ABSTRACT IMPACT: This research will aid clinical and policy solutions on lessening the vast health disparities and overall access issues for low-income, type 1 diabetes patients. OBJECTIVES/GOALS: Identify key barriers to accessing continuous glucose monitors (CGMS) and care options for low-socioeconomic status (SES) patients on public insurance. Low-SES patients with type 1 diabetes (T1D) have lower utilization rates of effective diabetes management technologies and worse clinical outcomes. METHODS/STUDY POPULATION: A literature review was conducted to understand the current research landscape for T1D and lead to the identification of potential barriers which included socioeconomic status, low-income, health literacy, and racial/ethnic minority. Clinicaltrials.gov was searched using the keyword ‘type 1 diabetes’ in conjunction with the identified barriers (as well as the keyword ‘barrier’). A follow up review of each state’s Medicaid programs was conducted to analyze cost and access options for CGMs and the overall financial burden of the disease on low-SES T1D patients. States that offered CGM coverage were further analyzed to determine reimbursement rates and actual out-of-pocket cost for patients. RESULTS/ANTICIPATED RESULTS: Of 285 trials identified from Clinicaltrial.gov searches, only seven relevant trials examined barriers and T1D for low-SES patients. Additionally, many of these studies, both in and outside of the clinical trial space, seldom distinguished between type 1 and type 2 diabetes’‘ an important distinction given that T1D has a higher financial burden and a quicker onset of complications. Currently, 39 states offer various insurance coverage through their Medicaid programs, but have clinical restrictions and requirements such as pediatric coverage only or minimum blood glucose requirement checks. Additionally, there is vast variability in reimbursement rates between states ($0-$800). DISCUSSION/SIGNIFICANCE OF FINDINGS: Study results indicate less effective diabetes management for low-SES T1D patients and a need for more intersectional clinical trial research. Differences in state’s Medicaid CGM coverage, expressed in disparate clinical outcomes for these T1D patients, belies financial incentives to health improvements, as annual US T1D costs are $14.4 billion.

ABSTRACT IMPACT: By developing and validating a simple and cost-effective at-home screening tool for loss of smell, we can efficiently detect infection with COVID-19, neuropsychiatric disease such as Alzheimer’s, and post-operative smell loss. OBJECTIVES/GOALS: To develop and validate a feasible and cost-effective screening tool for olfactory dysfunction (OD) using common household items. METHODS/STUDY POPULATION: The study has two phases. In the Development phase, 120 participants with self-reported smell changes will complete a survey with a list of 45 household items to smell. Item reduction to develop the NASAL Short Smell Test will occur by measuring content validity, factor analysis, and internal consistency. In the Validation phase, 200 participants with self-reported smell changes will take the NASAL Short Smell Test at baseline and again at three weeks. In both phases, the validated University of Pennsylvania Smell Identification Test (UPSIT) will be used as the gold standard. Measures of performance as well as test-retest reliability and sensitivity to change will be measured. RESULTS/ANTICIPATED RESULTS: We anticipate that the majority of participants will have at least half of the items in their household and will report ability to smell for each. Measures of sensitivity, specificity, likelihood ratios, and UPSIT score correlations will allow us to evaluate performance of each item. Item reduction will allow us to create the NASAL Short Smell Test, in which a handful of common items will be used to create a screening tool for smell loss. The Validation phase will allow us to measure discriminative performance of this tool as well as test-retest reliability and sensitivity to change, which we expect to be at least comparable to the validated UPSIT. DISCUSSION/SIGNIFICANCE OF FINDINGS: Current tools for diagnosis of OD are costly, time-consuming, and often require a clinician to evaluate. The validation of the simple at-home NASAL Short Smell Test to screen for OD will allow us to detect infection with COVID-19, neuropsychiatric disease, or post-operative smell loss quickly and efficiently.

ABSTRACT IMPACT: The WISE Indiana COVID-19 project facilitates rapid response and access to relevant and emerging evidence-based information for state personnel, healthcare providers and systems, managed care entities, community organizations, and all others involved in a professional capacity with the pandemic response. OBJECTIVES/GOALS: The COVID-19 project was developed to assist in responding to the Indiana Department of Health’s need for rapid and evidence-informed responses to complex questions about the pandemic and best practices for preventing, mitigating, monitoring and recovering from the COVID-19 global pandemic. METHODS/STUDY POPULATION: The WISE Indiana team was activated to assist in managing the project and immediately connected with university research librarians. Through our established networks, we were able to quickly engage academic researchers and clinicians across the state to rapidly respond to key questions about COVID-19 from government leadership. Research librarians added their expertise by conducting comprehensive searches of evidence-based clinical, public health, policy, and law literature and writing up detailed annotated bibliographies. Academic experts were also recruited to write daily summaries of emerging COVID-19 literature for the benefit of Indiana’s frontline responders and build and maintain an online repository of evidence-based learning materials for practitioners on the front lines. RESULTS/ANTICIPATED RESULTS: This work has informed key decision-making at many levels of Indiana’s COVID-19 response. Examples include data modeling for the IN.gov COVID-19 Dashboard, the allocation of Remdesivir, decisions about resuming elective procedures, and strategies for scaling back mitigation efforts. The WISE Indiana team has been able to engage over 40 academic experts from across the state of Indiana with expertise in pulmonary, infectious disease, law, epidemiology, mental health, public health, policy, and communications to assist in responding to key questions posed by government leadership and writing summaries of emerging COVID-19 literature which is summarized and accessible through our website: https://indianactsi.org/community/monon-collaborative/covid-19/. DISCUSSION/SIGNIFICANCE OF FINDINGS: The bidirectional exchange of information through the WISE Indiana collaborative network enable our team to quickly pivot to respond to the needs of our government leadership. Our team was able to rapidly translate the evidence-based information in order to respond to the policy and health outcomes needs of the state’s response to the global pandemic.

ABSTRACT IMPACT: Our research highlights the need for both parental and clinical support to promote PA engagement among higher risk youth with comorbid asthma and obesity; these findings will inform research and clinical efforts in the youth development, prevention science, and clinical psychology fields. OBJECTIVES/GOALS: Asthma incidence doubles in youth with obesity. Physical activity (PA) is beneficial for asthma management; however, parental influence on PA levels among youth with asthma and obesity is poorly understood. This study examines the association of parents and PA among youth with asthma and/or obesity, accounting for risk and protective factors. METHODS/STUDY POPULATION: Data from 5th, 8th, 9th, and 11th-graders were obtained from the 2019 Minnesota Student Survey (N=96,820). Linear regressions examined the impact of parent connectedness on PA across 4 groups (neither asthma nor obesity [OB], asthma only, OB only, comorbid asthma/OB). The p-value for significance was set at p<.001. For PA, youth reported how many days they were physically active (≥60 min/day) in the last week. Two items assessing youth perception of parent care and ability to talk to parents about their problems were used to measure parent connectedness. BMI was calculated using self-report height/weight, age, and gender. Control variables included age, race/ethnicity, and free/reduced lunch eligibility. Models 2-4 retained parent connectedness variables and added risk and protective factors. RESULTS/ANTICIPATED RESULTS: In Model 1, both parent variables significantly predicted PA for each risk group (β ranges: parent care=.07-.09; parent talk=.04-.05, p<.001), except for the asthma/OB group (parent talk: p>.001). Models 2 and 3 added risk factors. Depression was the most salient risk factor, particularly for the highest risk group (asthma/OB; β =-.13, p<.001). Safe neighborhood was positively associated with PA for all groups (βs= .05, p<.001) except the asthma/OB group (p>.001). In Model 4, extracurricular activity involvement (protective factor) was positively associated with PA across all groups (β ranges=: .07-.11, p<.001), and depression remained significant across all groups (β ranges=-.11 to -.14, p<.001). For models 2-4, only parent care remained significant for the neither asthma nor OB group (β =.04, p<.001). DISCUSSION/SIGNIFICANCE OF FINDINGS: Results demonstrate that although parent care is an important protective factor for youth PA engagement, it is less impactful when additional risk factors (e.g., depression) are present, particularly among the highest risk group (comorbid asthma/OB). Thus, clinical support is needed in addition to parent support among higher risk youth.

ABSTRACT IMPACT: Better understanding of the factors impacting disease severity and immunological response of MS patients on disease modifying therapy will enable better recommendations for vaccination options and risk mitigation strategies OBJECTIVES/GOALS: The Coronavirus Disease 2019 (COVID-19) and global health crisis has raised health concerns for patients with multiple sclerosis (MS). We aim to study the clinical characteristics, immunological laboratory data, and immunoglobulin response in patients with MS and COVID-19, to identify factors impacting disease severity and immune response. METHODS/STUDY POPULATION: Database search was done using DataDirect to search for MS patients who had tested positive for COVID-19 at the University of Michigan hospital. Patients with a positive nasopharyngeal swab polymerase chain reaction (PCR) for COVID-19 between March 1 and September 2020 were included. The primary outcome was the immunological laboratory data and immunoglobulin levels and the secondary outcome was their disease severity. We collected demographics, neurological history, MS treatment, Expanded Disability Scale Score (EDSS), comorbidities, and COVID-19 characteristics. A 7-point ordinal scale previously used to assess disease severity was used. Univariate and multivariate analyses will be performed to assess relationships between the collected variables. RESULTS/ANTICIPATED RESULTS: A total of 17 patients, mean age 53 (SD 11.6) years, mean disease duration, 6.2(SD 4.1) years were analyzed. 41% of patients had relapsing remitting multiple sclerosis, 17% had primary progressive MS. (88%) patients were on Disease Modifying Therapy (DMT) at the time of COVID-19 diagnosis. 2 patients died from COVID-19 complications. There was a higher proportion of patients with higher disease severity receiving Ocrelizumab. Only one patient showed positive IgG to SARS-CoV-2 after the resolution of infection. CBC with differential was obtained and a longitudinal follow-up of labs will be done. Regression analysis will be done to check the association between the use of DMT, immunological response, and COVID disease severity in them. The impact of COVID-19 on MS relapse, EDSS, and MRI activities will also be studied. DISCUSSION/SIGNIFICANCE OF FINDINGS: Recommendations to continue current DMT have been made, however, the immune response has not been correlated with the individual’s risk profile. Certain therapies may interfere with mounting a protective immune response of COVID-19 and this knowledge is crucial when advising patients regarding the choice of vaccine and risk mitigation strategies.

ABSTRACT IMPACT: For community engagement to be impactful and reduce health inequity, it needs to address timely needs in the community, including COVID-19 impacts. Here, we describe how pre- and post-COVID-19 food insecurity worsened mental health among community members served by HealthStreet University of Florida community engagement program. OBJECTIVES/GOALS: COVID-19 impacts the economic vitality and the mental health of communities; research and engagement activities must consider the context in which we are practicing and the needs of our community members. METHODS/STUDY POPULATION: HealthStreet, the University of Florida community engagement program, sends Community Health Workers (CHWs) where people congregate to assess social determinants of health and medical histories, used to make referrals to services and research opportunities. CHWs conducted follow-up COVID-19 assessments measuring perceived stress, loneliness, depression, anxiety, binge drinking, and opioid use, as well as high blood pressure and food insecurity. Here, we consider mental health outcomes among 1,300 adults who reported being food insecure either at some time in the past 12 months at baseline, or at the COVID-19 follow-up assessment, and completed both. Chi-Square Test was used to determine p-values. RESULTS/ANTICIPATED RESULTS: Overall, at the COVID-19 follow-up assessment, 37.1% (of 1,300) were still food insecure during COVID-19 (same), 20.3% (had become food insecure during COVID-19 (worse) and 42.6% were no longer food insecure (better). Those who were no longer food insecure were more likely to report less stress, while those still food insecure were more likely to report the highest stress and loneliness (p<0.0001), while the worse off group was in the middle. Those who stayed food insecure were most likely to report depression and anxiety, and also high blood pressure and using opioids (p<.05) compared to those getting worse or better. Binge drinking behavior was not significantly different across groups. DISCUSSION/SIGNIFICANCE OF FINDINGS: Community engagement activities across CTSIs must be sensitive to the needs of their communities. HealthStreet findings show that new and continuing food insecurity negatively influence mental health problems, pointing to the need for engagement to address multiple problems.

ABSTRACT IMPACT: This is the first examination of risk factors for prolonged opioid use after an ICU stay and will inform efforts to strengthen prescribing guidelines and care transition models for patients after critical illness. OBJECTIVES/GOALS: The majority of patients in intensive care units (ICU) receive opioids during admission, and up to 25% receive a prescription at discharge. However, transitions of care and prolonged use after discharge remain unknown. We aim to characterize risk factors for prolonged opioid use after an ICU stay. METHODS/STUDY POPULATION: A retrospective study using insurance claims from Optum Clinformatics ®Data Mart was conducted for opioid-naive adult patients (18-64 years) with an ICU admission from 2010 to 2019. The primary outcome was new persistent opioid use, defined as a continued prescription fill 91-180 days after discharge, in addition to a fill in the first 90 days. The primary exposure was an opioid fill at discharge. The ICU admission was characterized using the Clinical Classification System from the Agency of Healthcare Research and Quality, based on patients’primary diagnosis code. Diagnoses were combined into 11 groups highlighting the affected organ system/mechanism of injury. Logistic regression evaluated the associations of patient demographic and clinical characteristics with the probability of persistent opioid use. RESULTS/ANTICIPATED RESULTS: In this cohort of 90,721 patients discharged from the ICU, 3.3% continued to fill opioids at 6 months. An opioid prescription fill (OR 3.1; 95% CI 28 - 3.3) and benzodiazepine prescription fill (OR 1.6; 95% CI 1.4 - 1.8) within 3 days of ICU discharge were each significantly associated with the development of new persistent opioid use. Patient diagnosis groups of Musculoskeletal/Trauma (OR 2.3; 95% CI 2.0 - 2.6), Neoplasms (OR 1.6; 95% CI 1.5 - 1.9), and GI/Hepatobiliary (OR 1.5; 95% CI 1.3 - 1.8) were significantly more likely to develop new persistent use when compared to the Cardiovascular diagnosis group. DISCUSSION/SIGNIFICANCE OF FINDINGS: Opioid prescriptions at discharge after an ICU stay increase the odds of prolonged opioid use. These results will inform efforts to strengthen prescribing guidelines and care models after a critical illness. Further work will characterize the trajectory of prescribing and patient exposure to high-risk prescribing after ICU discharge.

ABSTRACT IMPACT: The integration of patient-reported outcome measures into clinical care is feasible and can facilitate patient-centered care for individuals with systemic lupus erythematosus. OBJECTIVES/GOALS: Patient-reported outcome measures (PROMs) are powerful tools which can facilitate patient-centered care by highlighting individuals’ experience of illness. The aim of this study was to assess the feasibility and impact of implementing web-based PROMs in the routine clinical care of outpatients with systemic lupus erythematosus (SLE). METHODS/STUDY POPULATION: Outpatients with SLE were enrolled in this longitudinal cohort study at two academic medical centers. Participants completed PROMIS computerized adaptive tests assessing multiple quality of life domains at enrollment and prior to two consecutive routinely scheduled rheumatology visits using the ArthritisPower research registry mobile or web-based application. Score reports were shared with patients and providers before the visits. Patients and rheumatologists completed post-visit surveys evaluating the utility of PROMs in the clinical encounters. Proportions with confidence intervals were calculated to evaluate survey completion rates and responses. RESULTS/ANTICIPATED RESULTS: A total of 105 SLE patients and 16 rheumatologists participated in the study. Subjects completed PROMs in 159 of 184 eligible encounters (86%, 95% CI 81 - 91), including 90% of visit 1’s (95% CI 82 - 95) and 82% of visit 2’s (95% CI 72 - 90. Patients and rheumatologists found that PROMs were useful (91% and 83% of encounters respectively) and improved communication (86% and 72%). Rheumatologists reported that PROMs impacted patient management in 51% of visits, primarily by guiding conversations (84%), but also by influencing medication changes (15%) and prompting referrals (10%). There was no statistically significant difference in visit length before (mean=19.5 min) and after (mean=20.4 min) implementation of PROMs (p=0.52). DISCUSSION/SIGNIFICANCE OF FINDINGS: The remote capture and integration of web-based PROMs into clinical care was feasible in a diverse cohort of SLE outpatients. PROMs were useful to SLE patients and rheumatologists and promoted patient-centered care by facilitating communication.

ABSTRACT IMPACT: This work has the potential to help clinicians decide which infants exposed to in utero opioids, will need to be treated early or can be discharged home early based on their risk, thus reducing prolonged hospitalization OBJECTIVES/GOALS: To develop and validate a prediction model with inclusion of clinical and demographic risk factors to identify infants with NAS likely to need pharmacotherapy. METHODS/STUDY POPULATION: A pooled cohort of 761 infants from 5 different studies including 2 trials and 3 observational cohorts will be used to develop the model.

All infants >than or equal to 37 weeks gestational age born to mothers with history of OUD will be included. Infants with congenital disorders and severe medical and surgical illnesses will be excluded. Multivariable mixed effects logistic regression modeling will be performed to predict the need for pharmacologic treatment for NAS. Candidate variables will be included based on clinical knowledge and previously published data. Model performance will be evaluated by measuring discrimination using Area Under the Curve (AUC) statistics and calibration. Model will be internally validated using boot strap validation. RESULTS/ANTICIPATED RESULTS: Pending data analysis DISCUSSION/SIGNIFICANCE OF FINDINGS: Opioid Use Disorder in pregnancy has resulted in concurrent rise in NAS incidence. NAS affects opioid exposed infants variably and accurate prediction of its severity and need for treatment remains elusive. Known clinical and demographic factors can predict the need for NAS therapy in opioid exposed infants, aiding clinical decision making.

ABSTRACT IMPACT: To date, our Scholars have been highly productive in the conduct of impactful research and have contributed to the literature through dissemination of their findings. OBJECTIVES/GOALS: The primary purpose of the Great Plains IDeA Research Scholars Program (RSP) is to support the development and retention of early-career faculty preparing to compete for external funding as clinical-translational research (CTR) investigators. We developed processes for RSP applications, prioritization, and selection criteria. METHODS/STUDY POPULATION: In year 1, we admitted 4 Scholars and have since added 5 additional Scholars. Scholars are retained in the program until they receive R- or K-level funding or if progress is deemed to be substandard on two consecutive 6-month reviews (no awards revoked to date). Each scholar was assigned a mentor(s) or mentoring team. Each participant developed 1-year goals and a 4-5-year plan that included a refined proposal to collect preliminary data, a timetable for grant submissions (with a focus on R01 applications or equivalent), and personal goals to enhance chances of success. Scholars composed an Individual Development Plan (IDP) with mentor(s) feedback to identify the skills needed to achieve goals. Each Scholar completed pilot work to generate the requisite preliminary data for an extramural grant application. RESULTS/ANTICIPATED RESULTS: Over four years, we have had 9 scholars from 4 sites with 51 total applications. All scholars completed required grant writing seminar courses, an 8-hour Responsible Conduct of Research course, and were given access to seminars and workshops sponsored by the Great Plains IDeA CTR. Scholars received 0.5 FTE in research support and $50,000 annual funding to support their research and/or career development activities. Seven of 9 scholars have completed the program to date, collectively receiving an R01 (1), a U01 (1), a K23 (1), a VA Career Development Award (1), or COBRE pilot projects leadership roles (3). All remain active faculty at their institution. Two remaining scholars are working towards independent funding: both have submitted extramural grant applications with anticipated funding this year. DISCUSSION/SIGNIFICANCE OF FINDINGS: To date, our Scholars have been highly productive in the conduct of impactful research. They have submitted 36 grants; culminating in 27 funded projects and >$7.5 million in total funding for 7 graduates. They have disseminated their findings through 121 publications and 48 invited regional/national presentations.