On the Front Lines: Meaningfully Connecting with Caregiver Participants to Mitigate Moral Distress among Clinical Research Staff

Background/Purpose: The COVID-19 pandemic exacerbated moral distress among psycho-oncology clinical research coordinators (CRCs). The current mental health crisis and lack of professional resources, paired with the intensity of CRC-participant communication and supportive nature of CRCs' roles on psychosocial trials, often evoke feelings of powerlessness and guilt among CRCs. However, CRC-participant communication (e.g., consent discussions, qualitative interviews) can also cultivate meaning and purpose for CRCs when vulnerable populations (e.g., cancer caregivers) share their gratitude for clinical trials and the efforts of the research team. This enhanced meaning may alleviate feelings of moral distress. The purpose of this presentation is to examine caregiver participants' appreciation and gratitude for research and discuss the potential avenues for reducing moral distress among CRCs. Method(s): This study was part of a larger RCT of Meaning-Centered Psychotherapy delivered to 60 adult caregivers of patients with Glioblastoma Multiforme who scored > 4 on the Distress Thermometer. A subset of 9 caregivers completed qualitative interviews with a CRC providing feedback on the trial, including perceptions of the initial approach process, which were transcribed and analyzed using an inductive thematic analytic approach. Result(s): All caregivers appreciated being approached for the trial, were grateful for the support CRCs offered, and the opportunity to help other caregivers. Additionally, caregivers shared the belief that psychosocial trials and resources should be offered to all caregivers at the time of diagnosis. This feedback enhances purpose among CRCs and serves as a reminder that their efforts produce meaningful change, which may reduce moral distress. Conclusions and Implications: Caregivers were grateful for the opportunity to participate in research and appreciated the efforts of the CRC. CRCs are uniquely positioned to be gateways for caregivers to receive needed support and acknowledgement which subsequently bolsters meaning and mitigates moral distress. Further research is needed to explore the relationship between moral distress and meaning among research staff.

Optimizing a team approach for successful accrual to and conduct of clinical trials in a community oncology practice

Background: Oncologists and advanced practice providers (APPs) routinely work as part of a team to provide quality cancer care in today's healthcare environment. However, this does not always translate into the realm of clinical research. It is estimated that only 2-8% of the adult oncology population enrolls in a clinical trial, with more than 20% of current trials failing to meet accrual goals. These numbers are projected to be even worse due to the impact of the COVID pandemic. Our Oncologist/APP team in conjunction with a clinical research coordinator (CRC) set out to develop a workflow to approach and offer clinical trials to patients in our practice with the goal of increasing clinical trial accrual and improving clinical trial conduct. Methods: Between 1/1/19-12/31/21, a community breast oncology focused practice in the Hawaii M/U NCORP implemented a plan with the goal to increase accrual to clinical trials. Building on the prior experience of both clinicians, the practice developed a comprehensive team approach between the Oncologist, APP, and CRC. This approach included four components: 1) Clinic workflow for clinical trial screening, introduction, and follow-up of potential participants;2) Shared clinical trial visits between MD & APP;3) Protocol reviews by MD who reviewed treatment protocols & APP who reviewed symptom management and cancer care delivery research (CCDR) protocols. All clinical trial reviews were discussed with CRC for coordination input;4) Protocol leadership between MD serving as local primary investigator (PI) on treatment trials, APP serving as local PI and/or site champion on symptom management and CCDR protocols. Results: From 2019- 2021, our practice was able to accrue over 23% of our patients to clinical trials in a community practice setting, despite the COVID-19 Pandemic. Of the 149 unique accruals during this period, 59% of accruals were interventional trials and 41% were observational trials. Clinical trial accrual was racially diverse and mirrored the patient population. During this period, there were minimal protocol deviations observed based on review of shadow charts on this group of clinical trial patients. Conclusions: Through this team approach, our practice has been successful in having a high rate of clinical trial accrual while maintaining excellent clinical trial conduct even during the pandemic. We believe our team approach that utilizes the APP to the full scope of practice along with CRC empowerment in addition to the engaged oncologist is key to our success. Oncology practices and healthcare systems must value and engage all potential members of the team to maximize their clinical trial ability and to continue to offer/ enroll patients in clinical trials as the standard of care.

RESPONDING TO THE COVID CHALLENGE: EVALUATING A NEW METHOD OF ADVERSE EVENT RECORDING IN RESPONSE TO REMOTE WORKING

BACKGROUND: The SARS-COV2 pandemic had huge impact on how clinical research is conducted when clinical research coordinators (CRC) transitioned to working remotely. An urgent transition of paper documentation into electronic formats had to occur without compromising participant safety or data integrity. Adverse event (AE) reporting had previously been captured in various paper formats with wet signature. AEs, attribution, severity, and clinical significance had to be changed into being electronically captured and incorporated into the medical record that captures the events in real time. METHOD: We assessed the satisfaction of the new method of AE recording amongst pediatric hematology oncology physicians and staff in a large academic institution during the COVID pandemic through a REDCap survey. The survey assessed the time, effort, perceived efficacy and overall acceptability of the paper-based and electronic methods of AE documentation. RESULTS: Seventy-one staff members were surveyed. Fifty (65%) responded, including 6 participants who were not involved in the AE reporting process and did not complete the survey. Of the remaining 44 participants, 43 (98%) preferred an electronic documentation method. Secondary results and further analysis will be presented at the meeting. CONCLUSIONS: The COVID pandemic has changed how CRC report AEs and electronic documentation seems to be the preferred method of documentation.

Research ready: Strategies for successful implementation of research in clinical settings

Through our experience implementing pragmatic studies, the Louisiana Public Health Institute recognized clinic support staff as unique stakeholders in clinicbased research whose role in study implementation is often overlooked. Our project, Research Ready, aimed to find innovative ways to engage staff in the design and implementation of research studies. Specifically, the project team designed, piloted, and disseminated materials to improve clinic staff capacity to partner in research. During this pandemic, reliance on clinical staff for study adherence is critical. COVID-related research has been rapidly implemented, which relies upon having well-prepared staff to handle the rapid implementation of new protocols. The team developed and piloted two tools for improving staff engagement in research activities: a training for clinic support staff and a guide for researchers. The staff training was developed to inform clinic staff, such as medical assistants and nurses, about basic research principles and considerations for supporting the implementation of research in a clinical setting. The training is available in three formats: e-learning, facilitated session, and self-guided workbook. The researcher guide was created to share insights and best practices for engaging and partnering with clinic staff to successfully implement pragmatic research. Both resources are available on Louisiana Public Health Institute's website. The Research Ready resources were informed by interviews conducted with clinic support staff and researchers (including principal investigators, study managers, and clinical research coordinators) who had implemented studies in outpatient settings. Clinic staff from a variety of settings were interviewed, including Federally Qualified Health Centers, private healthcare systems, and academic medical centers. Research staff were either affiliated with academic institutions or clinical research firms. Major themes identified in the key-informant interviews include (1) clinic staff play key roles in implementing research: they are gatekeepers of clinic workflow and brokers of patient trust;(2) clinic staff lack knowledge about research and the research process, which is a barrier to implementing studies in clinic settings;(3) communication and relationship-building are important facilitators for researchers seeking to work with clinical staff;(4) clinic staff prioritize the care and wellbeing of their patients, which can be both a barrier and a facilitator of clinic-based research. The training was piloted in three sites with a total of 52 participants. Participants were surveyed after completing the training. Survey results showed that participants thought the training was easy to understand and increased their knowledge about research. Results also showed that participants felt the information from their training was applicable to their jobs. As more research is conducted in clinic settings, researchers and clinic staff will benefit from best practices to assure a mutual understanding of research objectives and processes. Identifying strategies for successful implementation of research in clinical settings will enhance the conduct of pragmatic research and allow it to equitably reach patients in diverse outpatient care settings. Using the Research Ready materials, researchers can ensure that clinic staff have adequate understanding of research principles and that staff concerns about time and competing priorities are addressed and accounted for in study workflows.

Adaptive COVID-19 treatment trial data management: ensuring success in a constantly-evolving, highdemand pandemic environment

Remdesivir (GS-5734) was identified as a promising therapeutic candidate for COVID-19, at a time when no therapeutic agents had shown to be efficacious for the treatment of coronavirus disease 2019 (COVID-19). A series of rapid randomized, double-blind, placebocontrolled Adaptive COVID-19 Treatment Trials were developed, all written into one Protocol document, to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID- 19. The first study (ACTT-1) was a multi-center trial conducted in 73 sites globally (N = 1062), that demonstrated remdesivir shortened the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection. This presentation focuses on the unique challenges presented by the high-profile Adaptive COVID-19 Treatment Trial and how the data management team ensures its success in this pandemic environment. Typically, a data management team may take several weeks or months to design and build a database upon receipt of a new protocol but due to the high priority of the Adaptive COVID-19 Treatment Trial study, the database was initially built in 2 days. Having such a short turnaround time meant the team had to focus on critical items such as randomization and forms that collected data related to safety signals. Flexibility was also important since study sites were being identified and activated on a rolling basis, and many were international which meant various formatting differences, specifically with laboratory results. For both internal and external stakeholders to ensure proper communication and organization, it was crucial to maintain a proper balance of collaboration yet still identifying clear leaders of functional groups to avoid having ''too many cooks in the kitchen.'' Scheduling frequent meetings and utilizing collaboration software, rather than relying on email communication, helped all parties to brainstorm and resolve issues efficiently. The Adaptive COVID-19 Treatment Trial was divided into multiple stages (called ACTTs) where each new Adaptive COVID-19 Treatment Trial introduced a different therapeutic combination. Each Adaptive COVID-19 Treatment Trial was designed to enroll over 1000 trial participants across 100+ sites, and it was not uncommon for the stages to overlap, creating many challenges with data management. Data queries were often sent to sites weekly or even multiple times a week, and data managers would go above and beyond by working nights and weekends to accommodate the high workload and shortened timeframe. Safety and endpoint data were the top priority during data cleaning and the volume of queries was not just a challenge for the data management team but also for the sites that had to juggle the trial in addition to clinically managing their COVID patients who had a brand new disease. Meeting deadlines was essential but doing so at the expense of the cleanliness of the data was not an acceptable option, so new processes had to be implemented in order to avoid this from occurring. It was also critical to be ''audit-ready'' at all times due to the high-profile nature of the study, so an internal team was dedicated to ensuring that all documentation was present and complete throughout the course of the study. Mock audits were held so that issues could be resolved a Food and Drug Administration audit. In this presentation, four speakers will introduce the study in more detail and demonstrate how being more adaptable and communicative enabled the data management team, in collaboration with the other study stakeholders, to successfully manage the trial. Each presentation will last approximately 20 min and they are listed below in more detail and in chronological order. The remaining 10 min will be devoted to a question and answer session with audience members. National Institutes of Health Clinical Project Manager Ms Nomicos is a Clinical Project Manager at the National Institute of Allergy and Infectious Disease who, along with several other Clinical Project Managers, was respons ble for general oversight of study conduct and contractors on the Adaptive COVID-19 Treatment Trial. Ms Nomicos will introduce the ACCT trial and provide some background information, as well as briefly explain the study objectives, design, and procedures. Ashley Bowersox, MPH (Emmes) Ms Bowersox is a Senior Data Manager in the Vaccine and Infectious Diseases group, supporting the Clinical and Epidemiological Studies in Infectious Diseases. She served as the Forms Design Lead and DM Project Manager on the Adaptive COVID-19 Treatment Trial. Ms Bowersox will discuss database design considerations and in particular the need to build the database with flexibility to accommodate rolling identification and activation of study sites as well as attention to the unique needs of the international sites participating in the study. Ashley Wegel, CCRA, MEd (Emmes) Ms Wegel is an Associate Project Leader in the Vaccine and Infectious Diseases group, supporting the Clinical and Epidemiological Studies in Infectious Diseases. She served as the Forms Design Lead and DM Project Manager on the Adaptive COVID-19 Treatment Trial. Ms Wegel will present site management and data management strategies for meeting incredibly demanding database freeze and lock timelines required by sponsor to support safety reviews and publications and continuously improve upon forms design and interface for each new stage. Kelly Clark (Duke Human Vaccine Institute) Ms Clark is a Clinical Research Coordinator in the Duke Vaccine Trials Unit at the Duke Human Vaccine Institute, one of the enrolling sites on Adaptive COVID-19 Treatment Trial. Ms Clark will discuss the challenges of working on a rapid study with tight timelines, requiring quick responses to a large volume of research data queries, while clinically managing their COVID patients who had an unfamiliar and daunting new disease.

Strengthening the clinical research workforce through a competency-based orientation program: Process outcomes and lessons learned across three academic health institutions.

Clinical research coordinators are increasingly tasked with a multitude of complex study activities critical to scientific rigor and participant safety, though more than half report not receiving appropriate training. To determine the reproducibility of an established clinical research workforce orientation program, collaborative partners across Clinical and Translational Science Award institutions seeded core principles and structure from Mayo Clinic's Clinical Research Orientation program within Penn State University and the University of Mississippi Medical Center from 2019 to 2021. Training concepts were established and tied to those domains deemed critical by the Joint Task Force for Clinical Trial Competency for the conduct of clinical research at the highest levels of safety and quality possible. Significant knowledge and confidence gains and high overall program satisfaction were reported across participants and partner sites, despite programs being required to pivot from traditional, in-person formats to entirely virtual platforms as a result of the COVID-19 pandemic. The successful standardization and translation of foundational clinical research training has important efficiency and efficacy implications for research enterprises across the USA.

Virtual coordinator and site training and reorganization of a multisite consortium upon grant renewal: Challenges of the NeuroNEXT network.

The COVID-19 pandemic abruptly forced changes in how to conduct multicenter clinical research. Gone were the days of face-to-face meetings and working together in person. Virtual teams became the norm rather than exception. The Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT: NN) was created with a vision to conduct studies in neurological diseases through partnership with academia, private foundations and industry. 1 A fundamental aspect of the establishment and maintenance of this network was and is the NeuroNEXT virtual coordinator network. We found ourselves well-prepared for methods required of the pandemic because of our prior experience.