OBJECTIVES/GOALS: We aim to describe the preschool age developmental outcomes of children born full term or late preterm requiring care in the Childrens Wisconsin (CW) neonatal intensive care unit (NICU). Our objective is to develop a model to predict which NICU infants are at high risk for abnormal preschool age development based on their neonatal characteristics. METHODS/STUDY POPULATION: Retrospective cohort study including full term (≥ 37 weeks) and late preterm (34-36 weeks) infants admitted to the CW NICU between 1/1/2013-12/31/2015 with a developmental assessment by a general practitioner or neuropsychology evaluation between 3-6 years of age. Data extraction will include maternal history, neonatal and delivery factors, and developmental evaluation results. Descriptive statistics will be used to determine the proportion of patients with abnormal preschool development stratified by NICU diagnoses, surgical procedures, subspecialty involvement, and patient demographics. Decision tree analysis will be performed to generate a prediction model identifying those infants at higher risk than their peers for an abnormal developmental assessment at 3-6 years of age. RESULTS/ANTICIPATED RESULTS: Analysis to date reveals 1360 patients ≥ 34 weeks gestation admitted to the CW NICU between 1/1/2013-12/31/2015. 80 patients received neuropsychology evaluations and the remaining 1280 patients had general practitioner developmental assessments. We anticipate that those infants referred for neuropsychology evaluation will have a higher proportion of abnormal developmental assessments when compared to those patients with routine general practitioner assessments. In addition, we hypothesize that common neonatal factors among the infants who received neuropsychology assessments will best predict abnormal preschool development within the decision tree analysis. DISCUSSION/SIGNIFICANCE: This study is one of the first to define risk factors in full term and late preterm infants cared for in the NICU associated with abnormal preschool age development. Identifying these infants at high-risk early on will allow providers to initiate early developmental interventions, schedule close NICU follow-up care, and provide parental counseling.

ABSTRACT IMPACT: We are adapting a global telehealth platform and model of care to the U.S. context in order to solve the problem of undertreatment of age-related hearing loss and, in turn, facilitate healthy aging and social engagement among older adults. OBJECTIVES/GOALS: Intelehealth is a nonprofit startup that provides medical care to last-mile populations in India by equipping frontline health workers with an open-source digital assistant and telemedicine platform. Here, we explore how this technology and model of care might be adapted to address health inequities in the context of the U.S. healthcare system. METHODS/STUDY POPULATION: We first sought to identify a specific healthcare need that we could address as a case study on applying the Intelehealth model more broadly in the U.S. context. We began with a needs assessment, wherein we conducted primary ethnographic research, expert interviews, and literature review to identify problems in the general areas of health disparities, community health workers, and telemedicine accessibility. We then scored each need on clinical impact, feasibility, business potential, and strategic fit. After a top need was selected, a root cause analysis was performed. Brainstorming and solution concepting will be followed by prototyping, iterative design with primary stakeholder feedback, usability testing, and finally implementation and validation of the solution. RESULTS/ANTICIPATED RESULTS: Of 106 needs, the most highly scored was undertreatment of age-related hearing loss (ARHL). The third most common chronic condition in the U.S., ARHL presents a significant barrier to healthy aging and the single largest modifiable risk factor for dementia; yet only 15% of those with ARHL regularly use hearing aids. Thus, a large market segment - nearly 30 million Americans - is underserved by the current hearing care paradigm. Root cause analysis revealed that the primary reasons for hearing aid non-use include stigma around aging, denial of hearing loss, poor awareness of resources, and insufficient education around proper use and maintenance. These barriers, being primarily sociocultural in nature, may be optimally addressed by community health workers, making ARHL an ideal fit for the Intelehealth model. DISCUSSION/SIGNIFICANCE OF FINDINGS: We have identified ARHL as an optimal test market for Intelehealth in the U.S. By developing a targeted intervention to improve hearing aid access and acceptability among older adults, we will create a generalizable model for delivering care through community health workers equipped with a decision support and telemedicine platform.

OBJECTIVES/GOALS: The Translational Science Benefits Model (TSBM), developed at Washington University in St. Louis, was used to create a survey to collect group-level data on the real-world impacts of research. It was used with two cohorts of CTSA-supported pilot studies to compare the benefits of campus-community partnerships to campus-only projects. METHODS/STUDY POPULATION: Investigators from two funding streams were surveyed: a campus-based cohort (n=31), and a campus-community partnership cohort (n=6). All studies were related to COVID-19. The Translational Benefits Survey collected quantitative and qualitative data for each of the 30 TSBM benefits, in 4 benefit categories: clinical, community, economic and policy. Text provided by investigators to support each reported benefit was evaluated by two coders through a process that required coder consensus to verify a benefit as realized. Verified benefits were aggregated for each cohort, and the percentage of projects per cohort with realized clinical, community, economic and policy benefits were calculated. RESULTS/ANTICIPATED RESULTS: Campus-community partnerships did not realize any clinical benefits, whereas 26% of campus-based projects realized at least one clinical benefit. In contrast, campus-community partnerships were more likely to realize community health benefits (17% vs 10% of campus projects) and economic benefits (17% vs 13% of campus projects). We identified a substantial amount of self-reported benefits (64% across all categories) that were unable to be confirmed as realized using the provided text, which either described activities not relevant to the selected benefit, or lacked critical details needed to verify that the benefit was realized. DISCUSSION/SIGNIFICANCE: This project demonstrates that the TSBM can be utilized to collect group-level data and to compare cohorts’real-world benefits. It also illuminates the need to improve the process for verifying self-reported benefits. Sharing data on these real-world impacts has the potential to convey the strengths of translational science to the public.

OBJECTIVES/GOALS: Sodium (Na) intake can elevate blood pressure and is a factor in developing chronic kidney disease (CKD). Twenty-four-hour urinary Na (24hUNa) is the gold standard for assessing Na intake but is burdensome. Validated equations estimate 24hUNa (e24hUNa) from a spot urine sample, but these estimations are not validated against a known Na intake in CKD. METHODS/STUDY POPULATION: The current study is a secondary analysis of a 9-day controlled feeding study in moderate CKD patients matched to healthy adults. Only CKD patients were used for the current analyses (n = 8). Participants consumed a controlled diet for 9 days, providing ~2400 mg Na/d as determined by inductively coupled plasma optical emission spectroscopy (ICP). On days 7 and 8, participants collected all urine in an inpatient setting, beginning with a fasting sample on day 7. Urine sample mineral analyses were performed by ICP and urinary creatinine by the Jaffe reaction. The day 7 fasting urine sample was used to calculate e24hUNa using 6 published equations. Log-transformed Na intake, measured 24hUNa, and e24hUNa were compared by repeated-measures ANOVA with planned contrasts using SAS. RESULTS/ANTICIPATED RESULTS: Fifty percent of the CKD patients (n = 4) were female; 63% (n = 5) were white, and 37% (n = 3) were black. On average, participants were aged 56.6 ± 13.8 y with a BMI of 31.7 ± 9.4 kg/m2 and eGFR of 40.7 ± 7.9 mL/min. Based on actual food intake, average Na intake on day 7 was 2024 ± 388 mg. Average measured 24hUNa was 2529 ± 1334 mg. The main ANOVA was significant (p = 0.02). Results from the planned contrasts found that e24hUNa from the SALTED cohort, an equation developed specifically for CKD patients, was significantly higher than both Na intake (p<0.001) and measured 24hUNa (p = 0.007). For the remaining 5 equations, e24hUNa was not significantly different from measured 24hUNa nor dietary Na intake. DISCUSSION/SIGNIFICANCE OF IMPACT : Our results suggest that e24hUNa calculated using most published equations may provide a reliable and low-burden method of assessing dietary Na intake in moderate CKD patients. These findings should be confirmed in larger samples. Additional studies are needed to validate or dispute the use of the SALTED equation for estimating Na intake.

OBJECTIVES/SPECIFIC AIMS: If intranasal ketamine can be utilized for pain control in cancer patients, this could provide them with superior analgesia and better quality of life, without the risk of significant respiratory depression associated with opioid medications. We seek to obtain preliminary data via a clinical trial addressing safety, feasibility, and utility of this novel technique for the treatment of persistent uncontrolled cancer pain. These findings would be an important initial step towards testing the effectiveness of intranasal ketamine as a non-opioid medication for cancer pain used as potential maintenance outpatient therapy. These initial findings would be applied to a subsequent trial to determine the effectiveness and associated toxicities of ketamine in a larger sample of cancer patients, and address the compelling need to identify new, successful management therapies for cancer pain. Specific Aims: 1. To evaluate (pharmacodynamic) effects of NAS ketamine on Patient Reported Outcomes (PROs), such as pain scores, side effects, depression, quality of life, and functional status. A clinical trial will be conducted where NAS ketamine will be given to a sample of patients with cancer related pain. Patient Reported Outcomes (PROs), such as pain scores, depression, quality of life, and functional status will be noted on Numerical Pain Rating Scale (NPRS), Montgomery Asberg Depression Rating Scale (MADRS), and Edmonton Symptom Assessment (ESAS), Eastern Cooperative Oncology Group (ECOG) and Patient Reported Outcome Measurement Information System (PROMIS) scales respectively. 1. To measure pharmacokinetics of NAS ketamine through analysis of ketamine and its metabolite norketamine to determine pharmacokinetic properties. During this clinical trial blood samples will be drawn at specified intervals and sent for analysis. 3. To determine opioid sparing effect of NAS ketamine. Opioid use will be measured by documenting use of rescue medications prior to and during the study and by evaluating total opioid consumption prior to and during the study. METHODS/STUDY POPULATION: Study sample: In the search for improved therapies for chronic cancer pain, medications with novel mechanisms of action have been sought. One such promising pharmacologic approach is ketamine. We specifically intend to measure utility of ketamine in patients with pain related to cancer or cancer treatment. Ketamine has shown to reverse central sensitization and opioid tolerance in rat models. Since ketamine is Scheduled III in United States and has abuse potential, we do not intend for ketamine to replace opioids, but use in patients who have failed opioid therapy. Since the investigators of the study practice at Emory, subjects will be from oncology and pain clinics (the supportive oncology clinic, oncology clinics, the pain clinic and Acute Pain Service) at Emory. The trial will be conducted at the Phase 1 Unit of the Winship Cancer Institute (WCI) at Emory. Subjects may be identified and contacted via telephone with information about the study prior to their next clinic appointment in order to allow time for them to consider the study. Eligibility criteria: Patients will be eligible to participate if they are: 1. Adults with uncontrolled cancer related pain a. Male and female subjects at least 18 years of age. b. Patients with uncontrolled pain related to cancer or cancer treatment. c. Uncontrolled pain will be defined as i. pain which persists for more than 7 days and is rated >/=4 on NPRS, and/or ii. use of breakthrough medication more than 4 times in 24 hours d. Failed other pain medications such non-steroidal anti-inflammatories such as ibuprofen, acetaminophen, opioids such as tramadol, hydrocodone, oxycodone etc. and antineuropathics such as gabapentin. 2. Able to provide informed consent a. Patients who are able to understand written and verbal English. Patients will be excluded from the study if they have any of the following: 1. Conditions increasing the risk of side effects from ketamine a. Conditions not safe due to cardiovascular effects of ketamine i. Presence of severe cardiac disease-EF <15% in patients with known history of cardiac disease ii. Uncontrolled Stage 2 hypertension or greater (systolic blood pressure > 160 and/or diastolic blood pressure >100) iii. Baseline tachycardia, HR >100 b. Conditions not safe due to potential effect of ketamine on intracranial and intraocular pressure i. Presence of elevated ICP ii. Uncontrolled glaucoma c. Presence of uncontrolled depression or other psychiatric comorbidity with psychosis 2. Conditions not safe due to potential side effects reported in ketamine abusers a. History of liver disease b. History of interstitial cystitis 3. Conditions where delivery of intranasal medications may be unreliable a. Active allergic or infectious rhinitis b. Patients with lesions of nasal mucosa 4. Conditions where fetus may be exposed to ketamine in utero (ketamine is category C medication) a. Pregnant women, nursing mothers and women of childbearing potential not using contraception known to be highly effective. b. Highly effective contraception methods include combination of any two of the following: Use of oral, injected or implanted hormonal methods of contraception or; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository; Total abstinence; Male/female sterilization. 5. Conditions with medication abuse potential a. Illicit substance abuse within the past 6 months b. Documented history of medication abuse/misuse (e.g. Unsanctioned dose escalation, broken opioid agreement etc.) 6. Conditions where ketamine metabolism may be altered, resulting in erroneous dose response relationship a. Clinical requirement for medications that are concurrent inducers or strong inhibitors of CYP3A4. CYP3A4 substrates are allowed. (Ketamine is metabolized by CYP3A4) Study sample limitations: Subject factors that may affect the final resultant study sample of subjects with full data for analysis. 1. Subjects who may not get pain relief with ketamine may not follow up and resulting incomplete data not eligible for analysis that may erroneously enhance positive effect of ketamine on pain relief. To account for this effort will be made to document the reason for lack of follow-up by contacting patient via telephone or at next scheduled clinic visit within Emory Healthcare. 2. Since patients coming to Emory are typically insured, the study will not adequately capture indigent population. It is not the intention of the current study to investigate differences in pain characteristics or responses of patients with insurance vs indigent population and will need to be addressed via future trials. Since this is a single center trial, the results of this trial might lack external validity required to support widespread changes in practice. This will be a pilot trial to figure out likely most efficacious dose. If this trial is successful, a multi-site randomized clinical trial will be conducted next. Primary Study Measures Primary exposure Intranasal Ketamine for cancer related pain Ketamine is an FDA approved anesthetic with amnesic, analgesic, dissociative, and sedative properties. It is unique among anesthetic agents in that it does not depress cardiovascular and respiratory systems. Ketamine is a noncompetitive, antagonist of N-methyl-D-aspartate (NMDA) receptors that blocks the NMDA channel in the open state by binding to the phencyclidine (PCP) site located within the lumen of the channel. Antagonism of NMDA receptors produces antinociception of persistent or neuropathic pain in animal models and analgesia in pain states in humans. The NMDA receptor is believed to play a role in the development of opioid tolerance and ketamine has been shown in a rat model to prevent fentanyl-induced hyperalgesia and subsequent acute morphine tolerance 5. Ketamine also interacts at a number of other receptor sites to block pain. Some of these sites include voltage-sensitive calcium channels, depression of sodium channels, modulation of cholinergic neurotransmission, and inhibition of uptake of serotonin and norepinephrine. Ketamine also interacts with kappa and mu opioid receptors; however, in humans, naloxone, an opioid antagonist, does not antagonize the analgesic effects of ketamine. Safety and efficacy of ketamine as an anesthetic and analgesic agent is well-documented 2-4. Ketamine is not labeled by the FDA as an analgesic agent. Low (subanesthestic) doses of ketamine have minimal adverse impact upon cardiovascular or respiratory function but produce analgesia and modulate central sensitization, hyperalgesia, and opioid tolerance. Cancer pain, especially in end stages, can be very complicated and is mediated by a variety of pathways: visceral, nociceptive, neuropathic and central. If ketamine can be utilized for pain in end stage cancer patients, this could provide them with superior analgesia and better quality of life, without the risk of significant respiratory depression associated with opioid medications. One of the challenges that we face with ketamine is the route of administration. The most common route is intravascular or intramuscular. Although it has been given orally and rectally, the bioavailability of ketamine when given via these routes is limited to 20-30%. Intranasal (NAS) administration has advantages of being needle free method of administration with potential for outpatient therapy. It lacks hepatic first pass effect resulting in higher bioavailability compared to oral route. Large surface area, uniform temperature, high permeability and extensive vascularity of the nasal mucosa facilitate rapid systemic absorption of intranasal administered drugs 6. In the pilot trial conducted by the study investigators, single dosage of intranasal ketamine has been shown to be feasibility and effective option for temporary pain reduction in patients with cancer related pain. The investigators now seek to obtain feasibility and efficacy data on long-term use of intranasal ketamine for cancer related pain. Ketamine is a scheduled III medication. A physician with a DEA license can order intranasal ketamine from a compounding pharmacy. Primary outcome of interest: Pain scores will be recorded on Numerical Pain Rating Scale (NPRS) at regular intervals throughout the study. NPRS is the most responsive tool to document pain intensity when compared to Visual Analogue Scale (VAS) and Visual Rating Scale (VRS) for measuring pain, 7 showing higher compliance rates, better responsiveness, ease of use, and good applicability relative to VAS/VRS8. Minimal clinically important differences (MCIDs) for pain ratings varies substantially based on patient population and statistical technique used, range of 0.4 to 3.7 points has been reported as a MCID. In general, improvements of pain severity</=1.5 points on NPRS could be seen as clinically irrelevant 9-13. Above that value, the cutoff point for “clinical relevance” depends on patients’ baseline pain severity, and ranges from 2.4 to 5.3 11-13. Higher baseline scores require larger raw changes to represent clinically important differences 14. Primary aim: To determine efficacy of intranasal ketamine in reducing cancer related pain. A clinical trial will be conducted to determine effect of intranasal ketamine on cancer related pain. Pain scores will be recorded on Numerical Pain Rating Scale (NPRS) at regular intervals throughout the study. Minimal clinically important differences (MCIDs) for pain ratings varies substantially based on patient population and statistical technique used, range of 0.4 to 3.7 points has been reported as a MCID. In general, improvements of pain severity</=1.5 points on NPRS could be seen as clinically irrelevant 9-13. Above that value, the cutoff point for “clinical relevance” depends on patients’ baseline pain severity, and ranges from 2.4 to 5.3 11-13. Higher baseline scores require larger raw changes to represent clinically important differences 14. Several clinical trials for pain have reported a reduction of 2 points on NPRS to be clinically important.15-17 Therefore for the purposes of this study, MCID of 2 was used for sample size calculations. A prior research study done by Carr et al. studied effects of intranasal ketamine for breakthrough pain in patients with chronic pain of various etiologies. 18 Total number of subjects in this study was 20 (4 of these had cancer related pain).This study demonstrated a mean reduction of 2.7 units on NPRS (P<0.0001), with standard deviation of 1.87. Since MCID is 2, effect size using this (MCID/SD) = 1.05. Power and sample size table: Assumptions: 1. T-test is the appropriate test (may not be the appropriate test since we have a small sample size and may not be able to assume normality of means based on the central limit theorem) 2. Distribution of reductions in pain score is normal 3. Effect size of 1.05 is clinically meaningful; Sample Size: A sample size of 7 from a population of 20 (in the study done by Carr etal.) achieves 80% power to detect a NPRS difference of −2 between the null hypothesis mean of 0.0 and the alternative hypothesis mean of 2 with an estimated standard deviation (SD) of 1.87 and with a significance level (alpha) of 0.05 using paired t-test assuming that the actual distribution is normal. We will include 10 patients to account for the possibility that the observed pain reduction in the current study may be different than the study done by Carr, as in this study patients were given ketamine for breakthrough pain, as opposed to for baseline pain. We will enroll 25 patients in the study to account for potential dropouts. RESULTS/ANTICIPATED RESULTS: Majority of subjects experienced the largest decrease in their pain with the 10mg IV dose. Side effects included nausea/vomiting and a feeling of unreality. All side effects resolved by the end of each study visit. No severe adverse events occurred. DISCUSSION/SIGNIFICANCE OF IMPACT: Further study is required to elucidate safety of NAS ketamine with long term use for cancer related pain.

Tesamorelin, a synthetic growth hormone-releasing hormone, is indicated for the reduction of visceral adipose tissue (VAT) in people with HIV. Here, we performed a post hoc analysis of participants receiving tesamorelin for 26 weeks in a phase III clinical trial. Efficacy data were compared between individuals with and without dorsocervical fat, stratified by tesamorelin response. Among tesamorelin responders, VAT and waist circumference (WC) decreased in both dorsocervical fat groups and did not statistically differ (VAT P = 0.657, WC P = 0.093). These data demonstrate that tesamorelin is equally effective and should be considered in the treatment of excess VAT regardless of the presence of dorsocervical fat.

Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.

NIH/NIGMS-funded IDeA-Clinical and Translational Research (CTR) networks seek to expand translational research infrastructure to support research that has at its endpoints measurable clinical, public health, technological, or economic benefits. This retrospective case study followed 14 projects that received Pilot funding from the Great Plains IDeA-CTR (GP IDeA-CTR) at the University of Nebraska Medical Center. It focuses on the impact of pilot funding and GP IDeA-CTR resources on subsequent clinical and translational research. Metrics include extramural awards, lessons learned that relate to clinical and translational research infrastructure, and demonstrated and potential benefits using the Translational Science Benefits Model (TSBM).

OBJECTIVES/GOALS: Evaluation of the contributions of the CTSI core services to the science of translational science requires focused protocols that are rigorous developed and piloted. The goal of this presentation is to report on the process of protocol development and present the results of protocol pilot implementation. METHODS/STUDY POPULATION: Translational science’ (TS) is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process (Austin, Clin Trans Sci. 2021; 14:1629-1647). A key tenet of translational science is to understand common causes of inefficiency and failure in translational research projects (e.g., incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability, ineffective clinical trial recruitment). The navigation steps and mapping to resources for translational researchers provides an opportunity to develop effective navigation tools and study the barriers to effective translation. RESULTS/ANTICIPATED RESULTS: The UF-FSU Evaluation Committee has developed and piloted an evaluation protocol that aims to assess the role of CTSI service centers in addressing specific TS barriers. The protocol is informed by interviews with CTSI service users, and is grounded in the Donabedian Framework of Quality Assessment and Lean principles. The pilot implementation of the protocol showed its relevance and applicability across multiple UF-FSU core service centers. DISCUSSION/SIGNIFICANCE: The barriers to translational science are not unique but addressing them is rarely within the scope of individual translational research projects. Conversely, service centers within the CTSA institutions are uniquely positioned to address TS barriers thus enhancing to the operational efficiency of the CTS enterprise and promoting the science of TS.

Objectives/Goals: Despite persistent health disparities, rural individuals are underrepresented in clinical trials, due in part to access barriers. We investigated if targeted strategies enhanced recruitment, engagement, and retention of rural adolescents in the TEENS+ randomized clinical trial, a 4-month family-based behavioral weight loss intervention. Methods/Study Population: Adolescents (12–16 y) and parents with obesity were eligible for TEENS+. Treatment converted to virtual in COVID-19, allowing eligibility to expand to more rural areas. We leveraged Informatics, a practice-based research network, and direct marketing to identify potential rural participants. Targeted engagement strategies included: rural physician outreach, physician-endorsed letters, providing tablets and mobile hotspots, reimbursing travel, and offering in-person or remote assessment visits. Chi-square tests evaluated differences in screener completion and enrollment of rural families before (T0) and after (T1) changes were made. Noninferiority tests evaluated rural vs. nonrural retention and engagement (% attendance, % dietary self-monitoring) and engagement based on digital tool receipt. Results/Anticipated Results: N = 211 dyads enrolled (n = 54 in T1: 48% male; 41% Black). Screener completion by rural families significantly increased from T0 (9.8%) to T1 (15.1%; p = .043). Yet, there was no significant change in rural adolescent enrollment (T0 = 10%; T1 = 9%; p = .844). Sixteen adolescents (30%) received study tablets, and none needed mobile hotspots. Mean adolescent attendance was 75%±28% for group and 94%±18% for individual sessions, with no significant differences based on rural status or tablet use. Rural adolescent self-monitoring (via app) was 28%, compared with 50% for non-rural adolescents (p = .074). Retention was 94% at 4m and 89% at 8m for T1 participants, with no differences based on rural status. At the primary endpoint (12 m), retention was significantly higher for rural (100%) vs. non-rural (87%) participants; p = .013. Discussion/Significance of Impact: Rural adolescent screener hits increased yet enrollment was unchanged. However, rural attendance was comparable and retention exceeded, compared to nonrural participants. Strategies to yield equitable representation and engagement in clinical trials are essential for geographic generalizability and to reduce rural health disparities.

ABSTRACT IMPACT: The results from this study will improve needs assessment practices. OBJECTIVES/GOALS: The discovery phase in project development is necessary to better understand the needs and requirements of the intended market. This paper compares the outcomes of two virtual data collection methodologies, NSF I-Corps Customer Discovery interviews and REDCap surveys, for a needs assessment. METHODS/STUDY POPULATION: Clinical and Translational Science Award (CTSA) Directors and Academic Administrators across the Consortium were asked about the types of skills needed to assess clinical research professional competencies and the need for a competency-based self-assessment tool (CBST). Parallel methods were used to extract qualitative and quantitative data. The first approach was to conduct interviews using I-Corps customer discovery guidelines, and data was collected using Innovation Within software. Targeted requests were sent via cold email outreach to 102 individuals within 63 CTSA hubs. The second approach involved the use of the NJ ACTS Training and Education Offering Inventory REDCap Survey which was distributed via LISTSERV to 63 CTSA hubs. Response rates and user insights from each method were compared. RESULTS/ANTICIPATED RESULTS: Twenty-one of 63 CTSA hubs responded to the survey (response rate: 33%) while 18 of 63 hubs participated in an interview (response rate: 28%). Twenty-two individuals out of 102 were interviewed (response rate: 21%). Fifty-nine percent of interviewees and 62% of survey respondents indicated a clear need for a CBST; types of responses varied. Forty user insights were obtained from ten interviews. Two insights were gained in the survey from the eight who were prompted to fill out the free-text response. Both survey participants and interviewees indicated that communication and team science soft skills were the most important competencies. Regarding hard skills, interviewees preferred written skills while survey participants favored ‘scientific design and concept’ skills. DISCUSSION/SIGNIFICANCE OF FINDINGS: Results suggest the use of a survey or an interview for a needs assessment is dependent on several factors: need for insights, burden of time, desire to obtain quantitative vs. qualitative data, and question format. The interview was more effective than the survey in addressing the key question and obtaining insights from the intended market.

OBJECTIVES/SPECIFIC AIMS: The goal of the eResearch platform is to make consenting for clinical trials more convenient, accessible, and faster while retaining an ethical and informed consenting process. eResearch e-consent also allows for enhanced standardization and efficiency for research collaborations across academic research institutions, which, ultimately, helps drive discovery of better health care for our patients and communities. METHODS/STUDY POPULATION: The UMN’s CTSI and AHC Information Systems developed software, called eResearch Suite, for electronic consenting. The eResearch Suite includes viewing a consent, a “Check Your Understanding” quiz to assess comprehension of critical study details, and a signature block that captures the participant signature electronically and with an automatic date and time stamp. The eResearch Suite also has the capability to randomize participants, track participants via a master list, collect participant data, collect internal study data, and generate emails to participants. The eResearch Suite platform is written in Ruby on Rails. RESULTS/ANTICIPATED RESULTS: We have pilot tested the eResearch platform with one study thus far. Preliminary results of the study show that all participants consented via eResearch, with 64% of participants consenting remotely via eResearch before their first study visit. Participants e-consented using various devices including desktop computers, tablets, and smart phones. Participants also filled out surveys and questionnaires before their study visits, which saved the study team time and money. DISCUSSION/SIGNIFICANCE OF IMPACT: eResearch electronic consenting (e-consenting) changes the way potential participants consent for studies. e-Consenting is important because it allows individuals, or their Legally Authorized Representatives, to consent remotely. This may be faster, more convenient for people, reduce coercion, increase comprehension, and allow for consenting information or process to be shared with an individual’s family/friends. In acute and emergent settings we anticipate eResearch e-consenting will result in significant reduction of consent time by replacing faxed and paper consent with e-consent available via email and mobile devices. This allows legally authorized representatives to sign consent remotely, reduces the time physicians spend faxing consents, and allow them to avert more focus back on their patients. Time savings, whether for consent or study visits, may also result in a cost savings for studies.

OBJECTIVES/GOALS: The goal of Miami CTSI’s Mentored Translational Research Scholars (KL2) Program is to identify outstanding early-stage investigators and prepare them to become the next generation of highly skilled independent researchers who translate fundamental knowledge and new technologies from the laboratory to the clinic and to the community. METHODS/STUDY POPULATION: Evaluation of the KL2 program focused on assessing progress in the following areas: 1) scholar productivity during and after graduating from the program; 2) continued engagement of KL2 program graduates in clinical and translational research; scholar productivity during and after graduating from the program; 3) outcomes such as establishing independent research careers, obtaining research funding, and establishing collaborations; and 4) research impact. We used a developmental evaluation approach and benefits-framework model to conduct program evaluation, incorporating both in a program-specific logic model. Bi-annual surveys were used to measure scholar feedback and progress, and utilization of CTSI services. RESULTS/ANTICIPATED RESULTS: Since 2013, the KL2 program has trained 21 scholars,17 of whom have completed training, and four are still in the program. Of the 21 scholars, 52% are female and 38% are underrepresented minorities (URM)–significantly higher than the 12% URM for overall CTSA KL2 scholars. Scholars have 176 total publications related to their KL2 projects and have received $52.4m in total research funding. In addition, 50% of the projects focused on health disparities. Overall, 48% of KL2 scholars have received large subsequent federal awards including three NIH K awards and six NIH R awards. Scholars actively utilized CTSI services during and after graduation. Programmatic enhancements such as adding institutional scholars and using scholar feedback to improve program resources were also implemented. DISCUSSION/SIGNIFICANCE: Miami CTSI’s KL2 program has demonstrated success in fulfilling its program goals. The process and outcome evaluation has provided a better understanding of program performance and progress and has demonstrated alignment with CTSI’s overall goals on addressing health disparities and its commitment to diversity and equity.

OBJECTIVES/GOALS: Faculty pursuing their first independent research grants often struggle to express their ideas in a concise, compelling way. Thus, we developed the “Research and Scholarship Storytelling Bootcamp” to equip these faculty with narrative development skills applicable across disciplines and mechanisms. METHODS/STUDY POPULATION: Early-career researchers who were preparing either their first NIH R-series application or an NSF CAREER award proposal were invited to participate. Enrollment was limited to 20 participants. Those accepted learned the “And-But-Therefore” narrative framework by reading a short book and attending 4 synchronous lectures. Between sessions, they applied the framework by drafting abstracts and Specific Aims/Project Summary documents and reviewing their fellow participants’ work. We assessed participants' comfort with storytelling, perceptions of preparedness, and confidence regarding funding chances, before and after the program using a visual analog scale (max 100 points) and calculated Cohen’s d to evaluate the effect size of any changes. RESULTS/ANTICIPATED RESULTS: Thirty people applied for 20 slots, indicating strong demand. Eleven NIH applicants and 9 NSF applicants enrolled. Before the program, participants rated their comfort with storytelling at 45 ± 25, their preparedness at 39 ± 24, and their funding confidence at 39 ± 26. Nine total participants completed all sessions, assignments, and surveys. Completion rates were comparable for NIH- and NSF-targeting participants. After the program, completing participants reported increases in their comfort with storytelling (68 ± 14 post vs 32 ± 20 pre, d = 1.46), perceived preparedness (64 ± 20 post vs 48 ± 26 pre, d=0.58), and confidence in funding chances (56 ± 19 post vs 40 ± 27 pre, d=0.75). DISCUSSION/SIGNIFICANCE: This program was the first of its kind for multidisciplinary early-career faculty at our institution. The program successfully achieved its objectives for those who completed all activities. Future analysis of survey comments and proposal success rates will reveal barriers to full program engagement and opportunities for further training.

OBJECTIVES/GOALS: The rib construct is a novel device for treating childhood hyperkyphosis and kyphoscoliosis. The purpose of this study was to investigate the biomechanics, mechanism, and clinical outcomes of this device. The overarching hypothesis was that the rib construct is safe and effective for correcting hyperkyphotic spinal deformity. METHODS/STUDY POPULATION: Biomechanical evaluation: An ex vivo porcine spine biomechanical study compared traditional pedicle screw proximal fixation to the rib construct in terms of proximal fixation strength and construct stiffness. Porcine model hyperkyphosis correction with rib construct: An in vivo hyperkyphotic porcine model was used to study the ability of the rib construct to correct hyperkyphosis in the developing porcine spine. Human hyperkyphotic correction with rib construct: A retrospective study was conducted to examine the radiographic outcomes, complication rates, procedure times, and blood losses experienced by human patients that received rib construct surgery. RESULTS/ANTICIPATED RESULTS: Biomechanical evaluation: The rib construct was significantly less prone to proximal fixation failure and less stiff compared to pedicle screws. Porcine model hyperkyphosis correction with rib construct: The average T6-T14 thoracic kyphosis was 35.8 ± 3.2° at the time of hyperkyphosis creation surgery. In response to corrective surgery with the rib-hook construct, T6-T14 thoracic hyperkyphosis decreased immediately post-op to 11.3 ± 7.8° and continued to decrease to 7.8 ± 7.6° until final follow-up 8 weeks post-op (n = 3). Human hyperkyphosis correction with rib construct: Pre-op sagittal Cobb angle was 81 ± 31° and fell to 43 ± 24° post-op and to 38 ± 24° at final follow-up; indicating ~100% correction (normal thoracic kyphosis is 40°). DISCUSSION/SIGNIFICANCE OF IMPACT: The results suggest that the rib construct is a highly effective technique and superior to existing methods.

OBJECTIVES/GOALS: Individuals with intellectual and developmental disabilities (IDD) have lower levels of moderate-to-vigorous physical activity (MVPA) and a greater risk for sedentary-related comorbidities compared to their typically developing peers. Understanding activity patterns may provide opportunities for targeted physical activity interventions. METHODS/STUDY POPULATION: Secondary analyses were performed on baseline accelerometer data pooled from 2 clinical trials and a pilot study in adolescents (11-17 years) and young adults (18-21 years) with IDD. MVPA was assessed using accelerometers worn on the non-dominant hip during waking hours over 7 consecutive days. Data were collected at 60 hertz and activity counts were aggregated over 60 second epochs. Wear time was determined with the Choi algorithm and MVPA was classified using the Troiano adult or Freedson age-specific child cut-points. Mixed effects linear regressions were used to determine the effects of day of the week, time of the day, and season on MVPA. Diagnosis, gender, and age were used as fixed effect covariates with random intercepts varying among the participants and days of observation within each participant. RESULTS/ANTICIPATED RESULTS: There were 231 individuals (15.6 ± 2.8 years, 51.5% female) who had IDD (36.8% Autism, 48.1% Down syndrome) with 22,498 minutes of MVPA. Individuals with IDD wore the accelerometers an average of 592 ± 254 min./day and completed 13.5 ± 17.9 min./day of MVPA. Average MVPA was lowest in individuals with Autism (12.6 ± 11.4 min./day) and Down syndrome (13.2 ± 9.3 min./day) when compared to those with other IDDs (16.8 ± 10.8 min./day). Participation in MVPA was similar in males (13.4 ± 10.7 min./day) and females (13.7 ± 9.9 min./day). Mixed effects linear regressions showed that individuals participated in fewer minutes of MVPA on the weekend (β = -0.75, p < 0.001) and from 12-3 pm (reference) when compared to before 12 pm (β = 0.87, p < 0.001) and 3-7 pm (β = 0.66, p=0.007). No significant seasonal effects were found. DISCUSSION/SIGNIFICANCE: Individuals with IDD were significantly less active on the weekend, but they did participate in more minutes of MVPA in the morning and late afternoon/early evening. Physical activity interventions aiming to increase MVPA on the weekend and during the early afternoon may increase the number of weekly minutes of MVPA in individuals with IDD.

ABSTRACT IMPACT: ReacStick concussion testing and monitoring can serve as a 'vital sign for the brain', allowing for an immediate, objective assessment on the field or at the bedside. This project examines the entrepreneuship process from invention to commercialization. OBJECTIVES/GOALS: ReacStick is the first objective, portable, measure of concussion likelihood and severity and uses simple and complex reaction time testing. We detail the entrepreneurship process from product invention through its current mid-stage (patented, 20+ publications, etc.) to future commercialization for diverse applications. METHODS/STUDY POPULATION: ReacStick was invented in 2010 and underwent extensive testing and validation of the underlying innovations. The regulatory landscape of the product was examined, and 510(k) was found to be the best pathway. Competitive analysis was done examining alternative products and comparing against the current gold standards. A customer discovery process was undertaken, and stakeholders were interviewed for feedback and iteration. Testing and validation were completed with athletes, older adults, and people taking medications. An overview of the necessary commercialization concepts is: market opportunity/monetization, intellectual property considerations, regulatory processes, commercialization plan. RESULTS/ANTICIPATED RESULTS: ReacStick accurately predicts concussion and time to recovery and was patented through UM Tech Transfer in 2010, with 10 years currently remaining on the patent. Through customer discovery processes, athletics was determined to be the most viable first market to enter. Next steps include seeking additional patent protection, capital investors, delivery of minimum viable product followed by iteration and improvement for military, emergency medicine and acute care use. The current remaining timeline involves 12-18 months to commercialization and includes regulatory approval, additional patent protection, collaboration with regulatory consultants, capital fundraising and product production. DISCUSSION/SIGNIFICANCE OF FINDINGS: The research team has gone through a lengthy process toward commercialization of ReacStick. Proof of concept and extensive validation of the underlying technology have been completed and the regulatory process has been mapped. Our experience can serve as a model of many of the steps and challenges that lie on the path from lab to sale to end users.