OBJECTIVES/GOALS: Objectives: The study goal is to identify discriminating symptom characteristics of PAD versus non-ischemic conditions to improve recognition. Just as nausea, back, and jaw pain were once thought to be unrelated to myocardial infarction and coronary artery disease, patient-reported symptoms of PAD are frequently overlooked as being a sign of PAD. METHODS/STUDY POPULATION: Methods: Using a prospective de novo population-based cross-sectional design we will link symptom descriptors to PAD disease status using diagnostic testing in individuals who report lower extremity or buttock symptoms (n = 100). Symptom descriptors will be obtained via questionnaires and structured interviews will be completed pre and post physical function tests. Using near infrared spectroscopy, we will measure calf muscle tissue oxygenation levels to further differentiate ischemic vs. non-ischemic symptoms during exercise. The primary outcome will be the diagnostic accuracy of patient-reported symptoms which discriminate between PAD and non-PAD conditions. Positive predictive value and accuracy will be calculated using receiver operating characteristic (ROC) curve and chi-square analysis. RESULTS/ANTICIPATED RESULTS: Results: Previous studies from which symptom descriptors have been obtained were from patients with known PAD, of which 85-88% of participants were male.1–2 Seventy-six percent of this sample thus far is female. Nationally, PAD prevalence is 20% in those over the age of 70 years, however 58% of our study participants tested positive for PAD (via ankle brachial index test).3 The most commonly reported symptoms of PAD are “numbness” and “aching” vs. those without PAD most commonly reporting “cramping”. These results trend against our current understanding of PAD symptomatology, which is that cramping is the cardinal symptom of PAD.4 Preliminary analysis suggests that balance is a sensitive and specific predictor of PAD. Recruitment is ongoing, therefore results are preliminary. DISCUSSION/SIGNIFICANCE OF IMPACT: Translation of the results will impact primary care and community health. Improved disease detection will position providers to refer patients to exercise therapy before symptoms become disabling. Understanding the diagnostic accuracy of symptoms prepares us to apply novel techniques, such as statistical modeling, to systematically predict PAD.

OBJECTIVES/GOALS: Mothers with cancer who have young children experience life disruptions when treatment procedures limit mother-child interactions. This study proposes the development of an intervention combining the Coaching approach with the Model of Playfulness to improve Quality of Life (QoL) and wellbeing of these patients and their young children. METHODS/STUDY POPULATION: This embedded mixed method study will be guided by the two initial phases of the ORBIT Model for the development of behavioral interventions for patients with chronic diseases. Participants will be mothers in the post-acute treatment stage of cancer (n = 6) and their children who are between 2 years and a half and 6 years, 11 months. Phase 1A, Definition, builds on qualitative data from a concurrent study exploring the experiences of mothers with cancer playing with their young children. As part of this phase, we will develop a play-based coaching intervention. In Phase 1B, Refinement, we will employ in-depth semi-structured interviews and standardized tools to evaluate acceptability of the intervention and preliminary outcomes. This will serve to further refine the intervention. RESULTS/ANTICIPATED RESULTS: Phase 1A will yield a plan for the intervention and data to enhance its initial implementation. Phase 1B will yield data, from the perspective of the mothers, about acceptability of the intervention procedures (e.g., delivery strategy, place for the intervention, time devoted, and outcome measures). This will enable modifications to the intervention. Additionally, Phase IB will yield preliminary data from specific QoL and wellbeing measures. For the mother, data about anxiety and depression symptoms, stress levels, and parental self-efficacy; for the child, emotional and behavioral indicators; for both: playfulness. DISCUSSION/SIGNIFICANCE OF IMPACT: This study entails the development of an intervention to enhance QoL and wellbeing of mothers with cancer and their children. Play moments as the centerpiece of the intervention, represent an innovative approach. Findings will guide the design of future feasibility studies to advance the development of this outcome driven intervention.

OBJECTIVES/GOALS: The modified Atkins diet (MAD) is used in the management of drug-resistant epilepsy in adults. Some patients on MAD show an increase in serum levels of total cholesterol and low-density lipoprotein (LDL) cholesterol. We explored whether dietary fat composition predicts short-term elevations in serum lipid levels in diet-naïve adults who begin MAD. METHODS/STUDY POPULATION: Participants self-reported their diet intake with 3-day food records at baseline, 1 month and 2 months. Food records were analyzed using Nutrition Data System for Research software. Fasting serum levels of total cholesterol (TC), high-density lipoprotein (HDL) cholesterol, and triglycerides were also collected and LDL level calculated at baseline, 1 month, and 2 months. RESULTS/ANTICIPATED RESULTS: 38 patients submitted complete food records at each study visit (baseline, 1 month, and 2 month). Compared to baseline diet intake, there was a significant reduction in daily carbohydrate intake at 1 and 2 months months (p<0.001). There was also a significant increase in daily saturated fatty acid (SFA) intake at 1 and 2 months (p<0.001), daily mono-unsaturated fatty acid (MUFA) intake at 1 and 2 months (p<0.001), and daily cholesterol intake at 1 month (p<0.05) and 2 months (p<0.001), but no change in daily poly-unsaturated fatty acid (PUFA) intake over time. Compared to baseline, there was a significant increase in serum LDL at 1 month (p<0.001) and 2 months (p<0.01) and an increase in serum TC at 1 month (p<0.01) but not 2 months. DISCUSSION/SIGNIFICANCE OF IMPACT : Despite a significant increase in total fat, saturated fat and mono-unsaturated fat intake as well as an increase in total cholesterol and LDL levels following MAD initiation, dietary fat composition appears to minimally predict serum lipid values in the short term. CONFLICT OF INTEREST DESCRIPTION: Tanya McDonald has received speaking honoraria from Nutricia North America. Bobbie Henry-Barron receives grants from Johns Hopkins Institute for Clinical and Translational Research (ICTR) which is funded in part by Grant Number UL1 TR 001079 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research, Nutricia and Vitaflo. Diane Vizthum receives grants from the Johns Hopkins Institute for Clinical and Translational Research (ICTR) which is funded in part by Grant Number UL1 TR 001079 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Mackenzie C. Cervenka has received grant support from Nutricia North America, Vitaflo, Army Research Laboratory, The William and Ella Owens Medical Research Foundation and BrightFocus Foundation. She receives speaking honoraria from LivaNova, Epigenix, Nutricia North America and the Glut1 Deficiency Foundation and performs consulting with Nutricia North America and Sage Therapeutics and receives Royalties from Demos Health.

OBJECTIVES/GOALS: It is hypothesized that the global secular trend toward earlier puberty onset, with implications for many future health outcomes, is related to the obesity epidemic. This study aims to examine prospective associations between weight during specific developmental windows and timing of puberty onset. METHODS/STUDY POPULATION: This study includes 1,296 mother-infant dyads from the Boston Birth Cohort, a predominantly minority (>80% black/Hispanic), low-income, and urban prospective birth cohort recruited and followed between 1998 and 2019. Age at peak height velocity (APHV), a well-defined and standardized proxy for puberty onset, is derived by fitting height measurements recorded during clinical visits using a mixed effects growth curve model. Multiple linear regression is performed to examine the relationships between early childhood (ages 2-5y) and prepubertal (ages 6-9y) overweight and obesity, weight trajectories between these two periods, and APHV, while controlling for known contributors to early puberty. RESULTS/ANTICIPATED RESULTS: Compared to counterparts with normal BMIs, kids who were obese during ages 2-5y (boys: −0.21y, CI[−0.39, −0.04]; girls: −0.22y, CI[−0.39, −0.05]) or ages 6-9y (boys: −0.27y, CI[−0.43, −0.11]; girls: −0.37y, CI[−0.52, −0.23]) had an earlier APHV. Being overweight during ages 6-9y was also associated an earlier APHV (boys: −0.26y, CI[−0.46, −0.07]; girls: −0.26y, CI[−0.42, −0.10]). Looking at weight trajectories, kids who were persistently overweight or obese from ages 2-5y to ages 6-9y had an earlier APHV (boys: −0.28y, CI[−0.45, −0.12]; girls: −0.31y, CI[−0.46, −0.16]), as did girls with normal BMIs during ages 2-5y and who were overweight or obese during ages 6-9y (−0.45y CI[−0.64, −0.26]). DISCUSSION/SIGNIFICANCE OF IMPACT: The temporal and dose-response relationships seen in this historically understudied population suggests that childhood obesity is etiologically important in the development, and even programming, of early puberty. This has implications for prediction, prevention, and mitigation of health disparities.

OBJECTIVES/GOALS:

1. 1. Determine test characteristics of Neuro ICU nurse interpretation of real-time bedside qEEG for seizure detection

2. 2. Determine difference in time to detection of seizures between qEEG interpretation and raw cEEG reads

3. 3. Determine how seizure characteristics affect accuracy of qEEG reads

METHODS/STUDY POPULATION:

• Subjects: Nurses caring for patients admitted to the Neuro ICU at Duke University Hospital who are initiated on cEEG.

• Nurses evaluate qEEG display at the bedside on an hourly basis after undergoing a standardized qEEG training session. The standard practice of independent review of cEEG and treatment by the Neuro ICU team remains unchanged.

• Post-hoc review of cEEG data by two blinded, board-certified neurophysiologists will be performed for each patient. The raw cEEG data will be scored for the number of seizures present per hour, background, seizure duration, and seizure spatial extent.

• The time from first seizure occurrence to clinical recognition will be recorded.

RESULTS/ANTICIPATED RESULTS:

• Thus far, 91 patients with 583 1-hour blocks of nurse interpretations have been studied, with 6 patients experiencing seizures while on study. Enrollment will be completed on 1/17/20

• Preliminary data show a sensitivity of 95.8% (79.9%, 99.9%), specificity of 95.2 (93.1%, 96.8%), positive predictive value of 46.0% (36.9%, 55.4%), negative predictive value of 99.8% (98.7%, 99.9%), positive likelihood ratio of 19.8 (13.6, 28.9), negative likelihood ratio (0.04 (0.01, 0.3). All confidence intervals are 95%. False alarm rate is 0.05/hour.

• Further analyses are pending completion of enrollment in January 2020.

DISCUSSION/SIGNIFICANCE OF IMPACT: Nurse interpretation of real-time bedside qEEG for seizure detection is feasible in the Duke Neuro ICU. QEEG functions well as a screening tool with good specificity and low false alarm rate. Use of qEEG by nurses could lead to shorter time to seizure detection, which may improve patient outcomes. CONFLICT OF INTEREST DESCRIPTION: Safa Kaleem, BS: Research reported in this publication was supported by a Pfizer Foundation grant and the Duke Clinical Translational Science Institute (CTSI). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Pfizer Foundation or the Duke CTSI. Jennifer H. Kang, MD: None to declare. Alok Sahgal, MD: None to declare. Christa B. Swisher, MD: Received speaker’s honorarium from EISAI and UCB.

OBJECTIVES/GOALS: The current opioid epidemic has placed post-operative pain management under scrutiny. Limiting post-operative pain can decrease overall opioid usage in the recovery period, especially after orthognathic surgery. Several studies have illustrated the efficacy of pregabalin in decreasing postoperative pain and opioid usage in adults undergoing orthognathic surgery. We aim to study the effects of a single dose of preoperative pregabalin on postoperative pain and total opioid consumption after orthognathic surgery in individuals with cleft lip and palate. METHODS/STUDY POPULATION: This was a retrospective cohort study of consecutive patients who received Le Fort I midface advancement between June 2012 and July 2019 by one of two surgeons at a single institution. We took advantage of our institution’s implementation, beginning in 2016, of a one-time dose of preoperative pregabalin for LeFort I midface advancement. All patients had diagnosed cleft lip and palate. The treatment group received a one-time preoperative dose of pregabalin. The control group did not receive pregabalin. Total morphine milligram equivalents (MME) consumption was calculated by adding intraoperative opioid administration and postoperative opioid consumption during admission. Postoperative pain control during admission consisted of oral oxycodone and intravenous (IV) hydromorphone or morphine. Duration of hospitalization and pain intensity assessed with the numeric pain rating scale (0-10) were also recorded. The mean postoperative pain assessment scores during admission was calculated for each patient. The median of these individual mean pain assessment scores for each group was subsequently computed. RESULTS/ANTICIPATED RESULTS: Twenty-three patients (14 males, 9 females) were included in this study; 12 patients received pregabalin (median dose: 150mg, range: 100-200mg). Mean age (years) at operation of the pregabalin (18.3 ± 1.9) and control groups (17.8 ± 1.9) were also equivalent (p = 0.571). Median hospital stay for both groups was 1.0 day. The pregabalin group had significantly lower consumption of total opioids during admission (total MME 70.95 MME; IQR: 24.65-150.17) compared to the control group (138.00 MME; IQR: 105.00-232.48) (MU = 31.00, p = 0.031). Although pain scores in the treatment group (3.21 ± 2.03) were lower than in the control group (3.71 ± 2.95), the difference was not statistically significant (p = 0.651, 95% Cl [−1.75, 2.75]). DISCUSSION/SIGNIFICANCE OF IMPACT: Based on the results, a one-time preoperative oral dose of pregabalin before orthognathic surgery in patients with cleft lip and palate reduced total opioid consumption during admission. However, there was no difference in length of stay or pain scores within the two groups. A single preemptive oral dose of pregabalin should be considered an effective adjunct to pain management protocols in patients undergoing orthognathic surgery.

OBJECTIVES/GOALS: Type 1 diabetes (T1D) results from the autoimmune destruction of insulin-producing β-cells. Emerging data suggest that differences in intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. The prebiotic high amylose maize starch (HAMS) alters the gut microbiome profile and metabolites positively by increasing production of beneficial short chain fatty acids (SCFAs) that have significant anti-inflammatory effects. HAMS also improves glycemia, insulin sensitivity and secretion in healthy non-diabetic adults. Further, an acetylated and butyrylated form of HAMS (HAMS-AB) that increases beneficial SCFA production, namely acetate and butyrate, has been safe and effective in disease prevention in mouse T1D models. The objective of the proposed study is to assess the effect of administering a prebiotic, such as HAMS-AB, on the gut microbiome profile, SCFA production, glycemia and β-cell function in humans with T1D. METHODS/STUDY POPULATION: We hypothesize that administration of HAMS-AB will (i) improve the gut microbiome profile in humans with T1D, (ii) increase SCFA production, and (iii) improve β-cell health, β-cell function and overall glycemia. We propose a pilot randomized controlled cross-over trial of HAMS-AB in 12 youth with newly-diagnosed T1D. We will use state-of-the-art markers to profile the gut microbiome (using 16S rRNA sequencing), measure stool SCFA levels (using gas chromatography), asses β-cell stress/death (by measuring proinsulin to C-peptide ratios) and glycemia (assessed by continuous glucose monitoring and HbA1c measurements). RESULTS/ANTICIPATED RESULTS: We expect that the use of HAMS-AB in newly diagnosed youth with type 1 diabetes will alter the gut microbiome profile (thus increasing the number of fermenters and SCFA levels), β-cell function and glycemia in humans with T1D. DISCUSSION/SIGNIFICANCE OF IMPACT: Given the unknown long-term effects of immune-modulatory therapy on those at risk for or those diagnosed with T1D, the use of a prebiotic such as HAMS-AB offers a simple, safe, yet inexpensive and tolerated dietary alternative approach to mitigating disease.

OBJECTIVES/GOALS: This investigation aimed to mitigate barriers to father involvement in communication intervention for children with ASD and contribute to clinical practice by examining the effects of a hybrid parent coaching intervention for fathers of children with ASD that is tailored to fit both father’s interaction and communication styles as well as individual child characteristics. The Hybrid Father Communication Coaching (HFCC) combined online parent coaching lessons with in-person father-child aquatics sessions in order to increase father’s use of responsive verbal and play strategies. Distal effects on child communication were also investigated. METHODS/STUDY POPULATION: A single subject, multiple baselines across strategies experiment was conducted with one dyad (i.e., father, child with ASD). In the present study, a hybrid father coaching model was used. Parent communication coaching sessions were delivered online, and weekly, father-child aquatics sessions were conducted in person, to provide opportunities for the father to use three targeted responsive strategies (i.e., follow-in comments, follow-in directives, responsive object play) during father-child physical activity. Collateral measures of child communication skills were also investigated. Single subject designs are particularly suitable for autism interventions, as they allow for experimental control with participants who are from heterogeneous populations (McReynolds and Kearn, 1983). The child participant was 5 years, 6 months at the start of intervention and had previously received a community diagnosis of ASD. Throughout the duration of the study, the child attended full-time kindergarten and received in-school speech-language therapy, as a well as 18-20 hours per week of Applied Behavioral Analysis intervention, occupational therapy, physical therapy and speech-language therapy after school. The participating father was a biological parent who resided with the child continuously since birth. The participating father had no other formal parent training in communication intervention before participating. RESULTS/ANTICIPATED RESULTS: The hybrid father communication coaching program (HFCC) yielded positive results for both father and child participant. The father quickly achieved a high level of competency using two of the three, targeted strategies (i.e., follow-in comments, follow-in directives). However, use of a third strategy (i.e., responsive object play) was not maintained above baseline levels. The follow-in comments strategy was used by the participating father more frequently than the follow-in directives strategy. Small increases were documented for child use of spontaneous single words across intervention phases and increased single word use over was maintained eight weeks following intervention. DISCUSSION/SIGNIFICANCE OF IMPACT: The present study provided information regarding the efficacy of a clinically relevant hybrid parent-coaching program, tailored to both father and child characteristics, to enhance fathers’ use of responsive strategies and increase communication skills for children with ASD.

OBJECTIVES/GOALS: Initiation of JUUL use by young adults is one of the most significant issues of concern within the debate on vaping. Despite the proliferation of products and the surge in prevalence, no studies have investigated individual-level interventions or prevention strategies for pod-mod use. METHODS/STUDY POPULATION: Participants (N = 947) were young adults (<30 years old) recruited from Amazon’s Mechanical Turk based on smoking (never, former, and current smokers) and JUUL use status (never and current users), resulting in 6 use groups. In a pre-post design, participants completed baseline assessments, were presented with a brief JUUL-specific educational intervention, and completed post-assessment measures. The one-page intervention provided basic information about JUUL and stated that JUUL is harmful to non-smokers but could be beneficial to smokers if they completely switch. Primary outcomes were changes in JUUL knowledge, perceived harmfulness, intentions for future use, and motivation to change. RESULTS/ANTICIPATED RESULTS: Participants (Mage = 26.1) were male (57%) and White (75%). Overall, the intervention increased JUUL-related knowledge, risk perceptions, commitment to quitting, and readiness to quit JUUL (ps<.01). Similarly, participants showed decreased interest in future JUUL use, interest in purchasing JUUL, and interest in future regular use (ps<.01). Non-JUUL users showed decreased interest in initiating JUUL use after viewing the intervention (p<.01). There were significant Time X Group interactions for JUUL-related knowledge (p<.001), with never JUUL/never smokers showing the greatest increase in product knowledge following the intervention. However, no other interaction effects were significant. DISCUSSION/SIGNIFICANCE OF IMPACT: The intervention was effective in increasing knowledge and risk perceptions while reducing intentions for future use. The intervention was most effective in increasing knowledge among non-users, suggesting that brief educational interventions may be useful tools for preventing pod-mod initiation. CONFLICT OF INTEREST DESCRIPTION: Dr. Carpenter has received consulting honoraria from Pfizer. All other authors have no conflicts to disclose.

OBJECTIVES/GOALS: Although many physicians conduct clinical trials as Principle Investigators, a systematic training is often lacking. Instead, most receive on-site training, potentially compromising data quality and human subject safety. This research assesses the landscape for physician training through medical school curriculums. METHODS/STUDY POPULATION: This project explored training programs for physician researchers, specifically in the emerging field of quality management systems (QMS). To understand the scope of academic research available for QMS and Good Clinical Practice (GCP) training and lack of clinical trial training implemented in medical school curricula, a literature review was conducted. Available training for physicians was assessed through existing training programs from the FDA, NIH, DIAMOND, ACRP, and Google for accessibility in terms of costs, completion timelines and certification, format (online vs. in-person), and inclusion of GCP and QMS training in the curriculum RESULTS/ANTICIPATED RESULTS: Literature review revealed that not much is known about physician researcher training beyond the institutional requirement for minimal GCP review. Examination of select medical school curriculum also discovered a lack of clinical trial training for students interested in clinical research. Furthermore, existing training programs and modules available for physicians are limited as their syllabi do not include QMS training. In addition, these programs commonly have inaccessible registration links, are expensive, and have significant time commitments for in-person courses. These findings support the need for more accessible and effective training and certification tools for physician researchers. DISCUSSION/SIGNIFICANCE OF IMPACT : QMS training is not included medical school curricula or programs for physician researchers, potentially compromising data integrity and subject protection. This research supports the development of essential QMS training concepts and practical approaches for physician researcher clinical trials.

OBJECTIVES/GOALS: The impact of baseline BMI on glycemic response to group medical visits (GMV) and weight management (WM)-based interventions is unclear. Our objective is to determine how baseline BMI class impacts patient responses to GMV and interventions that combine WM/GMV. METHODS/STUDY POPULATION: We will perform a secondary analysis of Jump Start, a randomized, controlled trial that compared the effectiveness of a GMV-based low carbohydrate diet-focused WM program (WM/GMV) to traditional GMV-based medication management (GMV) on diabetes control. The primary and secondary outcomes will be change in hemoglobin A1c (HbA1c) and weight at 48 months, respectively. Study participants will be stratified into BMI categories defined by BMI 27-29.9kg/m2, 30.0-34.9kg/m2, 35.0-39.9kg/m2, and ≥40.0kg/m2. Hierarchical mixed models will be used to examine the differential impact of the WM/GMV intervention compared to GMV on changes in outcomes by BMI class category. RESULTS/ANTICIPATED RESULTS: Jump Start enrolled 263 overweight Veterans (BMI ≥ 27kg/m2) with type 2 diabetes. At baseline, mean BMI was 35.3 and mean HbA1c was 9.1. 14.5% were overweight (BMI 27–29.9) and 84.5% were obese (BMI ≥ 30). The proposed analyses are ongoing. We anticipate that patients in the higher BMI obesity classes will demonstrate greater reductions in HbA1c and weight with the WM/GMV intervention relative to traditional GMV. DISCUSSION/SIGNIFICANCE OF IMPACT: This work will advance the understanding of the relationship between BMI and glycemic response to targeted interventions, and may ultimately provide guidance for interventions for type 2 diabetes.

OBJECTIVES/GOALS: Preterm birth is the most common birth complication in the United States. To date, there are no effective public health strategies to reduce the burden of prematurity. Using geospatial information system (GIS) mapping, we identified the most salient risk factors of preterm birth across US counties targetable for future interventions. METHODS/STUDY POPULATION: Risk factors of preterm birth were identified from the perinatal health nonprofit organization, March of Dimes, and included factors such as obesity, smoking, insurance coverage and poverty. US 2013 county-level data on sociodemographic characteristics, behavioral risk factors and preterm birth were extracted and combined from the American Census, Center for Disease Control, and US Health Resources and Services Administration. Spatial autocorrelation and multivariate spatial regression were used to determine the risk factors most strongly associated with preterm birth. These models were adjusted for race, given well-documented race disparities for preterm birth. As a case-study comparison, we mapped risk factors in the two states with the highest and lowest proportion of preterm births in 2013. RESULTS/ANTICIPATED RESULTS: In our preliminary analysis, obesity was the factor most strongly associated with preterm birth (ß = 7.32, SE: 1.13, p<0.001) at the US county-level. Surprisingly, smoking was not found to be significantly associated with preterm birth. In 2013, Vermont had the lowest prevalence of preterm birth at 7.6% and Mississippi had the highest prevalence of preterm birth at 13.1%. Health insurance coverage and obesity were the two risk factors that differed between Vermont and Mississippi. The median proportion of uninsured individuals in Mississippi counties was four times higher than that of Vermont counties (26.3% vs 10.9%, p<0.01). Similarly, the median obesity prevalence in Mississippi counties was significantly higher than the median obesity prevalence in Vermont counties (38.8% vs. 25.2%). DISCUSSION/SIGNIFICANCE OF IMPACT: Public health efforts aimed at reducing obesity and increasing health insurance coverage may have the greatest impact at addressing the US burden of preterm birth. Further, geospatial mapping is a powerful analytic tool to identify regions in the US where preterm birth interventions would be most beneficial.

OBJECTIVES/GOALS: A workflow management tool is essential in order to help support consistent processes with transparency in next steps of the study process. Prior to this tool, staff has relied upon extensive training and coaching on the study process. While resources and guidelines exist, it requires additional time for staff to identify these resources and allows for confusion and rework. Implementation of a systematic workflow management tool was identified as a critical need in order to support streamlined processes, improve transparency and support business continuity, and to accelerate the study process. METHODS/STUDY POPULATION: This effort was undertaken as part of the Protocol Lifecycle Management effort to implement a comprehensive clinical trial management system for clinical research studies. Mayo Clinic has designed a workflow management tool within the Velos eResearch system. The workflow manager is dynamic and will present specific activities based on the study design and responses to data entered on the ad hoc forms. A Workflow Build group contributed to the design of the workflow in order to reflect appropriate, current operational processes. The workflow was vetted and validated with research teams. In addition to designing activities, planned dates and target timelines were established for relevant workflows to help promote transparency in the study start-up timelines and allow study staff to identify overdue activities. Study status controls were designed in the workflow to protect study staff from inadvertently changing the status until appropriate activities are complete. RESULTS/ANTICIPATED RESULTS: A dynamic workflow has been designed and implemented in the Velos eResearch system to support Mayo Clinic research sites. This system will be implemented February 24, 2020 to all consenting studies. DISCUSSION/SIGNIFICANCE OF IMPACT: The implementation of this workflow management tool is critical to help support research operations in a large, academic medical center. Benefits to implementation are expected to include improved transparency in the study status and next steps, reductions in rework due to confusion in next steps, better understanding from new staff in the appropriate study process, and improved timelines for study start-up. As we prepare for the implementation of the Velos eResearch system at Mayo Clinic, the workflow management tool has been identified in training sessions as a positive benefit.

OBJECTIVES/GOALS: Atopic dermatitis is one of the most common chronic childhood conditions worldwide and is associated with poor mental health outcomes. Our aim is to determine whether childhood atopic dermatitis is associated with symptoms of depression throughout childhood and adolescence, and whether this association is mediated by serum inflammatory markers. METHODS/STUDY POPULATION: We will perform a longitudinal analysis of over 7000 children from an existing prospective cohort. The primary exposure is atopic dermatitis (AD) annual period prevalence measured by a standardized questionnaire at 12 time points between age 6 months and 16 years. Depression is measured using self-reported responses to the Short Moods and Feelings Questionnaire at 6 time points between 10 and 18 years of age. Cross-sectional regression analyses will be performed to compare depressive signs between children with and without AD and test for dose-response effects with AD and depression. Longitudinal analyses will be conducted using mixed-effects models to estimate the average effect across childhood. We will complete a mediation analysis to determine the extent to which IL-6 and CRP mediate this association. RESULTS/ANTICIPATED RESULTS: We anticipate that atopic dermatitis will be associated with SMFQ scores in a dose response relationship, and that inflammatory markers CRP and IL-6 will partly mediate this association. DISCUSSION/SIGNIFICANCE OF IMPACT: Childhood is a critical time for mental health. Understanding the longitudinal relationship between atopic dermatitis, depression, and inflammatory mediators is crucial as new biologic treatments targeting inflammatory cascades are approved for atopic dermatitis and have the potential to prevent mental health conditions.

OBJECTIVES/GOALS: Young and middle-aged adults with a myocardial infarction (MI) represent an understudied group potentially with unique risk indicators such as emotional stress. We sought to investigate if mental stress-induced myocardial ischemia (MSIMI), a marker of cardiovascular vulnerability to psychological stress, is associated with poor outcomes among this population. METHODS/STUDY POPULATION: We studied 306 patients (150 women and 156 men) ≤61 years of age who were hospitalized for MI in the previous 8 months. Clinical, behavioral and psychosocial factors were assessed with standardized measures. Patients underwent myocardial perfusion imaging with mental stress (public speaking) and conventional stress (exercise or pharmacological testing). MSIMI and conventional stress-induced ischemia were defined as a new or worsening perfusion defect. Patients were followed for 3 years for adverse events, which were independently adjudicated. Cox proportional hazard models were used to estimate the association of MSIMI and CSIMI with a composite endpoint of recurrent MI or cardiovascular (CV) death with adjustment for demographic, clinical and psychosocial risk factors. RESULTS/ANTICIPATED RESULTS: The mean age of the sample was 50 years (range, 22-61). MSIMI occurred in 16% of the patients, and conventional ischemia in 35%. Over a 3-year follow-up, 28 individuals had a recurrent MI and 2 died due to cardiovascular causes. The incidence of the composite endpoint of MI or CV death was more than doubled in patients with MSIMI (20%) than those without MSIMI (8%), HR 2.6, 95%CI, 1.2-5.6. Further adjustment for demographic and clinical risk factors and depressive symptoms did not substantially change the relationship. In contrast, conventional stress ischemia was not significantly related to the outcome (HR 1.4, 95%CI, 0.6-3.0). DISCUSSION/SIGNIFICANCE OF IMPACT: Young and middle-aged individuals with MSIMI after MI have a >2-fold higher likelihood of recurrent MI and CV mortality compared with those without MSIMI. In this patient group, MSIMI is a better risk indicator than ischemia with a conventional stress. These findings point to psychological stress as an important determinant of risk in this patient population. Ischemia induced by mental stress is a potent risk indicator in young post-MI patients. Stress-reduction interventions may be especially beneficial in patients who show this abnormal response.

OBJECTIVES/GOALS: Damage to the sensorimotor cortex areas or/and motor/sensory pathways after a stroke could lead the motor system to a loss of controllability for joints. We investigate the loss of individual joint controllability called a loss of individualization during arm movement, which would provide an insight into abnormal motor coordination. METHODS/STUDY POPULATION: We recruit 12 chronic stroke survivors with Fugl-Meyer score between 26 and 50. A robotic exoskeleton with minimum mechanical resistance is equipped to measure the movements of the shoulder, elbow and wrist joints, respectively. Surface EMGs on muscles related to the joints are recorded using 11 wireless pre-amplified electrodes. Participants are asked to move the shoulder, elbow, or wrist joint individually throughout their range of motion, without moving the other joints voluntarily. RESULTS/ANTICIPATED RESULTS: It would be expected that participants show more difficulty in individualization of the distal joint in comparison with the proximal joint. A reduced joint range of motion would be observed in a descending order of the wrist, elbow and shoulder. These results are in line with the proximal-to-distal gradient of motor deficits after a stroke. Intention of moving the distal joint would induce a greater deviation in the position of the proximal joint than that of the distal joint when moving the proximal joint. A non-negative matrix factorization algorithm would reveal a decreased number of muscle synergies in the groups with a loss of individuation in comparison with the groups with no loss. DISCUSSION/SIGNIFICANCE OF IMPACT: We demonstrate that a stroke leads to a lack of individual joint controllability, with a greater deficits on the distal joint, and that it is related to a decreased number of muscle synergies across the corresponding joints. CONFLICT OF INTEREST DESCRIPTION: N/A.

OBJECTIVES/GOALS: To determine if a multi-modal, interdisciplinary intervention delivered to a group of prediabetic patients will result in reduced rates of diabetes progression. This project is a retrospective evaluation that will exam the feasibility and possibly efficacy of this intervention. METHODS/STUDY POPULATION: We will evaluate outcomes of 50 participants for the clinic, aged 21-60 inclusive. Patients will have a Body Mass Index >25kg/m2 with a diagnosis of prediabetes. Patients must be non-pregnant, using approved contraception, and agree to not become pregnant for 1 year after enrollment. After enrollment, the initial treatment period is for 1 year and includes a 12 week low calorie diet plan, a 6-month intensive behavioral and lifestyle modification plan followed by a 6 month behavior reinforcement extension. Weight management medications may be used if appropriate for the patient from a clinical perspective during the 6-month intensive behavioral/lifestyle modification. RESULTS/ANTICIPATED RESULTS: It is anticipated that there will be decreased weight with a mean weight loss goal of approximately >10%. Furthermore, it is expect that there will be improvement of other markers of metabolic disease. These include improvement of lipid values (LDL-C, HDL-C, Triglycerides, Total Cholesterol) as well as blood pressure with expected blood pressures of below 130/80 in greater than 50% of participants. Finally, It is expected that 50% or greater participants will have improvement of glycemic control. It is anticipated that greater than 50% of participants will have improvement of glycemic control and achieve normoglycemia. These values will be determined based upon fasting glucose or A1c. DISCUSSION/SIGNIFICANCE OF IMPACT: The significance of this intervention is enormous. By demonstrating feasibility in this trial, we can work toward both assessing efficacy and possibly dissemination of this model program. If these interventions provide durable changes at scale, this could help slow the epidemic of obesity and obesity related comorbid conditions.

OBJECTIVES/GOALS: There is not much known on how to improve informed consent understanding and there are no effective interventions that have been identified to improve understanding rates of information. This study seeks to assess participants understanding of the informed consent. METHODS/STUDY POPULATION: We studied a non-probability sample of 245 participants, 57% female, with age range from 6 to 84, currently enrolled in clinical trials conducted at an urban city, multi CTSA institution. A self-administered questionnaire approved by IRB was utilized. Redcap database was utilized for data entry. The items in the questionnaire reflected understanding of the informed consent (e.g., purpose for the study, participants’ rights, risks, benefits). Participants completed the survey during their first visit to the research centers or on a follow-up visit. Data were collected from July 2018 to November 2019. Data were analyzed descriptively by summary statistics. RESULTS/ANTICIPATED RESULTS: African Americans were 44%, Non-Hispanic Whites were 36%, Hispanic 6%. Others 13%. 52% married, 12% completed High school, 74.8% completed College, 13% less High school. 91% read the form themselves. 99% knew the purpose of the study; 99% knew they could quit the study at any time. While (113) 47% indicated knowledge of the potential risk, only (12)10.6% could not list any associated risk. 98% stated they had information on who to call with questions regarding the study. (204)86% knew of a potential benefit, only (11)5% could not name some study benefit. 38% were unsure/did not know the total number of visits study required of them. 74% knew the duration of the study. DISCUSSION/SIGNIFICANCE OF IMPACT: Extended discussion and more time on one-one by the study teams in this CTSA tend to increase trust. This approach has been reported to be most effective in improving participant understanding of informed consent process and may result in the positive experience.

OBJECTIVES/GOALS: Many clinical prediction models have been developed to guide tuberculosis (TB) treatment, but their results and methods have not been formally evaluated. We aimed to identify and synthesize existing models for predicting TB treatment outcomes, including bias and applicability assessment. METHODS/STUDY POPULATION: Our review will adhere to methods that developed specifically for systematic reviews of prediction model studies. We will search PubMed, Embase, Web of Science, and Google Scholar (first 200 citations) to identify studies that internally and/or externally validate a model for TB treatment outcomes (defined as one or multiple of cure, treatment completion, death, treatment failure, relapse, default, and lost to follow-up). Study screening, data extraction, and bias assessment will be conducted independently by two reviewers with a third party to resolve discrepancies. Study quality will be assessed using the Prediction model Risk Of Bias Assessment Tool (PROBAST). RESULTS/ANTICIPATED RESULTS: Our search strategy yielded 6,242 articles in PubMed, 10,585 in Embase, 10,511 in Web of Science, and 200 from Google Scholar, totaling 27,538 articles. After de-duplication, 14,029 articles remain. After screening titles, abstracts, and full-text, we will extract data from relevant studies, including publication details, study characteristics, methods, and results. Data will be summarized with narrative review and in detailed tables with descriptive statistics. We anticipate finding disparate outcome definitions, contrasting predictors across models, and high risk of bias in methods. Meta-analysis of performance measures for model validation studies will be performed if possible. DISCUSSION/SIGNIFICANCE OF IMPACT: TB outcome prediction models are important but existing ones have not been rigorously evaluated. This systematic review will synthesize TB outcome prediction models and serve as guidance to future studies that aim to use or develop TB outcome prediction models.

OBJECTIVES/GOALS: To determine predictors of mortality in non-severe hemophilia A (NSHA) patients. METHODS/STUDY POPULATION: The ATHNdataset was used to identify NSHA patients who have authorized the sharing of their demographic and clinical information for research. Factors examined included race, ethnicity, hemophilia severity, Hepatitis B, Hepatitis C and HIV infections. A mortality rate was calculated for each factors examined. The relative risk of death between patients in different categories of the factors was assessed by using the ratio of these mortality rates. To adjust for the effects of all of the studied factors with mortality, a multivariate analysis was performed using logistic regression. All hypothesis testing was two-tailed, with a significance level of .05. RESULTS/ANTICIPATED RESULTS: A total of 6,606 NSHA patients were followed for an average of 8.5 years. During 56,064 person years of observation, 136 (2.1%) NSHA patients died; 20% of deaths were malignancy-related. Mortality rates were similar across racial group. Hispanic patients were 60% less likely to die than non-Hispanic patients (p = 0.006). Patients with Hepatitis C infection and HIV infection were 7 times as likely to die compared to those without infections (p<0.001). After adjusting for the effects of all examined factors in a multivariate analysis, patients with hepatitis C and HIV infection remain significantly associated with increased mortality at 6.1 times and 3.6 times the risk, respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: Despite significant improvement in the therapeutic approaches for infectious diseases, Hepatitis C and HIV infections remain strong predictors of mortality in this NSHA cohort. CONFLICT OF INTEREST DESCRIPTION: N/A.