Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions-A report from the "Health Equity through Diversity" seminar series.

INTRODUCTION: In recent years, there has been increasing awareness of the lack of diversity among clinical trial participants. Equitable representation is key when testing novel therapeutic and non-therapeutic interventions to ensure safety and efficacy across populations. Unfortunately, in the United States (US), racial and ethnic minority populations continue to be underrepresented in clinical trials compared to their White counterparts. METHODS: Two webinars in a four-part series, titled "Health Equity through Diversity," were held to discuss solutions for advancing health equity through diversifying clinical trials and addressing medical mistrust in communities. Each webinar was 1.5 hours long, beginning with panelist discussions followed by breakout rooms where moderators led discussions related to health equity and scribes recorded each room's conversations. The diverse groups of panelists included community members, civic representatives, clinician-scientists, and biopharmaceutical representatives. Scribe notes from discussions were collected and thematically analyzed to uncover the central themes. RESULTS: The first two webinars were attended by 242 and 205 individuals, respectively. The attendees represented 25 US states, four countries outside the US, and shared various backgrounds including community members, clinician/researchers, government organizations, biotechnology/biopharmaceutical professionals, and others. Barriers to clinical trial participation are broadly grouped into the themes of access, awareness, discrimination and racism, and workforce diversity. Participants noted that innovative, community-engaged, co-designed solutions are essential. CONCLUSIONS: Despite racial and ethnic minority groups making up nearly half of the US population, underrepresentation in clinical trials remains a critical challenge. The community engaged co-developed solutions detailed in this report to address access, awareness, discrimination and racism, and workforce diversity are critical to advancing clinical trial diversity.

Influence of Literacy, Self-Efficacy, and Social Support on Diabetes-Related Outcomes Following Hospital Discharge.

Objective: To evaluate the relationship between health literacy, social support, and self-efficacy as predictors of change in A1c and readmission among hospitalized patients with type 2 diabetes (T2D). Methods: This is a secondary analysis of patients with T2D (A1c >8.5%) enrolled in a randomized trial in which health literacy (Newest Vital Sign), social support (Multidimensional Scale of Perceived Social Support), and empowerment (Diabetes Empowerment Scale-Short Form) was assessed at baseline. Multivariable models evaluated whether these concepts were associated with A1c reduction at 12 weeks (absolute change, % with >1% reduction, % reaching individualized target) and readmission (14 and 30 days). Results: A1c (N=108) decreased >1% in 60%, while individualized A1c target was achieved in 31%. After adjustment for baseline A1c and potential confounders, health literacy was associated with significant reduction in A1c (Estimate -0.21, 95% CI -0.40, -0.01, p=0.041) and >1% decrease in A1c (OR 1.37, 95% CI 1.08, 1.73, p=0.009). However, higher social support was associated with greater adjusted odds of reaching the individualized A1c target (OR 1.63, 95% CI 1.04, 2.55, p=0.32). Both higher empowerment (OR 0.23, 95% CI 0.08, 0.64, p=0.005) and social support (OR 0.57, 95% CI 0.36, 0.91, p=0.018) were associated with fewer readmissions by 14 days, but not 30 days. Conclusion: The study indicates that health literacy and social support may be important predictors of A1c reduction post-discharge among hospitalized patients with T2D. Social support and diabetes self-management skills should be addressed and early follow-up may be critical for avoiding readmissions. Clinical Trial: NCT03455985.

Effectiveness of a Diabetes-Focused Electronic Discharge Order Set and Postdischarge Nursing Support Among Poorly Controlled Hospitalized Patients: Randomized Controlled Trial.

BACKGROUND: Although the use of electronic order sets has become standard practice for inpatient diabetes management, there is limited decision support at discharge. OBJECTIVE: In this study, we assessed whether an electronic discharge order set (DOS) plus nurse follow-up calls improve discharge orders and postdischarge outcomes among hospitalized patients with type 2 diabetes mellitus. METHODS: This was a randomized, open-label, single center study that compared an electronic DOS and nurse phone calls to enhanced standard care (ESC) in hospitalized insulin-requiring patients with type 2 diabetes mellitus. The primary outcome was change in glycated hemoglobin (HbA1c) level at 24 weeks after discharge. The secondary outcomes included the completeness and accuracy of discharge prescriptions related to diabetes. RESULTS: This study was stopped early because of feasibility concerns related to the long-term follow-up. However, 158 participants were enrolled (DOS: n=82; ESC: n=76), of whom 155 had discharge data. The DOS group had a greater frequency of prescriptions for bolus insulin (78% vs 44%; P=.01), needles or syringes (95% vs 63%; P=.03), and glucometers (86% vs 36%; P<.001). The clarity of the orders was similar. HbA1c data were available for 54 participants in each arm at 12 weeks and for 44 and 45 participants in the DOS and ESC arms, respectively, at 24 weeks. The unadjusted difference in change in HbA1c level (DOS - ESC) was -0.6% (SD 0.4%; P=.18) at 12 weeks and -1.1% (SD 0.4%; P=.01) at 24 weeks. The adjusted difference in change in HbA1c level was -0.5% (SD 0.4%; P=.20) at 12 weeks and -0.7% (SD 0.4%; P=.09) at 24 weeks. The achievement of the individualized HbA1c target was greater in the DOS group at 12 weeks but not at 24 weeks. CONCLUSIONS: An intervention that included a DOS plus a postdischarge nurse phone call resulted in more complete discharge prescriptions. The assessment of postdischarge outcomes was limited, owing to the loss of the long-term follow-up, but it suggested a possible benefit in glucose control. TRIAL REGISTRATION: ClinicalTrials.gov NCT03455985; https://clinicaltrials.gov/ct2/show/NCT03455985.

Uncovering Susceptibility Risk to Online Deception in Aging.

OBJECTIVES: Fraud in the aged is an emerging public health problem. An increasingly common form of deception is conducted online. However, identification of cognitive and socioemotional risk factors has not been undertaken yet. In this endeavor, this study extended previous work suggesting age effects on susceptibility to online deception. METHODS: Susceptibility was operationalized as clicking on the link in simulated spear-phishing emails that young (18-37 years), young-old (62-74 years), and middle-old (75-89 years) Internet users received, without knowing that the emails were part of the study. Participants also indicated for a set of spear-phishing emails how likely they would click on the embedded link (susceptibility awareness) and completed cognitive and socioemotional measures to determine susceptibility risk profiles. RESULTS: Higher susceptibility was associated with lower short-term episodic memory in middle-old users and with lower positive affect in young-old and middle-old users. Greater susceptibility awareness was associated with better verbal fluency in middle-old users and with greater positive affect in young and middle-old users. DISCUSSION: Short-term memory, verbal fluency, and positive affect in middle-old age may contribute to resilience against online spear-phishing attacks. These results inform mechanisms of online fraud susceptibility and real-life decision-supportive interventions toward fraud risk reduction in aging.

Design and rationale of the high-sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial.

BACKGROUND: Acute heart failure (AHF) is a common presentation in the Emergency Department (ED), and most patients are admitted to the hospital. Identification of patients with AHF who have a low risk of adverse events and are suitable for discharge from the ED is difficult, and an objective tool would be useful. METHODS: The highly sensitive Troponin T Rules Out Acute Cardiac Insufficiency Trial (TACIT) will enroll ED patients being treated for AHF. Patients will undergo standard ED evaluation and treatment. High-sensitivity troponin T (hsTnT) will be drawn at the time of enrollment and 3 hours after the initial draw. The initial hsTnT draw will be no more than 3 hours after initiation of therapy for AHF (vasodilator, loop diuretic, noninvasive ventilation). Treating clinicians will be blinded to hsTnT results. We will assess whether hsTnT, as a single measurement or in series, can accurately predict patients at low risk of short-term adverse events. CONCLUSION: TACIT will explore the value of hsTnT measurements in isolation, or in combination with other markers of disease severity, for the identification of ED patients with AHF who are at low risk of short-term adverse events.

Developing a standardized measurement of alcohol intoxication.

INTRODUCTION: We assessed multiple examinations and assessment tools to develop a standardized measurement of alcohol intoxication to aid medical decision making in the Emergency Department. METHODS: Volunteers underwent an alcohol challenge. Pre- and post-alcohol challenge, subjects were videotaped performing three standardized clinical examinations: (1) Standardized Field Sobriety Test (SFST) examination, (2) Hack's Impairment Index (HII) examination, and (3) Cincinnati Intoxication Examination (CIE). Emergency clinicians evaluated the level of intoxication using five standardized assessment tools in a blinded and randomized fashion: (1) SFST assessment tool (range 0-18), (2) HII assessment tool (range 0-1), (3) St. Elizabeth Alcohol Intoxication Scale (STE, range 0-17), (4) a Visual Analog Scale (VAS, range 0-100), and (5) a Binary Intoxication Question (BIQ). Construct validity was assessed along with inter- and intra-rater reliability. RESULTS: Median scores pre- and post-alcohol challenge were: SFST 6 (interquartile range 5) and 11 (3), respectively; HII 0 (0.05), 0.1 (0.1); STE 0 (1), 1 (2); VAS 10 (22), 33 (31). For BIQ, 59% and 91% indicated intoxication, respectively. Inter-rater reliability scores were: SFST 0.71 (95% confidence interval 0.48-0.86) to 0.93 (0.88-0.97) depending on examination component; HII 0.90 (0.82-0.95); STE 0.86 (0.75-0.93); VAS 0.92 (0.88-0.94); BIQ 0.3. Intra-rater reliability scores were: SFST 0.74 (0.64-0.82) to 0.87 (0.81-0.91); HII 0.85 (0.79-0.90); STE 0.78 (0.68-0.85); VAS 0.82 (0.74-0.87); BIQ 0.71. VAS reliability was best when paired with the HII and SFST examinations. CONCLUSIONS: HII examination, paired with either a VAS or HII assessment tool, yielded valid and reliable measurements of alcohol intoxication.