OBJECTIVES/SPECIFIC AIMS: Chromosome 22q11.2 deletion syndrome (22q) has a prevalence almost as common as Down syndrome. 22q is well known for medical complications, including congenital heart disease and immune dysfunction. However, children with 22q also have borderline cognitive abilities, are at high risk for ADHD and anxiety, and have poor independent living skills (adaptive function). Parenting is one modifiable factor that has been found in typically developing populations to promote independent functioning and protect against the development of anxiety disorders. This study investigates the associations between parenting, anxiety, and adaptive functioning in 22q. METHODS/STUDY POPULATION: Parent-child (ages 4–11) dyads participated in an ongoing study involving observed parenting during challenging tasks plus questionnaires of parenting, child anxiety, and child functioning. In total, 52 dyads [22q=25; typical development (TD)=27] have enrolled to date. Parents completed questionnaires, including the Parenting Styles and Dimensions Questionnaire (PSDQ), Spence Children’s Anxiety Scale, and Adaptive Behavior Assessment System for Children (ABAS-II). PSDQ dimensions of interest included Parental Psychological Control (PPC: the management of child behavior through the manipulation of emotions, expectations, and independence), Authoritative, Authoritarian, and Permissive, and the subscales of these broad dimensions. Scores were compared using t-tests and multiple regression models were used to investigate the relationships between 1-parenting and anxiety and 2-parenting and adaptive function. RESULTS/ANTICIPATED RESULTS: Mean age was 7.8+2.1 years. Full Scale IQ (TD: 112.3 vs. 22q: 82; p<0.001) and ABAS-II Global Adaptive Composite (TD: 102.7 vs. 22q: 69.2; p<0.001) were significantly higher in the TD group. Parents in the 22q group reported higher levels of PSDQ PPC (22q: 2.3 vs. TD: 2.1; p=0.06), specifically overprotection (22q: 3.7 vs. TD: 3.3; p=0.04), and lower Authoritative parenting (22q: 4.1 vs. TD: 4.4; p=0.03), across the subscales. There were no differences in Authoritarian or Permissive parenting. Children with 22q had higher Spence Total Anxiety scores (22q: 62.5 vs. TD: 47.4; p<0.001). Self-reported PPC and group (R2=0.3, F3,48=8.1, p<0.001) predicted child anxiety with a main effect of PPC (β=16, p=0.02). Group tended to moderate the association between PPC and anxiety (β=−17.5, p<0.10), with PPC predicting anxiety for the 22q group (r=0.35, p<0.09), but not the TD group (r=−0.08, ns). At this time, a relationship between PPC and child ABAS-II GAC in 22q (r=−0.14; p=0.5) is not identified. DISCUSSION/SIGNIFICANCE OF IMPACT: Children with 22q are at high risk for anxiety and poor adaptive outcomes. These results suggest that parents of children with 22q use higher levels of PPC, which is correlated with increased child anxiety. These analyses also provide support for parenting interventions to improve anxiety in children with 22q and possibly mitigate the serious mental health risk in this population.

OBJECTIVES/SPECIFIC AIMS: (1) Provide basic brain knowledge about development and resiliency. (2) Develop an understanding of how a mother can impact a child’s brain development. (3) Foster a sense of agency to increase the likelihood that a mother will enact positive changes. (4) Develop the ability to recognize a connection between one’s own behaviors and a child’s development and behaviors. METHODS/STUDY POPULATION: Tested the efficacy of a 4-week intervention program on neurodevelopment for homeless mothers. Mothers (n=4) residing at the Center for the Homeless in South Bend, IN were recruited. Used community partner feedback, weekly surveys, and pre/post tests to look at changes in basic content knowledge, behavioral change, and self-efficacy. RESULTS/ANTICIPATED RESULTS: Preliminary results indicate an increase in knowledge about neurodevelopment, although results on behavioral changes are inconclusive. The program is anticipated to run a second time with a new group of parents residing in the Center for the Homeless to increase sample size. DISCUSSION/SIGNIFICANCE OF IMPACT: Anticipated that the results will add to the existing literature concerning effective interventions in strengthening parenting and neuroscience knowledge in vulnerable populations.

ABSTRACT IMPACT: The goal of this evaluation study is to enhance the ability of the External Review Board to advise the CTSA at UTMB how to improve translational science activities. OBJECTIVES/GOALS: The purpose of this study is to evaluate the work of the External Review Board (EAB) for the Institute for Translational Sciences/CTSA at the University of Texas Medical Branch-Galveston. This evaluation is conducted through the perceptions of professional and community board members. The outcome consists of an inventory of best practices. METHODS/STUDY POPULATION: We collected data by means of semi-structured interviews with all eight member of the EAB. The interviews were conducted via telephone, lasted approximately 30 minutes each, and were audio-recorded with respondents’ permission. Respondents’ identities were held in confidence. The IRB at UTMB reviewed our study. The interviews were transcribed. The data were analyzed by means of an inductively-oriented, grounded theory approach (Charmaz, 2006). Emergent themes led to the formation of a series of best practices. RESULTS/ANTICIPATED RESULTS: Common concerns included the need for more extensive training for new members; circulation of the agenda before the meeting; and the value of more structured main leadership. The members generally agreed that the breakout groups were valuable because they encouraged them to engage in hands-on responses to practical problems. One of the key epistemological findings was the consensus view that the evaluation of the EAB should be an ongoing project, as opposed to a yearly task. This serious approach to evaluation would be conducive to a process analysis of the EAB, since medical, social, economic, and cultural conditions surrounding and influencing translational science are generally in flux (e.g., the COVID-19 pandemic and the various stages in the CTSA grant). Overall, the EAB experience was quite positive for them. DISCUSSION/SIGNIFICANCE OF FINDINGS: The strongest sentiment expressed in the interviews was that the CTSA at UTMB should focus and build on its strength--the science of team science--as opposed to any concerted search for weaknesses that the term “evaluation” occasionally implies.

OBJECTIVES/GOALS: People experiencing homelessness vs. housed peers have higher rates of substance use disorders as well as increased emergency medical services (EMS) use. However, it is unknown if EMS administers naloxone at different rates to people experiencing homelessness. We address if patient housing status impacts naloxone administration by EMS providers. METHODS/STUDY POPULATION: We conducted a retrospective, cross-sectional analysis of electronic patient care reports (ePCRs) for all 911-incidents attended by the Los Angeles Fire Department (LAFD) during the study period, January to December 2018. Individuals who were medically assessed by the LAFD and who were administered naloxone by LAFD EMS were included. Exclusion criteria was incomplete ePCRs. The primary outcome was prevalence of EMS naloxone administration by housing status in the city of Los Angeles. We used descriptive statistics and a logistic regression model to examine differences in care. RESULTS/ANTICIPATED RESULTS: Naloxone was administered in 2,438 of the 345,190 incidents that occurred during the study period. 608 (25%) incidents involved people experiencing homelessness. Top indications for naloxone administration were similar in both groups: overdose, altered consciousness and cardiac arrest. Of those who received naloxone, people experiencing homelessness were more likely to be male (82% v 67%) and younger (41 v 46 years). People experiencing homelessness were more likely to receive naloxone (OR 2.6, 95% CI 2.4-2.9). People experiencing homelessness received naloxone at a rate of 44 times that of housed peers. A logistic regression model adjusting for gender, age, respiratory depression and transport status showed people experiencing homelessness remained more likely to receive naloxone (OR 2.3, 95% CI 2.0-2.5). DISCUSSION/SIGNIFICANCE: Emergency medical services are more likely to administer naloxone to people experiencing homelessness than housed peers. There is a need to identify bias and factors that impact prehospital care and patient outcomes of people experiencing homelessness. New care pathways for people confronting homelessness and opioid use disorders are needed.

OBJECTIVES/SPECIFIC AIMS: This study seeks to test the feasibility and effectiveness of a brief acceptance and commitment therapy (ACT) treatment for chronic pain patients in a primary care clinic METHODS/STUDY POPULATION: Primary care patients aged 18 years and older with at least 1 pain condition for 12 weeks or more in duration will be recruited. Patients will be randomized into (a) ACT intervention or (b) control group. Participants in the ACT arm will attend 1 individual visit with an integrated behavioral health provider, followed by 3 weekly ACT classes and a booster class 2 months later. Control group will receive enhanced primary care that includes patient education handouts informed by cognitive behavioral science. Data analysis will include 1-way analysis of covariance (ANCOVA), multiple regression with bootstrapping. RESULTS/ANTICIPATED RESULTS: The overall hypothesis is that brief ACT treatment reduces physical disability, improves functioning, and reduces medication misuse in chronic pain patients when delivered by an integrated behavioral health provider in primary care. In addition, it is anticipated that improvements in patient functioning will be mediated by patient change in pain acceptance and patient engagement in value-consistent behaviors. DISCUSSION/SIGNIFICANCE OF IMPACT: This pilot study will establish preliminary data about the effectiveness of addressing chronic pain in a generalizable integrated primary care setting. Data will help support a larger trial in the future. Findings have potential to transform the way chronic pain is currently managed in primary care settings, with results that could decrease disability and improve functioning among patients suffering from chronic pain.

OBJECTIVES/SPECIFIC AIMS: Thionamides are anti-thyroid drugs (ATD) that are commonly used to treat autonomous thyrotoxicosis. Although efficacious, these medications carry a risk of neutropenia or agranulocytosis in a small but finite proportion of the patients who receive them. Some risk factors for thionamide-induced neutropenia have been identified, including body mass index (BMI) and dose, but the role of race and ethnicity in the pathogenesis of this potentially life-threatening side effect is not known. We hypothesize that there will be no effect of race or ethnicity on the change in absolute neutrophil count (ANC) following initiation of thionamide therapy among adult patients with thyrotoxicosis. METHODS/STUDY POPULATION: Data from the electronic medical record at UNM HSC were obtained using a standard database query for the years 2000–2016. Inclusion criteria were the prescription of an ATD, an ANC recorded within 30 days of initiating ATD therapy (pre-ATD), and an ANC recorded between 75 and 365 days after starting an ANC (post-ATD). Patients taking other agents known to cause neutropenia and agranulocytosis, such as clozapine, allopurinol, or chemotherapy, were excluded. Patients were assigned to racial and ethnic groups as follows: Hispanic, non-Hispanic Caucasian (NHC), native American, Black, and Asian. The post-ATD ANC was defined as the nadir ANC observed after the ATD was started. “Delta ANC” was defined as [(post-ATD ANC)−(pre-ATD ANC)]. ANOVA analysis with Bonferroni-adjusted post-hoc testing was performed to examine differences in the mean changes of ANC across ethnic groups. RESULTS/ANTICIPATED RESULTS: In total, 123 adult patients met inclusion and exclusion criteria and were included in the analysis. No significant difference was found between any of the racial groups with regard to age, sex, BMI, pre-ATD ANC, or the pre-ATD to post-ATD ANC interval. The native American group showed a significantly greater post-ATD ANC (not shown) and Delta-ANC as compared with the other groups. Delta ANC Hispanic=−1.4±3.3, Caucasian=−0.6±3.3, Black=−0.9±4.1, Asian=−3.8±4.8, native American=3.6±5.1 (all units per mm3; p<0.001). DISCUSSION/SIGNIFICANCE OF IMPACT: In this cohort of New Mexicans with thyrotoxicosis, native American race was protective against thionamide-induced neutropenia.

OBJECTIVES/SPECIFIC AIMS: The prevalence of kidney stone disease has increased significantly in the United States in the last 2 decades. While several studies have reported that disparities in access to and quality of medical care exist, there is a need for a more thorough investigation of factors that negatively impact patients seeking care specifically for kidney stone disease. We sought to examine whether kidney stone patients received different standard of care in the emergency department (ED) according to their race/ethnicity, gender, age, body mass index, socioeconomic status (SES), and insurance status. METHODS/STUDY POPULATION: We conducted a retrospective study of patients presenting to the ED at Montefiore Medical Center between January 1, 2014 and December 31, 2016. Patients with a diagnosis of nephrolithiasis were identified using ICD-9/10 codes and electronic chart review was used to assess each patient’s ED course as well as to gather sociodemographic information. The primary outcomes of interest were administration of pain medication, prescription of alpha-1 antagonists to facilitate stone passage and whether or not patients received CT scan or ultrasound. Associations of these outcomes with age categories, sex, race/ethnicity, body mass index category, SES and insurance status were examined using multivariate logistic regression models. RESULTS/ANTICIPATED RESULTS: A total of 1200 patients were included in this analysis of which 616 (51%) were women. A large proportion of patients were minorities (40% Hispanic and 15% non-Hispanic African-American), whereas 21% were Caucasian and 24% declined to report race/ethnicity. Patients between the ages of 55–64 and those older than 65 were less likely to receive pain medication compared to younger patients aged <35 years (OR=0.48, 95% CI: 0.27–0.86 and OR=0.46, 95% CI: 0.21–1.00, respectively). Women were less likely than men to undergo any form of diagnostic imaging (OR=0.52, 95% CI: 0.35–0.76) including CT scan (OR=0.50, 95% CI: 0.35–0.72). Similarly, patients in the lowest quintile of SES received less imaging than patients in higher SES categories (OR=0.50; 95% CI: 0.27–0.90). Furthermore, African Americans (both genders) and women were less likely to be prescribed an alpha antagonist medication (e.g., tamsulosin) to facilitate stone passage compared with White patients (OR=0.61, 95% CI 0.36–1.03) and men (OR=0.68, 95% CI: 0.49–0.92), respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: We found that multiple disparities exist among patients presenting to the ED for nephrolithiasis. A more thorough investigation into the causes of these disparities is warranted to limit their impact on patient care.

OBJECTIVES/GOALS: Contingency management (CM), wherein patients earn prizes for behavior change, is the gold-standard for reducing stimulant misuseand has been shown to improve medication adherence.We aim to describe the feasibility, acceptability, and effectiveness of CM to reduce stimulant use and optimize ART adherence in Women’s HIV primary care. METHODS/STUDY POPULATION: Using the ADAPT-ITT model for adapting evidence-based HIV interventions, we implemented the CoMBostudy at the Ward 86 Women’s Clinic at San Francisco General Hospital. Inclusion criteria are (1) adult age women with HIV, (2) suboptimal ART adherence, (3) stimulant use disorder with goal of reduced-use. Participants receive weekly CM for 12 weeks with escalating incentives for point-of-care urine testing negative for stimulants and positive for tenofovir ART. We use mixed methods to evaluate feasibility and acceptability ofCoMBowith quantitative process measures, sequential explanatory in-depth interviews with participants and staff, and effectiveness by proportion of point-of-care urine tests without stimulants and with tenofovir. RESULTS/ANTICIPATED RESULTS: CoMBoStudy enrollment began in September 2023; n=10 participants have enrolled with an additional n=20 planned.We will report feasibility and acceptability using:1) the number of women with HIV, stimulant use disorder, and suboptimal ART adherence enrolled vs. recruited, 2) the number and proportion of CM sessions attended/missed, 3) cost per participant, and 4) participant-reported facilitators and barriers to CM engagement. We will report preliminary effectiveness based on: 1) proportion of POC tests negative for stimulants, positive for ART, and 2)trend in self-reported stimulant use assessed weekly during CM. DISCUSSION/SIGNIFICANCE: Women with comorbid HIV and stimulant use disorder have demonstrated poor outcomes including reduced ART adherence and faster progression to AIDS. This work aims to expand access to evidence-based treatment for stimulant use disorder for women with HIV and share key opportunities and challenges for doing so in the women’s health HIV primary setting.

OBJECTIVES/GOALS: Physician-scientists play a vital role in biomedical research but this chosen career path has many challenges, such as long training periods and funding. The University of Rochester (UR) CTSI pipeline programs address this by enabling medical trainees to partake in enriched research experiences. METHODS/STUDY POPULATION: The UR CTSI TL1 is a training grant from the National Center for Advancing Translational Science (NCATS), which funds predoctoral trainees. The TL1-funded physician-scientist pipeline includes the Academic Research Track (ART) year-out program and the Medical Science Training Program (MSTP). We describe the characteristics and training outcomes of TL1-funded trainees. We also obtained testimonials of current and former trainees regarding their career component decision-making, and their perception of programs, in order to identify how best to address the challenges of the physician-scientist workforce, and to facilitate the transition between the clinic and bench. RESULTS/ANTICIPATED RESULTS: From 2006-2019, the UR CTSI has had 56 ART trainees and 17 MSTP trainees complete training; six trainees have transitioned into the MSTP after completing the ART program. As of 2019, 63 of 67 graduated trainees (94%) have continued their engagement in CTS after graduation. Importantly, our programs have facilitated the careers of 31 women (39.7%) and 12 under-represented minorities (15.4%). We will present a breadth of qualitative data to inform which parts of the TL1-related programs have been successful, and which parts could use programmatic improvement to aid the transition into the physician-scientist workforce. DISCUSSION/SIGNIFICANCE OF IMPACT: Physician-scientist training barriers in the US have resulted in a shortage of these professionals in the clinical and translation workforce. Our data show the UR CTSI has been successful in addressing several of these challenges via the TL1-funded ART, MSTP, and ART/MSTP dual program pipeline.

OBJECTIVES/GOALS: Our study aims to 1) examine the link between engagement in CLR Academy and youth diabetes risk factors—physical activity, nutrition, mental health, and weight status; 2) examine CLR’s role in moderating the relationship between perceived discrimination and these risk factors. Includes a program evaluation of CLR & interviews of members. METHODS/STUDY POPULATION: Youth-onset diabetes is rising in American minority communities. Youth sports programs like the Community Leadership Revolution (CLR) Academy in Washtenaw County, MI are emerging responses to this issue. CLR targets diabetes risk factors through team sports by promoting mindfulness and healthy habits. Employing a mixed-methods, pretest-posttest approach, our study focuses on how the frequency of engagement in CLR impacts CLR’s effect on youth’s diabetes risk factors. Considering the discrimination minority youth experience, we also aim to see if CLR potentially buffers the impact of perceived discrimination on diabetes risk factors. A posttest program evaluation of CLR will also include semi-structured interviews with CLR staff and participants. RESULTS/ANTICIPATED RESULTS: There is potential that youth with high engagement in CLR Academy may see enhanced benefits in managing diabetes risk factors compared to less active participants. This may be particularly true for youth experiencing high perceived discrimination, with potential marked improvements in mental health, like reduced anxiety and depression. Additionally, through a program evaluation and semi-structured interviews, our study aims to uncover the factors contributing to CLR’s success as a community-led intervention while also identifying areas for enhancement. Post-study, CLR will receive financial support to integrate these insights into their program, furthering their effectiveness in youth diabetes prevention and overall well-being. DISCUSSION/SIGNIFICANCE: This study may provide significant insights into the relationship between sports participation, diabetes risk factors, and perceived discrimination. The findings could help CLR improve its program and guide more effective diabetes prevention strategies in minority youth through other youth sports programs.

OBJECTIVES/SPECIFIC AIMS: Emergency (911) dispatchers are the first link in the chain of care for the estimated 240 million emergency calls made each year. Yet even as emergency medicine, public safety, and public health have seen increasing study, emergency dispatch has very seldom been included in that research. Part of the reason is that, while emergency medicine is connected with hospital physicians and public health with university departments, emergency dispatch is largely invisible, not represented in university programs, and staffed by professionals without research training–and often without higher education or academic degrees. The purpose of our Dispatch Research Workshop is to engage these professionals in guided research projects of their own design, with the ultimate aims of both engaging more emergency dispatchers in research and increasing the field’s overall capacity to generate evidence-based practice. METHODS/STUDY POPULATION: The workshop is help in tandem with a national Emergency Dispatch conference. Participants are recruited through advertisements in professional journals and relevant social media sites. The workshop is co-led by members of a partnership between the nonprofit organizations the International Academies of Emergency Dispatch and the UCLA Prehospital Care Research Forum, along with the dispatch data aggregation company FirstWatch. The Workshop occurs over two eight-hour days, and participants generally have no research experience or background. By the end of the second day, groups have developed research questions and methods, begun to write IRB proposals, and created data collection and analysis plans. Throughout the remainder of the year, research mentors support the completion of the project, and completed projects are presented at the following year’s conference and submitted (if desired) for publication. RESULTS/ANTICIPATED RESULTS: During the first two years of the workshop, 36 attendees participated (17 the first year and 19 the second). Three successful attendees of the first workshop helped lead the second as research mentors. Three research projects were completed from the first year; all three were presented as posters and are now being prepared for publication as manuscripts. Four projects have emerged from the second year’s workshop. Assessments and one-on-one interviews with participants at the end of each workshop have led to continuous change and improvement in the delivery of the material, as well as the outline of a year’s worth of support materials, which is currently in development. DISCUSSION/SIGNIFICANCE OF IMPACT: Developing a true evidence base for practice in emergency dispatch will serve all of our communities, and feedback from our participants (as well as significant existing research in practitioner-engaged research) indicates that those who participate in research have a better understanding of the value of evidence-based practice, are more likely to adopt it, and are more likely to raise questions and test theories in their own professional life. Also, providing these practitioners the opportunity to conduct and publish research raises their stature and the stature of their profession, helping it achieve its rightful place alongside other professions in public safety and health.

OBJECTIVES/GOALS: The objective of the study is to test the feasibility and acceptability of a remote glucose monitoring program for pregnant Marshallese women with pre-gestational (PGDM) or gestational diabetes (GDM) without excluding women with limited English proficiency. The study will explore changes in patient-physician communication and self-efficacy. METHODS/STUDY POPULATION: Twenty Marshallese pregnant women with PGDM or GDM will be identified for recruitment. The patient will meet with a bilingual staff member to explain the study and provide consent. At enrollment, patients will complete an enrollment survey and be provided with the iGlucose monitor and receive training its use. Their provider(s) will receive access to their patient’s online portal for monitoring. At 14 days postpartum patients will receive a post-intervention survey and invitation to participate in interview, and their provider(s) will receive a satisfaction survey for the remote monitoring program. RESULTS/ANTICIPATED RESULTS: We hypothesize that the use of a remote glucose monitoring intervention is feasible and acceptable for Marshallese women with PGDM or GDM. Further, we hypothesize that the remote glucose monitoring program will increase satisfaction with physician-patient communication and will increase self-efficacy with glucose management. We anticipate that providers will find the program feasible and acceptable for use with the Marshallese population. DISCUSSION/SIGNIFICANCE: RPM technology can transform the way PGDM and GDM are managed. RPM may have greater benefits when there is a lack of language concordance by providing more time for patient-provider communication, thereby improving patient satisfaction and decreasing the risk of negative outcomes for Marshallese women.

Objectives/Goals: Our goal was to develop a method for creating a streamlined, Clinical and Translational Science Awards (CTSA)-specific translational science scoring rubric to be used to differentiate between translational science and translational research projects during the pilot proposal review process. Methods/Study Population: We created a survey using the 24 Translational Science Principle-based questions sourced from Schneider et al.’s 2023 manuscript in JCTS. Survey respondents were asked to rank the questions from 1 to 24, with “1” being the question that is the most impactful for defining translational science at Penn State. The survey was distributed to our CTSA staff, faculty, and leadership who are well-versed in translational science across all CTSA Cores. The rankings were averaged per question. The five questions with the most impactful average score were selected to be used to evaluate translational science at our CTSA. Results/Anticipated Results: Nine individuals, including faculty, staff, and leadership, across five CTSA Cores completed the survey. The average ranking scores ranged from 6.1 to 20.3. The top five ranked items represented the following four Translational Science Principles: generalizable solutions, efficiency and speed, focus on unmet needs, and cross-disciplinary team science. Importantly, these five items and corresponding translational science principles reflect our CTSA priority areas, the infrastructure support we provide, and the translational research activities conducted at our CTSA. For example, team science is highlighted throughout our CTSA programming, including mini presentations during our CTSA meetings. Discussion/Significance of Impact: This method allows CTSA teams to reflect on their institutional work and share Core-specific perspectives of translational science. This CTSA-specific rubric allows for streamlined translational science pilot proposal evaluation in alignment with site specific CTSA mission and vision.

OBJECTIVES/GOALS: Neonatal endotracheal tubes (ETTs) are usually uncuffed to avoid subglottic stenosis and other complications, but cuffed ETTs allow better ventilation. Our goal was to detect and control pressure in the cuff below the limit of occluding venous flow to minimize the risk of subglottic stenosis. METHODS/STUDY POPULATION: We designed a pressure sensor to fit on a 2.5 ETT for prototype testing in 8 age adult female rabbits. Eight uncuffed age- and sex- matched rabbits served as control. Study duration was 2 hours during which pressure in the cuff was limited by novel sensor (intervention) or auscultation (control). Anesthesia was maintained with sevoflurane. Ventilation was provided mechanically. Subsequently the tracheae were removed, sectioned crosswise, and compared histologically for mucosal damage. RESULTS/ANTICIPATED RESULTS: Preliminary data demonstrated an almost 30% greater amount of intact mucosa in the intervention group. The sensor also provided data on heart rate and respiratory rate, although this signal was not optimal. After filing an invention disclosure and provisional patent, we are refining our device to include multiple compartments for local control of cuff pressure and applying for a STTR Phase I/II application. DISCUSSION/SIGNIFICANCE: Ventilation in neonates with uncuffed ETTs can be suboptimal due to leak around the tube, but cuffed ETTs pose the threat of subglottic stenosis and other complications. We have designed a prototype cuffed ETT with a sensor to maintain low cuff pressure while preventing leaks and largely avoiding damage to the tracheal mucosa.

OBJECTIVES/GOALS: We have developed a comprehensive Translational Research Navigation Program to guide investigators all the way from protocol development through study closure. As the program evolved, we initially developed organizational tools and then restructured them into a series of checklists to ensure that critical elements were not excluded or duplicated. METHODS/STUDY POPULATION: A series of checklists to assure that all research elements, including regulatory, scientific, and institutional, are addressed from protocol inception through study closure were developed by clinical research coordinators/navigators. The checklists are periodically updated and modified to reflect changing local and national regulations and policies. The first tool became the “Protocol Development Checklist” and then additional tools were developed and modified into a suite of navigation checklists that include “Protocol Implementation Checklist,” “Protocol Conduct Checklist,” and “Protocol Completion Checklist.” RESULTS/ANTICIPATED RESULTS: The checklists have been incorporated into the Translational Research Navigation Program and have enhanced the organization and quality of protocols throughout their lifespan. For example, implementation of the Protocol Development Checklist resulted in a reduction in time to IRB approval (currently 10 days), and implementation of the Protocol Implementation Checklist has impacted the time from IRB approval to study start-up. The Protocol Conduct Checklist has aided investigators in being better prepared and more organized for study conduct activities and the Protocol Closure Checklist has assured timely protocol closure and regulatory compliance, including reporting to ClinicalTrials.gov. DISCUSSION/SIGNIFICANCE OF IMPACT: Protocol checklists are powerful tools to enhance thoroughness, organization, and quality of the clinical research process. The Rockefeller University protocol checklists are available to the CTSA and Scientific Communities. CONFLICT OF INTEREST DESCRIPTION: NA.

ABSTRACT IMPACT: This paper reveals the myriad techniques that CTSA hubs use to support, promote and expand team science including many ways to involve the community, students, scholars and other multidisciplinary scientists. OBJECTIVES/GOALS: The Great CTSA Team Science Contest (GTSC) was developed in the NCATS Workgroup on Institutional Readiness for Team Science to collect stories describing the many ways hubs were promoting and supporting team science across the CTSA consortium. METHODS/STUDY POPULATION: Our qualitative data analysis examined the different designs from a high level - namely we categorized how many of the stories were competitions for pilot funding, training programs on team science competencies, communication skills training, workshops for educating community collaborators about research and/or training investigators about community-based research, advancing promotion and tenure for team science, etc. We discuss specific examples of different designs and who they were intended to benefit. RESULTS/ANTICIPATED RESULTS: Launched in July 2018, the contest received 170 submissions from 45 unique CTSA hubs. Qualitative analysis addressed the following questions about team science: 1) Who or what group championed it? 2) Who benefitted or who were the intended recipients? 3) What was the desired outcome? (e.g. team science skills, communication skills, getting the community involved, fostering new collaborations, expanding capacity for team science, etc.) 4) What method(s) did they use? 5) What translational science stage was addressed? DISCUSSION/SIGNIFICANCE OF FINDINGS: This analysis includes examples of team science research, resources or interventions including successful team dynamics and knowledge integration. This paper reveals the myriad techniques that CTSA hubs use to support, promote and expand team science including involving the community, students, scholars and other multidisciplinary scientists.

OBJECTIVES/GOALS: Asymmetries in lung pathophysiology can result in a maldistribution of gas between regions of the lungs which may generate dangerous pressures that are not observable by clinicians. Our study aims to demonstrate and quantify this through use of high-fidelity simulators to represent a range of commonly encountered clinical pathologies. METHODS/STUDY POPULATION: A benchtop study was performed with two high-fidelity breathing simulators, each representing one lung. This system allows for real-time monitoring of pressure and lung dynamics in a two-lung asymmetric injury model. One simulator was set to a fixed compliance and a resistance. A second simulator had a range of compliance and resistance values. Data were collected for 15 different test cases across a distribution of asymmetries. Each test case is run for 30 cycles. At the end of each ventilatory cycle, a short expiratory hold is performed, allowing pressure in the lung simulator, tubing, and ventilator circuit to equilibrate between cycles. RESULTS/ANTICIPATED RESULTS: Maldistribution of tidal volume was demonstrated when the compliance ratio between lung models (CL1/CL2) was 0.2 and the resistance ratio (RL1/RL2) was 10 with 23.9% (99% CI: 23.9-24.0%) of the gas volume distributed to lung 1 (103 mL L1 vs 327 mL in L2). Additionally, the injured lung when compared with the normal lung experienced higher peak pressures (12.8 cm H2O vs. 6.9 cm H2O, L1 and L2 respectively) and higher compartmentalized plateau pressures (11.5 cm H2O vs. 6.8 cm H2O, L1 and L2 respectively). DISCUSSION/SIGNIFICANCE: We demonstrate significant maldistribution of volume and pressures between two lungs in an asymmetric injury model. This study suggests significant impact of asymmetry in current lung-protective mechanical ventilation strategies and calls for better understanding of case-specific pathophysiologic changes affecting each of the two lungs.

OBJECTIVES/GOALS: The RPPR Tool was created to accurately and systematically track our CTSA’s overall program goals and core’s progress in real time. It establishes and centralizes the continuous collection of key performance indicators and fosters accountability and transparency among cores and leadership. METHODS/STUDY POPULATION: Using the University of Chicago’s Annual Progress Report REDCap data dictionary, UI Institute for Clinical and Translational Science (ICTS) core managers convened to explore the adaptability of the reporting format for the CTSA. The team developed the more user friendly and easily accessible RPPR Reporting Tool using REDCap to better fit our CTSA. The RPPR in REDCap provides a central location to monitor the activities for each core, gather status updates, generate performance reports, and identify key performance indicators and challenges to prevent failures in the future. All data are transparent and accessible on-demand to individual core managers, evaluators, and ICTS leadership. RESULTS/ANTICIPATED RESULTS: UI’s RPPR Tool has improved the compliance with ongoing monitoring and reporting of CTSA program’s performance. Documenting all relevant information in a centralized space has eased the administrative and evaluation burden of preparing the RPPR. Furthermore, REDCap as a commonly used tool allows the core managers to complete this reporting with minimal guidance. This tool encourages each core to be accountable for documenting their respective progress. The transparency of the reporting allows the Co-PIs along with the leadership team to access the data at any given time to stay updated on the ICTS’ overall progress and to make the appropriate improvements as needed. DISCUSSION/SIGNIFICANCE OF IMPACT: The RPPR is a required component of all CTSA grants. UI’s RPPR Tool has been instrumental in comprehensively tracking progress of the ICTS and its contributions to translational research. UI is collaborating with CTSA peers to improve the RPPR Tool, so it can become an asset for any CTSA to adapt.

OBJECTIVES/GOALS: Older adults in rural communities are at an elevated risk of falling. Perturbation-Based Balance Training (PBT) is a highly effective fall prevention paradigm but its feasibility in the community is unknown. The purpose of this study was to determine the feasibility and acceptability of PBT to older adults and local clinicians in rural communities. METHODS/STUDY POPULATION: 19 older adults (60+ years) were recruited from communities in rural Montana to take part in a PBT program. The PBT program was implemented using a bespoke portable PBT treadmill developed by our research team and validated against commercial PBT treadmills. To increase ecological validity, the program was implemented by local clinicians. The PBT program lasted 6 weeks, with 1 session per week, participants received up to 35 trip perturbations per session. The feasibility and acceptability of PBT to participants and clinicians was assessed within the Theoretical Framework of Acceptability, prospectively and retrospectively via interviews and surveys, and concurrently via field notes. RESULTS/ANTICIPATED RESULTS: Data analysis is ongoing and will be complete by the time of presentation. Preliminary results suggest the portable PBT program was generally acceptable to older adults and local clinicians. Perceived effectiveness was generally positive and increased balance awareness and low burden are emerging as common themes. Local clinicians indicated the burden of implementing PBT was low, PBT fit within their views on fall prevention, and had a high level of perceived effectiveness. There appear to be a few limitations to feasibility, which are primarily related to the weight and transportation of the treadmill. We are currently working to refine the treadmill and lower its weight and are developing a grant with local clinicians and extension agents that would facilitate transportation to a broader network of communities. DISCUSSION/SIGNIFICANCE: Our preliminary findings suggest PBT is feasible in rural communities and accepted by older adults. Increased balance and fall awareness and low burden are emerging as important factors in the feasibility and acceptability of PBT. This study provides a foundation for future studies to translate other PBT modalities from the lab to the community.

OBJECTIVES/SPECIFIC AIMS: This presentation will highlight theframework, domains, and approaches of the “Engaging the Voice of theCTS Customer and Collaborator System” created at the University ofMinnesota Clinical and Translational Science Institute (CTSI) in response to theneed to improve the stakeholder engagement, quality, efficiency, consistency,and transparency of the clinical and translational work. This system addresses 3important results-based accountability measures/questions:“What should we do?”, “How well did we doit?”, and “Is anyone better off?”. According toWoolf (2008), “translational research means different things todifferent people.” Social networks and systems that supporttranslational processes and outcomes are complex, nonlinear, andmultidisciplinary (Smith et al., 2017). In this highlyuncertain and fluid context, the input of program stakeholders is paramount tomove translation forward. NCATS Strategic Plan (2016) directs the grantees toengage patients, community members and nonprofit organizations meaningfully intranslational science and all aspects of translational research. Engagement ofstakeholders throughout the lifecycle of a translational research projectensures the project processes and outcomes are relevant to and directly addresstheir needs and will be more readily adopted by the community.“Customer” (among other terms are Beneficiary,Collaborator, Client, Community, Consumer, Service User, etc.) is a person,organization, or entity who directly benefits from service delivery or program(Friedman, 2005). Customers can be: direct and indirect, primary and secondary,internal and external. Our analysis of CTS stakeholders (“Who are ourcustomers/collaborators?”) produced the following list ofcustomers and collaborators: researchers, University departments, translationalscience workforce, patients, community members and entities, nonprofitorganizations, industry collaborators, NCATS/NIH, CTSA hub partners,and CTSI staff. The “Voice of the Customer” (VOC) is theterm used to describe the stated and unstated needs or requirements of theprogram’s customer. The “voice of the customer”is a process used to capture the feedback from the customer (internal orexternal) to provide the customers with the best quality of service, support,and/or product. This process is about being proactive and constantlyinnovative to capture the changing needs of the customers with time. Related tothe VOC is the concept of user innovation that refers to innovations developedby consumers and end users. Experience shows that sometimes the best product ora process concept idea comes from a customer (Yang, 2007: p. 20). Capturing andutilizing such ideas are also relevant to VOC and can be operationalized andimplemented as a valuable strategy. The University of MinnesotaCTSI’s key objectives, goals, and uses of engaging the VOC andcollaborator are as follows: (1) Engage CTSA customers (“relevantstakeholders”) in multiple aspects of translational science and lookfor opportunities to include their perspective (per NCATS strategic principles).(2) Inform continuous improvement, strategic management, and M&Eefforts, the identification of customer needs and wants, comprehensive problemdefinition and ideation, new concept development and optimization. (3) SynergizeNCATS and partner expectations and campus/hub needs. (4) TranslateVOC into functional and measurable service requirements.METHODS/STUDY POPULATION: A case study of the programmatic andmethodological approach/technique development. The VOC at the UMNCTSI has been captured in a variety of ways: regular and ad hoc surveys,interviews, focus groups, Engagement Studios, formal call forpatient/community ideas and proposals, informal conversations,customer/community membership and participation in the AdvisoryBoards and Executive Leadership Team meetings, and observations. Our VOCvariables and metrics assess customer needs, wants, knowledge, and skills;customer satisfaction with processes and outcomes; and customer ideas forimprovement and innovation. The ensuing customer feedback and other data havebeen used to identify and incorporate the important attributes needed in theCTSI processes, products, and dissemination. UMN CTSI partners in engaging andcapturing the VOC include our past, current, and potential customers andcollaborators, communities, program staff and service providers, programadministration, communication staff, M&E team, internal and externaldata collectors. RESULTS/ANTICIPATED RESULTS: The proposedcomprehensive approach shows sound promise to enhance customer and collaboratorengagement, critical thinking, learning, strategic management, evaluationcapacity and improvement within clinical and translational scienceorganizations. DISCUSSION/SIGNIFICANCE OF IMPACT: This structuredapproach’s impact is significant in that it fills the current gap inthe practice, literature, and methodology and offers a practical example of a“practice that works” for CTR (and other) organizationsand programs striving to improve their stakeholder engagement and programimpact. Leveraging and synergizing the VOC and community engagement approachescan help CTS organizations advance beyond capturing individualproject/service experiences to drawing a holistic portrait of aninstitution-level (and, potentially, a nation-level) translational scienceprogram.

References

Friedman M. Trying Hard Is Not Good Enough: How to ProduceMeasurable Improvements for Customers and Communities. Trafford,2005.

National Center for Advancing Translational Sciences. NCATSStrategic Plan [Internet], 2016. NIH(https://ncats.nih.gov/strategicplan)

Smith C,et al. Toward a science of translational science. Journal ofClinical and Translational Science 2017; 1:253–255.

Woolf SH. The meaning of translational research and why it matters.JAMA 2008; 29: 211–213.

Yang, K. Voice of the Customer Capture andAnalysis. US: McGraw-Hill Professional, 2007.