OBJECTIVES/GOALS: A major barrier to older adult (65+) over-the-counter (OTC) safety is the lack of actionable research on factors affecting older adult decisions during OTC selection. This goal of this study is to develop and validate a survey instrument based on the Protection Motivation Theory to measure older adults perceived risk of OTCs. METHODS/STUDY POPULATION: The 24-item OTC Protection Motivation survey underwent revision using a consult from the UW Survey Center as well as rigorous cognitive interviewing and pilot testing with 8 older adults. It was administered to 103 community-dwelling older adults. OTC misuse data was gathered from 15 of the participants. OTC misuse evaluated by three pharmacy experts on the basis of OTC appropriateness given participants age, existing conditions, concurrent medication use, and intention to adhere to label guidelines. Multivariate linear regression was used to examine the relationship between OTC misuse and protection motivation. Exploratory factor analysis (EFA) was used to determine a model of best fit to describe the factor structure of the OTC Protection Motivation survey. RESULTS/ANTICIPATED RESULTS: The EFA yielded a 5-factor model of protection motivation, which included the components of deliberative risk perception, a combination of experiential and affective risk perception, threat severity, protective behavior intent, and perceived efficacy in protective behavior engagement. The EFA-based item reduction resulted in a final 18-item OTC Protection Motivation survey. DISCUSSION/SIGNIFICANCE: Older adults, who have the lowest health literacy levels, are responsible for 30% of OTC medication use and 61.5% of emergency department visits due to adverse drug events. This study is the first to characterize the relationship of OTC protection motivation and OTC misuse to inform patient-centered interventions for older adult OTC safety.

Given the convergence of the long and challenging development path for medical devices with the need for diagnostic capabilities for mild traumatic brain injury (mTBI/concussion), the effective role of public–private partnership (PPP) can be demonstrated to yield Food and Drug Administration (FDA) clearances and innovative product introductions. An overview of the mTBI problem and landscape was performed. A detailed situation analysis of an example of a PPP yielding an innovative product was further demonstrated. The example of PPP has led to multiple FDA clearances and product introductions in the TBI diagnostic product category where there was an urgent military and public need. Important lessons included defining the primary public and military health objective for new product introduction, the importance of the government–academia–industry PPP triad with a “collaboration towards solutions” Quality-by-Design (QbD) mindset to assure clinical validity with regulatory compliance, the development of device comparators and integration of measurements into a robust, evidence-based statistical and FDA pathway, and the utility of top-down, flexible, practical action while operating within governmental guidelines and patient safety.

OBJECTIVES/GOALS: The main objectives are to obtain a preliminary profile of the adult Puerto Rican patient with hearing impairment and to identify the factors, variables and barriers that thess patients face accessing intervention and adscribing to it. METHODS/STUDY POPULATION: Adults between the ages of 21 and 64 years old were surveyed using a questionnaire with items guided to obtain information regarding their socio-demographic and health characteristics and the variables associated to treatment access and adherence to the intervention plan. A descriptive approach will be used to create the sample profile and an age stratified analysis will be used to interpret the empirical data. The identified variables associated to treatment access and adherence will be identified and analyzed to study if there is a possible geographic zone and socio-economical association. RESULTS/ANTICIPATED RESULTS: Preliminary results suggest that regardless of the subject’s age and degree of hearing loss their socio-economical strata is a decisive factor in treatment adherence as well as the lack of medical insurance coverage for therapy, hearing prosthesis and assistive technology for the hearing-impaired. Access to service was found to be a barrier associated to the subjecs geographical place of origin. DISCUSSION/SIGNIFICANCE: Research findings suggest that there is an association between the socio-economical status of the Puerto Rican hearing impaired patient, the lack of medical coverage and the level of treatment adherence. Patients from a lower socio-economical status and remote towns exhibited less adherence which points to a health disparity for this population.

OBJECTIVES/GOALS: Roughly 8% of children in the United States have a diagnosed food allergy (FA). The ubiquity of most food allergens increases the potential for accidental exposures. Clinical trials (CT) are used to test novel treatments for FA. This project will evaluate the influence of biopsychosocial factors on interest in CT participation for pediatric FA. METHODS/STUDY POPULATION: This project is subsumed under the FORWARD study (5R01AI130348-04), a multisite study currently underway at four pediatric FA clinics across the United States. Eligible participants include patients and families who meet the following criteria: 1) New clinic visit presenting for a possible FA complaint and/or has a physician diagnosis in a follow-up clinic visit; 2) child is between the age of 6-months and 12 years at intake visit; 3) are English speaking, and 4) no history of developmental disorders. Parents are asked to complete an intake survey, followed by a series of quarterly surveys administered via REDCap. A single variable from the intake survey queries interest in CT participation; quarterly surveys assess FA knowledge, attitudes, health beliefs, and management practices. RESULTS/ANTICIPATED RESULTS: To date, 890 families have completed the intake survey. Working hypotheses include: 1) parents of older children and children with a higher condition severity rating will report greater levels of interest in CT participation; 2) parents with greater FA knowledge, more health management beliefs that support action, and less FA-related anxiety, will report greater levels of interest in CT participation; 3) relative to White families, African American families will be less interested in participating; 4) families with >1 child with FA will report greater levels of interest in CT participation; 5) families who are uninsured, low-SES, and are unemployed will report lower levels of interest in CT participation; and 6) families with higher educational attainment will report lower levels of interest in CT participation. DISCUSSION/SIGNIFICANCE: This study will advance decision science, address existing disparities, and have far-reaching clinical implications. This novel approach will enhance our ability to predict who is at the greatest risk of anaphylaxis and help healthcare providers identify families who could benefit from experimental treatment options for pediatric FA.

OBJECTIVES/GOALS: Determine if exposure to violence at different life stages (childhood versus recent exposure) in postpartum women is associated to increased risk of weight retention more than 1 year and no more than 2 years after delivery, thus increasing health risk in short and long term. METHODS/STUDY POPULATION: Participants will be recruited from a cohort of post-partum women who received services from the Puerto Rico Women and Children Program (PR WIC) during pregnancy and postpartum period as per PR WIC established criteria. Families that have completed their participation in a Lifestyle intervention trial will be paired 2:1 with eligible nonparticipants that fulfill trial enrollment criteria. Language, culture validated instruments will be used to document maternal violence exposure in childhood and recent exposure, defined as within the last 12 months. To asses weight retention, pre-pregnancy weight will be compared to actual weight at the moment of evaluation, anthropometric measurements (weight, length, body composition, and fat mass) will be used to determine the health risk category for each participant. RESULTS/ANTICIPATED RESULTS: Expected results will be that there is an association between violence exposure and weight retention among post-partum women, thus influencing their weight status. The use of the questionnaires as screening tool for history of violence and whether recent or childhood exposure should be considered a health risk during pregnancy and post-partum predisposing women to adipose tissue related disorders. DISCUSSION/SIGNIFICANCE: Findings will reinforce the importance of integrated screening and proactive management of social determinants of health within clinical and social services that target this population. Also, contribute to the development of strategies tailored to break violence cycle as a public health measure.

The COVID-19 pandemic led to an increased need to conduct research and community engagement using digital methods. Unfortunately, the shift away from in-person research activities can make it difficult to engage and recruit participants from under-resourced communities that lack adequate digital infrastructure. At the beginning of the pandemic, our team recognized that imminent lockdowns would significantly disrupt ongoing engagement with low-income housing resident community partners and that we would ultimately bear responsibility if that occurred. This manuscript outlines the development of methods designed to create capacity for virtual engagement with a community advisory board that were subsequently applied to a longitudinal mixed-methods study. We describe how our experience engaging low-income housing residents during the height of the pandemic influenced the approach and offer guidelines useful for engaging under-resourced communities regardless of setting. Of these, a strong commitment to providing technology, unlimited data connectivity, and basic digital literacy training/technical support is most important. While each of these is essential and failure in any one area will reduce overall effectiveness of the effort, providing adequate technical support while maintaining ongoing relationships with community members is the most important and resource-intensive.

OBJECTIVES/GOALS: Since 2013, managers of community engagement (CE) programs across the Clinical and Translational Science Award (CTSA) consortium funded by the National Center for Advancing Translational Sciences (NCATS) have convened monthly to build connections, share knowledge, and enable collaboration. METHODS/STUDY POPULATION: Notable for focus on staff leadership, the CE Brokers group has been central to the ongoing success of CTSA community engagement partnerships and approaches to research. In early 2022, a survey of the 139-member group asked about their roles and responsibilities, the ways the CE Brokers network has contributed to their hubs adoption and development of best practices and innovations, resources and lessons learned, and the creation of opportunities for members to collaboratively conduct and disseminate original research, and research on the science of community engagement. The survey also asked CE Brokers if they or their community partners are part of an underrepresented community. RESULTS/ANTICIPATED RESULTS: These demographic data will be shared, along with analyses of data on growth of the group over time, evolving themes, and a SWOT analysis completed in 2021. DISCUSSION/SIGNIFICANCE: This will provide a platform to explore new avenues for the CE Brokers and their impact within the NCATS CTSA consortium, in line with the evolving direction of the clinical and translational research enterprise.

OBJECTIVES/GOALS: COVID-19 has taken a big toll on health, mental health and community well-being. COVID-19 has also presented unique opportunities for community engagement programs to sustain their work within communities. Low-tech methods of engagement might provide opportunities for success. METHODS/STUDY POPULATION: When we could not be in the field due to COVID-19, we recontacted our 12.4k HealthStreet members by phone and in 12 months successfully contacted 3.2k. By contrast, over the two COVID affected years (2019 & 2020), our in-person recruitment efforts in the community fell to 832 from 1817 in the two prior years (2017 & 2018). Reconnecting with existing members is an important aspect of sustainable community engagement. RESULTS/ANTICIPATED RESULTS: While 8/10 of the 3.2 K sample had internet access in their homes, 9/10 said having it was somewhat to very important. Importantly, 1 in 3 people who had additional needs or suggestions were looking for better COVID-19 knowledge or ways to reduce the threat of illness, 1 in 4 wanted resources; and 1 in 5 encouraged us to keep doing what we were doing. Among recontacted members, 30.2% indicated a high stress level (8 & over on a 10 point scale) while 15.2% reported a high level of loneliness (8 & over on a 10 point scale). High stress was significantly more likely among those identifying as African American (23.1%) compared to non-African American (16.6%). Loneliness did not vary (10.1% among both). DISCUSSION/SIGNIFICANCE: Sustainable community engagement was important to reach community members during the pandemic, especially given the high rates of stress and loneliness among members contacted. In-person connections were reduced, but phone contact provided an opportunity for successful engagement.

OBJECTIVES/GOALS: The prevalence of patients with end-stage kidney disease (ESKD) in PR has increased in the last decade along with an aging population, while waitlisted patients have decreased. Our objective is to compare clinical and sociodemographic characteristics of patients with ESKD on dialysis who are waitlisted from those who are not waitlisted. METHODS/STUDY POPULATION: Retrospective study of all patients with ESKD who received dialysis in PR from 2013-2019, based on the United States Renal Data System data. Variables: (1)waitlisting status (yes or no; waitlisting date); (2)sociodemographics (age at dialysis initiation, sex, zip-code area, health insurance type, and employment status); and (3)clinical characteristics (dialysis initiation date, primary diagnosis of renal disease, comorbidities including obesity, diabetes, peripherovascular/cardiovascular disease, cancer, etc.). Statistics: (1)descriptive statistics (continuous - central tendency [mean, median] and dispersion [standard deviation, interquartile range]; and categorical [frequencies and percentages]); (2)Chi-square test, Students t-test, and Mann Whitney U test to evaluate differences. RESULTS/ANTICIPATED RESULTS: We expect patients on dialysis not waitlisted will be older and have more comorbidities than those who are on dialysis and waitlisted. DISCUSSION/SIGNIFICANCE: Kidney transplant is the choice of therapy for ESKD and its benefits are better quality of life, improved survival, and best long term-cost effectiveness. If our hypothesis is true, findings will highlight the importance of characterizing which patients with ESKD on dialysis are kidney transplant candidates when considering barriers to waitlisting.

OBJECTIVES/GOALS: Our research has three main aims: 1. Measure attitudes toward a SARS-CoV-2 vaccine among BIPOC. 2. Assess the effectiveness of race-conscious public health messages in changing attitudes toward a SARS-CoV-2 vaccine. 3. Test the efficacy of financial incentives to increase uptake of a SARS-CoV-2 vaccine. METHODS/STUDY POPULATION: We surveyed 784 unvaccinated residents of L.A. County. To recruit participants, we collaborated with Qualtrics. The survey randomized participants to one of three public health messages, as well as one of two financial compensation schemes. Twenty-five participants completed semi-structured interviews via Zoom or telephone. Interviews were audio recorded, translated into English if needed, and transcribed. The inductive, semi-structured interview guide focused on three domains: i) concerns and distrust toward a COVID vaccine, ii) policy interventions and/or government action related to a COVID vaccine, iii) non-pharmacological policy interventions related to the COVID-19 pandemic. Major emergent themes were identified and analyzed using Watkins (2012) team analysis of qualitative data steps. RESULTS/ANTICIPATED RESULTS: Many BIPOC remain vaccine hesitant: 2/3 of the survey respondents stated that they did not intend to or were not sure if they planned to get vaccinated. Follow-up interviews show that fear of vaccine side effects, bodily autonomy in choosing to get vaccinated are major concerns. However, public health measures like masking and physical distancing remain preferred safety methods for BIPOC residents. Misinformation and overcommunication in public health messaging concerning vaccine eligibility may be a major barrier to vaccine uptake among BIPOC. DISCUSSION/SIGNIFICANCE: Real world financial compensation mechanisms need to provide large enough compensation to avoid a crowding out of altruistic vaccination motivations and to effectively incentivize increased vaccine uptake. Additionally, short race-conscious public health messages were ineffective at improving vaccine attitudes.

OBJECTIVES/GOALS: Health insurance status is associated with differences in access to healthcare and health outcomes. The objective of this study was to test the hypothesis that among infants born in the United States, maternal private insurance compared with public Medicaid insurance would be associated with a lower infant mortality rate (IMR). METHODS/STUDY POPULATION: This ecological study used data from the Center for Disease Control and Prevention (CDC) WONDER expanded linked birth and infant death records database 2017-2018. We included hospital-born infants from 20 to 42 weeks of gestational age (wga) if the mother had either private or Medicaid insurance. We excluded infants with congenital anomalies and infants who died due to congenital anomalies. We used negative-binomial regression adjusted for race, sex, multiple birth, and any maternal pregnancy risk factors (as defined by the CDC) to determine the difference in IMR between private and Medicaid insurance. Chi-square or Fishers exact test was used to compare differences in categorical variables between groups. RESULTS/ANTICIPATED RESULTS: We included 6,901,328 infants; 53.6% had private insurance and 46.4% were insured by Medicaid. Privately insured infants had a lower IMR compared with Medicaid insured infants (2.84/1000 vs. 5.32/1000; adjusted relative risk (aRR) 0.71; 95% confidence intervals (CI) 0.62 to 0.81; p<.0001). The privately insured had higher rates of 1st trimester prenatal care compared to those with Medicaid (85.6% vs. 66.6%; p<.00001). Rates of infant morbidity and maternal morbidity (per CDC definitions) were lower among the privately insured compared to those with Medicaid (both p<.00001). The privately insured had lower rates of preterm (9.1% vs. 11.0%), extremely preterm (0.5% vs. 0.7%), low birth weight (7.1% vs. 9.6%), and extremely low birth weight (0.5% vs. 0.7%) births compared to those with Medicaid (all p<0.001). DISCUSSION/SIGNIFICANCE: Private insurance is associated with a lower IMR compared to Medicaid insurance. Privately insured pregnancies also have higher rates of early prenatal care, less morbidity, and less preterm and low birth weight births. There may be opportunities to improve access to care and pregnancy outcomes among Medicaid insured pregnancies in the United States.

OBJECTIVES/GOALS: The Penn State CTSI has been working diligently to help communities in their fight against COVID-19. As the rapidly evolving COVID-19 situation has unfolded the Penn State CTSI has been able to provide support to our community stakeholders. As our communities have and are faced with unprecedented challenges, our CTSI has been there every step of the way. METHODS/STUDY POPULATION: The Penn State CTSI is unique as it sits in rural Pennsylvania that not only spans a wide catchment area but also many diverse communities. The Penn State CTSI connected with our communities throughout the pandemic to bring timely and culturally appropriate information about the novel COVID-19 pandemic through our own institution and in partnership with community leaders. Stakeholder boards were formed to hear from various communities about hardships and challenges that were and are being faced due to COVID-19. RESULTS/ANTICIPATED RESULTS: The Penn State CTSI provided our communities with information through various different platforms to ensure that needs were being met in dissemination of pertinent information related to COVID-19. No only was information tailored to the specific needs that were discussed during stakeholder boards, the information was provided in different languages and platforms in order to meet cultural and other needs to ensure health equity and literacy were met. DISCUSSION/SIGNIFICANCE: Not only did the Penn State CTSI provide these services to our current community partners new partnerships were formed to create stronger alliances amongst those being serve. Members of the Penn State CTSI were invited to serve on state and local advisory bords and became trusted messengers in our communities.

Clinical research is complex, and research-related terms can be challenging to understand. Clear, supportive communication with patients, potential study participants, and their caregivers must be prioritized by healthcare providers as well as investigators and their research teams. In clinical research, health literacy best practices support the ethical tenets of respect, justice, and beneficence. Plain language advances the understanding of informed consent documents, as well as comprehension of educational information, recruitment materials, study instructions, and study results summaries, among others. Further, a more collaborative research partnership is fostered when study participants are given understandable materials, while a lack of understanding can delay accrual and decrease adherence. We launched a pilot initiative to develop a consensus-driven, plain language clinical research glossary to promote clarity, consistency, and transparency across clinical research stakeholder groups. The resulting resource, described herein, is intended to be used widely to support a greater understanding of clinical research and empower study participants. Considerations for expansion are also discussed.