Faculty Bibliography

RATIONALE/BACKGROUND:During the coronavirus disease pandemic, audio-only and video telehealth visits became more widely available, but the relative patient satisfaction between telehealth and in-person modalities is not well-described. AIMS AND OBJECTIVES/OBJECTIVE:Our objective was to compare patient satisfaction with audio-only, video, and in-person adult primary care visits at a large, urban public healthcare system. METHODS:In this cross-sectional study, we used aggregated data from Press Ganey patient satisfaction surveys at 17 primary care facilities at New York City Health + Hospitals for visits between 1 June 2021 to 30 November 2021. We compared mean scores for questions common to surveys for each modality in domains of Access, Care Provider, and Overall Assessment using pairwise comparisons with two-tailed t-tests. RESULTS:There were 7,183/79,562 (9.0%) respondents for in-person visits and 1,009/15,092 (6.7%) respondents for telehealth visits. Compared to respondents for in-person visits, respondents for telehealth visits were more likely to be aged 35-64 years, Asian, and speak English as their primary language, and less likely to be ≥65 years old, Black or other race, and speak Spanish or another language as their primary language (p < 0.001). Patients reported higher mean satisfaction for Access measures for telehealth visits than in-person visits (p < 0.001). For Care Provider satisfaction questions, video visits generally had higher mean scores than in-person and, in turn, audio-only visits. For Overall Assessment questions, video visits had higher mean scores than in-person and, subsequently, audio-only visits. CONCLUSION/CONCLUSIONS:Of the visit modalities, video visits had the highest mean satisfaction scores across all domains. Telehealth may improve experiences with access, but audio-only visits may provide poorer visit experiences.

BACKGROUND/UNASSIGNED:Nonadherence to antihypertensive medications remains a persistent problem that leads to preventable morbidity and mortality. Behavioral economic strategies represent a novel way to improve antihypertensive medication adherence, but remain largely untested especially in vulnerable populations which stand to benefit the most. The Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP) was designed in this context, to test whether a digitally-enabled incentive lottery improves antihypertensive adherence and reduces systolic blood pressure (SBP). DESIGN/UNASSIGNED:BETTER-BP is a pragmatic randomized trial conducted within 3 safety-net clinics in New York City: Bellevue Hospital Center, Gouveneur Hospital Center, and NYU Family Health Centers - Park Slope. The trial will randomize 435 patients with poorly controlled hypertension and poor adherence (<80% days adherent) in a 2:1 ratio (intervention:control) to receive either an incentive lottery versus passive monitoring. The incentive lottery is delivered via short messaging service (SMS) text messages that are delivered based on (1) antihypertensive adherence tracked via a wireless electronic monitoring device, paired with (2) a probability of lottery winning with variable incentives and a regret component for nonadherence. The study intervention lasts for 6 months, and ambulatory systolic blood pressure (SBP) will be measured at both 6 and 12 months to evaluate immediate and durable lottery effects. CONCLUSIONS/UNASSIGNED:BETTER-BP will generate knowledge about whether an incentive lottery is effective in vulnerable populations to improve antihypertensive medication adherence. If successful, this could lead to the implementation of this novel strategy on a larger scale to improve outcomes.

Despite the many clerkship models of medical education, all can be considered a form of experiential learning. Experiential learning is a complex pedagogical approach involving the development of cognitive skills in an environment with a unique culture with multiple stakeholders, which may impact learner motivation, confidence, and other noncognitive drivers of success. Students may delay the transition to the clerkship year for myriad reasons, and the intricate nature of experiential learning suggested this may impact student performance. This retrospective, observational study investigated the impact of clerkship postponement by measuring subsequent clerkship performance. Pre-clerkship and third-year clerkship performance were analyzed for three cohorts of students (classes of 2018, 2019, and 2020, N = 274) where students had the option to delay the start of their clerkship year. A mixed analysis of variance (ANOVA) and paired t-tests were conducted to compare academic performance over time among students who did and did not delay. Across three cohorts of students, 12% delayed the start of the clerkship year (N = 33). Regardless of prior academic performance, these students experienced a significant reduction in clerkship grades compared to their non-delaying peers. Delaying the start of the clerkship year may have negative durable effects on future academic performance. This information should be kept in mind for student advisement.

BACKGROUND:Reducing unnecessary routine laboratory testing is a Choosing Wisely® recommendation, and new areas of overuse were noted during the COVID-19 pandemic. OBJECTIVE:To reduce unnecessary repetitive routine laboratory testing for patients with COVID-19 during the pandemic across a large safety net health system. DESIGNS, SETTINGS AND PARTICIPANTS/UNASSIGNED:This quality improvement initiative was initiated by the System High-Value Care Council at New York City Health + Hospitals (H + H), the largest public healthcare system in the United States consisting of 11 acute care hospitals. INTERVENTION/METHODS:four overused laboratory tests in noncritically ill hospitalized patients with COVID-19 were identified: C-reactive protein (CRP), ferritin, lactate dehydrogenase (LDH), and procalcitonin. A two-pronged electronic health record intervention was implemented consisting of (1) nonintrusive, informational nudge statements placed on selected order sets, and (2) a forcing function of one consecutive day limit on ordering. MAIN OUTCOME AND MEASURES/METHODS:The average of excess tests per encounter days (ETPED) for each of four target laboratory testing only in patients with COVID-19. OBJECTIVE:Interdisciplinary System High-Value Care Council identified four overused laboratory tests (inflammatory markers) in noncritically ill hospitalized patients with COVID-19: C-reactive protein (CRP), ferritin, lactate dehydrogenase (LDH), and procalcitonin. Within an 11-hospital safety net health system, a two-pronged electronic health record intervention was implemented consisting of (1) nonintrusive, informational nudge statements placed on selected order sets, and (2) a forcing function of one consecutive day limit on ordering. The preintervention period (March 16, 2020 to January 24, 2021) was compared to the postintervention period (January 25, 2021 to March 22, 2022). RESULTS:Time series linear regression showed decreases in CRP (-17.9%, p < .05), ferritin (-37.6%, p < .001), and LDH (-30.1%, p < .001). Slope differences were significant (CRP, ferritin, and LDH p < 0.001; procalcitonin p < 0.05). Decreases were observed across weekly averages: CRP (-19%, p < .01), ferritin (-37.9%, p < .001), LDH (-28.7%, p < .001), and procalcitonin (-18.4%, p < .05). CONCLUSION/CONCLUSIONS:This intervention was associated with reduced routine inflammatory marker testing in non-intensive care unit COVID-19 hospitalized patients across 11 hospitals. Variation was high among individual hospitals.

Objectives UpRi is a first-in-class NaPi2b ADC with a novel scaffold-linker-payload that enables high drug-to-antibody ratio and controlled bystander effect. NaPi2b is a sodium-dependent phosphate transporter protein broadly expressed in high-grade serous ovarian cancer (HGSOC), with limited expression in healthy tissues. Interim data from the Phase 1b expansion cohort of heavily pretreated patients with recurrent HGSOC has been reported. These data demonstrated clinically meaningful activity, notably in patients with NaPi2b-high tumors (TPS>=75). Effective and well-tolerated treatments for PROC remains an unmet medical need. The standard of care, singleagent chemotherapy, has limited efficacy, significant toxicities, and short duration of response. UPLIFT was designed as a single- arm Ph2 registrational trial for UpRi monotherapy in PROC. Methods UPLIFT is enrolling patients with PROC with up to 4 prior LoT. Prior bevacizumab is required for patients with 1-2 prior LoT only; it's not required for patients with 3-4 prior LoT. Patients may enroll regardless of NaPi2b expression; <= Grade 2 peripheral neuropathy is permitted. Primary platinum refractory patients are excluded. UPLIFT will enroll ~180 patients globally, including ~100 patients with high NaPi2b expression. UpRi is dosed IV at 36 mg/ m2 up to ~80 mg dose maximum Q4W. Baseline tumor samples (fresh or archived) will be collected for central analysis of NaPi2b expression. The primary endpoint is ORR in NaPi2b-high expressing patients. The cut-off for high NaPi2b expression is TPS>=75. Secondary endpoints include ORR in the overall population, duration of response, and safety. UPLIFT is conducted in collaboration with ENGOT (ENGOT-ov67) and GOG (GOG-3048). NCT03319628 Results trialinprogress Conclusions trialinprogress

Objectives GEN-1, an IL-12 DNA plasmid formulated with a synthetic carrier is being evaluated with neoadjuvant platinumtaxane chemotherapy (NACT) in patients with advanced epithelial ovarian cancer. OVATION 2 is a multi-center, randomized, open-label phase I/II study evaluating the safety, antitumor activity, and immunological response to GEN-1 at a dose of 100 mg/m2 intraperitoneal (IP) actively enrolling at 20 centers in USA and Canada. Methods Up to 130 patients will be randomized 1:1 to receive either NACT plus GEN-1 or NACT alone. The phase I portion will evaluate safety in at least 6 patients administered in 8 weekly infusions starting at cycle 1 week 2 in combination with three 21-day cycles of carboplatin AUC 6 with paclitaxel 175 mg/m2 (PC). Following interval cytoreductive surgery an additional 9 weekly GEN-1 IP infusions starting at cycle 4 week 1 with three 21-day cycles of PC. If no dose limiting toxicities are found, then the study will continue into the phase II portion. To evaluate biological activity a subgroup of patients will have tumor tissue at initial biopsy/laparoscopy collected and at interval cytoreductive surgery. Tissue will be analyzed for the density of CD8, FoxP3, IDO-1, PD-1, and PDL-1 cells. Blood, peritoneal fluid/wash will be collected before and after treatment in a subgroup of patients to quantify for levels of IFN-g. The primary endpoint is PFS. Results Trial in progress: there are no available results at the time of submission. Conclusions Trial in progress: there are no available conclusions at the time of submission

Background. In-vitro neutralizing antibody (Ab) titers correlated with ~250 IU/ mL Spike Ig Ab level for the Delta COVID-19 variant, establishing the 2021 French and Swiss cutoff for booster guidance. In a New York City healthcare clinic where those guidelines were adopted, we aimed to quantify vaccination responses in HIV + and HIV- individuals to assess the utility of quantifying antibodies to guide booster timing. Methods. Adults who were fully vaccinated against SARS-CoV-2 virus (i.e., 2 Pfizer, 2 Moderna or 1 J&J vaccine) were included if >1 Roche SARS-CoV-2 Semi-Quant Spike Ig Ab test was performed >21 days after vaccination and before any booster (through 03DEC2021). Vaccine response was assessed at the first Ab test and considered adequate (>250 IU/mL) or inadequate (low: >=51 to <=250 IU/ mL; no response: < 51 IU/mL). The rate of Ab decline was estimated with linear regression, using all sequential Ab tests over the first 6 months between vaccination and boosting. Analyses were stratified by vaccine type, HIV status and CD4 count in HIV+ ( >200 cells/muL cutoff). Results. Out of 1979 patients, 869 completed their primary vaccinations, of whom 825 (95%) had >=1 eligible Ab test (HIV+: 512; HIV-: 313; Table). Overall, 83% had an adequate immune response to vaccination (Pfizer: 82%, Moderna: 94%, J&J: 51%), with similar findings regardless of HIV status and CD4 count (Figure 1). In those with >=2 Ab tests within six months between vaccination and boosting, Ab levels declined at a rate of 91 IU/mL per month (95% CI: -138, -44). While some variation was observed, rates of Ab decay were generally consistent across vaccine, HIV status and CD4 count strata (Figure 2). Only 1/7 breakthrough COVID-19 infections occurred post booster (6 days later Conclusion. In the pre-omicron era, primary COVID immunization with a mRNA vaccine generally yielded adequate Ab responses, although inadequate responses were observed in 19% of Pfizer, 6% of Moderna, and 49% of J&J vaccine recipients. Ab levels decreased at an average rate of 91 IU/mL per month after primary immunization. Variability in vaccine responses and Ab declines show the utility of measuring spike Ig Ab levels rather than using empiric time frames for booster guidance. Omicron-specific quantitative IgG neutralization levels must be established to inform preventative care

Background. CAB+RPV LA is a complete regimen for treatment of virologically suppressed people with HIV (PWH). As an injectable therapeutic administered by a healthcare provider (HCP), CAB+RPV LA may alleviate challenges with adherence to daily oral therapy and reduce fear of HIV status disclosure with oral treatment. Real world perspectives from HCPs and PWH are needed to enable successful delivery of this treatment in US healthcare settings. Methods. BEYOND is a 2 year prospective, observational, real-world study of utilization, outcomes, and experience of PWH initiating CAB+RPV LA across 30 US sites. HCPs at participating sites (treaters, injectors, drug acquisition/reimbursement staff) completed surveys at site activation (Sep 2021-Feb 2022; with follow-up surveys planned at 6, 12, 24 months) evaluating experiences to date with implementation of CAB+RPV LA at their sites. Results. HCPs from 24 sites responded to the initial survey (Table 1). 75% ofHCPs estimated that >=25% of their PWH are eligible for CAB+RPV LA, and 71% of sites are proactively discussing the regimen with >=25% of PWH. The majority (79%) of treaters reported they were extremely/very positive about administering CAB+RPV LA. Over 90% of injectors reported a positive overall opinion about administering CAB+RPV LA, and 86% reported the injections were easy to administer.Most (87%) HCPs reported injection visits taking <=45 minutes, including waiting time. Over 95% of sites have patient reminder systems; 86% will manually identify missed injections and all reported manual follow up by site staff. All sites utilizing the injection education video on the external HCP website (n=15/15) found it helpful and 94% (n=16/17) utilizing reimbursement specialists found them to be helpful. In their experience to date, most clinics reported only needing to increase coordination with the pharmacy team and add injection training to implement CAB+RPV LA. The most frequently reported benefits of implementing CAB+RPV LAbyHCPs included assurance of patient adherence and patient engagement in their HIV treatment (Table 2). Conclusion. Early real-world data from US HCPs in this study indicates interest in and anticipated uptake of CAB+RPV LA at their sites, positive overall opinion, and multiple benefits of administering the CAB+RPV LA regimen to PWH