In this paper, we introduce the Team Effectiveness Model for Science (TEMS) and describe a multiphase set of interventions for forming a new team or developing an existing team. TEMS uses a shared mutual learning mindset as the model’s central and guiding element. It shows how team mindset leads to behavior and to results and how this affects the characteristics of effective team functioning. TEMS addresses two related questions: What are the variables that contribute to effective teams? and How do the variables need to be designed to make their relevant contributions? Team models often answer the first question without fully answering the second. By addressing three gaps, TEMS contributes to enhancing science team effectiveness. Gap 1 is the absence of explicit core values, assumptions, and norms that serve as the foundation for developing and maintaining science team effectiveness. Gap 2 is the absence of a process for integrating the science and relationship aspects of a science team. Gap 3 is the absence of team processes and structures that are derived from the team’s values, assumptions, and norms. Using TEMS to design new or intervene with existing teams focuses on shifting mindset, developing behavioral skills, and designing processes and structures congruent with the new mindset.

OBJECTIVES/SPECIFIC AIMS: Type 2 diabetes (T2D) is costly and burdensome, but strong evidence exists that lifestyle change and weight loss can improve glycemic control and lower co-morbidities for patients with T2D. We used national data to examine whether the frequency of diet and/or physical activity counseling for patients with T2D in ambulatory settings has been responsive to accumulation of evidence supporting lifestyle change. METHODS/STUDY POPULATION: We used National Ambulatory Medical Care Survey (NAMCS) data over the period 2005-2015 from 31,475 patients with provider-reported T2D. We built multivariate logistic regression models, adjusting for patient, provider, and practice level characteristics (i.e. patient demographics, physician specialty, site of care, and region), to assess changes over time in the provision of diet or exercise counseling during ambulatory care visits, as reported through provider/staff chart review. We also examined whether changes in counseling over time varied by key patient and provider characteristics. We used non-overlapping confidence intervals (CI) to assess for statistical significance. RESULTS/ANTICIPATED RESULTS: Proportions of patients with T2D who received diet or exercise counseling were no different over time: 30% in 2005 [95% CI: 25%-35%] and 25% in 2015 [95% CI: 18%-31%]. Adjusted models show Hispanic patients had higher likelihood of receiving diet or exercise counseling, compared to whites (OR: 1.38 [CI: 1.03-1.85] for diet; OR: 1.37 [CI: 1.01-1.85] for exercise), and younger age was associated with higher likelihood of diet or exercise counselling, compared to those over 75 (age 30-49, OR: 1.47 [CI:1.18-1.82] for diet OR: 1.63 [CI: 1.30-2.03] for exercise). Among provider and practice-level characteristics, metro area and type of provider were associated with higher odds of receiving any diet and/or exercise counseling with visits in a metro area (OR: 1.23 [CI: 1.03-1.48]) and with an advanced practice provider (OR: 1.77 [CI: 0.97-3.22] having higher likelihood of receiving any diet or exercise counseling. DISCUSSION/SIGNIFICANCE OF IMPACT: Up to 30% of Americans with diabetes received any diet or exercise counseling in ambulatory visits, and this remained low over a decade. There were significant differences in counseling across patient, provider, and practice characteristics. Future studies are needed to better understand what interventions might improve counseling in ambulatory settings.

OBJECTIVES/GOALS: The CTSA consortium’s Informatics Enterprise Committee has developed a maturity assessment model for Clinical Trial Management Ecosystems (CTME). This poster will show the improvements achieved using this model at the University of Iowa as well as guidance on how to apply it at other CTSA hubs. METHODS/STUDY POPULATION: The CTME maturity model consists of 11 categories including, study management; regulatory; financial; and reporting. Each category has 3 subcategories: standardization; complexity; and monitoring, while each subcategory is comprised of 1 to 5 maturity statements: initial; developing; aspiring; capable; and efficient. The maturity assessment team at Iowa—comprised of key personnel from clinical research and compliance, accounting, and administration—have used the CTME maturity model to assess Iowa’s research performance across the 11 categories. The initial maturity ratings for each category revealed any gaps in research operations, which led to developing strategies to address the gaps. RESULTS/ANTICIPATED RESULTS: The assessment team initiated a CTME maturity planning project—holding regular meetings to review Iowa’s CTME research maturity and plan changes to improve our CTME maturity ratings. This analysis is done at the statement level to minimize the scope of actions needed and keep resource loads for improvements low. Proposed improvements are assigned to a team member who serves as an “accountability leader.” Such leaders develop action plans aimed at increasing maturity at least one level. The leaders are responsible for acquiring the resources to carry out the plan. Each action plan identifies qualifiers reviewed by the team to confirm that the maturity level has been met. DISCUSSION/SIGNIFICANCE: The CTME maturity model has been shown to be effective in identifying gaps in organizational operations at the University of Iowa, where it has led to incremental steps to improve clinical research operations. The utilization of the model at other CTSA hubs will be discussed at this session.

OBJECTIVES/GOALS: A new mandate for Clinical & Translational Science Award (CTSA) Programs is for pilot grant funding to support clinical and translational science (CTS) projects that study challenges in the translational research pipeline. This pivot requires new structures and supports to help investigators design and implement high-quality CTS projects. METHODS/STUDY POPULATION: The Michigan Institute for Clinical & Health Research (MICHR) at the University of Michigan (U-M) has launched two rounds of pilot funding since March 2023. Faculty and staff across U-M’s three campuses, community members, and those at collaborating institutions and hospitals were eligible to apply. New pre-award supports included a CTS project framework; a recorded webinar that educated about CTS and the funding opportunity; office hours to provide tailored project feedback; a letter of intent to screen for alignment with CTS; and reviewer training for academic and community reviewers. Funded projects operate like 'mini cooperative agreements”, with MICHR experts partnering with awardees to refine evaluation plans, prepare work products, advise on dissemination, and navigate emergent challenges. RESULTS/ANTICIPATED RESULTS: The first round of funding was launched in the absence of pre-award supports; ten applications we received from faculty proposing translational research rather than CTS. We quickly re-released the FOA, expanding eligibility to staff. We received nine applications, ultimately funding four staff and one faculty studying operational challenges in translation and helping them create robust evaluation plans. We piloted the pre-award supports in our second round, with 40 individuals viewing our webinar and 11 attending office hours. Those who watched the webinar before attending office hours better understood how to embed CTS questions within their programs of research. We recently received 19 letters of intent, addressing both operational and scientific challenges, with 16 eligible to submit applications. DISCUSSION/SIGNIFICANCE: Education and personalized feedback seem to elicit a higher yield of CTS projects. Staff are already adept at solving operational challenges, so the pre-award supports were most critical for faculty accustomed to writing traditional translational research proposals. Staff have most benefited from guidance in evaluation and dissemination.

OBJECTIVES/GOALS: Our primary objective is to determine the demographic and linguistic characteristics of student research assistants (SRAs) in a large student-run free clinic associated with a mid-western university. Our secondary objective was to determine if the SRAs perceived any impact of those characteristics on their duties and ability to conduct research. METHODS/STUDY POPULATION: We plan to conduct a 15-question electronic survey of Student Research Assistants at the student run free clinic. There are a variety of projects that require varying levels of commitment from researchers, which will be aggregated. This survey has been modified from a previously validated survey that focused on the demographic and linguistic characteristics of pediatric research coordinators. This survey will be emailed out to student research assistants and will be done over a period of 3 months. The study population will be predominantly undergraduate students who are all interested in a career in healthcare, ages expected to range from 18-25. RESULTS/ANTICIPATED RESULTS: We anticipate that the majority of student research assistants will be older students and will be students who identify as non-white/caucasian, as the majority of students volunteering at this free clinic do not identify as white. Additionally, we anticipate that students will feel that their racial/ethnic identity will positively impact their recruitment efforts. We also anticipate that the ability of a student research assistant to speak another language is expected to positively affect their perceived recruitment efforts. We also anticipate that gender will influence the student researchers’ perceptions of their recruitment efforts. DISCUSSION/SIGNIFICANCE: An individual’s background can directly impact how they perceive their contributions towards research. Considering the paucity in research for underinsured and uninsured and the rise in undergraduate student research assistants, optimizing research efforts and SRA confidence is essential to increase the accuracy and efficiency of research.

OBJECTIVES/SPECIFIC AIMS: To further explore the role of vWF in the pathogenesis of scleroderma by identifying its location within the tissue of sample biopsies obtained as part of routine diagnosis with the use of immuno-histochemical staining. METHODS/STUDY POPULATION: We examined 8 skin biopsies from 2 patients with systemic sclerosis (SSc), 2 with localized scleroderma (LS) and 4 with JDM. Double immunofluorescence staining was performed in each tissue with antibodies against vWF and collagens type I and III. DAPI (4′, 6-diamidino-2-phenylindole) was also used for counterstaining of inflammatory cells. Tissue staining patterns were compared between groups. RESULTS/ANTICIPATED RESULTS: Biopsies were obtained from the upper extremity of 7 females and the lower extremity of 1 male. Median age, symptom duration, and serum levels of vWF antigen around the time of biopsy was 8 years (IQR 4.5-11), 5.5 months (IQR 2.5-7), and 245% (IQR 203-302 for 7 patients), respectively. All but 1 biopsy was performed prior to initiation of immunosuppressive therapy. Immunofluorescence staining showed a superficial and deep perivascular inflammatory cell infiltrate that co-localized with vWF in all tissues. There was expression of vWF in the extravascular tissue of patients with JScl co-localizing with collagen III in the reticular dermis (Figures 1 and 2). In comparison, vWF expression was restricted to the endothelium and did not co-localize with collagen in the dermis of patients with JDM (Figure 3). Patients with SSc had higher expression of vWF as compared to patients with LS. DISCUSSION/SIGNIFICANCE OF IMPACT: vWF may participate in the pathogenesis of cutaneous inflammatory conditions. We have demonstrated that vWF co-localizes with cellular inflammatory infiltrates in the perivascular areas and in the dermis of patients with JScl and JDM. We additionally speculate that vWF may participate in the pathogenesis of fibrosing skin diseases based on evidence of increased extravascular expression in the tissue of patients with JScl (vs. JDM), and its co-localization with collagen. vWF expression intensity in the dermis of JScl patients may relate to disease extension (SSc vs. LS).

Achieving the clinical, public health, economic, and policy benefits of translational science requires the integration and application of findings across biomedical, clinical, and behavioral science and health policy, and thus, collaboration across experts in these areas. To do so, translational teams need the skills, knowledge, and attitudes to mitigate challenges and build on strengths of cross-disciplinary collaboration. Though these competencies are not innate to teams, they can be built through the implementation of effective strategies and interventions. The Science of Team Science (SciTS) has contributed robust theories and evidence of empirically-informed strategies and best practices to enhance collaboration. Yet the field lacks methodological approaches to rigorously translate those strategies into evidence-based interventions to improve collaborative translational research. Here, we apply lessons from Implementation Science and Human-Centered Design & Engineering to describe the Wisconsin Interventions in Team Science (WITS) framework, a process for translating established team science strategies into evidence-based interventions to bolster translational team effectiveness. To illustrate our use of WITS, we describe how University of Wisconsin’s Institute for Clinical and Translational Research translated the existing Collaboration Planning framework into a robust, scalable, replicable intervention. We conclude with recommendations for future SciTS research to refine and test the framework.

OBJECTIVES/GOALS: NCATS requires that CTSA-funded pilot projects focus on translational science (TS) and evaluate the translational process. However, a consistent understanding of TS remains elusive. This gap is being addressed by a consortium of 12 CTSA hubs aimed at identifying distinctive features of TS and translational research (TR) proposals. METHODS/STUDY POPULATION: CTSA External Review Exchange Consortium (CEREC) is a reciprocal review collaboration among CTSA hubs. Reviewers were CEREC members from hubs that submitted CTSA applications (PAR-21-293); read the Notice of Funding Opportunity (NOFO) Clinical and Translations Science Pilot Module; and discussed TS with their hubs “a fair amount” or “quite a bit” and then they independently categorized proposals. Proposals were labeled TS or TR if reviewers reached a consensus on category assignment; without consensus, proposals were labeled unclassified. In addition to category assignment, reviewers commented about their classifications. R was used to evaluate the comments and create word clouds with phrases/themes that distinguished between the categories of proposals. RESULTS/ANTICIPATED RESULTS: Twelve CEREC participating hubs submitted 26 proposals, which were funded prior to the new NCATS TS requirements. Eight reviewers from distinct CEREC hubs evaluated and classified each proposal as TS or TR. Consensus (at least 87% agreement) was reached for 12 proposals, 6 TS and 6 TR. Reviewers provided comments describing the rationale for their classifications for 70% of the proposals. Qualitative analysis of the reviewers’ comments and rationale by classification (TS, TR, or unclassified) revealed common themes within and differences between groups and shed light on what defines TS and TR. The most frequent themes that distinguished TS from TR were generalizability across multiple diseases and a focus on increasing research efficiency. DISCUSSION/SIGNIFICANCE: NIH is focused on research that meets the new definition of TS. Investigators seeking to address this funding priority should explicitly state the relevance of their research to multiple diseases and to the acceleration of future research. Programs seeking to attract TS projects should instruct applicants to include this information.

OBJECTIVES/GOALS: CTSA Hubs represent complex centers where teams work to meet multiple goals of the CTSA grant. An existing challenge is to work collaboratively across teams. To address this challenge, a Translational Operations Group (TOG) was established. Results show enhanced intra-hub collaboration and communication while reducing inefficiencies. METHODS/STUDY POPULATION: The TOG is composed of all CTSA hub module program managers who are charged with operationalizing vision into reality. The TOG was formed in 2021 as a mechanism to integrate new team members, provide connection, and improve cross-core awareness and collaboration. Leveraging team science principles, a team charter was developed outlining specific TOG aims and objectives. Collectively, shared goals were identified with establishment of group norms, effective communication pathways, shared resources and knowledge and meeting cadence. Leadership of the group rotates among the TOG members annually further engaging all TOG members. Pre and Post (one year) surveys were developed and provided to TOG members to gauge TOG effectiveness and perceptions of TOG members. RESULTS/ANTICIPATED RESULTS: Survey results demonstrate the effectiveness of the TOG concept in promoting core/module awareness and goals, intra-core/module interconnectedness, and forming connections and integration into the CTSA hub ecosystem. Psycho-social questions demonstrated an increase in organizational self-esteem within the pre to post survey period in relation to the specific TOG member’s core/module and the CTSA hub as a whole. DISCUSSION/SIGNIFICANCE: Formation of a TOG has been successful within a virtual environment where connection is challenging. Integration of members to the operational activities is critical to foster a positive work environment, reduce silo effects, and provide a space for sharing resources and knowledge. Annual reflection of priorities contribute to the ongoing success.

Routine, nonmedical and ancillary medical costs associated with participation in clinical research create barriers to enrollment for economically disadvantaged individuals. To the extent that race, ethnicity, and gender are linked to SES, such barriers impact efforts to diversify clinical research enrollment. But payment policies and practices often reflect the longstanding and singular concern that payment to participants will bias decision-making and compromise informed consent. We argue that this concern must be viewed in a larger ethical context in which the untoward consequences for the individual participant and for the broader research enterprise are considerable when either inadequate or no payment is provided for expenses incurred (“reimbursement”) and time committed (“compensation”). Fairness in payment and protection from undue influence of payment on the informed consent process are important but distinct ethical considerations. Fundamentally, approaches to payment that leave participants financially worse off as a consequence of taking part in research are inherently unjust as they have a differential impact on recruitment and retention based on socioeconomic status. Sponsors, funders, investigators, and IRBs must be cognizant of the impact of inadequate payment on clinical trial inclusion of historically understudied groups. We address practical and fair payment strategies to advance inclusion, the additional barrier of ancillary medical costs, and potential unintended consequences of payment.

OBJECTIVES/GOALS: * To analyze and compare disease support (funding, research productivity, drug development) and burden between systemic lupus erythematosus (SLE), which particularly affects Black women, and similar conditions that affect other groups of Americans. * To address the discrepancy of prevalence estimates of SLE in America. METHODS/STUDY POPULATION: This cross-sectional study examined publicly available data on disease funding metrics and research productivity indicators. We utilized the NIH Report database to calculate the total NIH funding and career development awards for SLE from January 1, 2008, to December 31, 2023 (estimated). We reviewed Form 990-T tax returns of SLE organizations to calculate private funding. We examined US-based interventional trials related to SLE on ClinicalTrials.gov between 2008 and 2024, using the terms SLE and lupus. We assessed FDA drug approvals for SLE from 2008 to 2024. We reviewed publicly available SLE disease characteristics such as prevalence, incidence, demographics, costs, and mortality rates. We repeated these methods for conditions like SLE but with different patient demographics. RESULTS/ANTICIPATED RESULTS: We will formulate SLE support based on its avaialble federal and private funding, clinical trials, and drug approvals. We will determine the ratio of SLE support to disease burden and compare it to other conditions that affect different demographics in the US. There is currently a discrepancy in the range of prevalence of SLE in the US (178,362 to 1.5 million), so we will work with specialists to provide a better understanding of the actual prevalence. DISCUSSION/SIGNIFICANCE: SLE is a chronic disorder that is associated with hospitalizations, organ failure, and premature mortality. It has established disparities in incidence, treatment, and outcomes along gender, racial, and socioeconomic lines. Our study highlights the need for policy changes within research funding to address disparities and improve outcomes.

OBJECTIVES/GOALS: Health care accounts for an estimated 10% of U.S. greenhouse gas (GHG) emissions. Concerted efforts to decrease waste are needed including critical appraisal of single use items. The purpose of this study was to conduct life cycle analyses (LCA) of a pediatric single use laryngoscope to inform environmental impact and identify targets to reduce waste. METHODS/STUDY POPULATION: LCA was used to quantify the environmental impact of a single use pediatric laryngoscope. LCA is an industry standard measure of energy consumption, water consumption, and GHG emissions encompassing a “cradle-to-grave” assessment. The GREET model (Greenhouse gases, Regulated Emissions and Energy use in Technologies) and Open LCA model were used as sources for product/raw material data. Separate analysis was completed for the battery powering the light emitting diode (LED) lights. RESULTS/ANTICIPATED RESULTS: The LCA revealed 598.2 g of CO2 equivalents for the 121g single use pediatric laryngoscope. There were an estimated 26,849 cases that used single use laryngoscope last year at our free-standing children’s hospital resulting in 16.1 metric tons of CO2 equivalents. This is equivalent to 41,273 miles driven by an average gasoline powered vehicle. The 1.5 V battery was the highest contributor to the laryngoscope’s GHG emissions. While the battery has an estimated 2,800 hours of life, single use laryngoscopes are reported in the literature as being used for only an average of 30 seconds to 2 minutes. DISCUSSION/SIGNIFICANCE: Single use laryngoscopes are high contributors to GHGs. Specifically, the batteries contained in the laryngoscopes are wasteful and challenging to remove and recycle. Future efforts to decrease waste in the OR should target use of similar items that have reusable battery components to improve environmental sustainability.

OBJECTIVES/GOALS: Investigators have an ethical obligation to return study results back to participants in a timely and layperson-friendly manner, but most do not. This lack of communication can erode trust in the research enterprise. One solution to this issue is Plain Language Summaries (PLS). METHODS/STUDY POPULATION: We investigated and collected best practices for PLS and results dissemination as part of formative research for a pilot PLS project. This pilot was used to inform the development of our own PLS resources, which we will share broadly with other CTSAs. We employed a two-part system for analysis. First, we examined extant PLS resources from five major, publicly accessible sources spanning academia, government, publishing, and nonprofits for themes and best practices. Then, we examined actual PLS from each source and collected more specific feedback. We examined PLS structure, length, inclusion of graphics, multiple language availability, readability, and potential for improvement. RESULTS/ANTICIPATED RESULTS: Guidance sources recommended that PLS have logical and organized structures, and included essential trial information (e.g., study drug, adverse events). Suggestions for length varied widely, from 250 words to 15 pages. Guidance also recommended the use of media, including infographics, audio, and video. Only pharma guidance recommended multilingual PLS. Actual PLS included many common trial elements, including study purpose, treatment description, results, and adverse events. PLS in our analyses were 10-12 pages, and contained many infographics, including flow charts of study phases, visual explanations of treatment and participant demographics, and adverse event tables. None were multilingual, and most were readable at the 7th grade level, although one used undergraduate-level language. DISCUSSION/SIGNIFICANCE: General guidance was similar across sources. In our analyses of PLS, we found novel recommendations, such as including auditory pronunciation guides, and personalized thank you letters to participants. In future research, we recommend focusing on novel dissemination methods such as short interactive videos and patient-actor testimonials.