedIn. A link to the survey was shared with approximately 17,000 aforementioned site representatives over a period of three months. The survey consisted of one section each for the indicators of best practice for the recruitment of diverse patient populations during clinical trials: 1) Site Overview (10 items), 2) Site Recruitment and Outreach (9 items) and 3) Patient Focused Services (6 items). These three indicators and the total of 25 items make up the DSAT. Each of the total 25 items on DSAT required participants to self-report on a 6-point scale. The fourth section collected background information about the participant and their site. After the survey was closed, two types of summative scores were compiled, one for each of the indicators and an overall summative DSAT score (range from 25-150). Higher summative scores on each indicator and the overall DSAT are reflective of increased use of best practices for the recruitment of diverse patient population during clinical trials. Internal consistency reliability (Cronbach’s alpha) and construct validity for the entire sample were evaluated and are reported. Bivariate and multivariate statistics were conducted to examine the relationship between site characteristics and their summative indicator and DSAT overall scores. Results: The instrument was deemed to have exceptional reliability. Cronbach's alpha coefficient for internal consistency reliability for the entire sample was 0.929. Construct validity established using the exploratory factor analysis indicated a three component solution accounting for 49% of the explained variance. There was no statistically relationship between site characteristics and their summative indicator and DSAT overall scores. Conclusion: The DSAT has exceptional reliability and good construct validity. When paired with the findings that site characteristics have no statistical relationship with the DSAT indicators and overall summative scores, it is contended that this instrument could be used by different site backgrounds as a self-assessment measure to evaluate the extent of the use of best practices related to recruitment of diverse patient populations during clinical trials. The rigorous development of the instrument and exceptional statistical results make the tool easily the highest standard of measurement available related to this construct.

1174. Phase 2 STRIVE Clinical Trial of Rezafungin for Treatment of Candidemia and/or Invasive Candidiasis Demonstrates Consistent Trough Concentrations Across Diverse Patient Populations

Background Rezafungin is a novel echinocandin antifungal in development for treatment as well as prevention (prophylaxis) of invasive fungal infections. STRIVE (NCT02734862) is a global, randomized, double-blind, placebo-controlled, Phase 2 trial evaluating safety and efficacy of IV rezafungin once weekly (QWk) for treatment of candidemia and/or invasive candidiasis compared with standard-of-care (IV caspofungin once daily with optional oral stepdown). Here we report pharmacokinetic (PK) data from the completed STRIVE trial analyzed by patient demographics at baseline. Methods Rezafungin Day 8 trough (Cmin) concentrations from patients treated with rezafungin were summarized categorically by race (black or white), sex (male or female), and geographic region (North America [NA], or Europe [EU]), or plotted versus continuous variables of age, body weight, body mass index (BMI), and body surface area (BSA). As the first dose of rezafungin was 400 mg for all rezafungin-treated patients, data from both dose groups (Group 1: 400 mg QWk; Group 2: 400 mg in Week 1 followed by 200 mg QWk) were combined in this analysis. Results Rezafungin mean Cmin (SD) values were 1.8 (0.7) and 2.3 (1.2) in black and white patients, 1.9 (1.0) and 2.6 (1.2) in males and females, and 1.9 (0.6) and 2.4 (1.3) in patients from NA and EU. There were small differences in point estimates between the groups, but there was a great deal of overlap and the differences are not expected to be clinically meaningful (Figure). Similarly, no trends in Cmin values were observed across a range of ages (20-80 years), weights (~40-155 kg), BMI (~15-65 kg/m2), and BSA (~1.4-2.4 m2). Figure Conclusion No meaningful differences in rezafungin Cmin values were observed in patients grouped by sex, race, or geographic region, or across a wide range of patient factors, including age and body weight and size. These findings indicate that a single rezafungin dose regimen can be expected to provide consistent PK across diverse patient populations. Disclosures Shawn Flanagan, PhD, Cidara Therapeutics, Inc. (Employee, Shareholder) Christopher M. Rubino, PharMD, Institute for Clinical Pharmacodynamics, Inc. (Employee)Spero Therapeutics (Grant/Research Support) Taylor Sandison, MD, MPH, Cidara Therapeutics, Inc. (Employee, Shareholder)

REACT: A feasibility study to test the integration of a cancer registry early case ascertainment process via electronic pathology reporting with an online clinical trial matching tool.

207 Background: Representation of diverse patient populations in prostate cancer clinical trials is essential to ensure results are applicable to all men. However, underrepresentation among underserved populations remains a critical problem. Population-based cancer registries provide a potential platform to overcome problems with inclusion of diverse patient populations in clinical research when used as a source for recruitment. Methods: Leveraging statewide implementation of early-case ascertainment (ECA) via electronic pathology for cancer case identification, we performed a feasibility study within the Greater Bay Area Cancer Registry to (1) test a process using ECA to identify new cases of advanced prostate cancer for potential enrollment into clinical trials and (2) test the utility of an online clinical trial matching tool to improve matching of underrepresented patients into clinical trials. All study materials were translated into Spanish, and recruiters were Spanish-speaking. Results: A total of 419 cases were identified from 19 reporting facilities through ECA and sent invitation letters; 18 cases were excluded due to physician contraindication, and 68 (16%) declined participation. All enrolled participants (N=54) completed baseline surveys. To date, 40 participants completed follow-up surveys after using the online matching tool. Most participants were White (80%), of higher income (>$150,000; 41%), and college-educated (70%). Thirty-seven percent indicated awareness of cancer clinical trials, 69% stated interest in participating in clinical research, and 72% held a positive attitude towards cancer clinical trials. However, 46% indicated they would not participate in a randomized study. To assess utility of the matching tool, 65% indicated it increased their interest in participating in a clinical trial. Conclusions: ECA needs to ensure sociodemographic data are available to make it useful as a tool for clinical trials. Preliminary results indicate ECA used in combination with an online clinical trial matching tool may serve as an important recruitment vehicle for prostate cancer clinical trials.