OBJECTIVES/SPECIFIC AIMS: The goal of this initiative was to address this cancer health disparity in the Appalachian counties and help participants develop, implement and evaluate evidence-based “PN” that effectively and positively impacts patient and outcomes of the HealthyWomen Program. Following were the objectives of this training program: (1) To understand the broad range of roles and responsibilities associated with “PN”, including care coordination and case management, in the Pennsylvania HealthyWoman Program in Pennsylvania and the National Breast and Cervical Cancer Early Detection Program. (2) To identify and assess local resources and expertise for evidence-based “PN” in the HealthyWoman Program. (3) To utilize “PN” in association with public education and targeted outreach initiatives in the HealthyWoman Program. (4) To implement strategies to manage and evaluate “PN” for the HealthyWoman Program. METHODS/STUDY POPULATION: The series of PN training was held at Pittsburgh, Camp-Hill, Wilkes-Barre and Philadelphia during June 2017. In total, 86 participants attended the training program at one of these 4 locations. Attendees represented organizations that provided breast, cervical and colorectal cancer outreach, screening and treatment. The participants of the training were solicited by regional program managers of the HealthyWoman Program of the PA Department of Health. The Harold Freeman model for patient navigation model was used to train the participants on the concepts of patient navigation. The training was built upon the Health Belief Model and Chronic Care Model, which defined the specific program constructs. The curriculum covered 2 important aspects, that is, clinical knowledge related to breast and cervical cancer along with aspects of patient navigation. Participants represented small, and large academic institutions/health care systems, cancer centers, federally qualified health centers, health departments as well as community-based screening programs and organizations. RESULTS/ANTICIPATED RESULTS: A total of 86 participants were trained; 78% had formal education and training in health-related field. In total, 62% of the participants had previous experience of patient navigation; 42% had training in social service related field and 50% had prior experience as community health worker. The demographic details reflected that majority of the participants (94%) were female. Most of the participants (30%) belonged to 50–64 years of age group followed by 30–39 years (23%) and 40–49 years (22%) of age group, respectively. As part of ethnic distribution, 70% of the participants were White Americans followed by Black/African Americans (17%). Furthermore, association of previous training in health and social service field with and without experience as a community health worker (n=84) and Navigator (n=86) was also analyzed. Among the participants, 44% had both community health worker experiences along with a prior training in social service related field whereas 42% of the respondents only had prior social service related training. This association of previous training in social service related field and prior community health worker experience was statistically significant with a p value of <0.05. Additionally, 81% of the participants who had previous experience in health-related training also possessed the prior experience as community health worker. Also, 81% of the participants who had previous training in health-related field also had a prior experience of patient navigation. In all, 38% of the participants who had a previous experience in social service field also had a prior experience of patient navigation. DISCUSSION/SIGNIFICANCE OF IMPACT: The training program established a pool of patient navigators which will contribute towards reducing the cancer health disparity in the Appalachian region of Pennsylvania. The participants reflected a wide diversity in the navigators’ backgrounds and differences across programs in their choices of patient navigators. It is important to consider this diversity when designing curricula materials and the methods of delivery in a patient navigation training program. As PN training programs are developed and implemented, further data is needed to guide practitioners and administrators in their efforts to include separate curriculum and materials for experienced and lay navigators. In addition, it is also important to assess the role and involvement of patient navigators in research and clinical trials. In total, 82% of the participants when asked agreed to be contacted for participation in research studies. Specific curriculum which includes research could be designed for further development of patient navigators. PN training and implementation knowledge is critical to the development of standards and best practices in this emergent area of cancer care.

OBJECTIVES/SPECIFIC AIMS: There is no consensus on what constitutes translational research. To effectively support translation of research into practical settings, universities must determine who is involved, in which disciplines, and what results. In addition, it is unclear whether these researchers would see “translational research” as describing their work. METHODS/STUDY POPULATION: A survey assessing perceptions, successes, and barriers to the application of research was distributed to faculty, fellows, and graduate students within the University of Michigan. This survey included a question on the definition of translational research. RESULTS/ANTICIPATED RESULTS: Investigators of every rank and school participated (n=865), and all schools reported forms of applied research. Over 70% of participants said it was important to use research results beyond academia, and those responses represented diverse successes ranging from product development to artistic endeavors. Common barriers to such as lack of time and funding were also widely experienced. The definitions of translational research were divided between strictly health-oriented or broadly focused application. However, both definitions and familiarity with the term differed by field. DISCUSSION/SIGNIFICANCE OF IMPACT: Translation of research is widespread throughout the university, and many would define translational research to include their research discipline. Strategic university policies could benefit society by enhancing translation and application across many disciplines.

OBJECTIVES/SPECIFIC AIMS: The population of cancer survivors is rapidly growing in the United States. Long term and late effects of cancer, combined with ongoing management of other chronic conditions, make cancer survivors particularly vulnerable to polypharmacy and its adverse effects. We examined patterns of prescription medication use and polypharmacy in a population-based sample of cancer survivors. METHODS/STUDY POPULATION: Using data from the Medical Expenditure Panel Survey (MEPS), we matched cancer survivors (n=5216) to noncancer controls (n=19,588) by age, sex, and survey year. We defined polypharmacy as using 5 or more unique medications. We also estimated proportion of respondents prescribed specific medications within therapeutic classes and total prescription expenditures. RESULTS/ANTICIPATED RESULTS: A higher proportion of cancer survivors were prescribed 5 or more unique medications (64.0%, 95% CI 62.3%–65.8%) compared with noncancer controls (51.5%, 95% CI 50.4%–52.6%), including drugs with abuse potential. Across all therapeutic classes, a higher proportion of newly (≤1 year since diagnosis) and previously (>1 years since diagnosis) diagnosed survivors were prescribed medications compared to controls, with large differences in central nervous system agents (65.8% vs. 57.4% vs. 46.2%), psychotherapeutic agents (25.4% vs. 26.8% vs. 18.3%), and gastrointestinal agents (31.9% vs. 29.6% vs. 22.0%). Specifically, nearly 10% of cancer survivors were prescribed benzodiazepines and/or opioids compared to about 5% of controls. Survivors had more than double prescription expenditures (median $1633 vs. $784 among noncancer controls). Findings persisted similarly across categories of age and comorbidity. DISCUSSION/SIGNIFICANCE OF IMPACT: Cancer survivors were frequently prescribed a higher number of unique medications and inappropriate medications or drugs with abuse potential, increasing risk of adverse drug events, financial toxicity, poor adherence, and drug-drug interactions. Adolescent and young adult survivors appear at increased risk of polypharmacy.

OBJECTIVES/SPECIFIC AIMS: Opioid prescribing is common and increasing in certain areas of the country with known risk of misuse and dependence. Our study examined the association of opioid prescription at discharge after hospitalization for acute coronary syndrome (ACS) or acute decompensated heart failure (ADHF) with emergency department (ED) care or all-cause readmission, intended healthcare utilization (follow-up with physician within 30 d of discharge and cardiac rehab participation), and all-cause mortality. METHODS/STUDY POPULATION: The Vanderbilt Inpatient Cohort Study is a prospective cohort of hospitalized patients age >18 enrolled with either ACS or ADHF between 2011 and 2015 (index hospitalization). We then excluded those who died during the index hospitalization, patients with hospitalization <24 hours, patients discharged to hospice care, or those who underwent coronary artery bypass surgery because of the high probability of receiving opioids. In addition, we limited the analyses to patients whom we had complete covariate data. The primary predictor variable was an opioid prescription at the time of hospital discharge. We collected healthcare utilization behavior for 90 days after discharge, and mortality data until March 8, 2017. Time-to-event analysis using Cox proportional hazard models was performed for both unintended healthcare utilization behavior and mortality outcomes. Logistic regression was performed for intended healthcare utilization (adherence to follow-up appointments and cardiac rehabilitation). All models were adjusted for demographic data, opioid use prior to index hospitalization, severity of illness, and healthcare utilization prior to the index hospitalization. RESULTS/ANTICIPATED RESULTS: There were 501 patients discharged with an opioid prescription and 1994 with no opioid prescription at discharge. Among patients with opioids at discharge 235 (47%) experienced unplanned healthcare events (71 ED visits and 164 readmissions) and among nonopioids patients 775 (39%) experienced unplanned healthcare events (254 ED visits and 521 readmissions) (aHR: 1.06, 95% CI: 0.87, 1.28). Patient mortality in the opioid group was 131 Versus 432 in the nonopioid group (aHR: 1.08, 95% CI 0.84, 1.39). Patients in the opioid at discharge group were less likely to attend follow up visits or participate in cardiac rehab (OR: 0.69, 95% CI 0.52, 0.91, p=0.009) compared with those not discharged on opioid medications. Sensitivity analysis of patients who were prescribed prehospital opioids (including prehospital opioids in the exposure group with postdischarge opioids) did not reveal a statistically significant increase in mortality (aHR: 1.09, 95% CI 0.91, 1.31) or unintended healthcare utilization (aHR: 1.12, 95% CI 0.89, 1.41) among opioid users. DISCUSSION/SIGNIFICANCE OF IMPACT: Morbidity and mortality related to opioid use is a public health concern. Our study demonstrates a statistically significant reduction in physician follow-up and participation in cardiac rehab among opioid users, both of which are known to decrease patient mortality. We did not find a statistically significant increase in unplanned healthcare utilization or mortality. Sensitivity analysis combining prehospital and posthospital opioid prescriptions did not reveal a statistically significant association between opioid use, hospital readmissions, or mortality. The hospital provides unique patient interactions where providers can make significant medical changes based on their patient’s clinical status. Continuing to understand the association between opioid use, healthcare utilization, morbidity, and mortality in recently hospitalized cardiac patients will provide data to support reduction in total opioid dose to improve clinical outcomes.

OBJECTIVES/SPECIFIC AIMS: The goal of this study is to characterize traumatic events and post-traumatic stress symptom severity experienced by caregivers of children with hydrocephalus. Results will eventually be evaluated and compared with demographic and medical characteristics. This study is part of a larger research project that aims to (1) determine the prevalence and risk factors for post-traumatic stress symptoms in pediatric hydrocephalus patients and their caregivers; (2) develop a targeted intervention to mitigate its effects and pilot test the intervention. METHODS/STUDY POPULATION: Caregivers of children with hydrocephalus that have received surgical treatment (CSF shunt or ETV/CPC) were enrolled during routine follow up visit in a pediatric neurosurgery clinic. Caregivers completed the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure that assesses the presence and severity of post-traumatic stress disorder (PTSD) symptoms. RESULTS/ANTICIPATED RESULTS: Participant responses (n=56) revealed that 57.14% of caregivers indicated that their most traumatic event was directly related to their child’s medical condition. In total, 23.21% of caregivers did not specify their most traumatic event and 1.79% of caregivers indicated that they had never experienced a traumatic event. Median Total Symptom Severity Score was 11 (mean: 15.32±14.92), and scores ranged from 0 to 67; 32.14% of caregivers scored 19 or greater, and 16.07% of caregivers scored 33 or greater, a value suggestive of a provisional diagnosis of PTSD. Severity scores by DSM-V clusters were as follows: cluster B—intrusion symptoms (mean: 4.91±4.77, median: 4, range: 0–20), cluster C—avoidance symptoms (mean: 1.27±1.87, median: 0.5, range: 0–8), cluster D—negative alterations in cognition and mood (mean: 4.86±6.07, median: 2, range: 0–22), and cluster E—alterations in arousal and reactivity (mean: 4.29±4.07, median: 3, range: 0–17). DISCUSSION/SIGNIFICANCE OF IMPACT: Preliminary results from this study indicate that post-traumatic stress symptoms are prevalent among caregivers of children with hydrocephalus. These results suggest that psychosocial issues such as PTSS may be a significant problem in need of treatment, that is not traditionally addressed as part of routine care for families of children with hydrocephalus. Characterizing post-traumatic stress symptoms in this population sets the foundation for the development of screening and treatment protocols for post-traumatic stress symptoms in caregivers of children with hydrocephalus. This study is the first step towards fundamentally improving routine clinical care and quality of life for patients with hydrocephalus and their caregivers by understanding and addressing the effects of traumatic stress.

OBJECTIVES/SPECIFIC AIMS: Previous studies suggest that prenatal exposure to environmental pollutants can have an adverse effect on brain development. We examine the association between prenatal near roadway air pollution (NRAP) exposure and early neurodevelopment. METHODS/STUDY POPULATION: The Center for the Health Assessment of Mothers and Children of Salinas (CHAMACOS) Study is a prospective birth cohort that began in 1999 with 605 mother-child pairs of primarily Mexican-American descent. Maternal residence during pregnancy was geocoded using ArcGIS and prenatal NRAP exposure was assigned using the CALINE4 line source dispersion model. We used composite Bayley Scale scores for cognitive and motor development, and created separate linear regression models at 6, 12, and 24 months of age. RESULTS/ANTICIPATED RESULTS: After adjusting for relevant maternal and child characteristics, preliminary estimates suggest that prenatal NRAP exposure is associated with a nonsignificant increase in Bayley Scale scores at 6 and 24 months (cognitive: β=0.13, p-value=0.20 and motor: β=0.08, p-value=0.58 at 6 months; cognitive: β=0.16, p-value=0.42 and motor: β=0.20, p-value=0.25 at 24 months) and a nonsignificant decrease at 12 months (cognitive: β=−0.07, p-value=0.64 and motor: β=−0.12, p-value=0.56). DISCUSSION/SIGNIFICANCE OF IMPACT: Our preliminary findings do not suggest that prenatal NRAP exposure is associated with early cognitive development. Additional exploration of co-exposures known to effect neurodevelopment should be examined in this rural population.

OBJECTIVES/SPECIFIC AIMS: While hospital-hospital transfers of pediatric patients is often necessary, some pediatric transfers are potentially avoidable. Pediatric potentially avoidable transfers (PAT) represent a process with high costs and safety risks but few, if any, benefits. To better understand this issue, we described pediatric inter-facility transfers with early discharges. METHODS/STUDY POPULATION: We conducted a descriptive study using electronic medical record data at a single-center over a 12-month period to examine characteristics of pediatric patients with a transfer admission source and early discharge. Among patients with early discharges, we performed descriptive statistics for PAT defined as patient transfers with a discharge home within 24 hours without receiving any specialized tests, interventions, consultations, or diagnoses. RESULTS/ANTICIPATED RESULTS: Of the 2414 pediatric transfers 31.2% were discharged home within 24 hours. Among transferred patients with early discharges, 348 patients (14.4% of total patient transfers) received no specialized tests, interventions, consultations, or diagnoses. Direct admissions were categorized as PAT 2.2-fold more frequently than transfers arriving to the emergency department. Among transferred direct admissions, PAT proportions to the neonatal intensive care unit (ICU), pediatric ICU, and non-ICU were 5.8%, 17.4%, and 27.3%, respectively. Respiratory infections, asthma, and fractures were the most common PAT diagnoses. DISCUSSION/SIGNIFICANCE OF IMPACT: Early discharges and PAT are relatively common among transferred pediatric patients. Further studies are needed to identify the etiologies and clinical impacts of PAT, with a focus on direct admissions given the high frequency of PAT among direct admissions to both the pediatric ICU and non-ICU.

OBJECTIVES/SPECIFIC AIMS: The objective of this study is to determine predictors and motives for sustained opioid use, prescription misuse, and nonmedical opioid use in the adolescent trauma population. METHODS/STUDY POPULATION: This is a prospective cohort study that will follow patients for 1 year and administer surveys to patients on prescription opioid usage; substance use; utilization of pain management and mental health services; mental and physical health conditions; and behavioral and social risk factors. Patient eligibility criteria include: (1) patient is 12–18 years of age; (2) admitted for trauma; (3) english speaking; (4) resides within Indianapolis, IN metropolitan area; and (5) consent can be obtained from a parent or guardian. Patients with severe brain injuries or other injuries that prevent survey participation will be excluded. The patient sample will comprise of 50 traumatically injured adolescents admitted for trauma who will be followed for 12 months after discharge. RESULTS/ANTICIPATED RESULTS: We expect that the results of this study will identify multiple risk factors for sustained opioid use that can be used to create targeted interventions to reduce opioid misuse in the adolescent trauma population. Clinical predictors such as opioid type, dosage, and duration that can be modified to reduce the risk of long-term opioid use will be identified. We expect to elucidate clinical, behavioral, and social risk factors that increase the likelihood adolescents will misuse their medication and initiate nonmedical opioid use. DISCUSSION/SIGNIFICANCE OF IMPACT: Trauma is a surgical specialty that often has limited collaboration with behavioral health providers. Collaborative care models for trauma patients to adequately address the psychological impact of a traumatic injury have become more common in recent years. These models have primarily been concerned with the prevention of post-traumatic stress disorder. We would like to apply the findings of our research to better understand what motivates adolescents to misuse pain medications as well as how clinical, individual, behavioral, and social factors affect medication usage. This may help identify patients at greater risk of developing a SUD by asking questions not commonly addressed in the hospital setting. For example, similar to how trauma centers have mandated brief interventions on alcohol use be performed for center verification, screening patients’ on their social environment may identify patients at greater risk for SUD than assumed. The long-term goal would be to prevent opioid use disorders in injured adolescents by providing better post-acute care support, possibly by developing and implementing a collaborative care model that addresses opioid use. Additionally, we believe our findings could be applied in the acute care setting as well to help inform opioid prescribing and pain management methods in the acute phase of an injury. Genetic testing to determine which opioid to prescribe pediatric surgical patients is starting to be done at some pediatric hospitals. Certain genes determine which specific opioid is most effective in controlling a patient’s pain and, further, using the optimal opioid medication can also reduce overdose. Our findings may help refine prescribing patterns that could increase or decrease the likelihood of developing SUD in patients with certain genetic, clinical, behavioral, and social characteristics.

OBJECTIVES/SPECIFIC AIMS: Determine timing of risk of readmissions within 30 days among patients first discharged to a skilled nursing facilities (SNF) after heart failure hospitalization and subsequently discharged home. METHODS/STUDY POPULATION: This was a retrospective cohort study of patients with SNF stays of 30 days or less following discharge from a heart failure hospitalization. Patients were followed for 30 days following discharge from SNF. We categorized patients based on SNF length of stay (LOS): 1–6 days, 7–13 days, 14–30 days. We then fit a piecewise exponential Bayesian model with the outcome as time to readmission after discharge from SNF for each group. Our event of interest was unplanned readmission; death and planned readmissions were considered as competing risks. Our model examined 2 different time intervals following discharge from SNF: 0–3 days post SNF discharge and 4–30 days post SNF discharge. We reported the hazard rate (credible interval) of readmission for each time interval. We examined all Medicare fee-for-service (FFS) patients 65 and older admitted from July 2012 to June 2015 with a principal discharge diagnosis of HF, based on methods adopted by the Centers for Medicare and Medicaid Services (CMS) for hospital quality measurement. RESULTS/ANTICIPATED RESULTS: Our study included 67,585 HF hospitalizations discharged to SNF and subsequently discharged home [median age, 84 years (IQR; 78–89); female, 61.0%]; 13,257 (19.2%) were discharged with home care, 54,328 (80.4%) without. Median length of SNF admission was 17 days (IQR; 11–22). In total, 16,333 (24.2%) SNF discharges to home were readmitted within 30 days of SNF discharge; median time to readmission was 9 days (IQR; 3–18). The hazard rate of readmission for each group was significantly increased on days 0–3 after discharge from SNF compared with days 4–30 after discharge from SNF. In addition, the hazard rate of readmission during the first 0–3 days after discharge from SNF decreased as the LOS in SNF increased. DISCUSSION/SIGNIFICANCE OF IMPACT: The hazard rate of readmission after SNF discharge following heart failure hospitalization is highest during the first 6 days home. Length of stay at SNF also has an effect on risk of readmission immediately after discharge from SNF; patients with a longer length of stay in SNF were less likely to be readmitted in the first 3 days after discharge from SNF.

OBJECTIVES/SPECIFIC AIMS: Children with medical complexity (CMC) comprise less than 5% of the pediatric population and over 40% of pediatric spending, yet receive poorer quality health care compared with other children. The American Academy of Pediatrics recently identified shared decision making (SDM) as a key quality indicator for CMC, but there is no consensus model for SDM in CMC. Objective: To create a model of SDM from perspectives of parents of CMC. METHODS/STUDY POPULATION: Interviews with parents of CMC explored SDM preferences and experiences. Eligible parents were ≥18 years old, English-speaking or Spanish-speaking, with a CMC <12 years old. Interviews were recorded, transcribed, and analyzed by 3 independent coders for shared themes using grounded theory. RESULTS/ANTICIPATED RESULTS: Interviews were with 31 parents [26 English speakers, median parent age 33 years (SD 11), median child age 3 years (SD 3.6)] in inpatient and outpatient settings. We identified specific, unique components of SDM that affect decision quality, the alignment of a decision with the parent’s preferences and values. Themes included: concerns about uncertainty of the child’s life trajectory, conflict during parent-provider communication, health system factors such as provider schedule; parent agency, and the influence of the source of information. DISCUSSION/SIGNIFICANCE OF IMPACT: Our findings provide specific components of SDM unique to CMC that can inform future research and interventions to support SDM for parents and providers of CMC.

OBJECTIVES/SPECIFIC AIMS: The advent of Highly Active Antiretroviral Treatments (HAART) has allowed HIV-positive individuals to live longer in recent years. This has resulted in a higher incidence of mortalities occurring in these individuals due to cardiovascular pathologies, as opposed to deaths due to HIV. Even with long-term HAART, persons living with HIV (PLWHIV) still exhibit inflammation, which is associated with deleterious cardiovascular outcomes. PLWHIV on HAART have a higher prevalence of hypertension, which is associated with an increased risk of cardiovascular events. Moreover, chronic inflammation has been shown to be related to the translocation of microbes and endotoxins across the gastrointestinal tract. Such microbial translocation (MT) is increased in individuals with digestive disorders and their associated symptoms (e.g., diarrhea, abdominal pain, and nausea). This study aims to explore the pathologies common to both MT-induced inflammation and cardiovascular symptoms by examining the associations between gastrointestinal symptoms and hypertension in PLWHIV on HAART. METHODS/STUDY POPULATION: The sample included 351 PLWHIV on HAART. Pre-existing de-identified data were analyzed. Sample demographics included 56.98 % African Americans, 41.31% Caucasians, ages 20–66 years (mean age=43.65years), 21% female, 89% male, HIV viral load, CD4 counts. Self-reported data from the Symptom Co-Morbidity Questionnaire and Socio-demographic questionnaire were analyzed with SPSS v.24. RESULTS/ANTICIPATED RESULTS: In total, 86 PLWHIV (24.50%) stated that they have hypertension; 39 subjects (45.3%) reported having diarrhea, 30 subjects (34.8%) reported nausea, and 12 (13.9%) reported constipation and vomiting. Among ethnicities with hypertension and gastrointestinal symptoms, African Americans compared with Caucasians had a higher percentage of diarrhea (28% vs. 17%), nausea (21% vs. 11%), constipation (11% vs. 2%), and vomiting (8% vs. 5%). Women compared with men reported a higher percentage of nausea (28% vs. 24%) and constipation (8% vs. 6%). Men compared with women reported a higher percentage of diarrhea (38% vs. 7%) and vomiting (8% vs. 5%). DISCUSSION/SIGNIFICANCE OF IMPACT: These data support the need for targeted screening to include both blood pressure and associated gastrointestinal symptoms. Further studies supporting these results may assist practitioners to target treatments that may prevent cardiovascular comorbidities.

OBJECTIVES/SPECIFIC AIMS: To study the role functional capacity plays in surgical outcomes for head and neck cancers. METHODS/STUDY POPULATION: In this single-institution cohort study, we combined preoperative anesthesia assessment information with oncology registry data for newly-diagnosed patients with squamous cell carcinoma of the oral cavity, pharynx, and larynx (HNSCC) treated with definitive surgery at Siteman Cancer Center from 2012 to 2016. Patient-reported exercise capacity was assessed as metabolic equivalents. Metabolic equivalents<4 was defined as poor functional capacity. The primary outcome measure was overall survival (OS). Kaplan-Meir survival analysis was used to compare the survival of patients with poor functional capacity (PFC) and patients with normal functional capacity (NFC). Cox proportional hazard regression was used to explore the independent prognostic role of functional capacity on overall survival after controlling for other factors. RESULTS/ANTICIPATED RESULTS: A total of 671 patients underwent surgical treatment for HNSCC. The average age was 62 years (range: 19–94 years). Majority of the patients were male (n=481; 72%), White race (n=589; 88%), and smokers (n=528; 79%). Of 671 patients, 22% (n=146) had PFC. Two-year OS rate in PFC patients was 70% compared with 85% in NFC patients (15% difference; 95% CI: 7%–23%). Unadjusted Cox proportional hazard analysis showed that PFC patients had 2.2 times higher risk of death (95% CI: 1.5–3.2) than NFC patients. After adjustment for age at surgery, BMI, preoperative weight loss, comorbidity score, tumor site, and TNM stage the magnitude of the association between functional capacity and OS decreased (aHR=1.3; 95% CI: 0.88–1.98). DISCUSSION/SIGNIFICANCE OF IMPACT: Poor functional capacity is associated with decreased overall survival, but the magnitude of the association, while clinically meaningful, decreases after controlling for other important patient and tumor factors. Nevertheless, we believe preoperative functional capacity status is an important patient factor to consider when discussing prognosis and attempting risk stratification. We also believe that functional capacity may be associated with 30-day unplanned readmissions and 90-day complications and are currently performing chart review to ascertain this information.

OBJECTIVES/SPECIFIC AIMS: Infants with single ventricle congenital heart disease (CHD) who undergo staged surgical reconstruction are among the pediatric patients at highest risk for thrombotic complications. Despite improvements in survival due to medical and surgical advancements, thrombotic complications are common and lead to increased morbidity and mortality, especially during the first two stages of surgical reconstruction. The burden of disease caused by thrombosis is not fully known, and the risk factors associated with thrombosis are not clear. Due to this knowledge gap, prevention of thrombosis with medication, a strategy called thromboprophylaxis, has not been standardized, leading to inadequate prevention of thrombosis. In order to understand the burden of thrombosis and then provide targeted thromboprophylaxis for thrombosis prevention, better characterization of thrombotic complications and the associated factors is needed. Hypothesis: I hypothesize that in infants with single ventricle CHD, the incidence of thrombosis will be more frequent after stage I Versus stage II reconstruction, despite the type of shunt used. Specific demographic, clinical, and surgical variables will be associated with an increased risk for thrombotic complications, and a model to predict which subset of infants is at increased risk will be developed. Specific Aim 1: Characterize the incidence of thrombotic complications at different time points from stage I through stage II of the single ventricle reconstruction (SVR) pathway and determine the demographic, clinical, and surgical factors associated with thrombosis in infants with single ventricle CHD. (1) Determine the incidence of thrombosis in infants with single ventricle CHD. (2) Compare the rate of thrombotic complications between the 2 most commonly used approaches for stage I reconstruction for the group of patients with hypoplastic left heart type of anatomy [modified Blalock-Taussig shunt (MBTS) vs. right ventricle to pulmonary artery shunt (RVPAS)]. (3) Determine the factors (demographic, clinical, and surgical) associated with thrombosis in infants with single ventricle CHD. Specific Aim 2: Determine which subset of infants with single ventricle CHD is at increased risk of developing thrombotic complications across the first 2 stages of surgical reconstruction. (1) Test the identified demographic, clinical, and surgical variables including, but not limited to, gestational age, sex, CHD diagnosis, baseline oxygen saturation, stage of reconstruction, shunt type, and other clinical data available in a univariable and multivariable analysis and study their potential interactions to construct a novel risk predictive model specific for single ventricle CHD. METHODS/STUDY POPULATION: To address the specific aims, I will utilize data from the SVR clinical trial public use data set. This data set includes a prospective cohort of infants, 0–14 months of age, enrolled from any of the 15 participating clinical centers from the years 2005 to 2009. Inclusion criteria for enrollment were diagnosis of hypoplastic left heart syndrome or related single, morphologic right systemic ventricle anomaly, planned Norwood procedure, and informed consent of parent or legal guardian. No additional subjects outside of this data set will be included. Exclusion criteria were a diagnosis of single, morphologic left ventricle anomaly, preoperative identification of anatomy rendering the MBTS or RVPAS technically impossible, and any other major abnormality or acquired extra-cardiac disorder that could independently affect the likelihood of the subject meeting the primary endpoint. The complication of stroke will be excluded from the analyses of factors associated with thrombosis. The complication of thrombosis as defined in this dataset is a composite of events that include arterial or venous thrombosis, thromboembolism, and pulmonary embolism. The data was collected in such a way that it will not be possible to separate these sub-types of thrombosis. Additional thrombotic events of interest are superior vena cava occlusion and inferior vena cava occlusion. Specific Aim 1: Patient data will be extracted from the SVR clinical trial public use dataset to characterize the incidence of thrombotic complications at different time points from stage I through stage II of the SVR pathway and determine the demographic, clinical, and surgical factors associated with thrombosis in infants with single ventricle CHD. In addition, I will compare the rates of thrombotic complications between the 2 most commonly used approaches for stage I palliation for the group of patients with hypoplastic left heart type of anatomy (MBTS vs. RVPAS) and will test the hypothesis that the risk of thrombotic complications is associated with the stage of palliative surgery (stage I vs. stage II). Specific Aim 2: We will test identified demographic, clinical, surgical, and newly identified variables in a univariable and multivariable analysis and study their potential interactions to construct a novel risk predictive model specific for single ventricle CHD. RESULTS/ANTICIPATED RESULTS: To determine feasibility for adequate numbers to be able to address the research aims, a preliminary analysis dataset was performed using a dataset from the Pediatric Heart Network. The PHN is a collaborative group of hospitals that participates in clinical research studies in children with CHD. For the SVR clinical trial, the PHN conducted a randomized clinical trial at 15 centers in North America between 2005 and 2009, prospectively enrolling infants with HLHS or single right ventricle anomalies who were to undergo the Stage I Norwood procedure. A total of 920 newborns were screened; 664 were medically eligible and 549 patients were randomized. The primary aim of the trial was to compare survival of infants randomized to receive either the Norwood procedure with the MBTS or the RVPAS. These patients were followed at specific time points, including from baseline (pre-Norwood), at the time of the Norwood procedure, between stage I and II, following stage II reconstruction, and at 14 months of age. At these time points, data were collected that includes demographic, radiologic, clinical, and surgical outcomes. Included in the clinical outcomes are complications, such a thrombosis. There was no screening process to assess for asymptomatic thromboses, suggesting that most, if not all, discovered thromboses were due to clinically relevant effects. A newer iteration of this study (SVRIII) expands the monitoring of this cohort until the Fontan stage at 2–6 years of age, but these data have not yet been released in the public use data set. A descriptive analysis of the frequency of thrombotic complications was assessed at each time point, as well as in aggregate. Data were extracted from the specific time periods of interest, identified as Pre-Norwood, during Norwood Hospitalization, in-between visits, and during Stage II Hospitalization. There were 549 infants who were randomized with available data to analyze. During the Norwood hospitalization, 37 infants had a thrombotic complication. Between Stage I and Stage II outpatient visits, 8 infants had a thrombotic complication. During Stage II hospitalization, 16 infants had a thrombus. Overall, 61 individual patients (11%) had a thrombotic complication. DISCUSSION/SIGNIFICANCE OF IMPACT: This study utilizing data from the Pediatric Heart will be the largest cohort ever utilized for characterizing thrombotic complications and determining the factors associated with thrombosis across the first and second stages of surgical reconstruction. More than 500 (n=549) subject’s data will be analyzed through the first two stages of reconstruction, while the largest analysis before this proposed analysis only included a total of 195 children. Notably, these prior studies did not include a comparison between the 2 shunt types in stage I reconstruction, leaving a gap in knowledge regarding the incidence of thrombosis comparing these groups. The analysis will be the first to address this gap and update the current literature. Preliminary data show that the overall incidence of thrombosis across the first 2 stages of surgical reconstruction was 11%, which is lower than the previously reported overall rates of 40%–50%. Despite the continued lack of evidence-based guidelines for thromboprophylaxis methods, the decreased overall rate is most likely due to more widespread practice of anticoagulation in general. Determining the factors associated with thrombosis across the first and second stages of surgical reconstruction will help identify those at risk. An innovative aspect of this analysis will be the use of disease-specific factors to develop a model to predict thrombosis. Unique factors include cardiac variables like ejection fraction, baseline oxygen saturation, shunt type (MBTS vs. RVPAS), and other echocardiographic parameters. While the use of thromboprophylaxis has been associated with decreased risk of thrombosis, there is no general consensus to guide thromboprophylaxis in this population, which can be burdensome and costly. Determining which subset of infants with single ventricle CHD are at increased risk of developing thrombotic complications will allow for the development of a prediction model to predict those at highest risk of developing a thrombotic complication. Developing a predictive model will be a novel way to identify patients at risk for thrombosis and will set the stage for targeted prevention of thrombosis.

OBJECTIVES/SPECIFIC AIMS: We aimed to assess trends in incidence of genital warts across human papillomavirus (HPV) vaccine-eligible and nonvaccine-eligible age groups to determine the impact of the HPV vaccine among Medicaid enrollees in the state of Tennessee. METHODS/STUDY POPULATION: We analyzed 2006–2014 medical and pharmaceutical claims data from TennCare (Tennessee’s Medicaid program) enrollees aged 15–64 years. Incident cases of genital warts were defined as persons 12 months disease free and: (1) a diagnosis of condyloma acuminatum, or (2) a diagnosis of viral warts and genital-specific procedure, or (3) a prescription for genital warts medication and genital-specific procedure. Mann-Kendall trend tests were performed to assess for significant trends in incidence of genital warts by sex and age group; average annual percent changes were calculated to quantify these trends. RESULTS/ANTICIPATED RESULTS: Our analysis is in progress. We hypothesize that we will observe declines in genital warts among younger, vaccine-eligible age groups and no changes in older, nonvaccine-eligible age groups, with largest declines among females aged 15–19 years from 2006 to 2014. We also expect to see declines among younger males due to herd protection, with greater declines after 2011, when the vaccine was approved for males. DISCUSSION/SIGNIFICANCE OF IMPACT: Significant declines among younger compared with older age groups would suggest HPV vaccine effectiveness for preventing genital warts.

OBJECTIVES/SPECIFIC AIMS: Background: Annually, 2.5 million traumatic brain injuries (TBI) occur with nearly 75% classified as mild TBI (mTBI), also known as a concussion. Mild TBI can be subtle and detection requires a high index of suspicion and a regimented evaluation process. This study was done to define the proportion of patients with a possible mTBI evaluated for concussion at a high volume urban trauma center. METHODS/STUDY POPULATION: Methods: A prospective cohort of patients was identified using a 3-question screen at the time of triage: did an injury occur; was the mechanism consistent with mTBI; was there a period of altered mental status. Patients who screened positive were thought to meet a minimum threshold for the evaluation of mTBI. Information about mTBI specific evaluation, management, and education was obtained from the patient’s charts. RESULTS/ANTICIPATED RESULTS: Results: 38,484 patients were screened over 16 weeks, of whom 453 (1.18%) screened positive for a possible mTBI and did not meet exclusion criteria. In total, 198 patients had documented loss of consciousness, 101 were diagnosed with mTBI, and 49 received mTBI discharge instructions. Overall, 32.5% of included patients had mTBI listed in the differential or as a diagnosis and 32.3% with loss of consciousness received a mTBI diagnosis. DISCUSSION/SIGNIFICANCE OF IMPACT: Conclusions: Many patients with a possible mTBI were not evaluated, managed, or educated for their potential injury. Changes in physicians’ approach to mTBI must occur to increase the proportion of patients receiving appropriate evaluation, management, and education. These results define the current reality of mTBI treatment in the Emergency Department and show the need for further experimental studies targeted at physician decision support interventions to improve mTBI care.

OBJECTIVES/SPECIFIC AIMS: The purpose of this study is to evaluate the extent of publication bias in anesthesia and to evaluate the characteristics of studies that are registered and unpublished. METHODS/STUDY POPULATION: We used the advanced search option and the key word “anesthesia” to identify anesthesia related studies in the ClinicalTrials.gov registry. For the purpose of this analysis we have randomly selected 50% of the anesthesia related studies from the year 2008–2013. We have collected information pertaining to drug/device study, origin, type, design, subspecialty, enrollment target, anesthesia type, and adult/ pediatric, sponsored/ investigator initiated, population studied and start and end date. Studies with an ongoing, terminated, or unknown status were excluded from the analysis. For results, we initially searched the results section associated with each study; also we searched for any publication link at the study result area of the registry. For studies with no results and publication links we searched on PubMed, Google Scholar, and Embase by trial registration number, study title, and investigators name for matching manuscripts. In addition, we also analyzed the proportion of studies with positive and negative conclusions. We used descriptive and univariate statistics to report the results. RESULTS/ANTICIPATED RESULTS: Overall, 5448 studies were identified within the queried timeframe. We have included 2649 studies in our final analysis and detailed analysis were performed for 1778 studies with the status “completed.” The mean, standard deviation of subjects enrolled in completed trials was 392.47±6378. Only 162 (9.9%) studies registered were in the pediatric population, and 1616 (90.9%) were in the adult population. Finally, of the reviewed studies, 1486 (83.6%) were investigator-initiated, 207 (11.6%) were sponsored, and 85 (4.8%) were registered as collaborated studies. Among the completed studies only 296 (16.6%) studies posted results to the result section of the registry. Additionally, a link associated with a publication was posted in only 393 (22.1%) of the studies. The proportion of studies with posted results were 208 (14%), 61 (29%) and 27 (31.8%) in investigator-initiated, sponsored, and collaborated studies p<0.001 respectively. In the 1778 studies we reviewed, 954 (53.7%) studies were associated with one publication. In the published studies, 721 (75.6%) studies reported a positive conclusion for their publication. DISCUSSION/SIGNIFICANCE OF IMPACT: Only, 53.7% of anesthesia related studies with a “complete” status in ClinicalTrials.gov were published. Furthermore, investigators fail to fulfill the requirement of making the results available in the results section of the registry. Lack of availability of published literature and the nonavailability of the results from these studies contributes to publication bias and also failure to honor the ethical responsibility of the investigator to share the results of the study with subjects and with the medical community around the world.

OBJECTIVES/SPECIFIC AIMS: Reducing radiologic exams has been a focus of cost reduction in healthcare systems. The utility and justification of obtaining cross-sectional imaging (PPCSI) before surgical intervention continues to be evaluated. For peripheral artery disease (PAD) consensus guidelines regarding PPCSI do not exist and may be influenced by patient complexity, variation of disease presentation, and physician preference. The objective of this study was to determine the utility of PPCSI before percutaneous PAD intervention. METHODS/STUDY POPULATION: Patients receiving first-time endovascular revascularization procedure for PAD from 2013 to 2015 were evaluated for PPCSI done within 180 days prior to revascularization. Patient and physician demographics, perioperative characteristics, and disease distribution/severity were evaluated. The primary outcome was technical success defined as improving inflow and/or revascularization of the target outflow vessels to <50% stenosis. RESULTS/ANTICIPATED RESULTS: Of the 348 patients who underwent an attempted revascularization procedure 159 (45.7%) patients underwent PPCSI, including 151 CTA and 8 MRA. Of these, 48% were ordered by the referring provider (84% at an outside institution), and 52% were ordered by the treating physician. PPCSI was performed a median of 26 days (IQR 9-53) prior to procedure. Individual vascular surgeon practice identified PPCSI rates ranging from 31% to 70%. On multivariate analysis chronic kidney disease (OR=0.35; CI 0.17–0.73) had the strongest effect against of PPCSI, and Inpatient/ED evaluation (OR=3.20; CI 1.58–6.50), aorto-iliac (OR=2.78; CI 1.46–5.29) and femoral-popliteal occlusions (OR=2.51; CI 1.38–4.55) most strongly predicted PPCSI. After excluding 31 diagnostic procedures, technical success did not differ between endovascular procedures with PPSCI (91.3%) or without PPCSI (85.6%), p=0.11. When analyzing 89 femoral-popliteal occlusions, technical success was higher with PPCSI (88%) compared to procedures without PPSCI (69%), p=0.026. DISCUSSION/SIGNIFICANCE OF IMPACT: PPCSI use is influenced by inpatient status, chronic kidney disease, and anatomic consideration. PPCSI was not associated with overall technical success although it appeared beneficial for femoral-popliteal occlusions. Routine practices of ordering of PPCSI may not be warranted when considering technical success but may be important in treatment planning. Further studies are warranted to determine if radiation, cost, and contrast load justify PPCSI.