ABSTRACT 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.

Funding agencies are increasingly seeking team-based approaches to tackling complex research questions, but there is a need to mobilize translational teams and create shared visions and strategic action plans long before specific funding opportunities are considered or even released. This is particularly evident for teams who want to pursue large-scale grants, where cross-disciplinary synergy is often required. In response, we created Research Jams, which are engaging yet structured brainstorming sessions that bring together groups for the first time to collectively generate novel research ideas, critically map the future of initiatives, prioritize opportunities and next steps, and build community. Research Jams leveraged various aspects of design thinking, including divergence and convergence, visual thinking, and amplifying diversity. We piloted seven Research Jams for a collective 129 researchers, staff, and partners across 50 University of Michigan units and external organizations. Feedback was overwhelmingly positive, with the vast majority of survey respondents indicating that the sessions were helpful for surfacing shared ideas or visions and that opportunities emerged they would like to pursue. Research Jams were ideal for cross-disciplinary groups who wanted to collaboratively ideate and strategize around complex problems in translational research. Importantly, these models have the potential for implementation with groups in any disciplinary domain who want to spur collaborations to address challenging problems. Our ultimate goal is for Research Jams to be the first intervention within a comprehensive support pathway that extends from early brainstorming all the way to grant submission.

ABSTRACT IMPACT: Results will inform the design of health information technologies that assess and improve clinicians’ interpersonal communication supporting co-management of care across health institutions. OBJECTIVES/GOALS: Poor communication and co-management of comorbidities during the referral process increase physician workload, patient burden, and safety risks. In this preliminary study, our objective was to understand how consultants’ notes support physician collaboration within and across health care institutions. METHODS/STUDY POPULATION: We reviewed medical records. Accessing the Indiana Network for Patient Care database, consultation notes were randomly selected from four specialties: cardiothoracic surgery, neurology, rheumatology, and oncology. These specialties were identified, in advance, as challenging in interprofessional communication. The notes reviewed were associated with in-person consultations at a medical network in the Midwest from 2016 to 2019, including internal and cross-institutional (i.e., external) referrals. The Quality of Consult Assessment tool was adapted to assess note quality and co-management facilitation. Two researchers reviewed all records independently. A consensus meeting was then held to discuss and resolve discrepancies. RESULTS/ANTICIPATED RESULTS: Medical records of ten patients with comorbidities were reviewed. The mean age was 67 (SD= 12 years); one patient was a child. All consultation notes contained clinical recommendations. Seventy percent of notes referred to explicit consultant responsibilities. Conversely, only one contained explicit responsibilities for referrers. Medical records denoted reliance on support staff to send messages among referrers, consultants, and patients via phone calls and facsimile. The use of fax machines to send medical records to referrers was more prominent after cross-institutional consultations. DISCUSSION/SIGNIFICANCE OF FINDINGS: Clinical documentation supported specialty referrals for transitions of care rather than co-management of care. Accessing medical records across institutions contributed to a lack of clinical context, and workflow inefficiencies, when attempting to co-manage clinical care.

ABSTRACT IMPACT: Investigators in clinical and translational research will be better supported by CTSAs that reduce barriers to the efficient and effective utilization of their program services. OBJECTIVES/GOALS: Evidence from three CTSAs show that investigators do not take advantage of all program services provided. This session will explore the patterns and sources of underutilization by sharing preliminary results from investigators and program managers. METHODS/STUDY POPULATION: Interviews with investigators at all three CTSA sites were conducted in Spring 2020. Investigators who had only used one program service and those who had used multiple program services across a span of three-years (2016 to 2018) were included in the sample. Investigators who had only used REDCap, were excluded. Interviews numbered about six interviews per site. Content analysis helped identify emerging themes and patterns. A survey with program managers at the three CTSA sites will be deployed in January 2021. Program managers across all programs will be included in the sample. Basic descriptive analysis will be used to analyze the data. RESULTS/ANTICIPATED RESULTS: Interviews with investigators at all sites illuminated ways different investigators use, learned about and leveraged services, as well as the barriers they encountered to using cross-program services. Investigators also provided thoughts on ways to address lack of program service use. Survey results are expected to clarify program managers’ knowledge of other program services in their CTSA, programs’ referral processes, and the barriers program managers face when recommending other services to users. DISCUSSION/SIGNIFICANCE OF FINDINGS: When investigators do not take full advantage of all program services provided, investigators are put at risk of having longer, less successful projects. Knowing the sources of underutilization can help curb this trend and effectively address investigator needs throughout the research process.

The Building Up Trial is a cluster-randomized trial that aims to address the issue of the leaky career pathway for underrepresented (UR) faculty in biomedical fields. Regulatory approval and recruitment for the Building Up Trial took place during the COVID-19 pandemic and the anti-racism movement. The pandemic and anti-racism movement personally and professionally impacted the target population and made recruitment challenging at both the institution and participant level. The target sample size for this study was 208 postdoctoral fellows or early-career faculty across 26 predominately white institutions. Challenges and adaptations are described. The Building Up Trial was delayed by 3 months. In total, 225 participants from 26 institutions were enrolled. Participants are predominately female (80%), Hispanic/Latinx (34%) or non-Hispanic/Latinx Black (33%), and early-career faculty (53%). At the institution level, obtaining Institutional Review Board (IRB) approval through a single Institutional Review Board (sIRB) posed the biggest challenge. We adapted to COVID-19-related challenges through simplifying sIRB forms, modifying study practices, and increasing communication with institutions. Recruiting UR postdoctoral fellows and faculty during the COVID-19 pandemic and anti-racism movement was challenging but not impossible. Studies should be prepared to modify study and recruitment policies to overcome additional barriers posed by the pandemics.

ABSTRACT IMPACT: This project successfully implemented a promising team science model by introducing and facilitating best practices to develop high functioning teams working to accelerate health innovations from bench to bedside. OBJECTIVES/GOALS: The goal of this project was to improve the team science knowledge, skills, and attitudes of interdisciplinary engineering students (undergraduate and graduate) who were partnered with health professionals to develop technical solutions to translational health challenges during a year-long Engineering Innovation in Health (EIH) program. METHODS/STUDY POPULATION: We adapted, implemented, and evaluated team science training content and approaches in the EIH program at the University of Washington (UW). EIH faculty and the UW Institute of Translational Health Sciences’ (ITHS) Team Science Core co-developed and delivered highly interactive team science training modules and evaluated their impact with biannual surveys. A student cohort was surveyed prior to the implementation of the team science trainings, which served as a baseline. Descriptive statistics were used to summarize student demographics and survey responses within and between years. Median and interquartile range of responses to Likert-type questions were calculated, and Mann-Whitney U Tests (independent samples Wilcoxin Rank Sum Tests) were used to test for differences within and between years. RESULTS/ANTICIPATED RESULTS: During both the baseline and the team training year, student demographics were similar in terms of gender and past experience working in teams. Team training during the first year of implementation was well-received. Post-implementation surveys of students demonstrated measurable improvement in team dynamics, communication, and effectiveness; including, students reporting higher levels of psychological safety and self-efficacy within their teams. Comparisons within the team training year and between the baseline and team training years identified numerous instances in which differences were statistically significant. DISCUSSION/SIGNIFICANCE OF FINDINGS: Tailored team science training in an interdisciplinary EIH program was successful at improving psychological safety and self-efficacy among undergraduate and graduate students and offers a promising model for similar settings and audiences.

ABSTRACT IMPACT: Many who suffer from end-stage organ disease do not qualify for solid organ transplantation because of obesity; however, bariatric surgery offers the potential to render select patients transplant-eligible, and in some cases, may lead to weight loss that is sufficient to reverse end-stage organ disease. OBJECTIVES/GOALS: As obesity prevalence grows, more end-stage organ disease patients will be precluded from transplant. Numerous reports suggest bariatric surgery in end-stage organ disease may help patients achieve weight loss sufficient for transplant listing, though the published data are limited. METHODS/STUDY POPULATION: We performed a systematic review/meta-analysis of studies of bariatric surgery to achieve solid organ transplant listing. RESULTS/ANTICIPATED RESULTS: Among 82 heart failure patients, 40.2% lost sufficient weight for listing, 29.3% were transplanted, and 8.5% had sufficient improvement with weight loss they no longer required transplantation. Among 28 end-stage lung disease patients, 28.6% lost sufficient weight for listing, 7.1% were transplanted, and 14.3% had sufficient improvement following weight loss they no longer required transplant. Among 41 cirrhosis patients, 58.5% lost sufficient weight for listing, 41.5% were transplanted, and 21.9% had sufficient improvement following weight loss they no longer required transplant. Among 288 end-stage/chronic kidney disease patients, 50.3% lost sufficient weight for listing and 29.5% were transplanted. DISCUSSION/SIGNIFICANCE OF FINDINGS: Small sample size and publication bias are limitations; however, bariatric surgery may benefit select end-stage organ disease patients with obesity that precludes transplant candidacy.

Dental service providers have limited capacity to identify strategies to implement evidence-based practices (EBPs). We developed a rigorous yet parsimonious scoping review approach to identify, select, and rate implementation strategies based on an oral health system context. From 153 strategies identified, we selected the top 11 strategies, which had a moderate level of support of evidence and where managers were the main actors. The main actions were to educate, remind, structure, and influence. Targets included dentists, dental hygienists, and assistants and managers from a large prepaid dental care delivery system. This approach responds to calls for rapid and innovative methods to implement EBPs in oral health.

This report describes how stakeholder groups informed a web-based care planning tool’s development for addressing root causes of poor health. Stakeholders included community members (n = 6), researchers (n = 6), community care providers (n = 9), and patients (n = 17). Feedback was solicited through focus groups, semi-structured interviews, and user experience observations and then qualitatively analyzed to identify themes. Each group contributed a unique perspective. Researchers wanted evidence-based content; community members and providers focused on making goals manageable; patients wanted care team support and simple action-oriented language. Our findings highlight the benefits of stakeholder input. Blending perspectives from multiple groups results in a more robust intervention design.

ABSTRACT IMPACT: Up to 33% of patients of patients who undergo reconstruction have hostile defects with coexisting soft tissue and osseous defects due to prior radiation, prior failed cranioplasty or concurrent infections we seek to identify optimal strategies for these patients based on the experience of a southeastern tertiary referral center. OBJECTIVES/GOALS: Scalp and calvarial defects in patients may result from a number of etiologies including trauma, burns, tumor resections, infections, osteoradionecrosis, or congenital lesions. Our objective was to retrospectively evaluate the use of alloplastic reconstruction alongside autologous reconstruction for high risk cranial defects. METHODS/STUDY POPULATION: An IRB approved retrospective review of patients who underwent cranioplasty of a hostile site at a Southeastern tertiary referal center between January 2008 and December 2018 was performed. The patients were stratified into three groups based on the type of implant used: autogenous (bone), alloplastic (PEEK, Titanium, PMMA), or mixed (combination of both types of graft). The primary outcome metric was a complication in the year following cranioplasty, identified by flap or bone graft failure, necrosis, or infection. Statistical analysis included t-tests and chi-square tests where appropriate using SPSS. RESULTS/ANTICIPATED RESULTS: There were 43 total cases in this time period; 15 autogenous, 23 alloplastic, and 5 mixed. The purely autogenous group had the highest complication rate (85%) and the alloplastic group had the lowest complication rate (38%). When stratified by specific material used for reconstruction (15 bone, 14 PEEK, 10 titanium, and 5 PMMA), overall complication rate was statistically significant (p=0.009; chi square test) with PEEK implants having the lowest complication rate (21%). The analysis documented an overall complication rate that was statistically different between the three groups (p=0.012). DISCUSSION/SIGNIFICANCE OF FINDINGS: This analysis interestingly found that in the setting of hostile cranial defects, cranioplasties would benefit from the use of prosthetic implants instead of autologous bone grafts, not only for avoidance of donor site morbidity but also for decrease in overall complications.

ABSTRACT IMPACT: Patients living in overcrowded zip codes were at increased risk of contracting severe COVID-19 after controlling for confounding disease and socioeconomic factors OBJECTIVES/GOALS: This study sought to examine whether residences in over-crowded zip codes with higher reported over-crowding represented an independent risk factor for severe COVID-19 infection, defined by presentation to an emergency department. METHODS/STUDY POPULATION: In this zip code tabulated area (ZCTA)-level analysis, we used NYC Department of Health disease surveillance data in March 2020 merged with data from the CDC and ACS to model suspected COVID-19 case rates by zip code over-crowdedness (households with greater than 1 occupant per room, in quartiles). We defined suspected COVID-19 cases as emergency department reported cases of pneumonia and influenza-like illness. Our final model employed a multivariate Poisson regression models with controls for known COVID-19 clinical (prevalence of obesity, coronary artery disease, and smoking) and related socioeconomic risk factors (percentage below federal poverty line, median income by zip-code, percentage White, and proportion of multigenerational households) after accounting for multicollinearity. RESULTS/ANTICIPATED RESULTS: Our analysis examined 39,923 suspected COVID-19 cases across 173 ZCTAs in NYC between March 1 and March 30 2020. We found that, after adjusted analysis, for every quartile increase in defined over-crowdedness, case rates increased by 32.8% (95% CI: 22.7%% to 34.0%, P < 0.001). DISCUSSION/SIGNIFICANCE OF FINDINGS: Over-crowdedness by zip code may be an independent risk factor for severe COVID-19. Social distancing measures such as school closures that increase house-bound populations may inadvertently worsen the risk of COVID-19 contraction in this setting.

COVID-19 has forced medical research institutions to conduct clinical research remotely. Here, we describe how a university’s mHealth Research Core helped facilitate the shift to remote research during the COVID-19 pandemic. In 2019 (pre-pandemic), we conducted stakeholder interviews and leadership group sessions to identify, create, and implement resources and core functions to support investigator-initiated mHealth research. Between April 2019 and February 2020, we identified four investigator needs: 1) a seminar series on trends in mHealth research, 2) mHealth case consultation services, 3) liaison services with institutional regulatory compliance groups, and 4) online navigation tools for implementation of mHealth methods (e.g., eConsent) and for building partnerships with technology vendors. To date, the mHealth Research Core has held seven seminars, completed 71 case consultations, assisted four COVID-related clinical studies, advised the IRB on shifting to remote research, and widely disseminated eConsent navigation tools. Although pre-pandemic stakeholder and investigator needs led to the creation of the mHealth Research Core, this institutional resource played a critical role in continuing clinical research during the pandemic by assisting investigators in rapidly shifting to remote study methodology.

ABSTRACT IMPACT: Evaluate the impact that the Kidney Allocation System has had on racial and ethnic disparities in pediatric deceased donor kidney transplant recipients. OBJECTIVES/GOALS: Racial and ethnic minority pediatric transplant candidates have known disparities in access to kidney transplantation. The Kidney Allocation System (KAS), implemented in 2014, was designed in part to alleviate some of these disparities thereby making transplant more equitable. We investigated the effect of KAS on reported disparities. METHODS/STUDY POPULATION: We utilized Scientific Registry of Transplant Recipients (SRTR) data to determine differences in new waitlist registrants, deceased donor (DDKT) and living donor kidney transplants (LDKT), HLA mismatch, and allograft survival among pediatric patients of different racial and ethnic backgrounds. RESULTS/ANTICIPATED RESULTS: Black pediatric patients represented 21.3% of new waitlist registrants pre-KAS and 18.9% post-KAS. Waitlist time increased for pediatric patients of all races post-KAS with the highest increase (131 days) in Asian patients (p < 0.01). The racial distribution of DDKT pre- and post-KAS was unchanged (White 38.4% vs 38.3%, Black 24.5% vs 22.5%, Hispanic 30.6% vs 31.1%, Asian 3.7% vs 4.4%, p = 0.12). The 3-yr graft failure rate is disproportionately worse in Black children compared to other races pre- and post-KAS (White 6.8% vs 5.3%, Black 14% vs 8.7%, Hispanic 8% vs 4.5%, Asian 6.6% vs 6.7%, Other 6.5% vs 2.9%) although there is a trend towards better graft survival in the post-KAS era. Graft survival worsened in Asian children in the post-KAS era (HR 2.34,95% CI 1.05 - 5.25, p=0.038). DISCUSSION/SIGNIFICANCE OF FINDINGS: Racial and ethnic disparities in pediatric ESRD patients have not been ameliorated by KAS. Children of color have longer waitlist time and are more likely to have graft failure. Alarmingly, allograft failure rate increased in Asian patients post-KAS, which merits further evaluation.

ABSTRACT IMPACT: Advanced spatial analysis techniques are used to target a community education intervention for Immigrant and African American women to increase breast cancer screening. OBJECTIVES/GOALS: We are addressing breast cancer screening disparities through the development of the COmmuNity kNowlEdge to aCtion Toolkit (CONNECT). CONNECT implements a mixed-methods approach using GIScience, community education, and social media to mitigate the impact of breast cancer screening disparities for Immigrant African and African American women. METHODS/STUDY POPULATION: We used advanced spatial analysis techniques, Spatially Adaptive Filters (SAF) to reveal mammography screening rates below the state level. SAF create screening maps of This new information allows lay health educators to identify and engage their communities in the Breast Cancer Champions program. We transformed and curated existing cancer educational material into culturally relevant educational training for lay health educators. Lay health educators participate in educational trainings and receive stipends for conducting formal and informal breast cancer education and screening events. RESULTS/ANTICIPATED RESULTS: We have identified four principles for designing culturally relevant education materials.

1. 1. Visual representation of the community in materials

2. 2. Positive Framing

3. 3. Statistics and graphs should be minimal

4. 4. Appropriate reading level and minimizing jargon

Due to COVID-19, our breast cancer champions are engaging with their community in socially responsible ways (i.e., engaging through social media, developing and placing community education flyers, community radio spots). Our social media campaign, which began in October has already attracted over 1000 followers. DISCUSSION/SIGNIFICANCE OF FINDINGS: Despite the disruption of COVID-19, our project continues reduce breast cancer screening disparities. We have developed and created culturally appropriate materials and are currently training Champions. By incorporating an online presence into our community outreach, we are increasing the ways we connect with our community.

ABSTRACT IMPACT: Interventions designed to improve access to healthy food are needed as a mechanism to improve diet quality and ultimately prevent diet-related chronic diseases. OBJECTIVES/GOALS: For people living in food deserts, access to grocery stores is an important consideration toward improving diet quality. The Grocery Access Program (GAP) provided discounted Lyft rides to grocery stores for residents in Baltimore, MD. This study will assess how the GAP impacted access to different food retail stores and healthy food purchases. METHODS/STUDY POPULATION: A mixed methods sequential explanatory design will be used. We collected survey data at baseline and mid-pilot on primary grocery shopping store, frequency of purchasing fruits and vegetables, and frequency of using the discounted Lyft rides for 90 program enrollees. The Healthy Food Availability Index (HFAI), a validated, observation-based instrument, will be used to measure healthy food availability at participants’ primary grocery shopping stores; HFAI scores range from 0-27. We will also compare frequency of self-reported fruit and vegetable purchases before and after GAP participation. Quantitative data analysis using paired sample t-tests and chi square tests will be followed by in-depth interviews with GAP participants; thematic analysis will be used to analyze qualitative data. RESULTS/ANTICIPATED RESULTS: This research is in progress; survey data collection is complete and store-level HFAI data collection will begin soon. We hypothesize that GAP participants will have shopped at stores with higher HFAI scores than non-participants, and that participants will have purchased healthy foods more frequently than they did prior to GAP participation. If these hypotheses are not supported, our qualitative findings will elucidate potential reasons and mechanisms for improving the program. If our hypotheses are supported, it will provide evidence for the GAP as a convenient, low-cost intervention to improve healthy food access for people in low-income communities. DISCUSSION/SIGNIFICANCE OF FINDINGS: Access to healthy foods is an important social determinant of health, and innovative strategies that can facilitate better dietary habits are needed in the area of food access research. Findings from this study could be used to scale up efforts that will foster better food access, healthier diets, and ultimately better health outcomes.

Obtaining informed consent is a fundamental and ethical practice within human subjects’ research. Informed consent forms (ICFs) include a large amount of information, much of which may be unfamiliar to research subjects, and the revised Common Rule resulted in several required additions to that language. As limited health literacy impacts many potential subjects, efforts should be made to optimize subjects’ ability to read and understand ICFs. In this brief report, we describe an assessment of ICFs at an academic medical center to evaluate longitudinal changes in readability with the introduction and update of a plain language ICF template.