OBJECTIVES/SPECIFIC AIMS: This research project aims to: 1) describe the incidents of workplace violence that have been reported to CalOSHA through the Workplace Violent Incident Reporting System for Hospitals; 2) determine if there are any relationships between the types of violent incidents reported and the unit or hospital where the event occurred; 3) describe what mitigation strategies facility representatives report having utilized immediately following a violent incident, such as changes to practice or involvement of law enforcement. METHODS/STUDY POPULATION: Reports submitted to CalOSHA pursuant to the Workplace Violent Incident Reporting System for Hospitals are considered public record and are available through the state’s Public Records Act (PRA) mandate. Records from 7/1/17 – 9/30/18 were obtained through the CalOSHA PRA request process. Descriptive statistics and correlations were calculated using Stata. RESULTS/ANTICIPATED RESULTS: Records reporting 11,116 individual events of violence were analyzed. These results do not include reports submitted by the five California State Hospitals, a group of facilities which treated nearly 13,000 patients in 2017, many of whom have a psychiatric diagnosis and are undergoing treatment mandated by judicial decision. For each record, 111 variables were reported, including description of the event itself, characteristics of the workers involved, factors which may have triggered the event, and what measures were taken to mitigate the situation during and after the incident. All events identified an aggressor; 10,357 (93%) described this individual as a patient. 11,048 reports had a unit or hospital location listed to describe where the incident occurred. Of these, 9393 (84.5%) were inpatient, behavioral health, or surgical units. A physical injury was reported in 3672 events (33%) and stress/psychological impairment was reported in 536 (5%) of the incidents. Police officers were deployed to the scene following the incident in 1122 (10%) of reported events, resulting in arrest of the perpetrator in 402 (3.6%) of the reported incidents. DISCUSSION/SIGNIFICANCE OF IMPACT: While the impulse to address the high prevalence of workplace violence towards healthcare providers has led to deserved attention from policy makers, safety regulators, and healthcare unions, plans for ensuring that new initiatives are achieving their desired effect for workers have yet to fully materialize. An ongoing concern is that incidents are known to be under-reported through official mechanisms, leading to challenges in determining the scope of the problem itself and evaluating the efficacy of interventions to address it. CalOSHA’s new reporting requirement and online interface provides a new channel for improving validity of prevalence data, as early findings indicate that less serious events are being reported through the system. In addition, information describing how hospital leaders report responding to incidents in their immediate aftermath will provide needed insight into what additional efforts are needed to support victims of violence given the unique challenges present in the healthcare industry.

OBJECTIVES/SPECIFIC AIMS: To analyze contemporary study design methods and clinical trial approaches in placebo research. METHODS/STUDY POPULATION: An analysis was conducted on the following studies: I. “Managing” the Placebo Effect: The Single-Blind Placebo Lead-in Response in Two Pain Models by RN Haden, et al. The objective of the study was to consider elements of the placebo response in the context of two pain models using a “single-blind placebo lead-in” design (SBPLI) by engaging the “placebo response” prior to randomization to active drug and placebo-controlled conditions. The methods of the study included two pilot drug trials using knee osteoarthritis (KOA) and non-radicular low back pain (LBP) subjects, SBPLI protocols were conducted. In the first study, 36 subjects with non-radicular CLBP were enrolled in a double-blind, randomized, placebo-controlled trial of hydromorphone ER. In the second study, a total of 42 subjects with chronic KOA pain were enrolled in a double-blind, randomized, placebo-controlled study of milnacipran. Gender and/or diagnosis affected placebo responses as observed in changes in patient self-reported pain, depressive and pain anxiety symptoms were examined. Additionally, the placebo response on performance-based tests (stair climbing, range of motion (ROM), sit to stand repetitions, and 6-minute treadmill distance) was evaluated. II. Randomized Placebo-Controlled Placebo Trial to Determine the Placebo Effect Size by L. Gerdesmeyer, et al. The objective of the study was to analyze the pure placebo effect on clinical, chronic pain through a blinded RCT. The methods of the study included 182 patients suffering from chronic plantar heel pain for over 6 months, who failed to respond to conservative treatments, were screened and 106 of these patients were enrolled into this study. The patients were randomly assigned to receive either a blinded placebo shockwave treatment or an unblinded placebo shockwave treatment. The primary outcome measure was the differences in percentage change of visual analogue scale (VAS) scores 6 weeks after the intervention. The secondary outcome measure was the differences in Roles and Maudsley pain score (RMS) 6 weeks after intervention. III. Open-label placebo treatment in chronic low back pain: a randomized controlled trial by C. Carvalho, et al. The objective of the study was to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. The methods of the study included 97 randomized participants in a 3-week randomized control trial comparing current treatment plus OLP to current treatment alone (TAU). RESULTS/ANTICIPATED RESULTS: N/a DISCUSSION/SIGNIFICANCE OF IMPACT: The aforementioned studies provide placebo researchers with contemporary and reliable methodologies to examine placebo effects on participants. These methodologies provide scientists with clinical translational research methodology styles based on the foundation of regulatory science.

OBJECTIVES/SPECIFIC AIMS: The objective of this study is to assess differences in outcomes between African Americans (AAs) and whites along the HCV care cascade. Primary outcome was retention in the HCV care cascade, measured in two ways. For viral RNA confirmation, retention was a percentage of those having screened antibody reactive. For hepatic ultrasound, primary care, HCV specialty clinic, treatment initiation, and sustained viral load (SVR), retention was a percentage of those found chronically infected by positive RNA viral load. Secondary outcome was time to follow-up from antibody screening to each subsequent step in the care cascade. METHODS/STUDY POPULATION: A retrospective cohort study was performed. AA and white patients who tested HCV antibody reactive from March to October 2015 at the University Medical Center (UMC) Emergency Department in New Orleans, LA were included in this study. Outcomes were assessed using the HCV Continuum of Care model, delineating successive stages of care from identification to cure. RESULTS/ANTICIPATED RESULTS: A total of 728 patients screened HCV antibody reactive, including 446 AAs and 282 whites. AAs (53.5 years, SD 10.2) were disproportionately older than whites (46.7 years, SD 11.9) (p <0.001), more likely to be insured (89.2% vs 78.7%, p<0.001), had higher rates of Medicare (28.0% vs 12.1%, p<0.001), and less frequent history of intravenous drug use (IVDU) (32.3% vs 46.1%, p<0.001). For AAs, retention in the treatment cascade was 96.2% for viral RNA confirmation, 50.9% for hepatic ultrasound, 26.8% for primary care, 35.2% for HCV specialty clinic, 14.5% for treatment initiation, and 9.6% for sustained viral response (SVR). Among whites, retention in the treatment cascade was 96.8% for viral RNA confirmation, 37.8% for hepatic ultrasound, 16.1% for primary care, 23.3% for HCV specialty clinic, 8.8% for treatment initiation, and 7.8% for SVR. AAs had a higher likelihood of receiving a hepatic ultrasound (OR=1.70; CI=1.19-2.25; p<0.005), following up with primary care (OR = 1.91, CI=1.21-3.02, p<0.005), and attending the viral hepatitis specialty clinic (OR=1.79, CI=1.20-2.68, p<0.005), as compared to their white counterparts. After adjusting for age, insurance, and history of IVDU, AAs did not have a higher likelihood of receiving a hepatic ultrasound (aOR=1.09, CI=0.995-1.19) or seeking primary care (aOR=1.05, CI=0.98-1.14). AAs had attenuated odds of attending viral hepatitis specialty clinic (aOR=1.09, CI = 1.01-1.19). There was no statistically significant difference in follow-up time in the treatment cascade for AAs versus whites. DISCUSSION/SIGNIFICANCE OF IMPACT: Race alone cannot explain differences in achievement along the care cascade. Significant differences in retention along the HCV care cascade appear to be related primarily to differences in age and insurance status. In our population, older AAs are disproportionately insured through Medicare, thereby expanding their access to health resources. Their white counterparts are younger and more uninsured, leading to decreased access to care and ability to attend HCV follow-up appointments. ED HCV screening programs are still in their infancy and have opportunities to improve their linkage to care rates. Additional interventions are needed to better connect patients screened positive in the ED to HCV specialist care, preserving equity across racial groups.

OBJECTIVES/SPECIFIC AIMS: The aim of the present study is to explore the relationships between resilience, pain catastrophizing, and functional outcomes in pre-and post-operative TKR patients. The primary outcome is the ability of the Brief Resilience Scale (BRS) to predict function using the Knee injury and Osteoarthritis Outcome Score Joint Replacement (KOOS, JR.) and overall health on the Patient-Reported Outcome Measurement Information System Global Health (PROMIS GH). METHODS/STUDY POPULATION: Recruited patients will provide informed consent during in-person office visits. At the pre-surgery intake appointment, patients will provide demographic information and complete baseline questionnaires assessing resilience, pain catastrophizing, knee stiffness, pain, and function, and impression of overall health. In-person or electronic follow-up assessments will be administered post-surgery at 6-week, 3-month, and 6-month appointments. RESULTS/ANTICIPATED RESULTS: We aim to recruit 150 patients for this study. We do not expect a difference in sociodemographic characteristics of the patient sample. P-values will be based on t-tests and correlations calculated by comparing only non-missing values. Each outcome measure will be examined at each time point and trajectories will be calculated to determine the change in each outcome over time. Using latent class growth modeling we will examine individual change over time for each outcome (BRS, PCS, PROMIS GH, and KOOS JR.), and the association of resilience and pain with change in function (KOOS, JR. total score) and overall health (PROMIS GH). DISCUSSION/SIGNIFICANCE OF IMPACT: To our knowledge, this is the only known study that will compare resilience, pain catastrophizing and longitudinal health outcomes in a single paradigm. Results will hopefully inform the design and implementation of future studies that will assess the impact of preoperative treatment of vulnerable patients. The ultimate goal is to improve functional recovery by using pre-identified psychological constructs as intervention points. Ideally, the same measures would be implemented, however, details of this plan will be established following completion of this study.

OBJECTIVES/SPECIFIC AIMS: We intended to investigate the relationship between children’s genetic admixture proportions and the incidence of obesity at 12 months of age METHODS/STUDY POPULATION: 821 twelve month old children were included and their genetic admixture was estimated using the ancestry and kinship toolkit (AKT). Weight for Length Percentile (WFLP) at 12 months of age was categorized as <95th percentile and ≥95th percentile. Multiple logistic regression analysis was performed to calculate odds ratios (ORs) with 95% confidence intervals (CIs) for association of admixture proportion including EUR, AMR, AFR, EAS and SAS with WFLP categories adjusting for maternal education, birth weight, frequency of breast feeding and juice consumption RESULTS/ANTICIPATED RESULTS: 821 children were included; WFLP <95th percentile = 671 (81.7%) and WFLP ≥95th percentile = 150 (18.3%). Crude odds ratios showed EUR admixture was protective (OR 0.45 (95% CI 0.27–0.74)) whereas AMR (OR 3.85 (95% CI 1.92 –7.70)) and AFR (OR 5.70 (95% CI 2.19 –14.85)) were positively associated with obesity. After adjusting for confounding variables, only AFR was associated with WFLP≥95th (OR 7.38 (95% CI 2.31 – 23.59)), AMR and EUR were no longer associated with WFLP≥95th DISCUSSION/SIGNIFICANCE OF IMPACT: The AFR admixture proportion remains associated with early childhood obesity after accounting for confounding variables, suggesting the ancestral genetic background may contribute to the differences seen in early childhood obesity

OBJECTIVES/SPECIFIC AIMS: Our objective is to examine the relationship between depression, childhood asthma and family structure. METHODS/STUDY POPULATION: We analyzed data from The National Survey of Children’s Health 2011-2012 for the variables family structure, parent’s smoking, education, poverty, available emotional support, and children’s age, gender, race/ethnicity, asthma, physical/mental health, access to care, and insurance. Data were analyzed using multiple logistic regression in STATA 14 (sampling and weight). RESULTS/ANTICIPATED RESULTS: Of the 95,000 participants, 3.8% had depression, 5.1% had anxiety, 8.5% had emotional, developmental, or behavioral problem, 14.6% had asthma and 19% were single-parent family. Asthmatics had higher chance for depression relative to non-asthmatics (Adjusted Odds Ratio (AOR)=1.5, 95% confidence interval (CI)=1.2-1.8), p=0.001). Those living in a single-family home had higher chance for depression than those living in 2-parents homes (AOR=2.5, 95% CI=1.9-3.2), p=0.001). Other predictors were lack of emotional support, age, poverty <100%, poor health, and smoking parent (p<0.05). DISCUSSION/SIGNIFICANCE OF IMPACT: We concluded that depression was associated with asthma in children from poor single family who lack an emotional support. Management of asthma should include screening and management of psychosocial factors.

OBJECTIVES/SPECIFIC AIMS: The purpose of the study was to describe patient characteristics associated with subsequent development of bowel ischemia. Primary outcomes were survival to discharge, 30-day and 1-year survival in patients with LVAD who subsequently develop bowel ischemia. Secondary outcomes included characteristics of patients who survive to discharge after bowel ischemia and those who do not. These included markers of patient condition prior to surgical/endoscopic intervention such as lactate levels, ICU admission, ventilator dependence, vasopressor and renal replacement requirements, as well as presence of sepsis. Of these, we predicted that lactate levels and white blood cell count would be significantly elevated pre- and post-operatively in patients who do not recover from bowel ischemic event. We used Mann-Whitney U Test to examine lactate levels between the two groups as our sample size was <30 and therefore necessitated the use of non-parametric testing. METHODS/STUDY POPULATION: In this single-center retrospective study, we analyzed all patients who underwent durable, CF-LVAD implantation at Duke University Medical Center (DUMC) between January 2008 and November 2018. Patients were screened using CPT codes for abdominal surgical exploration or ICD codes for intestinal vascular insufficiency. Final cohort was selected with confirmed diagnosis of intestinal ischemia based on surgical exploration or endoscopic intervention. Patient characteristics including pre-LVAD comorbidities, indication for LVAD implant, and clinical picture prior to bowel ischemic event were collected. Specific characteristics related to bowel ischemia were summarized, including diagnostic imaging, time from imaging study to operative intervention, and intraoperative details. Patient outcomes including survival to discharge, 30-day-, and 1-year survival were summarized. Patients were stratified based on survival to discharge status. Continuous variables were reported as median and interquartile range and compared using Mann-Whitney U test. Categorical variables were reported as proportions and compared using Fisher’s exact test as appropriate. RESULTS/ANTICIPATED RESULTS: A total of 754 patients underwent durable, CF-LVAD implant at DUMC, of which 21 subsequently developed intestinal ischemia (incidence 2.8%). The majority were male (81%) and treated as destination therapy (76.2%). Ten patients (50%) survived to discharge (one remains hospitalized). The proportions of patients receiving HeartMate II (60% vs. 50%, p=1.0), HeartMate III (20% vs. 10%, p=1.0), and HeartWare (20% vs. 40%, p=0.6) were not significantly different between patients who survived to discharge and patients who did not. Median time from LVAD implant to diagnosis of bowel ischemia did not vary significantly between the patient groups (11.5 days, IQR 34.75 vs. 16.5 days, IQR 173.8; p=0.40), nor did the median time from diagnosis to surgical intervention (264.5 minutes, IQR 497.8 vs. 323 minutes, IQR 440, p=0.82). In the 48 hours leading to diagnosis and intervention, renal replacement therapy (50% vs. 0%, p=0.033) was more prevalent in patients who did not survive to discharge. Differences in pre- and post-operative lactate levels were not significantly different in patient groups. A similar pattern of diagnostic study preference emerged from both groups, with CT being the most common (76.2%) followed by KUB (42.9%). Upper endoscopy/colonoscopy was performed in 7 patients (33.3%), of which 5 also had operative exploration. A total of 19 patients underwent abdominal exploration (90.5%). Nine had large bowel resection (42.9%) while 14 had small bowel resection (66.7% with average 75cm removed). Overall survival at 1-year was 33%. For those making it to discharge (n=10), one year survival was 60%. DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first institutional study to our knowledge to describe intestinal ischemia in patients receiving CF-LVAD therapy. Intestinal ischemia in patients receiving CF-LVAD therapy is associated with high mortality and morbidity. Diagnosis of bowel ischemia should be considered in patients presenting with clinical symptoms of bowel ischemia in addition to requirement of renal replacement therapy. Imaging modalities used were dependent on the clinical situation and were not always necessary prior to intervention. Further investigation is warranted to identify predictors of this morbid complication.

OBJECTIVES/SPECIFIC AIMS: Treatment of breast cancer surgery can be classified into two overall groups: Breast-Conserving Therapy (BCT) (including partial mastectomy (PM) and oncoplastic surgery (OS)) and MAST (including mastectomy (M) and M with breast reconstruction (M+R)). Breast reconstruction (OS or M+R) offers patients an improved quality of life by aesthetically symmetric breast, higher patient satisfaction and reduced re-excision rates. Furthermore, subgroups of M+R, mastectomy with implant placement (M+I) has doubled to 21%, meanwhile mastectomy with muscular flap reconstruction (M+MF) has declined to only 2% of overall breast cancer intervention. Furthermore, in patients with with ductal carcinoma in situ (DCIS), published national guidelines recommend that sentinel lymph node biopsy (SLNB) should be offered when treated with M and should not be offered when treated with BCS. Overall complication rates for breast cancer surgery vary depending on short-term or long term outcome but are approximately 2-40%. Mortality and overall morbidity are overall low in less than 5% of cases. Known wound or infectious complications have been associated with smoking, radiation, obesity and diabetes. Nevertheless, other patient comorbidities and surgical predictors influencing acute postoperative complications are contentious. Single institutional studies or reviews compared single or two groups of breast cancer interventions for post-operative complication rates. Few studies with large enough patient cohort to analyze all possible variables influencing post-operative acute complications following all breast cancer surgeries. Understanding surgical complications is crucial to patient safety and improving health outcomes. Therefore, this study examines the 30-day postoperative complication rates in breast cancer patients who underwent a PM, M, M+R, or OS. Using the NSQIP database, we aim to elucidate these surgical trends and complications trends, while expanding our understanding of predictive surgical factors. We also examined appropriate axillary management associated with surgical interventions between 2005 and 2016. METHODS/STUDY POPULATION: A retrospective cohort analysis was conducted using the ACS-NSQIP database from 2005 to 2017. All participant user files (PUF) were obtained and approved by ACS NSQIP. The Tufts Medical Center Institutional Review Board deemed this study exempt from institutional review, given ACS NSQIP database is a de-identified data set. Inclusion criteria for this study were women with classified post-operative diagnosis of invasive breast cancer (IBC) or ductal carcinoma in-situ (DCIS) breast cancer who underwent either any BCT or any MAST procedure. Post-operative diagnosis was classified according International Classification of Diseases Ninth/Tenth Revision (ICD-9/10) code for IBC or DCIS. Surgical (M, PM, OS, M+R) and axillary lymph node categorization were done using CPT codes known for each intervention. Exclusion criteria included males, benign breast surgery, surgery for benign breast disease, lobular carcinoma, patients undergoing breast cancer surgery with 2 CPT codes with ambiguous category placement and septic patients at time of surgery. For each intervention, a total of 16 complications were clustered into 8 groups and examined over the 13-year period. ALN management was categorized as follows: no intervention on ALNs, or ALN surgery (SLNB or ALN dissection (ALND)). Chi-square tests were performed for demographic and complication rate analysis. Smoothed linear regression and non-parametric Mann- Kendall test assessed complication trends. Uni-variate and multivariate logistical regression were computed to associate odd’s ratio for comorbidities, surgical predictors and patients demographics. RESULTS/ANTICIPATED RESULTS: A total of 226,899 patients met the inclusion criteria. Annual breast surgery trends changed as follows: PM 45.6% to 45.9 (p=0.21), M 36.8% to 25.5% (p=0.001), M+R 15.7% to 23.6% (p=0.03) and OS 1.8% to 5.0% (p=0.001). Analyzing the patient cohort who underwent breast conservation, categorical analysis showed a decreased use of PM alone (96% to 90%) with an increased use of OS (4% to 10%). For the patient cohort undergoing mastectomy, M alone decreased (69% to 52%); M+R with muscular flap decreased (9% to 2%); and M+R with implant placement increased (20% to 41%) – all 3 trends p<0.0001. The rate of ALN management has changed as follows: SNLB or ALND significantly increased in mastectomy patients from 53.6% to 69.5% (SS 1.5%, R2 0.69, p < 0.01), while it changed little in the BCS population: 22.5% to 26.4% (SS 0.4%, R2 0.18, p = 0.09). Complication rates have steadily increased in all mastectomy groups (p< 0.05) but not in BCT. Cumulative complication rates between surgical categories were significantly different in each complication cluster (all p<0.0001). Overall complication rates were: PM: 2.25%, OS: 3.2%, M: 6.56%, M+MF: 13.04% and M+I: 5.68%. The most common predictive risk factors were mastectomy interventions, increasing operative time, ASA class and BMI, smoking, recent weight loss, history of CHF, COPD and bleeding disorders (all p<0.001). Patients who were non-diabetic, younger (<60) and treated as outpatient all had protective OR for an acute complication (p<0.0001). DISCUSSION/SIGNIFICANCE OF IMPACT: The modern era of breast surgery is identified by the increasing use of reconstruction for patients undergoing breast conservation (in the form of OS) and mastectomy (in the form of M+R). Despite national recommendations for the management of axillary lymph nodes in patients undergoing breast surgery for DCIS, nearly 30% of cases continue to be mismanaged: more than 30% of patients with DCIS undergoing mastectomy fail to receive SLNB, and more than 26% of DCIS patients undergoing BCS are still receiving axillary lymph node surgery. Our study provides data showing significant trends that will impact the future of both breast cancer surgery and breast training programs. We also provide data comparing nationwide acute complication rates following different breast cancer surgeries that can be used to inform patients during surgical decision making.

OBJECTIVES/SPECIFIC AIMS: To evaluate gaps in knowledge for women who are cancer survivors regarding the impact of comorbidities and lifestyle behaviors on endometrial and cervical cancer risk, and to assess prevalence of established care with a primary care physician (PCP) among patients and evaluate acceptability of referral to a PCP METHODS/STUDY POPULATION: Single institution cross-sectional study examining all women aged 18 or older with a diagnosis of cervical or endometrial cancer who present for care by a gynecologic oncologist at Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine. Patients will be invited to complete a survey specific to cancer diagnosis that includes questions on participant background and sociodemographic information, knowledge of risk factors for their specific cancer site, and whether or not the patient has a primary care provider and the acceptability of referring RESULTS/ANTICIPATED RESULTS: Majority of women will be unaware of how comorbidities affect cancer risk and treatment outcomes. For women without a PCP, we anticipate that they will be accepting towards the notion of being referred to one for establishing care. DISCUSSION/SIGNIFICANCE OF IMPACT: Pilot information from this study will 1. Allow providers to improve cancer survivorship care plans by increasing collaboration between PCPs and oncologists to provide ongoing care, and 2. Afford information for providers on where gaps in knowledge exist so as to better education patients.

OBJECTIVES/SPECIFIC AIMS: Research overview: Providing patient-centered care is increasingly a top priority in the U.S. healthcare system.1,2 Hospitals are required to publicly report patient-centered assessments, including results from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction surveys.3 Furthermore, clinician and hospital reimbursements are partially determined by performance on patient satisfaction measures.3 Consequently, hospitals and clinicians may be incentivized to improve patient satisfaction scores over other important outcomes.4 Paradoxically then, the pursuit of patient-centered care may lead clinicians to fulfill patient requests for unnecessary and potentially harmful treatments.5 Opioid prescribing during hospitalizations may be particularly affected by clinicians’ seeking to optimize patient satisfaction scores.6,7 Satisfaction with pain care is an important predictor of overall patient satisfaction in the HCAHPS surveys,8,9 and clinicians report increased pressure to fulfill patient requests for immediate pain-relief.10,11 Therefore, clinicians may prescribe opioids to avoid receiving lower patient satisfaction scores.12,13 Furthermore, clinicians lack clear guidance on opioid prescribing for some populations, including non-surgical inpatients, who represent almost half of all hospitalizations.14 To reduce clinicians’ incentive to prescribe opioids as a means of achieving patient satisfaction, the Center for Medicare and Medicaid Services (CMS) temporarily removed questions related to patient satisfaction with pain care from the clinician and hospital reimbursement formulas beginning in 2018.15 Importantly, prior research16-20 has not rigorously tested the hypothesis implied by the CMS policy change: that certain opioid prescribing practices in inpatient pain care are associated with higher patient satisfaction. Objectives: The purpose of this study was to evaluate the association between the receipt/dose of opioids during non-surgical hospitalizations and patient satisfaction measured by the HCAHPS survey. METHODS/STUDY POPULATION: Methods/Study Population: We conducted a pooled cross-sectional study of adults (18 and older) with non-surgical hospitalizations within the 11-hospital healthcare system in a Midwestern state from 2011-2016. Data were extracted from electronic health records and linked to HCAHPS patient satisfaction surveys. We estimated the propensity score for receipt of any opioids during hospitalization and separately the receipt of high dose opioids (≥100 morphine milligram equivalent [MME]) based on patient, encounter, and facility characteristics for all hospitalizations with complete data. We used nearest neighbor matching to construct two matched samples to minimize selection bias and confounding by indication. We used a standardized difference threshold of < 0.1 as an indication of the balance between matched groups. Outcomes were compared with a test on the equality of proportions using large-sample statistics. All analysis was performed in STATA 14.0 analytical software. Main outcomes: We analyzed four dependent variables. Two pain-specific patient satisfaction variables were derived from the responses to the following survey questions: 1) “During this hospital stay, how often your pain was well controlled? (pain control)” and 2) “During this hospital stay, how often did the hospital staff do everything they could to help you with your pain? (pain help)”, with 4-point Likert scale responses ranging from “Never” to “Always.” We also used two global satisfaction measures derived from the responses to the following survey questions: 1) “Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay (overall patient satisfaction)?” and 2) “Would you recommend this hospital to your friends and family (willingness to recommend a hospital)? (4-point scale of “Definitely Yes” to “Definitely No”). Because the responses are not normally distributed, and the response options are truncated, we dichotomized each of these questions following previously published approaches8 and CMS methodology3 (e.g. “always” vs. all other responses or “9 or 10 rating” vs. all others). RESULTS/ANTICIPATED RESULTS: Results: Among 17,691 patients who reported that they needed pain medications during hospitalization in their HCAHPS survey, 43.7% (n=7,735) received opioids. Among the matched sample (n=8,848), 55% were female, 90% were white, 9% were black, 74% were emergency admissions, 29% had a circulatory diagnosis, 92% were discharged home, and the average pain score ranged from 0.2 to 7.1 during the hospital stay. Compared to matched patients hospitalized but did not receiving opioids, those who received opioids did not significantly differ in their rating of pain help (75% of patients without opioids rated that they always received help for their pain versus 75% of patients with opioids; p=.78), pain control (55% of patients without opioids reported that their pain was well controlled versus 54% on opioids; p=.93), willingness to recommend the hospital (69% of patients without opioids reported that they would definitely recommend a hospital versus 71% with opioids; p=.16) and overall rating of their care (47% of patients without opioids rated their hospitalization as 10 versus 46% on opioids; p=.22). DISCUSSION/SIGNIFICANCE OF IMPACT: Discussion: We found no evidence that receipt of opioids is associated with patient satisfaction, including at doses. To our knowledge, this is the first study that used propensity score matching to examine the association between inpatient opioid prescribing practices and patient satisfaction. Furthermore, our sample is unique in the inclusion of patients hospitalized for non-surgical indicators over a five year period in the multi-hospital healthcare system in a Midwestern state. Our findings add to the existing literature which has shown contradictory associations between opioid prescribing and patient satisfaction.16-22 Specifically, few studies that looked at surgical inpatients showed a lack of association between patient satisfaction16,18 and opioid prescribing, whereas others showed that receipt of opioids was associated with lower patient satisfaction.17-20 Our findings may imply that satisfaction with pain care may be achieved without administering opioids to non-surgical inpatients. Alternatively, satisfaction with pain care may not be influenced by opioid prescribing for non-surgical inpatients. Future research should further examine the association between opioid prescribing and patient satisfaction among non-surgical inpatients on a national scale to get a better understanding of the relationship between certain pain care practices and patient satisfaction.

OBJECTIVES/SPECIFIC AIMS: (1) To define and describe a cohort of patients aged ≥65 years with incident HL from SEER-Medicare data. (2) To identify patient, disease, and system-level factors associated with initial treatment for HL. METHODS/STUDY POPULATION: This retrospective cohort study utilized SEER-Medicare data from 1999-2014. Patients with incident classical HL were identified using SEER registry histology groupings. The cohort was restricted to those with Medicare Part A and B fee-for-service for 3 months prior to and 1 year after diagnosis (or until date of death) in order to fully capture claims for outpatient chemotherapy. Patients were excluded for the following reasons: missing month of HL diagnosis; unknown diagnostic confirmation; reporting from autopsy or death certificate; or another cancer diagnosis +/− 2 years of the HL diagnosis. Demographic and disease characteristics were defined based on SEER registry data. Broad treatment categories were defined using SEER data, while detailed treatment categories will be defined based on Medicare claims. Length of follow-up was defined as the number of months until the earliest of the following: death; end of continuous Medicare Part A and B fee-for-service enrollment; or the end of the available data (12/31/2014). Demographic, disease, and preliminary treatment characteristics were described for the cohort. Future analyses will explore patient and disease factors, including comorbidities and an estimate of frailty, as well as system-level factors associated with initial treatment of HL. RESULTS/ANTICIPATED RESULTS: We identified 2909 patients meeting eligibility for the cohort. The median length of follow-up was 22 months (Q1=5, Q3=62). Median age was 75.9 years (Q1=70, Q3=81), 49.6% were female, and 82.6% were non-Hispanic/White. Only 11.5% of patients were in rural or non-urban areas. 13.8% of patients were dual eligible for both Medicare and Medicaid. Nodular sclerosis was the most common histology (35.2%), followed by mixed cellularity (21.1%); 36.5% had histology that was not otherwise specified. Patients were evenly distributed across Ann Arbor Stage (21.8% with I; 22.3% with II; 25.8% with III; 24.2% with IV; 6% unknown). B symptoms were present in 35.2% of patients, absent in 39.6%, and unknown in 25.2%. Neither tumor bulk nor international prognostic score were available via SEER registry data. According to SEER registry data, most patients received some treatment for their HL (81.9%) and 75% of those patients initiated treatment within one month of diagnosis. 72% of patients died with median time to death of 9 months (Q1=3, Q3=43). DISCUSSION/SIGNIFICANCE OF IMPACT: We successfully identified and described a cohort of 2909 older patients with incident HL from the SEER-Medicare data. This provides a unique opportunity to study this cohort in a large, representative dataset with nearly 15 years of follow up. Future analysis will help us to better understand treatment patterns of HL in older patients and factors associated with treatment. These results can then be used to help improve care decisions and clinical outcomes.

OBJECTIVES/SPECIFIC AIMS: Chronically elevated cytokines from un-abating low-grade inflammation in heart failure (HF) results in Protein-Energy Malnutrition (PEM). However, the impact of PEM on clinical outcomes of admissions for HF exacerbations has not been evaluated in a national data. METHODS/STUDY POPULATION: From the 2012-2014 Nationwide Inpatient Sample (NIS) patient’s discharge records for primary HF admissions, we identified patients with concomitant PEM, and their demographic and comorbid factors. We propensity-matched PEM cohorts (32,771) to no-PEM controls (1:1) using a greedy algorithm-based methodology and estimated the effect of different clinical outcomes (SAS 9.4). RESULTS/ANTICIPATED RESULTS: There were 32,771 (~163,885) cases of PEM among the 541,679 (~2,708,395) primary admissions for HF between 2012 and 2014 in the US. PEM cases were older (PEM:76 vs. no-PEM:72 years), Whites (70.75% vs. 67.30%), and had higher comorbid burden, with Deyo-comorbidity index >3 (31.61% vs. 26.30%). However, PEM cases had lower rates of obesity, hyperlipidemia and diabetes. After propensity-matching, PEM was associated with higher mortality (AOR:2.48[2.31-2.66]), cardiogenic shock (3.11[2.79-3.46]), cardiac arrest (2.30[1.96-2.70]), acute kidney failure (1.49[1.44-1.54]), acute respiratory failure (1.57[1.51-1.64]), mechanical ventilation (2.72[2.50-2.97]). PEM also resulted in higher non-routine discharges (2.24[2.17-2.31]), hospital cost ($80,534[78,496-82,625] vs. $43,226[42,376-44,093]) and longer duration of admission (8.61[8.49-8.74] vs. 5.28[5.23-5.34] days). DISCUSSION/SIGNIFICANCE OF IMPACT: In the US, PEM is a common comorbidity among hospitalized HF subjects, and results in devastating health outcomes. Early identification and prevention of PEM in heart failure subjects during clinic visits and prompt treatment of PEM both in the clinic and during hospitalization are essential to decrease the excess burden of PEM.

OBJECTIVES/SPECIFIC AIMS: -This study aims to evaluate our retention rate into our prospective clinical trial. We will be comparing the rate of withdrawal both before and after our revamped informed consent process. -We aim to assess patient satisfaction with our study and u METHODS/STUDY POPULATION: -The informed consent process for an observational prospective study at our institution has been modified to lengthen the recruitment and consenting process. -In brief, the research protocol for this observational prospective aims to evaluate the role of steroids on ulcer healing in patients with ulcerative colitis. This study involves an initial standard of care colonoscopy with biopsies and photos. The areas biopsied are marked with a tattoo. The patients are started on steroids for management of their Ulcerative Colitis, and must return for two research colonoscopies at one week post- initial diagnostic visit, and at one month. Additional study biopsies are obtained at the one week visit and photo documentation is obtained. At the one month visit, only photos are obtained to document healing. -In addition to patients with active ulcerative colitis, this study recruits control groups of patients with UC in remission, as well as two groups of normal control patients (one group on steroids for non-IBD reasons, and one group not on steroids. -Prior to our informed consent intervention, patients were screened for eligibility on the day of their standard of care endoscopy. The study was explained to the patient prior to their endoscopy, often in the “pre-op” endoscopy suite. -Our intervention seeks to draw out the consent and recruitment process. All patients scheduled for upcoming endoscopies will be mailed a generic flyer announcing research studies occurring in the endoscopy suite. Patients will be pre-screened at least a week prior to endoscopy with the aid of the endoscopy scheduler. Patients interested in hearing about research will be contacted via phone by study personnel, and a copy of the consent as well as a brief summary will be mailed to the patient. -Patients potentially interested in study participation will be asked to arrive 30 minutes earlier than they typically would for their procedure, and they will be consented in a quiet and private consultation room. They will be given ample time to ask clarifying questions regarding the study. -At the conclusion of their participation, patients will receive an anonymous post-participation survey that seeks to assess their feelings regarding the study and their understanding of the research process. RESULTS/ANTICIPATED RESULTS: DISCUSSION/SIGNIFICANCE OF IMPACT: This study adds to the ongoing body of evidence suggesting that the informed consent process is more than the three key elements initially described by the Belmont Report 40 years ago. Several factors can impact patient’s willingness to participate in research, and the amount of time it takes for patients to achieve all three elements of consent can vary from person to person. The traditional method of consent just prior to study entrance is one that needs to be revisited, and we propose that prolonging the consenting process will positively impact not only patients, but also the overall research process by ensuring that those who decide to participate remain adherent to study protocols.

OBJECTIVES/SPECIFIC AIMS: The goal of this study was to determine the impact of an RN-guided preoperative educational intervention in a minimally invasive gynecologic oncology surgery cohort. Our specific objectives include: 1. To assess the impact of preoperative education on quality outcomes such as length of stay and discharge by noon rates. 2. To characterize the differential burden of post-operative communications on nursing staff in patients who received education versus those who did not. METHODS/STUDY POPULATION: This was a retrospective cohort study. We identified thirteen gynecologic oncology patients scheduled for minimally invasive surgeries (laparoscopic and robot-assisted) between March 2017 and July 2017. These patients served as the pilot for a quality improvement project comprised of a preoperative teaching session by a gynecologic oncology registered nurse (RN). Patients also received an educational booklet, designed by gynecologic oncology care team members including nurses and physicians. Educational topics included expectations for pre-, intra-, and post-operation; guidelines for post-op care at home, important contact information, and postoperative medication instructions. Patients were also given a prescription for their post-operative medications and asked to fill them before their surgeries. Following their surgeries, patients were asked to take a voluntary and anonymous 8-item online survey assessing their satisfaction with the educational intervention, their procedure, and their hospital stay. We matched these patients in a one-to-two ratio, to patients not included in the pilot, on the basis of surgery type and age. All subjects and controls spoke English as their primary language. We abstracted data from the electronic medical record including pathologic diagnosis, number of postoperative communications (telephone and email), content of postoperative communications, and various clinical characteristics. Outcome measures include length-of-stay, discharge-by-noon rate, percentage of patients with postoperative questions, and number of postoperative concerns communicated via telephone or email. RESULTS/ANTICIPATED RESULTS: There were 39 patients in the final cohort; thirteen of whom who participated in the pilot project, POET (Perioperative Educational Tool). Thirty-nine percent of POET patients had questions regarding their surgery or post-op care as compared with 61.5% of controls (P = 0.087). Nineteen percent of controls had questions about their postoperative medications, compared with zero percent of POET patients (P = 0.046). POET patients had an average of 0.69 postoperative communications, compared with 1.12 in controls. The length of stay was 8 hours in POET patients and 26 hours in controls (P = 0.317). The discharge before noon rate was 20% in POET patients and 25% in controls (P = 0.41). Of the 10 POET patients who completed the anonymous online survey, 100% liked the approach to teaching; 100% felt that they received consistent information regarding surgery, hospital stay, and post-op care, 100% felt prepared at discharge, 100% picked up their postoperative medications without difficulty prior to surgery. DISCUSSION/SIGNIFICANCE OF IMPACT: Patients uniformly had a positive response to their preoperative education. Although our primary outcomes were not statistically significant, the results of this unpowered, observational study suggest that anticipatory education such as we provided, may decrease the burden of post-operative communications related to surgical expectations. A preoperative teaching intervention may be especially valuable in educating patients about their postoperative medications. Although POET patients had significantly fewer questions about their postoperative medications, refilling their medications before their procedures did not seem to have an effect on discharge-by-noon rates. This may demonstrate that delays in disposition are not influenced by post-operative prescriptions. One limitation of our study is that we did not prospectively measure patient satisfaction with surgical care. Another limitation is that the pilot educational intervention was conducted entirely in English. To our knowledge, there exists no analysis of the effect of English language proficiency on outcomes such as patient satisfaction, length of stay, and discharge-by-noon rates, and other clinical outcomes in this surgical patient population. It is well-demonstrated in the literature that limited English proficiency contributes negatively to health care quality. Our next steps involve establishing a prospective study to measure the effects of preoperative education on patient satisfaction with their procedure, post-operative communications, and discharge by noon rates. We also plan to administer POET to Spanish- and Chinese-language speakers, to better understand the effect of limited English proficiency on our outcome measures of interest.

OBJECTIVES/SPECIFIC AIMS: Protein Energy Malnutrition (PEM) could compromise the body’s defense systems resulting in sepsis, which further depletes calorie stores. Among hospitalized patients, we investigate 1) the relationship between PEM and sepsis, 2) the impact of PEM on trends in mortality from sepsis, and 3) the influence of PEM on clinical outcomes of sepsis. METHODS/STUDY POPULATION: Using the 2014 Healthcare Cost and Utilization Project - Nationwide Inpatient Sample (NIS) patient’s discharge records, we identified patients with sepsis, PEM, and other clinical conditions with ICD-9-CM codes. After stratifying sepsis into two: uncomplicated (without shock) and complicated (with shock), we estimated the adjusted odds (aOR) of developing sepsis (total, uncomplicated and complicated) with PEM. Then, we selected hospitalizations with sepsis from 2007-2014 years of the HCUP-NIS, and calculated the trend in mortality from sepsis, stratified by PEM status, as an effect modifier. Finally, we matched PEM to no PEM (1:1) using a greedy algorithm-based propensity methodology and estimated the effect of having mortality, complicated sepsis and 10 other clinical outcomes and healthcare utilization (SAS 9.4). RESULTS/ANTICIPATED RESULTS: PEM was associated with higher odds for sepsis (aOR:3.97[3.89-4.05]), and complicated vs. uncomplicated sepsis (1.74[1.67-1.81]). Although mortality in sepsis has been trending down from 2007-2014 (−1.19%/year, p-trend<0.0001), the decrease was less pronounced among those with PEM vs. no-PEM (−0.86%/year vs. −1.29%/year, p-value < 0.0001). After propensity matching, PEM was associated with higher mortality (1.35[1.32-1.37]), cost ($160,724[159,517-161,940] vs. $86,650[85,931-87,375]), length of stay (14.76[14.68-14.84] vs. 8.49[8.45-8.56] days), and worse outcomes in general. DISCUSSION/SIGNIFICANCE OF IMPACT: PEM is a risk factor of sepsis and associated with poorer outcomes among septic patients. A concerted effort involving primary care physicians, nutritionists, nurses in identifying, preventing, and treatment of PEM in the community-dwelling individuals before hospitalization might mitigate against these devastating outcomes.

OBJECTIVES/SPECIFIC AIMS: The purpose of the current study is to determine predictors of linkage-to-care (LTC) outcomes among patients screened for hepatitis C virus (HCV) infection in the emergency department (ED). The study is one of the first to report the impact of factors influencing medical eligibility for HCV treatment. By establishing predictors of linkage outcomes, we hope to characterize patients at highest risk of being lost to follow-up. This information can be used to guide the development of targeted interventions and optimize linkage efforts at institutions with similar programs. METHODS/STUDY POPULATION: In 2013, we implemented an opt-out HCV screening program targeting baby boomers presenting to the ED. The screening program was expanded in 2015, and all patients who presented to the ED (an academic ED with 73,000 annual visits) between 2015 and 2018 were offered an HCV antibody test. Confirmatory RNA tests were ordered for all patients with a positive screening test, and those with confirmed infection were contacted (when possible) by a linkage coordinator, who sought to facilitate linkage to outpatient care. Patients were followed until they had been successfully linked to care or were lost to follow-up; successful linkage was defined as a patient attending a scheduled HCV clinic visit. Linkage outcomes (linked vs. not linked) among confirmed cases were analyzed based on previously described LTC barriers, sociodemographic factors, and factors influencing HCV treatment eligibility. Binary multiple logistic regression was used to model the relationship between predictors and LTC outcomes. RESULTS/ANTICIPATED RESULTS: Between August 2015 and June 2018, 48,947 patients were screened for HCV, yielding 4,026 positive results. HCV infection was confirmed in 1,798 patients, 1,651 of whom were eligible for the current study. By July 2018, 884 eligible patients (53.5%) had been successfully linked to care. Odds of linkage failure were decreased among patients with known linkage barriers including mental health disorders (adjusted odds ratio [aOR], 0.28; 95% confidence interval [CI], 0.21-0.37), active substance abuse (aOR, 0.65; 95% CI, 0.47-0.91), and ‘competing’ medical comorbidities (aOR, 0.31; 95% CI, 0.21-0.47); however, odds of linkage failure were increased in the presence of medical comorbidities leading to ineligibility for HCV treatment (aOR, 21.71; 95% CI, 7.02-67.13). Decreased odds of linkage failure were also found among patients belonging to the baby boomer population (aOR, 0.64; 95% CI, 0.46-0.91) and individuals with HBV co-infection (aOR, 0.36; 95% CI, 0.14-0.94). Finally, odds of linkage failure were increased among patients without health insurance (aOR, 1.952; 95% CI, 1.01-3.79) and with public health insurance (aOR, 2.140; 95% CI, 1.08-4.24). While African-American patients exhibited decreased odds of linkage failure in bivariate analyses, this association was not significant in the multivariate analysis. Variables ultimately found not to be predictive of linkage outcome included race, ethnicity, gender, homelessness, and incarceration. DISCUSSION/SIGNIFICANCE OF IMPACT: In contrast with current trends in the literature, our analysis found that patients with any of three well-described linkage barriers (mental health disorder, active substance abuse, and ‘competing’ comorbidities) exhibited decreased odds of linkage failure. It is possible that knowledge of these barriers by linkage personnel led to increased persistence of efforts for such patients, resulting in improved linkage among patients with these barriers. However, another possibility is that individuals with factors such as a mental health disorder or medical comorbidity were more likely to experience a clinical encounter, during which discussions about HCV treatment could take place. It is also possible that other contributing factors were unaccounted for by our analysis, such as internal programmatic issues, patient education and income levels, marital status, or other ‘destabilizing’ factors that would reduce a patient’s likelihood of being contacted by a linkage coordinator. While patients with general medical comorbidities were less likely to experience linkage failure, patients who were ineligible for HCV treatment due to a medical comorbidity were significantly more likely to experience linkage failure. While this finding is intuitive, it is nonetheless troubling, as we would expect patients with severe medical comorbidities to benefit greatly from health counseling, mental health services, substance abuse treatment, or other resources available through linkage. As a result of this finding, we intend to adapt our approach to medically ineligible patients, emphasizing the availability and potential usefulness of such resources. It is unsurprising that uninsured and publicly insured patients were less likely to be successfully linked to care, as HCV treatment continues to be associated with significant financial costs for such patients. However, it is also possible that confounding factors such as education and income level, which were not included in our analysis, would be more predictive of patients’ ability or willingness to undergo HCV treatment. More research is needed to improve linkage-to-care for patients with HCV. In the near future, we intend to conduct an internal evaluation, as well as a positive deviance analysis of other LTC programs, to determine additional ways to improve linkage outcomes for all patients screened for HCV in the ED.

OBJECTIVES/SPECIFIC AIMS: 1. To evaluate the effects of masculinizing chest reconstruction on the quality of life of female-to-male transgender individuals. 2. To develop and validate a quality of life survey for female-to-male transgender individuals undergoing masculinizing chest reconstruction gender-affirming surgery. METHODS/STUDY POPULATION:. We developed and refined the GENDER-Q using focus groups and exploratory interviews with FTM individuals that were recorded, transcribed, and coded. All consenting FTM patients undergoing chest reconstruction at UCSF Parnassus Medical center between 2017-2019 who meet World Professional Association for Transgender Health (WPATH) criteria for gender dysphoria will be enrolled in the study. The GENDER-Q will be co-administered with the WHO Quality of Life-BREF survey pre-operatively, 6 weeks post-operatively, and one year post-operatively through REDCAP, an online survey database. RESULTS/ANTICIPATED RESULTS: Approximately 70 patients will be enrolled in the study. Preliminary results detect statistically significant mean quality of life post-operative improvements in all three sections (Physical Health, Gender Presentation, Psychological Health) of the GENDER-Q at 6-week follow up that is maintained at one-year (p< 0.005). Statistically significant improvements were similarly achieved and maintained with the WHO QOL-BREF survey (p< 0.05). The mean reported improvement from baseline to follow-up appears to be more pronounced in the GENDER-Q survey compared to WHO QOL-BREF. The median time to complete the pre and post-operative surveys was 10 minutes. Calculation of Cronbach’s (0.67-0.81) and the Pearson Correlation Coefficient for each section revealed excellent internal validity. DISCUSSION/SIGNIFICANCE OF IMPACT: There are few studies assessing quality of life outcomes in transgender patients undergoing gender-affirming surgeries. A standardized and validated assessment tool will provide the means for which data can be pooled in large multi-center studies. Providing further evidence to support the positive health outcomes of gender-affirming surgeries can lead to broader access and reduce healthcare disparities among transgender populations.

OBJECTIVES/SPECIFIC AIMS: The Johns Hopkins University Clinicaltrials.gov (CT.gov) Program has previously reported on a study showing reduction of “Late Results – per FDAAA” from 111 to 0. What we hope to do here is to focus on non-late results records. Over the years, some institutions spend their efforts solely on late results in order to avoid any penalties from the Food and Drug Administration (FDA). However, there are a number of variables that labels “problem records” within the Protocol and Registration System (PRS). These records are also subject to penalties. Our goal has been to minimize problem records and establish processes to improve and maintain our institutional compliance in regards to regulations governing clinical trials registration and results reporting. METHODS/STUDY POPULATION: The Johns Hopkins University implemented a Clinicaltrials.gov program solely mandated to assist Principal Investigators (PIs) and other study team members with clinical trial registration and results reporting. The program has developed processes in its duty towards reducing problem records in the PRS. Full-time staff have been assigned to assist research teams with registration and results reporting, while ensuring compliance with all relevant regulations. Several methods have been utilized to track metrics, such as monthly reports and internal databases. Features within the PRS have also been used to draw attention to newly-identified problem records on a daily basis in order to rectify these issues with the study team promptly. In order to ensure compliance, our office communicates with study teams regarding the problems within their CT.gov record that requires attention. In challenging cases, our program will also collaborate with the CT.gov PRS Team at the NIH to facilitate the process and avoid multiple review cycles, which can delay registration or the posting of results. Our Program has also formed internal collaborations with the Institutional Review Board (IRB) which allows us to verify study status and view active study team members. This is especially useful in cases where the study team members who are listed on the CT.gov record cannot be reached or the contact information is outdated (a common occurrence with older studies). With access in the IRB, we can contact the current study team members who may not be listed in CT.gov and assist them to resolve any outstanding issues of non-compliance within their CT.gov record. RESULTS/ANTICIPATED RESULTS: From September 2015 (before our program was established) to September 2016 (three months after the institution of our program), the total amount of problem records increased from 44% (339/774) to 45% (383/852). Since then, the processes we have developed resulted in a decline in problem records to 30% (282/955) in September 2017, and a further decline to 8% (83/1075) as of September 2018. The short rise that was observed in 2016, was a potential indicator that if our program was not instituted, it would have been more difficult to maintain compliance. DISCUSSION/SIGNIFICANCE OF IMPACT: According to the FDA Draft Guidance released in September 2018 referring to the Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank, there are a number of ways to violate the FDA regulations, resulting in potential monetary penalties, which include “failing to submit required clinical trial information or submitting clinical trial information that is false or misleading”. These regulations apply to results as well as registration and study status updates. By paying attention to all problems that are identified by the PRS, institutions can rectify errors and remain complaint with all regulations that govern clinical trial registration and results reporting.

OBJECTIVES/SPECIFIC AIMS: The aim of the study is to examine the relation between dental fluorosis, serum and water levels of fluoride and Chronic Kidney Disease (CKD) among children. A link between dental fluorosis, fluoride level and CKD can be an indicator of the blind danger of fluoride toxicity that poses a great threat to the human health. METHODS/STUDY POPULATION: Dental fluorosis, serum and water levels of fluoride and CKD were examined in children 6-19 years old, using data from the National Health and Nutrition Examination Survey1999-2012 and 2013-2016. We used multiple logistic regression to adjust for the confounders (demographics, insurance, dental visit, and co-morbidity) to assess the relation between dental fluorosis, serum and water levels of fluoride and CKD. STATA 14.0 was used to analyze the data (sample design and weight). P < 0.05 is statistically significant. RESULTS/ANTICIPATED RESULTS: The prevalence of CKD was 13.9% and dental fluorosis was 34.3%. In the multivariate model, plasma fluoride level was independently associated with CKD (Adjusted Odds Ratio (AOR) = 1.68, 95% Confidence Interval (CI) = 1.06-2.68, p = 0.029) but not with dental fluorosis (AOR = 1.4, 95% CI = 0.87-2.2, p = 0.17) or water fluoride level (AOR = 0.91, 95% CI = 0.59-1.396, p = 0.659). DISCUSSION/SIGNIFICANCE OF IMPACT: Results indicated that serum fluoride level is independently associated with CKD but dental fluorosis and water fluoride level were not related to CKD. Increase awareness and screening for fluorosis in children are needed for early detection and prevention of organ damage. Prospective studies related to fluorosis and tissue damage are needed.

OBJECTIVES/SPECIFIC AIMS: Helping researchers assess and effectively translate innovations into healthcare improvements is a complex process (Terry et. al., 2013). The Clinical Translational Science Awards (CTSA)—supported by the National Institute of Health (NIH) under the auspices of the National Center for Advancing Translational Sciences (NCATS)— provide the resources and support needed to strengthen our nation’s clinical and translational research (CTR) enterprise. In 2008, Stanford University was awarded a CTSA from the NIH, establishing Spectrum (the Stanford Center for Clinical and Translational Research and Education). Under the Spectrum umbrella, the Byers Center for Biodesign manages the MedTech Pilot Program with the goal of translating discoveries into novel health technologies that address important unmet health needs. The MedTech Pilot Program is an innovative funding mechanism that seeks to (1) stimulate clinical translational research, (2) help promising projects bridge the gap between the bench and the patients’ bedside, and (3) encourage collaborative, transdisciplinary work. Specifically, the Pilot Program offers up to $50,000 to support projects involving medical devices and mobile technologies used for (1) therapeutic applications and (2) device-based patient-specific (or POC) diagnostic applications. This analysis of the MedTech Pilot Program will: 1) describe the Program’s structure and process; 2) highlight the intensive, hands-on mentorship and practical guidance awardees receive that enables them to more efficiently and effectively advance their projects toward patient care; and 3) characterize the progress of the 36 funded projects. METHODS/STUDY POPULATION: Key elements of the Pilot Program’s infrastructure and mentoring processes as they relate to project outcomes were identified. Additionally, outcomes data were collected from two sources: (1) annual survey of Pilot Awardees and (2) publicly available information relevant to the pilot projects. RESULTS/ANTICIPATED RESULTS: The Pilot Program’s framework and infrastructure has supported a diverse group of transdisciplinary projects. These projects were evaluated using both traditional and non-traditional metrics (e.g., patents, startups, publications). The initial investment of $1.5 million to fund 36 projects has led to over $88 million dollars in additional funding. Additionally, taking full advantage of the expertise in Silicon Valley, strong mentorship has helped advance projects along the clinical and translational path. DISCUSSION/SIGNIFICANCE OF IMPACT: The Pilot Program has benefited Stanford innovators and researchers by providing seed funding to help promising projects bridge the gap between the bench and the bedside. The intensive, hands-on mentorship, early pilot funding, and practical guidance pilot awardees receive effectively help translate their technologies into patient care.