Few studies have explored the challenges that the COVID-19 pandemic has presented for Clinical Research Units (CRUs), the solutions that have been implemented, and the changes that have been made in the operational guidelines for these entities. This study sought to identify and document common practices implemented by CRUs around the United States of America (USA) when addressing the unique challenges posed by the COVID-19 pandemic. This descriptive study utilized a non-experimental mixed-methods approach and gathered data from representatives of 43 CRUs across the USA. An online survey was followed by in-depth interviews. The findings show that challenges faced from the COVID-19 pandemic, changes made to daily operations, and lessons learned are very similar across CRUs. Although most CRUs never stopped performing essential clinical research, many adapted to the pandemic by engaging in virtual visits, and many played key roles in administering and supporting both COVID-19 therapeutic and vaccine trials. Follow-up interviews showed that processes for formal approval and reopening were similar across CRUs. In addition to highlighting the significance of the role played by CRUs during the COVID-19 pandemic, this study addresses the relevance of CRUs and lays the groundwork for future conversations on the importance of these units.

Post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (PASC) is a complex condition with multisystem involvement. We assessed patients’ experience with a PASC clinic established at University of Iowa in June 2020. A survey was electronically mailed in June 2021 asking about (1) symptoms and their impact on functional domains using the Patient-Reported Outcomes Measurement Information System (PROMIS) measures (Global Health and Cognitive Function Abilities) (2) satisfaction with clinic services, referrals, barriers to care, and recommended support resources. Survey completion rate was 35% (97/277). Majority were women (67%), Caucasian (93%), and were not hospitalized (76%) during acute COVID-19. As many as 50% reported wait time between 1 and 3 months, 40% traveled >1 h for an appointment and referred to various subspecialities. Participants reported high symptom burden-fatigue (77%), “brain fog” (73%), exercise intolerance (73%), anxiety (63%), sleep difficulties (56%) and depression (44%). On PROMIS measures, some patients scored significantly low (≥1.5 SD below mean) in physical (22.7%), mental (15.9%), and cognitive (17.6%) domains. Approximately 61% to 93% of participants were satisfied with clinical services. Qualitative analysis added insight to their experience with healthcare. Participants suggested potential strategies for optimizing recovery, including continuity of care, a co-located multispecialty clinic, and receiving timely information from emerging research. Participants appreciated that physicians validated their symptoms and provided continuity of care and access to specialists.

PurposePost-acute sequelae of SARS-CoV-2 (PASC) is a complex condition with multisystem involvement. We assessed patients’ perspectives and experience with a PASC clinic established at University of Iowa in June 2020.MethodsWe conducted a mixed-method survey in June 2021 to ask PASC clinic patients about 1) PASC symptoms and their impact on physical and mental health, and cognition using the PROMIS Global Health and Cognitive Function abilities items, and 2) satisfaction with clinic services and referrals, barriers to care, and recommended support resources.FindingsNinety-seven patients (97/277, 35% response rate) completed the survey. Most were women (67%, n=65/97), Caucasian (93%, n=90/97) and received outpatient care during acute COVID-19 illness (79%). Fifty percent reported wait time of 1-3 months and 40% traveled >1 hour for appointment. The most common symptoms >3 months from initial infection were fatigue (77%), “brain fog” (73%), exercise intolerance (73%), anxiety (63%), sleep difficulties (56%) and depression (44%). Qualitative analysis of open-ended answers added valuable context to quantitative results. A minority of patients reported significantly reduced functioning (≥1.5 SD below mean) of their physical health (22.5%), mental health (15.9%) and cognitive abilities (17.6%). Satisfaction with clinical services was high though participants identified barriers to care including scheduling delays and financial concerns. Respondents suggested potential strategies for optimizing recovery including continuity of care, a co-located multispecialty clinic and being provided with timely information from emerging research.ConclusionOur study reports high PASC symptom burden, its impact on health and patient experience with healthcare. It is important that primary healthcare professionals listen to patients with empathy and support them during recovery. Healthcare systems and policymakers should focus on accessible, comprehensive, and patient-centered integrated care.

OBJECTIVES/GOALS: CTRUs support clinical research. RUN is a Learning Research System that is created to enhance CTSA and non-CTSA research units capacity through implementing, assessing, and disseminating discoveries in methods, approaches, education, and training in clinical and translational science. METHODS/STUDY POPULATION: The RUN association began in July 2018 with eight universities. The association has grown to 44 hospitals, research, and academic institutions (including 36 CTSA institutions). A RUN Discussion Forum has been approved by the National Center for Advancing Science (NCATS) and utilized by RUN. The Discussion Forums are created with the goal of advancing CTSA Program objectives in high priority areas of clinical and translational science. RUN actively engages members through in depth scheduled monthly meeting discussions with various relevant topics regarding the development and evaluation of clinical trials metrics, benchmarks, and scholarly publication and presentation activities. RESULTS/ANTICIPATED RESULTS: Topics covered in RUN monthly meetings include research units general budget guidelines, staff recruitment and retainment strategies, EPIC use in scheduling CRU research visits, and PPE for investigational drugs in context of USP800 requirements. RUN members vary in geographic location, type of clinical research (outpatient vs inpatient), resources, and research subject volume. They are engaged in online discussion and learning opportunities to improve translational science practices. A recent article titled “Impact of COVID-19 on Clinical Research Units (CRUs)” in JCTS is an example of best practices learned by RUN members and shared with the broader research community. DISCUSSION/SIGNIFICANCE: RUN as a Learning Research System enhances clinical and translational research unit capacity and efficiency, encouraging collaboration to contribute with improving public health. This network is aligned with the CTSAs mission of developing innovative solutions to improve translational science.

OBJECTIVES/GOALS: The RPPR Tool was created to accurately and systematically track our CTSA’s overall program goals and core’s progress in real time. It establishes and centralizes the continuous collection of key performance indicators and fosters accountability and transparency among cores and leadership. METHODS/STUDY POPULATION: Using the University of Chicago’s Annual Progress Report REDCap data dictionary, UI Institute for Clinical and Translational Science (ICTS) core managers convened to explore the adaptability of the reporting format for the CTSA. The team developed the more user friendly and easily accessible RPPR Reporting Tool using REDCap to better fit our CTSA. The RPPR in REDCap provides a central location to monitor the activities for each core, gather status updates, generate performance reports, and identify key performance indicators and challenges to prevent failures in the future. All data are transparent and accessible on-demand to individual core managers, evaluators, and ICTS leadership. RESULTS/ANTICIPATED RESULTS: UI’s RPPR Tool has improved the compliance with ongoing monitoring and reporting of CTSA program’s performance. Documenting all relevant information in a centralized space has eased the administrative and evaluation burden of preparing the RPPR. Furthermore, REDCap as a commonly used tool allows the core managers to complete this reporting with minimal guidance. This tool encourages each core to be accountable for documenting their respective progress. The transparency of the reporting allows the Co-PIs along with the leadership team to access the data at any given time to stay updated on the ICTS’ overall progress and to make the appropriate improvements as needed. DISCUSSION/SIGNIFICANCE OF IMPACT: The RPPR is a required component of all CTSA grants. UI’s RPPR Tool has been instrumental in comprehensively tracking progress of the ICTS and its contributions to translational research. UI is collaborating with CTSA peers to improve the RPPR Tool, so it can become an asset for any CTSA to adapt.