Improving quality and efficiency of translational research: Environmental scan of adaptive capacity and preparedness of Clinical and Translational Science Award Program hubs.

Translational science is, by definition, groundbreaking; however, without an emphasis on quality and efficiency, some innovations in healthcare may translate into unnecessary risk, suboptimal solutions, and potentially loss of well-being and even lives. The COVID-19 pandemic and the Clinical and Translational Sciences Award Consortium's response created an opportunity for quality and efficiency to be better defined, expediently and thoughtfully addressed, and further studied as central foundations in the translational science mission. This paper presents findings of an environmental scan of adaptive capacity and preparedness to illuminate the assets, institutional environment, knowledge, and forward-looking decision-making needed to optimize and sustain research quality and efficiency.

Symptoms of Anxiety, Depression, and Stress among Families of Critically Ill Patients with COVID-19: A Longitudinal Clinical Trial.

Rationale: Families of critically ill patients with coronavirus disease (COVID-19) may be at particularly high risk for anxiety, depression, and post-traumatic stress disorder after hospital discharge. Objectives: To assess symptoms of anxiety, depression, and stress among families of patients with COVID-19 during and after intensive care unit (ICU) admissions and to use qualitative methods to determine the sources of emotional distress. Methods: Families of patients with COVID-19 who participated in an ICU study were approached for participation in this post-hospital discharge study. Participants completed the Hospital Anxiety and Depression Scale (HADS) and the Impact of Events Scale-Revised (IES-R) at up to three points during the ICU stay and once after the ICU stay. Mixed-effects models were used to compare trajectories of HADS and IES-R scores over the ICU and post-ICU periods. Telephone interviews with participants were evaluated using thematic content analysis. Results: Among the 90 families that participated from September 2020 to April 2021, 47 respective patients were alive and 43 were deceased. Average HADS anxiety, HADS depression, and IES-R scores after hospital discharge were significantly higher (greater symptom burden) among families of deceased versus surviving patients: 9.2 (95% confidence interval [CI], 7.8-10.6) versus 6.3 (95% CI, 4.9-7.6) (P < 0.01), 7.1 (95% CI, 5.7-8.6) versus 3.2 (95% CI, 2.3-4.1) (P < 0.001), and 36.1 (95% CI, 31.0-41.2) versus 20.4 (95% CI, 16.1-24.8) (P < 0.001), respectively. HADS anxiety and HADS depression scores began to diverge during the ICU stay, whereas IES-R scores diverged after the stay for families of surviving versus deceased patients. Qualitative analysis confirmed a higher burden of psychological symptoms among families of deceased patients. Memories from the ICU stay became a focal point for participants who lost their loved ones, whereas families of surviving patients were able to look positively toward the future. In addition, families of deceased patients often viewed friends and family as sources of stress, whereas families of surviving patients typically viewed their community as a source of support. Conclusions: Patient death was associated with symptoms of anxiety, depression, and post-traumatic stress disorder among families of ICU patients with COVID-19. Psychological support interventions may be most beneficial for families of patients who died of COVID-19. Clinical trial registered with www.clinicaltrials.gov (NCT04501445).

Integrating special and underserved populations in translational research: Environmental scan of adaptive capacity and preparedness of Clinical and Translational Science Award (CTSA) program hubs.

The COVID-19 pandemic has exacerbated health disparities and rendered them acutely more visible. Special and underrepresented populations need to be fully integrated into the translational research process from the very beginning and all the way through. This article presents findings and rapid analysis mini-case studies from the Environmental Scan (E-Scan) of adaptive capacity and preparedness of Clinical and Translational Science Award hubs, specific to the goal of integrating special and vulnerable populations in different institutional research settings. In our discussion of the findings and case studies, we flexibly apply local adaptive capacity framework concepts and characteristics, and, whenever possible, we present ideas on how to enhance capacity in those areas, based on the challenges and practices identified through the E-Scan. Although the past year has recorded incredible achievements in vaccine development, clinical trials, diagnostics, and overall biomedical research, these successes continue to be hampered by our inability to turn them into achievements equally available and accessible to all populations.

Learning about Adaptive Capacity and Preparedness of CTSA Hubs

IMPACT: This work will inform the ongoing development of adaptive capacity and preparedness of the CTSA Program and other clinical and translational research organizations in their quest of improving processes that drive outcomes and impacts, shaping effective programs and services, and strengthening their emergency readiness and sustainability. OBJECTIVES/GOALS: -Share the progress and preliminary findings of an ‘Adaptive Capacity and Preparedness of CTSA Hubs’ CTSA Working Group;-Improve our awareness and understanding of the efficient and effective changes helping CTSA hubs build robust capacity to address METHODS/STUDY POPULATION: A multi-case study including: - Triangulating multiple sources of information and mixed methods (survey/interviews of research administrators, researchers, evaluators, and other key stakeholders), literature review, document and M&E system information analysis, and expert review;- Describing CTSA hubs’ experiences as related to research implementation, translation, and support during the time of emergency;- Administering a comprehensive survey of the CTSAs addressing their challenges, lessons learned, and practices that work in various program components/areas. Data collection includes aggregate and cross-sectional data, with representation based on CTSA size, maturity, and population density. RESULTS/ANTICIPATED RESULTS: The described approach shows sound promise to investigate and share strategies and best practices for building adaptive capacity and preparedness of CTSAs -- across various scientific sectors, translational research spectrum, and the goals outlined by NCATS for the CTSA program. The anticipated results of this research will include the identified/shared innovative solutions and lessons learned for this rapidly emerging, high-priority clinical and translational science issue. ‘High-quality lessons learned’ are those that represent principles extrapolated from multiple sources and triangulated to increase transferability to new contexts and situations. DISCUSSION/SIGNIFICANCE OF FINDINGS: The project provides useful knowledge and tools to research organizations and stakeholders across multiple disciplines -- for mitigating the impact of the COVID-19 disaster via effective adjusting programs, practices, and processes, and building capacity for future successful, ‘emergency ready and responsive’ research and training.

Challenges faced by families of critically ill patients during the first wave of the COVID-19 pandemic.

OBJECTIVE: To understand how surrogates of critically ill patients adjusted to challenges that resulted from the COVID-19 pandemic. METHODS: Participants (N = 62) were surrogates of critically ill adults with COVID-19 in the ICU at an urban, academic medical center from March to June 2020. Participants were recruited using convenience sampling and took part in one-time qualitative individual interviews via telephone. Qualitative data were analyzed using thematic content analysis. RESULTS: Qualitative analyses yielded four types of challenges: Communication with the medical team, communication among family members, understanding and tracking medical information, and distress related to visitor restrictions. To adjust to challenges related to communication, participants developed routines for receiving updates from the medical team and providing updates to other family members. To adjust to the challenge related to comprehension, participants sought information from external sources such as family members in healthcare fields. To adjust to the challenge related to visitation, participants found some comfort in video calls with the patient. CONCLUSIONS: Surrogates of critically ill patients with COVID-19 faced multiple types of challenges yet adjusted to those challenges. PRACTICAL IMPLICATIONS: Future research should focus on ways to support the wellbeing of surrogates during times of restricted hospital visitation. Clinical trial registered at ClinicalTrials.gov (NCT03969810).