OBJECTIVES/SPECIFIC AIMS: Nonalcoholic steatohepatitis (NASH) is a common cause of chronic liver disease in the United States characterized by fat accumulation, inflammation, and fibrosis. Higher amounts of fat-free mass (FFM) and lower amounts of fat mass (FM) have been associated with better outcomes in several chronic diseases, recently also in NASH. Body composition is highly influenced by diet. However, the role of diet on body composition in patients with NASH is largely unknown. We hypothesized that consumption of polyunsaturated fatty acids (PUFA), healthy fatty acids mainly found in fish, nuts, and some vegetable oils, is associated with improved body composition, specifically greater FFM and lower FM, in NASH patients. METHODS/STUDY POPULATION: In total, 13 patients with histologically confirmed NASH underwent body composition testing via bioelectrical impedance analysis to estimate FFM% (% of body weight), FM% (% of body weight), and FFM/FM ratio. PUFA and saturated fat consumption was determined by standardized 5-pass 24-hour dietary recall. Correlations were computed using the Spearman rank test. RESULTS/ANTICIPATED RESULTS: Median body mass index (BMI) was 35.7 kg/m2 (32.8–42.7), median age of the sample was 50 years (46.3–57.3), and 73% were female. Median percent of calories from polyunsaturated fat was 6.8% (5.4–9.6). Percent of calories from PUFA was positively and significantly associated with greater FFM% (R=0.56, p=0.049), lower FM% (R=−0.59, p=0.035), and greater FFM/FM ratio (R=0.58, p=0.037). Additionally, a higher PUFA to saturated fatty acids ratio was also significantly correlated with greater FFM% (R=0.58, p=0.039), lower FM% (R=−0.64, p=0.020), and greater FFM/FM ratio (R=0.57, p=0.043). DISCUSSION/SIGNIFICANCE OF IMPACT: In patients with NASH, the consumption of PUFA is associated with higher FFM and lower FM, which suggests a protective role of these nutrients on body composition. A larger study on patients with NASH is warranted to confirm our findings on PUFA consumption and body composition, as well as to determine whether these effects will improve clinical outcomes.

OBJECTIVES/SPECIFIC AIMS: The iobio project enables anyone (eg, diagnosticians, MDs, genetic counselors, citizen scientists) to perform useful analysis of genomic data, without a need to rely on bioinformaticians. iobio uses a novel real-time analysis framework, coupled with powerful visualizations delivered in a standard web browser. The project successfully supports free academic/nonprofit users, but occasions exist where it is more applicable for the project to be delivered commercially. Frameshift Genomics is developing commercial applications and functionality, which will exist alongside and in coordination with the academic project. These products will be marketed to large institutions including genome institutes, hospitals, diagnostic labs etc., but also to individual users who do not have access to large compute resources, or bioinformatic analysts, and everything in between. METHODS/STUDY POPULATION: The commercial iobio project under Frameshift Genomics aims to develop applications and features that cannot be successfully supported by an academic model. For example, when analyses are scaled up to processing of extremely large data sets, a commercial product with access to compute resources makes more sense than an academic tool. Bam.iobio is an application that samples data from sequencing alignment files, taking seconds to generate and visualize statistics representative of the entire file. This app is offered for free academically. When analysis involves thousands of such files, however, the commercial application, multibam.iobio, is more suitable. Other examples, including support for licensed third-party software and permitting extensive computation via cloud platforms, can also only be reasonably be supported via commercial software. Finally, development of commercial applications is driving adoption of more rigorous testing platforms, delivering more robust products. A particular strength of the iobio platform is allowing non-bioinformaticians to understand their data, for example providing quality control functionality providing confidence in data sets and the conclusions drawn from them. Such analyses are critical to all users of genomic data, and the iobio platform is ideally suited to provide an intuitive, integrated framework for performing them. RESULTS/ANTICIPATED RESULTS: The iobio project has been readily adopted by many in the community and shows significant promise for democratizing genomic analysis. Work is ongoing, supported by NIH small business grants, to develop commercial applications that will be marketed to analysts and medical professionals from large genome institutes and universities, to individual project users and citizen scientists. DISCUSSION/SIGNIFICANCE OF IMPACT: There are currently a number of iobio tools available academically, and they have been embraced by many in the genomics community. In fact, a number of popular platforms (eg, Galaxy, the International Cancer Genome Consortium (ICGC) data portal, mygene2 at the University of Washington) have incorporated iobio tools into their own platforms. To date, the gene.iobio variant interrogation tool has been used in a number of diagnostic projects, aiding identification of putative causative variants, and the pre-release version of the commercial multibam.iobio tool has been critical in unearthing data quality problems in project level data.

OBJECTIVES/SPECIFIC AIMS: The goal of this abstract/presentation is to share lessons learned from participation in the NIH SBIR I-Corps Train-The-Trainer Program, discuss our experiences offering programs at our local institutions, and communicate our plans to develop an I-Corps@NCATS program that can be disseminated across the CTSA network. We believe that an I-Corps@NCATS program will enhance the process of scientific translation by taking best practices from NSF I-Corps and adapting the program to meet the needs of biomedical scientists in academic medical centers. By integrating I-Corps@NCATS training, we hypothesize that the clinical and translational investigator base will be better prepared to identify new innovations and to accelerate translation through commercialization. METHODS/STUDY POPULATION: The diverse, interdisciplinary team of investigators involved in this project span 9 CTSA Hubs, including UAB, Rockefeller, UC Denver, HMC-Penn State, UMass, UC Davis, Emory/Georgia Tech, Miami and Michigan. This team was funded by NCATS in 2015–2016 to participate in the CTSA I-Corps Train-The-Trainer Program in conjunction with the NIH-SBIR/STTR I-Corps national program. The goals were to observe the curriculum, interact with and learn from the NSF National Teaching Team and begin implementation of similar programs at our home institutions. Our I-Corps@NCATS team has been holding monthly, and more recently weekly, conference calls to discuss our experiences implementing local programs and to develop a strategy for expanding CTSA offerings that include innovation and entrepreneurship. Our experience revealed several challenges with the existing NSF/NIH I-Corps program offerings: (1) there is no standard curriculum tailored to academic clinical and translational research and biomedical innovations in the life sciences, and (2) the training process to certify instructors in the I-Corps methodology is a much more rigorous and structured process than just observing an I-Corps program (eg, requires mentored training with a national NSF I-Corps trainer). Our team is proposing to address these gaps by taking best practices from NSF I-Corps and adapting the program to create the I-Corps@NCATS Program, tailored to meet the needs of researchers and clinicians in academic medical centers. RESULTS/ANTICIPATED RESULTS: There are 3 primary anticipated results of our project. First, develop a uniform curriculum for the I-Corps@NCATS Program using the National Teaching Team of experts from the NIH’s SBIR I-Corps program. Second, build the I-Corps@NCATS network capacity through a regional Train-The-Trainer Program. Third, develop a set of common metrics to evaluate the effectiveness and impact of the I-Corps@NCATS Program across the community of CTSA Hubs and their respective collaborative networks. DISCUSSION/SIGNIFICANCE OF IMPACT: Over the past 10 years, CTSA Hubs have accelerated science by creating/supporting programs that provide research infrastructure, informatics, pilot funding, education/training, and research navigator services to investigators. These investments help to ensure that we are “doing science right” using the best practices in clinical research. Even so, it is equally important to make investments to ensure that we are “doing the right science.” Are our investigators tackling research problems that our stakeholders, patients, and communities want and need, to make sure that our investments in science have real-world impact? In order to accelerate discoveries toward better health, scientists need to have a better way to understand the needs, wants and desires of the people for whom their research will serve, and how to overcome key obstacles along the path of innovation and commercialization. To fill this gap, we propose that the CTSA Hubs should include in their portfolio of activities a hands-on, lean startup program tailored after the highly successful NSF Innovation Corps (I-Corps) program. We hypothesize that by adapting the NSF I-Corps program to create an I-Corps@NCATS program tailored to medical research, we will better prepare our scientists and engineers to extend their focus beyond the laboratory and broaden the impact of their research. Investigators trained through I-Corps@NCATS are expected to be able to produce more innovative ideas, take a more informed perspective about how to evaluate the clinical and commercial impact of an idea, and quickly prototype and test new solutions in clinical settings.

OBJECTIVES/SPECIFIC AIMS: To develop a regulatory science case study as an educational resource to inform the regulatory science considerations in medical product development for a range of scientific priority areas and emerging technologies. METHODS/STUDY POPULATION: Precision medicine represents one of the major regulatory science priority areas and the use of biomarkers holds promise for predicting the response to individual treatment strategies. Although progress has been made toward developing biomarkers, the development and validation of clinically useful biomarkers has presented significant regulatory science challenges, including the utilization of biomarkers in predicting responses to different cancer therapies. This case study reviews the technical, regulatory, and policy issues related to the development and use of lung cancer drugs Opdivo® and Keytruda® and an understanding of the codevelopment and utilization of their associated biomarkers. RESULTS/ANTICIPATED RESULTS: A detailed instructor guide with extensive resources such as diagrams and timelines will accompany the case study and will be used to highlight the development and approval process of 2 competing drugs and their associated biomarkers. The resources will provide a better understanding of their progression through the FDA regulatory process and opportunities and challenges for their use. DISCUSSION/SIGNIFICANCE OF IMPACT: Building on the case study framework we have developed, the detailed timelines and a collection of available resources, an extensive and modular case study will be finalized and made available to academic institutions, industry, regulatory agencies, and the public. The full case study and links to a series of resources will be disseminated as a standalone resource for integration into courses or programs interested in learning about specific regulatory science needs and opportunities to enhance medical product development and approval.

OBJECTIVES/SPECIFIC AIMS: The majority of obese adults do not become obese until adulthood. Although adults spend the equivalent of a 40-hour work week in front of the television (TV), there are mixed data on whether the sedentary behavior of TV viewing is linked with weight gain during adulthood. The purpose of this study was to examine the associations among sedentary behavior, measured as TV viewing and TV in the bedroom, with eating behavior, eating attitudes and cravings, fat gain, and blood pressure in healthy young adults over a 2-year period. METHODS/STUDY POPULATION: The sample included 73 healthy, nonobese adults (56% women, 80% white) who were 26.8±4.5 years of age with a body mass index of 22.9±2.4 kg/m2. Participants completed clinic visits at baseline and 2-years later (Year 2) which assessed weight, height, blood pressure, waist circumference, and total body fat measured by dual energy X-ray absorptiometry. A food frequency questionnaire was used to estimate dietary intake, and the eating inventory was used to assess dietary restraint, disinhibition, and hunger. At baseline, participants self-reported TV habits including number of hours/week of watching TV (including cable, VCR, DVD) and presence of a TV in the bedroom. For the analysis, participants were stratified by quartiles of TV viewing time. T tests were used to examine the association between TV viewing and bedroom TV. Linear regression models were used to examine the association between TV viewing and each anthropometric and body composition measure and change over the 2-year period, as well as with the dietary constructs. Models controlled for age, sex, and baseline body fat. Separate models were used to investigate the associations between bedroom TV and the same dependent variables. RESULTS/ANTICIPATED RESULTS: Participants reported an average of 13.3±10.8 hours/week of TV viewing, with 33.3% reporting a TV in the bedroom. There were no differences in age, sex, or race among the quartiles of TV viewing or between those who did and did not have a bedroom TV. Adults with a bedroom TV did not differ in hours/week of TV viewing compared with those without a bedroom TV. Amount of TV viewing was associated with higher systolic blood pressure at baseline (p=0.05) but with no other anthropometric or body composition indices nor with change in body composition over the 2-year period. Adults with a bedroom TV reported higher craving for sweets at baseline (p=0.03). Amount of TV viewing was related to lower consumption of vegetables (p=0.04) and fruit or fruit juice (p=0.03) at Year 2, but there was no association with total calorie consumption. TV viewing and bedroom TV were not related to dietary restraint, disinhibition, or hunger at either time point. DISCUSSION/SIGNIFICANCE OF IMPACT: Adults who watched more TV consumed fewer fruits and vegetables, and those with a TV in the bedroom reported higher craving for sweets. Though there were no observed relationships between TV habits and body composition change, the associations with cravings and food consumption warrant further exploration. Querying young adults’ TV and media use habits in clinical settings may alert physicians to those at risk of developing poor dietary habits.

OBJECTIVES/SPECIFIC AIMS: The American Academy of Pediatrics (AAP) recommends that preschool-aged children spend no more than 2 hours/day using digital screens such as TVs. However, there is a proliferation of digital screens in children’s daily lives both at school and at home. The purpose of this study was to examine factors that contribute to children’s screen-time, including their demographic characteristics and whether or not they have screen-time at school. METHODS/STUDY POPULATION: In total, 59 children (3.3±0.4 years of age; 47% female) enrolled in 3 child care centers participated. Center directors reported school screen-time; 1 center was classified as not providing screen-time and 2 centers were classified as providing screen-time. Parents reported child’s age, sex, and maternal education as a proxy for socio-economic status. Parents reported child’s out-of-school screen-time by responding to the question “During the past 30 days, on average how many hours per day did your child sit and watch TV or videos outside of school?” Additional questions queried how many hours per day did the child “use a computer or play computer games,” “play video games,” “use a smartphone,” and “use an iPad or tablet.” Children’s height and weight were collected using standard clinic procedures and body mass index (BMI) was calculated. T tests were used to examine differences in screen-time by age, sex, and school screen-time. General linear models were used to examine the influence of school screen-time (1=no screen-time, 0=between 1 and 60 min/day of screen-time), age, BMI, and maternal education on out-of-school screen-time and time spent with each device. Logistic regression analysis was used to examine likelihood of meeting screen-time recommendations based on the same characteristics. RESULTS/ANTICIPATED RESULTS: Parent-reported total screen-time was 6.3±3.6 hours/day (h/d); specifically, 2.5±1.1 h/d watching TV, 1.5±2.2 h/d using a smartphone, 1.1±0.9 h/d using a tablet, 0.8±1.0 h/d on a computer, and 0.5±0.7 h/d playing video games. Based on total screen-time, 15% of children met AAP recommendations; based on TV viewing only, 52% met AAP recommendations. The 4-year-old children viewed more screen-time overall compared to the 3-year-old children including on TV, computer, and tablet (p<0.05), but there were no sex differences. In fully adjusted linear models, out-of-school screen-time was lower among those who had no screen-time at school (p=0.02) and higher among older children (p<0.01). Computer use was higher among older children (p=0.02). Older children and those with lower maternal education were less likely to meet clinical recommendations based on TV viewing (p<0.05). There were no observed associations with likelihood of meeting clinical recommendations based on total screen-time. BMI was not a significant predictor of screen-time. DISCUSSION/SIGNIFICANCE OF IMPACT: The majority of children exceeded AAP screen-time limits, with screen-time sharply higher among older children, and the associations did not vary by weight status. Children who attended schools that allowed screen-time had higher amounts of out-of-school screen-time. Pediatricians and healthcare providers should query parents on children’s screen-time practices at home and at school and offer strategies to help families meet the clinical recommendations.

OBJECTIVES/SPECIFIC AIMS: This project has 2 overarching objectives: (1) to investigate the acceptability of the Michigan Surgical and Health Optimization Program (MSHOP) among referred patients, and to describe individual motivations behind enrollment Versus nonenrollment; and (2) to identify patient and program related factors associated with adherence and LOS and readmission rates. METHODS/STUDY POPULATION: Hypothesis—(1) MSHOP participants will report overall satisfaction with the program. Individuals that are satisfied with the program will be likely to perceive the program as effective. Subjects that declined MSHOP will be more likely to perceive their outcomes as immutable. (2) MSHOP patients will have shorter hospital stays and fewer readmission compared with patients who declined MSHOP. Methods—this study will use both qualitative and quantitative methods to investigate patient experiences and program efficacy. First, a convenience sample of patients who were referred to the MSHOP within the previous 12 months will participate in structured interviews to assess program acceptability, patient satisfaction with individual components of MSHOP, and perception of program efficacy. Interviews will also include patients who declined to enroll in MSHOP. Interviews for these subjects will include questions that assess why patients chose to decline enrollment. Second, there will be a retrospective cohort study comparing hospital outcomes among patients who enrolled in MSHOP Versus those who chose not to enroll. Analysis—interviews will be recorded and transcribed for thematic analysis to identify patterns associated with satisfaction or dissatisfaction with the MSHOP. Multivariate regression will be used to determine effect of MSHOP participation on postsurgical length-of-stay and 30-day readmission rate. Demographics and procedure type will be included as covariates. RESULTS/ANTICIPATED RESULTS: In total, 28 interviews have been transcribed, and are in the initial stages of thematic analysis. Interviews have thus far suggested that patients have been satisfied with MSHOP and would recommend the intervention to other patients. Retrospective data regarding hospital length of stay for MSHOP patients from September 2014 to December 2016 has been acquired and is being processed. The characteristics of patients that tend to participate more actively in MSHOP will be explored. We anticipate that active participation in the MSHOP will be associated with shorter hospital stays and fewer readmissions. DISCUSSION/SIGNIFICANCE OF IMPACT: This study will be one of the first to characterize patient perception of MSHOP, in particular its use of tracking step counts and breathing exercises to promote a form of prehabilitation that is easier to integrate into daily life. This project will investigate MSHOP’s effect on patient outcomes, as well as explore factors that may associate with better patient adherence and outcomes. This would help further optimize the MSHOP as an intervention.

OBJECTIVES/SPECIFIC AIMS: Motivation deficits are one of the strongest determinants of poor functional outcomes in people with schizophrenia. Mobile interventions are a promising approach to improving these deficits, as they can provide frequent cues and reinforcements that support goal-directed behavior. The objective of this study is to describe the intervention protocol and initial effectiveness of a personalized mobile text message intervention, Mobile Enhancement of Motivation in Schizophrenia (MEMS). METHODS/STUDY POPULATION: This pilot study will examine the effects of MEMS compared with a control group using a randomized design. Up to 40 outpatients with a schizophrenia-spectrum disorder will be recruited. All participants will set individualized recovery goals to complete over an 8-week period; those randomized to receive MEMS will also receive 3 sets of personalized, interactive text messages each weekday to reinforce and cue goal completion. Before and after the 8-week period, participants in both groups will complete validated measures of motivation, quality of life, and functioning. Both groups will also report their goal attainment after 8 weeks. RESULTS/ANTICIPATED RESULTS: It is anticipated that those in the MEMS group will demonstrate greater goal attainment and improvements in motivation, quality of life, and functioning compared with the control group. DISCUSSION/SIGNIFICANCE OF IMPACT: This project will test the initial effectiveness of a novel intervention for improving one of the most debilitating aspects of schizophrenia.

OBJECTIVES/SPECIFIC AIMS: To analyze how consumer physical activity monitors are currently used in biomedical research. METHODS/STUDY POPULATION: Searches were conducted in Ovid Medline, PubMed Medline, clinicaltrials.gov, and NIH RePORTER using search terms including Fitbit, Jawbone, Apple watch, Garmin, Polar, Microsoft band, Misfit, Nike, Withings, and Xiaomi. Results were quantitated by category: condition/topic, intervention, enrollment status, study type and design, age, grant mechanism, and primary outcome. RESULTS/ANTICIPATED RESULTS: Fitbit is used >80%. There are 127 clinical studies using Fitbit devices listed in clinicaltrials.gov. In total, 48 have been completed while 79 are ongoing. Some studies have already published their findings; 40 papers cited in Ovid MEDLINE report use of a Fitbit device. NIH is now funding research that uses consumer physical activity monitors, and the NIH RePORTER shows the number of grants using Fitbit is rapidly increasing. DISCUSSION/SIGNIFICANCE OF IMPACT: The current state and potential growth of this technology is transforming biomedical research and is enabling us to ask new and more granular questions about activity and sleep in health and disease.

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

OBJECTIVES/SPECIFIC AIMS: This study sought to develop a mHealth application which was capable of predicting the spread of infectious diseases during the height of the Ebola outbreak in Lagos, Nigeria. Following the success of this primary task, the research then sought to understand behavioral health issues which are indicative of chronic diseases, such as sedentary behaviors and where they occur at a geospatial level in real-time. The results of this study are now being used to develop a larger scale 500 person study in Rochester, NY, USA. METHODS/STUDY POPULATION: During a 3-month period individuals were asked to install a mobile health application known as Node onto the their android device. Consent was done remotely, individuals were recruited through the Lagos University Teaching Hospital, Nigeria Institute of Medical Research, and the University of Lagos. Participants were paid 50 USD/month for each month of study completion, while continuous location data was collected in addition to survey information about participants. RESULTS/ANTICIPATED RESULTS: During the study period 70 individuals enrolled, using this data we were able to create network based models which indicated that diseases were more likely to spread at the beginning of the week, and also indicated who would be most susceptible to being patient zero. In phase 2 we have started to look at behavioral patterns to determine the risk of chronic disease among our study population, by examining their human mobility patterns, since we can determine average sleep patterns, activity patterns using machine learning classifiers, and time spent in traffic—all of which we can visualize in a real-time geospatial manner with higher objectivity than traditional mechanisms for data collection. DISCUSSION/SIGNIFICANCE OF IMPACT: In developing countries, using Nigeria as our example most chronic disease and household studies only enroll a few thousand participants for a country numbering 150 million plus. Using our rapidly available application we were able within 1 week to enroll 70 participants on 1 year of funding, this creates a framework for larger scale public health studies which can be done in developing countries and also demonstrates the value in mHealth which can both answer questions of infectious disease and chronic diseases at the same time. Our results indicate that at an infectious disease level in city environments diseases may be prevented by targeting events early in the week. While at a chronic disease level the lack of reliable power results in less sedentary behavior as individuals seek locations to charge phones, while those with more stable western-like lifestyles have started to exhibit the conditions which cause such outcomes as obesity, which has begun to rise in developing countries. Ultimately, these results serve as a staging point to launch a more wide scale study both in the United States and Nigeria within the year, now that feasibility has been established.

OBJECTIVES/SPECIFIC AIMS: Our objectives with this project are to engage communities through technology creating a communication channel with affected communities and stakeholders about mosquito-borne illness, vector control and environmental health risk. Furthermore, engaging communities to electronically map ecological risks that impact mosquito-borne illness with the goal of creating a mobile application that will work as an ecological surveillance against mosquito proliferation and potential mosquito population reduction, and finally pilot test and evaluate potential benefits in communities where the application was used. METHODS/STUDY POPULATION: We propose a methodology to perform formative community work that will underscore a distributed, democratized ecological surveillance through an integration of multidimensional health behavior theories that address the challenges of ZIKV in Culebra, a marginalized island community off the coast of the main island of Puerto Rico. Using participatory design, we will develop, test, and evaluate users’ experiences towards mobile applications using qualitative (interviews) and quantitative (survey) methodologies. A mobile application with the capacity of mapping, use of social-media, crowdsourcing, and photo-voice in a dynamic and simple way will allow community members to alert “hot-zone” locations to the stakeholders interested in creating ecological action in their community. This multidimensional concept integrates explanatory and prospective approaches and will generate systematic short-term solutions for mosquito control and long-term solutions providing the necessary tools for community empowerment. RESULTS/ANTICIPATED RESULTS: Our proposed design will facilitate better understanding of the interactions between community members and socio-environmental determinants of mosquito-borne diseases. Furthermore, our proposed project will not only facilitate communication among members of a community, but also it will provide a platform for engagement and empowerment, establishing a change in the preventive paradigm of how communities face the negative impacts of micro-ecologies that surround them. DISCUSSION/SIGNIFICANCE OF IMPACT: Our proposed community collaboratory mHealth tool mZAP! (Zonas, Accion y Proteccion) will address the lack of community participation efforts against mosquito-borne diseases contributed simultaneously by the disengagement and disempowerment of community members. mZAP! will serve as an innovative tool to engage marginalized and communities made vulnerable in Puerto Rico. This approach should be successful as Puerto Rico is one of the most digitally connected countries in Latin America, with high mobile phone usage rates and social media use. Using mZAP!, communities will report and map breeding sites, use social media and crowd sensing, targeting against powerful tools against mosquito ecologies in their own environments. This application could result in an effective way to change the paradigms for public health approaches to use Information Communications Technologies (ICTs) to empower communities.

OBJECTIVES/SPECIFIC AIMS: To assess the usability and adoption of RxUniverse, a novel platform that enables health care providers to directly disseminate proven, evidence-based mobile health apps to patients. METHODS/STUDY POPULATION: Among 5 pilot clinical sites, 40 physicians and front-line providers consisting of medical assistants and receptionists were trained on the RxUniverse platform. They were instructed on the platform’s purpose, were shown a demonstration of the functionality, and were observed in a trial process of prescribing an app. Specific implementation plans were designed with the help of the clinic staff in order to best fit in with their present workflows. The well-validated System Usability Score (SUS) was used to assess the usability of the platform. Prescriptions of 100 relevant app prescriptions within a 8-week pilot period was set as the adoption goal. RESULTS/ANTICIPATED RESULTS: Within the pilot period, greater than 2000 apps were prescribed across all users. Of the 40 providers trained on the RxUniverse platform, 26 prescribed >5 apps during the trial period. Of these 26 individuals, 18 prescribed >20 apps, 14 prescribed >50 apps, and 5 prescribed >80 apps; 58% of users reported frequent use (weekly or daily) of the platform. In total, 19 responses were received for the SUS survey. The RxUniverse platform received a usability score of 82%. DISCUSSION/SIGNIFICANCE OF IMPACT: As the pace of innovation continues to accelerate, health care providers will need to quickly integrate new digital-based tools into their workflows, and patients will need to be able to easily and readily access these tools. RxUniverse provides the necessary mechanisms, user-friendly interface, and EHR integration functionality to accomplish this. The total number of apps prescribed surpassed 2000, which far exceeded the initial target of 100 apps. The platform also scored an 82% on the SUS, which is considered an “A” by industry standards. By comparison, other health apps considered to have to be in the highest-rating groups have reported scores of 77.5% and an overall average of 68% among all systems. These outcomes demonstrate the high adoption and usability of the RxUniverse platform, an important platform that can be used to prescribe the latest technologies directly to patients.

OBJECTIVES/SPECIFIC AIMS: This study sought to determine the accessibility, utilization, and preference for mobile phone use among a marginalized population of teens enrolled in an adolescent substance abuse treatment program and their parents. Specific study aims were to: (1) characterize mobile phone use, (2) assess the accessibility and reliability of mobile phone usage, (3) determine specific barriers to mobile phone use, and (4) examine parent and teen perceptions of the utility of integrating communication technology in substance use treatment. METHODS/STUDY POPULATION: In total, 103 (78.6% female; 75.7% Hispanic) parents of teens participating in an outpatient substance abuse treatment program with an average age of 42.60 (SD=9.28) participated in our study. Upon enrollment in a substance abuse treatment program between October 2014 and July 2016, parents completed a technology use survey as part of program development and a chart review of clinic outbound calls to parent mobile phones was completed to evaluate reliability of parent mobile phone access throughout treatment. Survey collection among teens is ongoing. Study population information for teens will be presented at the conference. RESULTS/ANTICIPATED RESULTS: The vast majority of parents owned a cell phone and used it as their primary phone (97.1%); 83% of parents owned smart phones in particular, with the majority being Android phones (68.7%). Parents were more likely to have pay-as-you-go (41.4%) and yearly (32.3%) contracts, and only 15% of the sample endorsed changing their phone number more than once in the past year (64%=never; 21%=once). Parents reported using several of the phone features: text (97%), email (76%), pictures (93%), and accessing the internet (92%); 92% reported they did not have a texting limit; and the most popular use of the mobile phone was to send and receive text messages (58.6%), followed by accessing the internet (19.2%). During the course of a 10-week treatment program, the clinic made 2776 confirmation phone calls to parents who completed surveys. Report of accessibility matched the clinic’s ability to reach parents. Of the 2776 calls, 97.2% were made to the original number provided, which was in service. Only 2.7% were determined to be disconnected, with the median number of days for disconnected service being 2 days with no voice and no texting capabilities (range=14) and 2 days with no voice, but with texting capabilities (range=28). In terms of parent perceptions of the utility of integrating communication technology in substance use treatment, 91% of parents reported they would be receptive to receiving text messages with parenting tips as aftercare support. Preferred content areas included: strategies for monitoring teen substance use (56%), strategies for using consequences (62%), suggestions for encouraging positive activities (62%), and ways to improve parent-child communication (63%). Accessibility, utilization, and preference for mobile phone use in a treatment program among teen respondents will be presented at the conference. DISCUSSION/SIGNIFICANCE OF IMPACT: This study characterized both subjective and objective mobile phone accessibility and usability among teens participating in an adolescent substance abuse treatment program and their parents. This study also provides information on teen and parent perceptions of using mobile phones during the aftercare period and ratings of acceptable messages following treatment. This data will help researchers design mobile-based interventions both during and after treatment, which is the future direction of our research group.

OBJECTIVES/SPECIFIC AIMS: Translating conventional and regenerative medicine strategies from the research laboratory into the clinic is a complex process that can delay bringing novel therapies to the patient. Navigating the increasingly complex regulation surrounding cell-based and combination product technologies is a major challenge for the translational biomedical scientist. To this end, Mayo Clinic created a new position, the “Translational Integrator,” as part of the cGMP Biomaterials Facility in the Center for Regenerative Medicine. METHODS/STUDY POPULATION: The Translational Integrator educates investigators about FDA standards and regulatory pathways; determines where the product is on the translational spectrum; works to understand the science behind the product; determines what additional studies may be needed; supports investigators in preparing for FDA communications and submissions; and educates researchers about institutional resources and funding mechanisms needed to move their product into manufacturing and trials. A primary objective is to meet investigators at an early stage in product development to avoid conducting potentially redundant work to meet regulatory requirements. RESULTS/ANTICIPATED RESULTS: Robust training in clinical and translational research methodology enables the integrator to facilitate the collaboration necessary between investigators, clinicians, institutional resources, regulators and funders to move products towards FDA IND/IDE approval and first-in-human trials. It is an iterative process using technology/translational readiness criteria, project management and review by subject matter experts that is highly interactive and customized to each project. Current projects include topics in orthopedic surgery and ENT. In creating and refining this position, several key lessons have been learned. DISCUSSION/SIGNIFICANCE OF IMPACT: First, the Translational Integrator must undergo constant reflection and assessment of investigator needs, which requires flexibility and understanding that their role may change in the context of each product. Second, the support that the Translational Integrator provides can shift the mindset of the investigator from being averse to engaging in the translational process to eager to move their product forward. Finally, for the investigator who does not personally want to move their work into first-in-human trials, establishing connections to intellectual property generation and licensing may support movement of their findings into patients.

OBJECTIVES/SPECIFIC AIMS: To improve the quality of evidence synthesis projects, including systematic reviews and other comparative effectiveness reviews, at the University of Utah. METHODS/STUDY POPULATION: Systematic reviews and other types of evidence syntheses are best when collaborative teams with expertise in multiple disciplines participate, including content experts, librarians and information specialists, systematic review methodologists, and statisticians. The Center for Clinical & Translational Science (CCTS), due to its interdisciplinary nature, connectivity to clinical experts, and existing Cores of methodologists, presented an opportune location for a Systematic Review Core. We designed the Systematic Review Core to focus on 2 primary aspects of evidence synthesis support: overall systematic review methodology guidance and in-depth information retrieval planning and execution. After establishing a conceptual partnership, a new position, Evidence Retrieval and Synthesis Librarian, was created to build capacity within the Core. RESULTS/ANTICIPATED RESULTS: Close connections with the CCTS’s Population Health Research Foundation have led to better interdisciplinary coverage of systematic reviews and other evidence syntheses produced by the University of Utah. We are able to partner with statisticians and clinical experts from formulating the question to completing the final manuscript. Hourly rates charged through a cost recovery model have enabled us to grow our staff able to work on the Core, as well as offset costs for major databases and resources these bibliographic data-heavy research methods require. After 1 year of existence, the Core is already at maximum capacity, with no sign of slowing. Projects have ranged from brief consultations to highly intense interactions for the duration of the research spectrum. We have also been added as key personnel to grants with systematic review components. DISCUSSION/SIGNIFICANCE OF IMPACT: Systematic reviews and other evidence syntheses are a labor-intense, interdisciplinary team effort that fit well within the scope of CTSA’s. They are a key component of the translation of science to practice, and can be used at all stages of the translational science spectrum. Quality of systematic reviews remains poor, particularly surrounding protocol development, sensitive search strategy design and reporting, and overall reporting. Librarians and information specialist involvement has been shown to positively correlate to the search strategy design and reporting aspects of systematic reviews, and librarians and information specialists increasingly act as systematic review methodologists. By including librarians and information specialists as part of the CTSA’s official Core structure, these systematic review methodologists are able to connect with statisticians, other methodologists, and clinical experts in a nexus of interdisciplinarity. At the University of Utah, the visibility and structure provided by the CCTS helps the Systematic Review Core with promotion, creating connections and opportunities for collaboration across the campus. This partnership has already led to increased uptake in services, and over time, we believe it will increase the quality of the science produced. CTSA’s have a natural partner with their health science library colleagues in translational science, as shown by this model.

OBJECTIVES/SPECIFIC AIMS: In this study, we propose to investigate effectiveness of 2 core services provided by the Center for Clinical and Translational Science (CCTS), home for CTSA program in the School of Medicine at the University of Utah. METHODS/STUDY POPULATION: We will apply a longitudinal database of research and tenure track faculty (n>600) in the School of Medicine at the University of Utah from 2006 to 2016 to estimate the effect of initial usage of the biostatistics and clinical services cores of the University of Utah CCTS on the probability of (a) ≥1 peer reviewed publication, (b) external grant funding, and (c) academic promotion within 1, 2, and 3 years after the initial contact. We will apply a “new users” design (Hernan et al., Epidemiology, 2008; 19: 766–779) to compare the outcomes of faculty initiating use of the 2 CCTS cores Versus faculty without prior use of these cores in a series of cohorts defined by the calendar year of initial contract with the 2 cores, with covariate adjustment performed within each cohort to account for measured confounders. Separate outcome models will be specified for each cohort, but the statistical models will be fit to stacked augmented data sets which include the data from each cohort. Using the stacked data set, results will be pooled across each of the cohorts to increase statistical power. Robust sandwich estimates of standard errors will be used to account for the inclusion of multiple assessments for each faculty member. RESULTS/ANTICIPATED RESULTS: Estimates of the effect of initiation of new CTSA usage on academic productivity outcomes will be obtained, and provided in conjunction with sensitivity analyses to address the potential impact of uncontrolled confounding. DISCUSSION/SIGNIFICANCE OF IMPACT: The proposed evaluation strategy should overcome some of the biases inherent in typical metrics for effectiveness of CTSA programs, and will be applied to evaluate success of future initiatives.

OBJECTIVES/SPECIFIC AIMS: Skillful research staff members are critical to productive translational research teams and yet their ongoing professional development is rarely formally addressed. Through the Strategic Teamwork for Effective Practice-Mentor Development Program (STEP-MDP), we aimed to both create a community of practice (COP) for research staff and build the skills needed to enhance research team performance. METHODS/STUDY POPULATION: We selected 16 participants of 32 staff-level applicants from among the NYU Schools of Medicine, Social Work and Nursing for the first STEP-MDP cohort. Participants included research assistants, coordinators, managers, and directors. We delivered 3, two-hour workshops, scheduled 3 weeks apart, focused on team communication, identifying team areas for improvement, and mentorship/coaching skills. Peer-Coaching Teams (PCTs) were created by pairing participants at the same position level, and PCTs worked together at each session to explore and practice learned skills. Sessions featured brief didactics, group-based learning and exercises based on participants’ real issues. A variety of active learning techniques such as brainstorming, role-playing, problem solving, and peer coaching were used. Practical core readings, worksheets, and summary cards were provided. PCTs met between sessions to practice coaching skills, and troubleshoot problems. RESULTS/ANTICIPATED RESULTS: Participants (n=16) completed a 37-item retrospective pre/post self-assessment of team behaviors and skills, and a STEP-MDP evaluation survey at the end. We saw pre-post improvements in each of 5 self-assessment domains: Communication (4 items, pre-mean 2.66, post mean 3.36, p≤0.001), Leadership (8 items, pre-mean 2.76, post mean 3.55, p≤0.001), Empowerment and Motivation (12 items, pre-mean 2.86, post mean 3.51, p≤0.001), Coaching (6 items, pre-mean 2.40, post mean 3.58, p≤0.001), and Community (3 items, pre-mean 2.33, post mean 3.76, p≤0.001). On average, PCTs met twice (range 2–4 times) between workshop sessions. Learners valued the PCTs, and 1 commented on the value of working with peers in PCTs, having no one in a similar position within his immediate work environment. Participants’ written comments strongly endorsed the value of the workshops for their work, with the coaching skills session seen as the most valuable. Some participants worry that skills will decrease over time without continued reinforcement. All but 1 participant reported that they planned to continue with the PCT. DISCUSSION/SIGNIFICANCE OF IMPACT: The number of applicants to our program suggests a need and motivation for staff to participate in the STEP-MDP. Participants’ reported improved skills and sense of community. To maintain the COP and address worry about degradation of skills we are planning to remind PCTs to meet once a month and will follow-up with them 3 and 6 months post intervention to evaluate their continued development. This spring a second cohort will receive the training. We believe developing these core teamwork skills will lead to more collaborative, efficient, and innovative research. We have implemented a successful program targeting critical members of research teams with potential to facilitate expansion of institutional capacity for translational research. It will be important to understand the long-term impact of the program on individuals, on team science, on research, and ultimately on the health of the public.

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.

OBJECTIVES/SPECIFIC AIMS: This report describes the evolution of scientific culture since the NIH/translational science (TS) mandate. The transition of the conduct of science to an increasingly translational model involves 2 dimensions of change. The first dimension consists of change in the structure and process of scientific work, in terms of factors such as funding, administration, application of new knowledge, and so forth. The second dimension consists of change in culture of scientific work. The culture of science is the set of values, assumptions, meanings, and traditions that inform the conduct of science. As part of the comprehensive evaluation of TS at the University of Texas Medical Branch-Galveston, we have monitored the status of the culture of science there through a sociological framework. We focused on the ways the changing culture of science facilitates and/or inhibits creative and effective medical research. We argue that the long-term success of TS is dependent upon the evolution of assumptions, everyday practices, and taken-for-granted ways of conducting research. Culture also provides meanings for who its people are and helps us define who we are to ourselves (ie, self-concept). In terms of the scientific enterprise, self-identity provides the motivation to participate in group activities or to be content with being a “lone ranger” researcher; the orientation to be either a leader or a follower; the security to take creative chances with one’s work or to simply conduct “normal science”; and the sense of esteem for being the best or simply doing one’s job. TS requires a constant “reengineering” of its total enterprise. Consequently, we raised the following research questions: (1) What is the traditional culture of science at UTMB? (2) How has the culture of science at UTMB changed since the introduction of the Clinical and Translational Science Award project? (3) What has been the relationship between the culture of science and the conduct of science at UTMB since CTSA? (4) How have cultural influences on self-concept changed? METHODS/STUDY POPULATION: Data have been collected by means of ongoing 1-on-1 interviews with CTSA participants at all levels; observations of lab and classroom interaction; participation in organizational and planning committees; and other everyday organizational activities. RESULTS/ANTICIPATED RESULTS: Following the grounded theory method of qualitative analysis and discovery, we found 3 stages of cultural change. Stage 1 is Cultural Invasion of the existing culture at UTMB by the implementation of the CTSA project. Stage 2 is Cultural Accommodation by which internal responses to change follow the normal scientific paradigm. Stage 3 is Cultural Expansion by which the organizational and cultural platform for conducting science has expanded regionally, nationally and cross-disciplinarily. DISCUSSION/SIGNIFICANCE OF IMPACT: Whether a distinct fourth stage emerges depends on such factors as funding and programmatic directives from NIH; the tension between research and clinical demands for resources; and the emergence of junior investigators schooled on the principles of TS.