Objectives/Goals: Diffusion of innovations (DoI) posits that new health-related ideas spread through communities over time and across stages of adoption. We will apply DoI to understand a paradigm shift toward seeing participants as partners in clinical research, specifically through delivery of plain language summaries of results. Methods/Study Population: The return of results in lay language (plain language) to clinical trial participants represents a paradigm shift in the EU and now the USA. We will conduct a systematic review of the implementation of “lay summaries” or “plain language summaries” in different jurisdictions to understand current regulatory influence. We will then review PLS samples and published studies to determine the rate of adoption by industry and non-pharmaceutical company sponsors. Using the DoI framework, groups will be placed in an adopter category. Finally, we will employ an implementation science approach to understand the diffusion process and the translation to participants, laying the groundwork for a culture of change in medical product development. Results/Anticipated Results: Our search on PubMed using key terms “Diffusion of Innovation” and “Plain Language Summary” did not produce any relevant results in the context of clinical trials in the USA, which illustrates a gap in the literature and application of this theory in this context. In the future analyses, we will examine factors influencing the adoption stage and outcomes, such as regulatory action, what best practices have been defined/implemented (if any), culture shifts in the context of clinical research, health communications, and inclusion of patient voices in clinical research. Our analysis will include a network analysis to evaluate characteristics that influence adoption of PLS in clinical research. We hope to identify who is at the forefront of innovation and why. Discussion/Significance of Impact: Novel application of DoI theory will help lay the groundwork for a culture of change in patient-focused drug development, specifically for the dissemination of results to patients. In future studies, we plan to develop a tailored framework for the inclusion of PLS as part of a paradigm shift in the patient-focused drug development process.

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: How do we care for a patient whose mental health is deteriorated such that their decision-making capacity may be compromised? The high-potency opioid crisis in Ontario demands that we provide effective care for the affected population. We must also avoid patients having a subjective experience of coercion and must protect their human rights and dignity. Methods/Study Population: Ontario’s legislation governing mental health care will be explored: the Ontario Mental Health, Healthcare Consent, and Substitute Decisions Acts. We will identify best practices/learning across locales. Patients who have been involuntarily treated/confined will be welcomed to voice what the law should contain. International strategies for: coercion reduction practices, advanced care directives, less prohibitionist care culture, and supports for social determinants of health (SDH) may also help Ontarians. Patients, family members, law enforcement, judiciary, community agencies, and healthcare professionals will be invited to contribute via focus groups to drafted mental health care legislative improvements. Thus, we ensure law enforces patient-defined quality care and practical workflows. Results/Anticipated Results: We hope to emerge from our focus group consultation with draft legislative and procedural edits for Ontario’s mental healthcare laws to ensure that the laws protect human rights and that the laws reflect patient-defined needs. We must ensure controls are in place to de-risk power imbalances and limit the incidence of potential procedural misuse. We intend to design legislated procedures to ensure that people don’t get inappropriately involuntarily confined/treated. We will incorporate the perspectives and lived experiences of patients who have experienced involuntary treatment and/or involuntary medical confinement (locally in a focus group(s)) and internationally (in literature) to inform this legislative development. Discussion/Significance of Impact: We will learn from engaged stakeholders about how to shape Ontario’s legislation to support quality mental health care. We hope to identify and draft legislation improvements that voice what patients and their families’ value, drafts informed by evidence-based best practices and informed innovation. Via inclusion, we create a policy that serves.

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: This literature review examines the current landscapes of plain language summaries (PLS), which are used to make research accessible to nonexpert audiences. It aims to identify gaps in their implementation by focusing on challenges related to consistency, accessibility, and quality across fields. Methods/Study Population: A systematic search was conducted using databases such as PubMed and Google Scholar, employing key search terms like “plain language summaries,” “scientific communication,” “health literacy,” “patient education,” “knowledge translation,” “accessibility in research,” “public engagement,” “lay-person,” and “lay summaries.” Literature from multiple sources (pharmaceutical companies/industry, nonprofit organizations, private–public partnerships, and government) was compared to assess the gaps in current PLS best practices. Results/Anticipated Results: Search results yielded 95 articles. Of those, 37 articles fit the criteria, highlighting critical gaps in PLS implementation for clinical research. Preliminary findings suggest a lack of standards and guidelines, as well as a need for more research on the effectiveness of PLS for improving knowledge transfer and patient engagement. Key limitations were identified for investigator-initiated trials (IITs). A best practice table, comparing recommendations from each group of sources, was developed with suggestions for writing effective PLS. While there is consensus on some principles (i.e., importance of simplicity), differences emerge regarding optimal length and the use of layperson glossaries and graphics. The table aims to serve as a guide for creating effective and standardized PLS across fields. Discussion/Significance of Impact: There are limited PLS best practice resources tailored for IITs. These findings could lead to more practical tools and a streamlined approach to enhance communication strategies for lay audiences. This would benefit trial participants and community members who rely on this information and bridge the gap between scientific communities and the public.

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.

Objectives/Goals: To identify the most impactful regulations regarding the approval and marketing of TMs in the U.S., E.U., Japan, Australia, China, and India enacted between the years 2000 and 2022. To explore TM-related regulations in new countries, Japan and Australia, for their novel regulatory approaches in intersecting Western and Eastern medical practices. Methods/Study Population: International regulatory bodies included in this study were chosen based on the country’s long history with TM and/or the existence of review processes specific to TM. TM-related regulatory changes that were enacted between the years 2000 and 2022 were identified and categorized into special departments, changes in clinical trials, or specialized tracks. The impact of these TM policies was measured via the number of TM-related INDs, approved applications, marketed drugs, and rejected applications per decade since 2000. This data was then organized alongside policies to draw conclusions about the influence of these regulatory changes. All data was collected using official government websites and journals published by independent, external research institutions accessed via USC’s library services. Results/Anticipated Results: Previous research revealed each country made efforts to integrate TMs into existing drug practices, such as clinical trials and safety requirements, although the extent and methods for the integration differed. Countries with a longer history with TMs are predicted to have regulatory systems that are more accommodating to the unconventional nature of TMs, making the approval and marketing of TMs much easier in these countries. As TM-related policies are more refined and increase in number in a given country, the number of TM-related applications and TMs marketed as legitimate, prescribable medications will also increase. Discussion/Significance of Impact: Timelines and charts displaying the impact of new TM-related regulatory changes will help identify a successful model for increasing TM IND submissions, approvals, and marketed TM drugs.

Objectives/Goals: The World Trade Center (WTC) Health Program (Program), a limited federal healthcare program for eligible people exposed to the terrorist attacks on September 11, 2001, expanded telemedicine services during the COVID-19 pandemic. We analyzed service use trends from 2020–2021 to describe how the program implemented telemedicine services. Methods/Study Population: We estimated use rates of telemedicine-eligible services and telemedicine services by all included program members and by subgroups of members defined by member type (responder or survivor) and selected characteristics for the study period 2020–2021. We described the use trends of total telemedicine-eligible visits, telemedicine visits, and in-person visits, respectively, by quarter. We calculated the quarterly rates of telemedicine use per 1000 living members. We used a multivariable logistic regression to examine associations between member characteristics and telemedicine use rates. Results/Anticipated Results: About 75% of telemedicine visits were related to mental health services. In the second quarter of 2020 (April–June), telemedicine use rate (367 visits/1000 members) increased, exceeding in-person service rate (152 visits/1000 members) by 1.4 fold. Telemedicine use rate decreased gradually in the rest of the study period but still represented 38% of total visits by the end of 2021. Regression models showed differences in telemedicine use rates by member type and by demographic characteristics. Survivor members (vs. responder members), those self-identified as non-Hispanic Other races (vs. non-Hispanic White), those with preferred non-English language (vs. preferred English), and those not living in the New York metropolitan area (vs. living in the New York metropolitan area) were less likely to use telemedicine. Discussion/Significance of Impact: The expansion of telemedicine service provided members uninterrupted access to necessary health services during the COVID-19 pandemic. It underscored the importance of extensive partner collaboration, the capacity to rapidly develop necessary technical guidance, and the flexibility to timely address frequent regulatory guidance updates.

Objectives/Goals: The purpose of this pilot study is to conduct a survey interview to understand the knowledge and attitudes of people experiencing homelessness (PEH) toward clinical trial participation, provide insights for future engagement strategies, and begin bridging the gap between clinical researchers and this marginalized group. Methods/Study Population: A 14-question survey, developed in collaboration with the street medicine (SM) team at the University of Southern California and other key stakeholders in PEH research, was administered in a survey–interview style to PEH in SM’s East Side Los Angeles area of operations. The questions were designed to assess PEH’s knowledge and attitudes toward the significance of clinical research and their potential participation. No identifying information was collected. To ensure diversity in responses, the surveys were conducted in different SM healthcare providers’ areas of operations. The responses were then analyzed both quantitatively and qualitatively, taking into account the broader perspectives that PEH may have toward clinical trial research. Results/Anticipated Results: A total of 9 PEH were surveyed. When asked to share their thoughts on “clinical trials” (CTs), most described the need to travel on-site to a practitioner to be studied/tested. They indicated that they knew what CTs were and that the FDA’s official definition was easy to understand. Only one respondent reported being part of a diagnostic trial, and one declined to answer. Four respondents indicated a willingness to participate in a CT. Four answered “maybe” and one answered “no.” Of note, most believed that CTs have a positive impact, and only one responded that they think researchers do not maximize health benefits and minimize risk. Outside of the allowed answer choices, respondents also shared that there should be payment for participation in a CT, even if they don’t expect any. Discussion/Significance of Impact: The survey results could significantly influence the future of clinical research, guiding it to be better tailored to PEH’s unique circumstances, thereby potentially improving their participation rates. A key objective for the future will be to increase the sample size of the survey to improve the applicability and impact of the results.

OBJECTIVES/GOALS: We explain our multi-platform, multi-audience approach to stakeholder engagement/communication, discuss KPIs for our Instagram accounts, and highlight five top performing posts. Finally, we provide tips to Hubs who would like to tailor and optimize their social media approach. METHODS/STUDY POPULATION: We employed Uses & Gratifications theory and formative research with stakeholders to inform our social media strategy. We run two Instagram accounts (main CTSI & Community Engagement [CE]), one Facebook page (CE), and one Twitter/X page (main CTSI). To understand impact, we collected social media analytics on both Instagram accounts (main CTSI and Community Engagement-specific accounts) to ascertain four social media-related Key Performance Indicators since the inception of the two accounts: reach, impressions, growth rate, and engagement. Additionally, we examined the five top-performing posts on each account that gave us insights into trending topics and ideas for future content. RESULTS/ANTICIPATED RESULTS: From January 2023 to October 2023, the reach for the main account was 3,578 and 38,235 for CE. The number of profile visits for the main account was 474 and 2,703 for CE. Engagement data on Instagram is only available for the last 90 days. For the main account, the number of post likes, comments and shares was 622 and 2,700 for CE. The views and reach for the five top-performing posts on the main and CE accounts ranged in the thousands. The content of the top-performing posts for the main CTSI account varied between highlighting our KL2 scholars' accomplishments, recap of campus-wide research events, and advertisements for upcoming educational webinars. CE’s top posts varied between highlighting their work in a South LA housing community, recaps of large community health events, and interviews with local key leaders. DISCUSSION/SIGNIFICANCE: CTSA Hubs have an ethical obligation to keep their local academic and community audiences apprised of their activities. Creating a formative research and theoretically-informed social media plan that varies by platform, and regularly evaluating performance insights allows us to track the type of content that appeals to our multiple audiences.