Clinical Trial Facilitators: A Novel Approach to Support the Execution of Clinical Research at the Study Site Level

In the summer of 2020, there were multiple efforts to establish safe and effective vaccines that would combat the spread of COVID-19. Efforts to eradicate the virus in the United States included Operation Warp Speed (OWS) which was a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD), and the private sector, that aimed to help accelerate control of the COVID-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. As the nation's largest integrated healthcare system, the US Department of Veterans Affairs (VA) was identified as a potential collaborator in several large-scale OWS Phase III clinical trial efforts designed to evaluate the safety and efficacy of various vaccines in development. Given the national (and global) importance of these trials, it was recognized that there would be a need for a coordinated, centralized effort within VA to ensure that its medical centers (sites) would be ready and able to efficiently initiate, recruit, and enroll into these OWS COVID-19 vaccine trials. To accomplish this mission, two groups within the VA Office of Research and Development (ORD) partnered to manage and provide support to these sites and facilitate their execution of these trials. The Partnered Research Program (PRP) is a division of VA ORD that is dedicated to developing partnerships that enhance Veterans' access to high-quality, multi-site clinical trials. PRP has an overall goal of establishing long-term relationships with external organizations that are committed to Veterans' health and VA's clinical research mission. The VA Cooperative Studies Program (CSP) is a clinical research infrastructure embedded within the VA healthcare system. CSP is also a division of the VA ORD and was established to provide coordination for, and enable cooperation on, multi-site clinical trials and epidemiological studies that fall within the purview of VA. Its infrastructure comprises a number of Coordinating Centers that are responsible for the planning and conduct of large multi-site clinical trials in the VA healthcare system. CSP also established a consortium of 10 VA medical centers (VAMCs) called the Network of Dedicated Enrollment Sites (NODES) that have teams (nodes) to provide site-level expertise and innovative approaches in addressing challenges to clinical trial execution. This (poster) outlines the partnership and activities undertaken by VA's PRP and CSP NODES groups to manage and support a large-scale OWS Phase III multi-site clinical trial. It focuses specifically on the determination to designate clinical trial facilitators to study sites, the important role that they played in getting this trial initiated at those sites in a timely fashion, and their work to ensure successful study enrollment.

Controllability is key: Goal pursuit during COVID‐19 and insights for theories of self‐regulation

The COVID‐19 pandemic has been an unprecedented public health emergency with wide‐ranging psychological impacts. The resulting uncertainty surrounding employment, finance, and health could impact how individuals think about and pursue their personal goals. Specifically, we anticipated that pandemic‐related goals would be perceived as less controllable, presenting a unique opportunity to test effects of controllability on self‐regulation. We elicited spontaneous self‐regulatory thought (SRT) data for personal goals related and unrelated to COVID‐19, predicting that (A) the relative prevalence of different SRT modes (e.g., dwelling, indulging, mental contrasting) would differ between COVID‐related and unrelated goals;and (B) the typical motivational benefit of mental contrasting (i.e., considering a desired outcome followed by present obstacles) would be attenuated for COVID‐related goals. As anticipated, UK‐resident adults (n = 288) judged COVID‐related goals such as keeping one's family safe to be less controllable compared to unrelated goals, and tended to engage different SRT modes (e.g., higher incidence of dwelling vs. indulging). Mental contrasting occurred equally for both goal types, but when predicting goal commitment, its typical beneficial effect was absent for COVID‐related goals. Results are consistent with the proposition that low subjective control influences both the cognitive processing of goals (i.e., promoting dwelling) and subsequent motivational outcomes. This poses a challenge to current theory, calling for greater emphasis on controllability as a contributing factor in self‐regulation and goal pursuit. [ FROM AUTHOR] Copyright of Journal of Applied Social Psychology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Assessment of a novel marker of ICU strain, the ICU Activity Index, during the COVID-19 pandemic in Victoria, Australia

Objectives: To validate a real-time Intensive Care Unit (ICU) Activity Index as a marker of ICU strain from daily data available from the Critical Health Resource Information System (CHRIS), and to investigate the association between this Index and the need to transfer critically ill patients during the coronavirus disease 2019 (COVID-19) pandemic in Victoria, Australia. Design: Retrospective observational cohort study. Setting: All 45 hospitals with an ICU in Victoria, Australia. Participants: Patients in all Victorian ICUs and all critically ill patients transferred between Victorian hospitals from 27 June to 6 September 2020. Main outcome measure: Acute interhospital transfer of one or more critically ill patients per day from one site to an ICU in another hospital. Results: 150 patients were transported over 61 days from 29 hospitals (64%). ICU Activity Index scores were higher on days when critical care transfers occurred (median, 1.0 [IQR, 0.4-1.7] v 0.6 [IQR, 0.3-1.2];P < 0.001). Transfers were more common on days of higher ICU occupancy, higher numbers of ventilated or COVID-19 patients, and when more critical care staff were unavailable. The highest ICU Activity Index scores were observed at hospitals in northwestern Melbourne, where the COVID-19 disease burden was greatest. After adjusting for confounding factors, including occupancy and lack of available ICU staff, a rising ICU Activity Index score was associated with an increased risk of a critical care transfer (odds ratio, 4.10;95% CI, 2.34-7.18;P < 0.001). Conclusions: The ICU Activity Index appeared to be a valid marker of ICU strain during the COVID-19 pandemic. It may be useful as a real-time clinical indicator of ICU activity and predict the need for redistribution of critical ill patients.