bluuebunny/crossref_metadata_2025 huggingface dataset:
68 Metformin prevents the diagnosis of Long Covid in phase 3 trial of early treatment.
Authors: Bramante Carolyn , Wirtz Esteban , Buse John , Boulware David , Nicklas Jacinda , Odde David , Cohen Ken , Puskarich Michael , Tignanelli Christopher , Klatt Nichole , Leibovitz David , Belani Hrishikesh
Published: April 2023

OBJECTIVES/GOALS: Chronic or new symptoms after infection with severe-acute-respiratory-coronavirus-2 (SARS-CoV-2) has been termed post-acute sequelae of Covid-19 (PASC) or Long Covid. Our objective is to present results from COVID-OUT, a phase 3 double-blind, randomized controlled trial of early outpatient treatment of Covid-19 with repurposed medications. METHODS/STUDY POPULATION: COVID-OUT enrolled adults age 30 to 85 with overweight or obesity who had proof of SARS-CoV-2 infection and fewer than 7 days of symptoms. In this 2 by 3 factorial design trial of metformin, ivermectin, fluvoxamine, or exact-matching placebo of each medication, participants were randomized 1:1:1:1:1:1 to the 6 treatment allocations. This abstract focuses on whether early treatment with metformin prevented Long Covid. Immediate release metformin was titrated to 1500mg daily over the first 6 days. We assessed the incidence of clinician-diagnosed Long Covid with follow up through 10 months after enrollment. We also assessed where participants were diagnosed with Long Covid, and where they received Long Covid treatment. RESULTS/ANTICIPATED RESULTS: Of 1124 participants, 98 (8.7%) report having a healthcare provider make a diagnosis of long covid. By arm, 6.9% (39/564) of metformin participants report having a diagnosis for long covid as compared with 10.5% (59/560) of matched placebo controls. The absolute reduction attributable to metformin was 3.6% (95%CI, 0.3% to 7.0%; P=0.031) with a relative risk reduction of 34% (95%CI, 3% to 55%). The metformin cost per long covid case averted was $28 (95%CI, $15 to $306). 10-month follow-up data will be available at the time of presentation as well as an analysis of baseline factors associated with the development of Long-Covid, independent of treatment allocation in the trial. DISCUSSION/SIGNIFICANCE: Metformin reduced the incidence of clinician-diagnosed long covid by 34% in a double-blind randomized placebo-controlled trial, and previous research published in-vitro activity by metformin against SARS-CoV-2 and other RNA viruses. Further investigation of metformin as early treatment for SARS-CoV-2 is warranted.
74 Development and content validation of a tool to assess quality of primary care practice
Authors: Berry Carolyn A. , Kwok Lorraine , Paul Margaret , Albert Stephanie L. , Blecker Saul , Shelley Donna
Published: April 2023

OBJECTIVES/GOALS: Primary care practices struggle to identify which combination of care structures and processes need to be implemented to improve practice performance and subsequently, patient outcomes. The goal of this study is to develop and validate a tool to assess care structures and processes that are associated with better quality and patient outcomes. METHODS/STUDY POPULATION: Data from a scoping review, Delphi study, and qualitative interviews with high-performing primary care practices contributed to the development and content validation of the Tool for Advancing Practice Performance (TAPP). From these sources we identified 314 items representing care structures (e.g., care team makeup, use of electronic health records) and processes (e.g., care coordination, panel management). We developed criteria for deleting and rescuing items and received input from our expert panel to refine the pool of items. We eliminated items that were redundant and lacked clarity/specificity. The tool was further modified based on feedback from cognitive interviewing and pilot testing with practice managers, quality improvement leaders, and physicians from primary care practices. RESULTS/ANTICIPATED RESULTS: The pool of 314 items was winnowed to 188 after applying criteria for deleting and rescuing items. During the expert review, 70 items were eliminated and 8 new items were added, resulting in a working tool of 126 items. We conducted eight cognitive interviews with the 126-item tool and received feedback on the content, item structure, and language, which led to the elimination of 13 items that were poorly or incorrectly understood by respondents. We also modified the language of 23 items for clarity. After cognitive interviewing, the resulting tool comprised 113 items. Fifteen practices piloted the tool and no additional items were eliminated. We modified the instructions for completing the tool and resolved technical issues related to online administration. DISCUSSION/SIGNIFICANCE: TAPP is a novel tool for assessing care structures and processes that are associated with better quality and patient outcomes in primary care settings. The tool can be used by researchers and primary care clinicians to identify areas for improvement in practice performance and patient outcomes related to chronic disease prevention and management.
75 Effect of probiotic supplementation on intestinal permeability in subjects with overweight and obesity: A systematic review of randomized controlled trials
Authors: DiMattia Zachary , Damani Janhavi , Rogers Connie J.
Published: April 2023

OBJECTIVES/GOALS: Obesity is associated with gut dysbiosis, inflammation, and increased intestinal permeability. Probiotic consumption may reverse these outcomes. The goal of this study is to evaluate the evidence linking probiotic consumption to changes in intestinal permeability in subjects with overweight or obesity. METHODS/STUDY POPULATION: Articles were searched in Pubmed, Web of Science, and CAB Direct through February 2022 using search terms: intestinal permeability, overweight or obesity, and probiotic supplementation. 694 articles were exported, and 289 duplicates were identified. Titles and abstract were screened in the 405 remaining references by two investigators to determine eligibility. Eligible studies had data extracted on study participant characteristics, probiotic strain used, probiotic dosage, length of intervention, and intestinal barrier outcomes. Results were summarized in tabular form based on intestinal permeability response to probiotics. Quality of the studies was assessed based on Cochrane–Risk of Bias’ tool (RoB2). RESULTS/ANTICIPATED RESULTS: Thirteen eligible studies were identified. Probiotic genera included Akkermansia, Bifidobacterium, Lactobacillus, Streptococcus, Lactococcus, and Bacillus. Single strain probiotics were used in 3 studies, while the other 10 used multi-strain formulas. Dosage and length of probiotic supplementation ranged from 2.4 x 10^7 to 5 x 10^10 CFU/person/day and 3 to 26 weeks, respectively. The most widely used gut permeability outcomes were serum lipopolysaccharide (LPS) (n=10) and mixed sugar solution consumption with urine analysis (n=6). Five of the 10 studies reported decreases in serum LPS following probiotic consumption, while the other 5 showed no effect. Urinary lactulose/mannitol ratio decreased in 1 of the 4 studies, and urinary lactulose percent decreased in 2 studies. DISCUSSION/SIGNIFICANCE: Probiotic supplementation may be remediating an obesity-induced increase in intestinal permeability as evidenced from the effect on serum LPS and mixed sugar solution assays. However, additional studies are needed to further clarify which strain of probiotic bacteria is most effective and the optimal intervention length in subjects with obesity.
76 Methods and Perceptions of Success for Patient Recruitment in Decentralized Clinical Trials
Authors: Miyata Brian , Tafuto Barbara , Jose Nadina
Published: April 2023

OBJECTIVES/GOALS: Patient recruitment, enrollment, and retention continues to be one of the leading barriers to successful clinical trials, and results do not always reflect the diversity of the general population. This systematic review aims to assess the impact of decentralized methods on recruitment, retention, and diversity on recent clinical research. METHODS/STUDY POPULATION: A systematic search of the literature, using databases such as PubMed, Cochrane Library and EMBASE to find publications reporting on the aspect of recruitment in decentralized clinical trials was performed. The titles and abstracts of the publications were assessed, excluded those lacking sufficient or pertinent information regarding decentralization in clinical trials. The remaining publications were reviewed for those reporting sufficient data regarding the impact of decentralization on the aspect of recruitment in clinical trials to be included in the focused analysis. Studies reporting on participant retention and diversity in addition to recruitment were emphasized. RESULTS/ANTICIPATED RESULTS: This systematic search returned 13 studies highlighting the role of decentralized clinical trial methods impacting participant recruitment, retention, and diversity in clinical trials. Out of the 13 studies, 10 reported improved recruitment using virtual or decentralized methods, and 7 of these reported improvements when compared alongside with traditional methods. 7 studies reported a positive impact on participant retention, with 4 of these directly comparing decentralized methods with traditional methods. Lastly, of these studies, 5 were reported to have trended towards diversity in the demographics of the sample population, including race or geographic location. DISCUSSION/SIGNIFICANCE: Related reviews have stated a lack of published comparable data to determine if DCTs (Decentralized Clinical Trials) improved recruitment and retention. Results suggest this review addresses such a gap, by providing data on how decentralized methods can benefit recruitment and retention, potentially highlighting a new standard.
78 Pharos: A Novel Mapping Software to Identify Cell Network Signal Strength for Mobile Health Epidemiology
Authors: Moore Carson , van Dam Govert , Odiere Maurice , Wright David , Scherr Thomas
Published: April 2023

OBJECTIVES/GOALS: The aim of this study was to design and implement the Pharos application to map the cellular network support structure around Lake Victoria in Western Kenya. Additionally, the Pharos app was used to collect images of disease-relevant vector and plant life surrounding the study sites to train a computer vision algorithm to map disease-relevant areas. METHODS/STUDY POPULATION: Pharos was provided to a 4-person team of healthcare workers. The app was pre-loaded on both iOS and Android devices to be used during the course of normal field activity. Pharos ambiently collects network data and the team was asked to capture images of landmarks relevant to their work in schistosomiasis control. The field team traveled to 4 counties of differing schistosomiasis risk surrounding Kisumu, Kenya in autumn 2022 and will return to these areas in early spring 2023. Cell signal indicators (upload and download speed) were collected and asynchronously uploaded to a database for further analysis. Additionally, all landmark images (cell network towers, landmarks (e.g. schools, churches, public centers), plant life, vectors, and water bodies) were recorded and tagged with GPS coordinates and time stamps. RESULTS/ANTICIPATED RESULTS: Iterative development powered by small, informal, user-centered focus group discussions with the field team led to several key adaptations to the Pharos software. On the first deployment, 1,297 unique upload and download events were recorded across 3 Kenyan cell providers and 1 American provider. 1,197 data points were collected in Kenya using both Android and iOS devices using several versions of the Pharos application. 154 unique landmarks were photographed, but a distinct difference in landmark recording was observed between devices, prompting a transition to iOS-only data collection. Of the landmarks recorded, the majority (120, 77.9%) were landmarks or cell network towers, while 22.1% were water bodies, plant life, or schistosomiasis vectors. DISCUSSION/SIGNIFICANCE: For the first time, high-detail maps of cellular signal and critical schistosomiasis-related landmarks were generated. Future work on this project is focused on training computer vision algorithms using the captured images of environmental and ecological factors to isolate possible areas of human disease transmission.
82 Tools to facilitate participant recruitment into research studies: Assessing early outcomes following implementation
Authors: Lee Chin Chin , Ransford Daru , Canales Carlos , Barreto Alfredo , Ramsingh Ishwar , Das Rosalina , Schulman Carl I.
Published: April 2023

OBJECTIVES/GOALS: The objective of this presentation is to describe different recruitment tools implemented by the Miami Clinical and Translational Science Institute (CTSI) to facilitate participant recruitment into research studies. METHODS/STUDY POPULATION: Participant recruitment is critical to the success of all research studies. In the effort of advancing clinical and translational science and to help investigators recruit volunteers for research studies, the University of Miami has two recruitment tools: 1) Consent to Contact (CTC), an opt-in research registry where University of Miami Health System patients are asked for permission to be contacted about studies matching their demographic and/or health profiles; and 2) UMiamiHealthResearch.org (UMHR), implemented with the Michigan CTSA, a community-based registry for volunteers to sign up and be contacted about studies. Study investigators can use these tools once they have obtained IRB approval for their research. RESULTS/ANTICIPATED RESULTS: The CTC was launched in 2016; to date, over 130,000 patients have enrolled in CTC; 69 studies have been approved with over 75,000 patients’contact information released to study teams. UMHR was launched in 2020. To date, the site lists 237 studies. A total of 2,727 portal visitors have expressed interest in participating in specific studies. Study team members were successful in engaging interested participants, and enrolling participants into studies. Overall, teams reported a positive impact on recruitment. Data collection on utilization and satisfaction of these recruitments tools is ongoing. In addition, focus groups of study team members are being conducted to identify best practices for using these tools, and findings will be presented. DISCUSSION/SIGNIFICANCE: The CTC and UMHR recruitment tools have demonstrated positive impact in helping study teams identify potentially eligible research volunteers. The continued promotion of these tools at the University of Miami Health System and in the community will be crucial to the recruitment process and execution of research studies.
84 A follow-up evaluation of an expanded good clinical practice online training course: The relevance of community engagement to health research study teams.
Authors: Samuels Elias , Champagne Ellen , Lyden Angela , Janevic Mary , Culp Michelle , Riddle Melissa , Jay Gina , Murphy Susan L.
Published: April 2023

OBJECTIVES/GOALS: This study evaluates the impact of an updated and expanded training for social and behavioral health researchers. Participants’ experience with training modules focused on community engagement is a focus of this evaluation as is the application of this training by participants in teams. METHODS/STUDY POPULATION: The Social and Behavioral Research training series for health researchers and team members was first created by faculty and staff of the Michigan Institute for Clinical and Health Research in 2018. This training was updated and expanded in 2021 with support from the National Institutes of Health to include new material regarding community-engaged health research as well as updates concerning technology and new federal regulations. Past participants of the training were invited to retake the training, as were clinical and translational researchers at University of Michigan who were new to the training. Surveys were sent to all participants after completing the training and a focus group of research staff was conducted to identify how they utilized the training in support of their teams. RESULTS/ANTICIPATED RESULTS: It is anticipated that at least 100 individuals will participate in the evaluation of the Social and Behavioral Research training between October 2022 and February 2023. Data extracted from U-M’s learning management platform will demonstrate how well participants performed on key knowledge checks embedded in the modules and how quickly they progressed through the sections of the training. These results will be compared to benchmarks derived from evaluations of the prior course which were conducted in 2018. A focus group of at least 10 individuals will demonstrate how health research staff utilized the training and associated resources to advance the scientific work of their study teams. DISCUSSION/SIGNIFICANCE: Comprehensive training programs for research best practices in social and behavioral health need to have tailored and up-to-date information for this group of researchers and staff. The results of this evaluation will demonstrate how this program contributed to the professional development of the health research workforce.
92 Effectiveness of an Academic Medical Center Clinical Research Coordinator Intern Program on Learning and Workforce Expansion
Authors: Orr Shelly , Helm Shirley , Harmon Mary , Moeller Gerry
Published: April 2023

OBJECTIVES/GOALS: The Clinical Research Coordinator (CRC) Intern Program was developed to increase knowledge and awareness of CRC’s vital role in conducting clinical studies. Program outcomes are to provide students with marketable skills and knowledge leading to employment within the clinical research ecosystem. METHODS/STUDY POPULATION: The CRC Intern Program is available to college students for health-related academic courses requiring an internship component. Didactic and experiential learning are incorporated into the program with students imbedded within well-established clinical research teams. Activities include attending IRB meetings, recruitment and enrollment, data collection and entry, and regulatory items. Students complete knowledge pre- and post-assessments (Competency Index for Clinical Research Professionals-CIRCP) via REDCap surveys to assess learner knowledge acquisition and program effectiveness. Demographic, program evaluation, and 3-month follow up survey data are analyzed using descriptive statistics. RESULTS/ANTICIPATED RESULTS: Beginning in Spring 2022, the Intern Program has accepted 9 students with 5 completing the program, with 2 of this 5 having been offered employment as CRCs. Preliminary CIRCP assessment data indicates increased CRC knowledge upon Intern Program completion. Demographic data shows that students are mostly female and non-white (43% African American, 29% Hispanic). Additional results from the current cohort will be shared upon program completion. Of note is the development of partnerships with local colleges, including community colleges, to build awareness of the CRC career path and to provide opportunities for CRC exploration resulting in expansion and diversification of the clinical research workforce. DISCUSSION/SIGNIFICANCE: There is an industry wide shortage of CRCs. Our internship program has provided an effective method to expand and diversify the CRC workforce through knowledge acquisition and application building CRC skills and competencies. Lessons learned and future plans for intern expansion will be discussed.
95 Evaluation of a Simulation Curriculum to Improve Nursing-Led Early Physical Rehabilitation of Critically Ill Children
Authors: LaRosa Jessica M. , Lenker Hallie , Brown Kristen , Shilkofski Nicole , Kudchadkar Sapna R.
Published: April 2023

OBJECTIVES/GOALS: Early pediatric intensive care unit (PICU) mobilization is safe and associated with improved outcomes. Nursing-specific mobility training is desired and improves mobilization compliance. Thus, our aim is to implement a nurse-targeted, simulation-based early mobility curriculum to determine if it increases the frequency of PICU mobilizations. METHODS/STUDY POPULATION: We will conduct a single center pre-post interventional study of an in situ nurse-targeted, simulation-based early mobility curriculum. We will prospectively evaluate mobilization events in 100 patients admitted during the pre-intervention phase (n=50) and the post-intervention phase (n=50). Inclusion criteria are children ages 1 day to 17 years old admitted to the PICU for ≥3 days. Exclusion criteria include specific mobility contraindications. PICU-wide deployment will be complete when >80% of nurses have participated in the curriculum. Demographic and clinical information will be obtained. Mobility data obtained will include number of nursing-led mobilizations, highest level of mobility achieved, and potential safety events. Data will be collected from the EMR and the nurse caring for the patient. RESULTS/ANTICIPATED RESULTS: The primary endpoint will be the change in the number of nursing-led mobilization events per patient day. The secondary effectiveness outcome is the highest level of mobility achieved by patients during mobilization events in a day. A final secondary end point will be safety events defined as unplanned extubations, medical device dislodgement, falls, and cardiac arrests. Descriptive statistics for continuous variables will be presented as the median and interquartile range and categorical variables will be expressed as percentages. The effect of the simulation curriculum on the clinical outcomes will be assessed using mixed-effects models. Due to the lack of normality in number of nurse-led mobilizations and highest level of mobility achieved, the analysis will be performed using log-normal models. DISCUSSION/SIGNIFICANCE: We hypothesize that we will demonstrate the crucial importance of hands-on nursing education to improve and increase early mobility of critically ill children
104 Milestone planning and leadership skills in professional women following participation in Capita3 Leader Launch program.
Authors: Hale Rena , York Pamala , Birr Barb , Ekker Stephen
Published: April 2023

OBJECTIVES/GOALS: The goal of this study is to demonstrate growth in leadership skills in areas of milestone selection, conditions of success, and self-efficacy for females in the Capita3 Leader Launch (LL) Program. METHODS/STUDY POPULATION: Forty females were self-selected to participate in the LL Program, a 21 day program which is organized around a highly significant career goal that each participant selects. The program is designed to guide participants through a unique and transformative process to increase the probability that each participant will achieve their selected career goal. In the fall of 2022, seventy people participated in the LL program. Participants were asked to fill out a Leadership assessment prior to participation and then again following participation in the program. RESULTS/ANTICIPATED RESULTS: Immediately after the program, participants self-report 86% increased confidence, 85% being on track to achieving their selected milestone or an appropriate pivot, and 80% feel more equipped to navigate their external environment. DISCUSSION/SIGNIFICANCE: This study demonstrates that the LL Program addresses barriers that are neither fully understood nor addressed by existing programs and policies for women. Future programs can use the LL Program to help females take on high visibility assignments, larger organizational roles, and leadership positions within the current organization environment.
105 Networking Strategies to Drive Clinical Research Management Workforce Engagement
Authors: Rutgers Lisa Palladino-Kim , Kota Veda , Mansuri Sana
Published: April 2023

OBJECTIVES/GOALS: The goal of this project was to create a professional network for the Rutgers Clinical Research Management master’s program to foster relationships between potential and current clinical research professional workforce members. A professional network provides an opportunity for its members to stay continuously engaged in the community. METHODS/STUDY POPULATION: Two Qualtrics surveys were created after researching the social presence of the Rutgers SHP community, similar master-level programs, clinical research professional networks, and general social landscapes. The surveys were sent through LinkedIn and email with telephone reminders to the Rutgers SHP CRM community to gather demographic information, preferred method of engagement, and desired network content. In addition, six alumni and two faculty SHP CRM members were interviewed via Zoom for further feedback. The data from these surveys was analyzed on excel and supported the creation of content and structure for the CRM Network. RESULTS/ANTICIPATED RESULTS: Survey results indicated 70% (n=20) of respondents preferred engagement through email or LinkedIn. Engagement topics included alumni/faculty news, workforce opportunities, and networking events. A LinkedIn page and website were created to highlight members’accomplishments and activities. An electronic quarterly newsletter was developed to expand the content with alumni and faculty editorials and future opportunities to engage with the Rutgers CRM program. Further data analysis revealed that 73% (n=16) preferred in-person vs remote events. A Facebook page was created to provide a forum for casual interactions that may lead to in-person opportunities. Seven participants volunteered to join the newly formed CRM Network Advisory Committee that will develop future content and manage the CRM Network. DISCUSSION/SIGNIFICANCE: The CRM Network was well received by the Rutgers CRM community as a tool to foster relationships between current and future clinical research professionals. Despite data limitations (small sample size and incomplete responses), the CRM Network was created and transferred to the Advisory committee for implementation and future expansion.
106 Neurosurgery Resident Feedback through Artificial-Intelligence
Authors: Porras Jose Luis , Soberanis-Mukul Roger , Vedula S. Swaroop , Huang Judy , Brem Henry , Gallia Gary L. , Unberath Mathias , Ishii Masaru
Published: April 2023

OBJECTIVES/GOALS: Surgical training is constrained by duty hour limits, bias, and a trial-and-error learning process. Surgeon skill variation is a healthcare system disparity that can impact patient outcomes. Incorporating validated, standardized assessment tools and machine learning (ML) algorithms may help to standardize and reduce bias in surgeon education. METHODS/STUDY POPULATION: To support assessment tool and ML algorithm development, we are curating an annotated video registry of neurosurgical procedures. Point-of-view video of resident and attending neurosurgeons performing craniotomies is recorded via an eye-tracking headset. A Delphi panel of neurosurgeons will review the video and determine which represent expert versus trainee performance. Neurosurgery attendings will be interviewed to provide descriptions of craniotomies which will be used to develop an
assessment rubric. A Delphi panel will determine what rubric components should be maintained. New craniotomy videos will be viewed by attendings in a blinded fashion while completing the assessment rubric. An online feedback platform is being developed allowing residents to prospectively track assessment data. RESULTS/ANTICIPATED RESULTS: We anticipate development of an annotated, institutional video database featuring craniotomies performed by residents and attending neurosurgeons. Using a Delphi approach, we anticipate achieving consensus on which videos reflect expert versus trainee performance. We anticipate development of a novel craniotomy assessment rubric that is both valid and reliable. Our online feedback platform will allow prospective tracking of assessment data from multiple sources and enhanced transparency in the feedback process. The video registry and assessment data will enable development of novel ML algorithms able to recognize craniotomy segments and estimate operator skill. DISCUSSION/SIGNIFICANCE: Building a video registry of procedures, validated assessment tools, and a prototype feedback platform enables a pipeline for ML algorithm development. Together these tools will help to standardize and optimize resident education translating to earlier operative independence, improved patient safety, and reduced bias during surgical training.
109 Pursuit of Fellowship Funding Through Peer Review Writing Groups
Authors: Ebanks Yasheca , Aleksunes Lauren
Published: April 2023

OBJECTIVES/GOALS: Pursuit of independent funding by predoctoral and postdoctoral fellows requires navigating the intricate steps in preparing extramural grant applications. The Workforce Development Core of the NJ Alliance for Clinical and Translational Science (NJ ACTS) sought to evaluate an interactive grant writing group of fellows mentored by a trained coach. METHODS/STUDY POPULATION: Participants meet weekly for 3 months to develop components of a fellowship application for submission to NIH and private foundations. Sessions were moderated by a senior faculty member trained as a coach by the National Research Mentoring Network. Participant grant submission and review of the program were collected annually for the period of 2019 to 2021 as well as demographics for the 2022 cohort. RESULTS/ANTICIPATED RESULTS: Over this period, 32 predoctoral and 19 postdoctoral fellows participated in the peer review writing groups with 24 trainees currently enrolled. The peer review writing group moved to Zoom in 2020 which has enabled expansion of training to include the 3 Hub institutions and 6 additional universities. Of the 41 survey respondents, 78% submitted fellowship applications to NIH (N=28) or a non-NIH agency (N=4). Eight of these applications are currently under review or have been resubmitted for peer review. 54% of reviewed applications have been funded as NIH fellowships, diversity supplements, career grants, or non-NIH fellowships. Over 90% of participants have recommended the writing group to other trainees. DISCUSSION/SIGNIFICANCE: In conclusion, a weekly grant writing group of predoctoral and postdoctoral fellows is an effective means to receive peer review of fellowship application components and support submissions for extramural funding.
110 REDCap as a Tool in Administrative Requirements for Academic Program Credentialing
Authors: Tafuto Barbara , Akurati Laasya , Lechner Doreen Waldron
Published: April 2023

OBJECTIVES/GOALS: Clinical research degree program accreditation brings value to university programs situated in competitive environments. While the requirements of accreditation can be burdensome and tedious, it remains important to program growth. The objective of this project was to assess the use of REDCap for the accreditation process to reduce that burden. METHODS/STUDY POPULATION: A review of credentialing requirements was conducted to identify required data and its sources. Initial course data from a small sample of courses was collected in Excel to better assess the order of the data collection process. REDCap was then used to create a series of data collection instruments that effectively met the program evaluation data needs and customized reports for three years of course learning outcomes. The instruments were developed for its translation to other programs. Faculty, administrators, and interns participated in 2 different types of data collection activities (excel and REDCap) and evaluated the differences between the experiences. RESULTS/ANTICIPATED RESULTS: Data collection included 85 courses, with a range of 3-22 objectives that classified aligned assignments among 8 clinical research professional domains, 50 competencies, and 3 learning levels. Student outcomes data was also calculated and recorded. The time to complete the data collection process using the REDCap tool verses the excel spreadsheet per course was notably more efficient. User satisfaction was 100% improved using the REDCap tool with the average score of 8.5 out of a 1-10 scale. User comments supporting the REDCap process focused on improved time to complete and ease of process. DISCUSSION/SIGNIFICANCE: The incorporation of REDCap into data collection for program accreditation data requirements highlights the efficiency and ease of electronic data capture compared to manual entry in excel. The development of instruments makes it easy to translate to other program evaluation and accreditation needs.
116 The long-term impact of a practice-oriented research training program for clinical and translational research staff and clinicians: Evaluating workforce development outcomes over time and professional careers.
Authors: Samuels Elias , Samuels Elias , Champagne Ellen , Ianni Phillip , Kalpakjian Claire Z. , Murphy Susan L.
Published: April 2023

OBJECTIVES/GOALS: There are few training programs for health research staff and clinicians like The Practice-Oriented Research Training program, that include opportunities to conduct funded clinical and translational research. The goal of this study is to evaluate the long-term impact of this program on participants professional development and advancement. METHODS/STUDY POPULATION: The Practice-Oriented Research Training program for health research staff and clinicians was operated by the Michigan Institute for Clinical and Health Research from 2008 through 2018. Participants received training and formed teams that received financial support to conduct a clinical or translational study with a faculty mentor. Eleven cohorts comprising 111 individuals participated. The long-term impact of the program was evaluated using sequential mixed methods. All participants were invited to evaluate the program via an online survey in 2021. Respondents were invited to participate in interviews in 2022. Secondary records of the participants’ publications, grants, and professional advancement were collected. RESULTS/ANTICIPATED RESULTS: 68 participants in the PORT program published 345 papers in peer-reviewed scientific journals following the program, averaging over 5 publications per participant. These publications have been cited over 4000 times with an average of over 13 citations per paper. Large proportion of program participants have continued contributing to health research; the vast majority of program participation chose to continue at the University of Michigan. Survey results indicate participants’ belief that the program had wide-ranging and enduring impacts on key aspects of their careers, including their application of research to practice. Interviews confirmed that the program helped many participants make substantial advancement in their careers. DISCUSSION/SIGNIFICANCE: Training programs for health research staff and clinicians can have a substantial and enduring impact on their professional development and advancement. The need for programs like PORT will increase as the health research workforce grows. These results inform recommendations for translational scientists.
118 The Undergrad Experience: Insights of a clinical research training program aimed at undergraduate students
Authors: Stevens Andrea , Raveen Neila , Pawelczyk Jim
Published: April 2023

OBJECTIVES/GOALS: Establishing a career trajectory geared towards undergraduates interested in a biomedical career has led to the development of a Clinical Research Training (CRT) Program. The purpose of this study is to evaluate the student experience of the program. It is our hopes to train the next generation of clinical researchers straight out of undergrad. METHODS/STUDY POPULATION: Establishing the success of the recently established Clinical Research Training Program and creating quality improvement measures has been analyzed with a focus on 5 domains. Outcome quality measurements and evaluation of the following domains have been completed from a student’s experience. These domains include: 1) the capstone course, 2) the internship experience, 3) career development opportunities, 4) hands-on training opportunities, and 5) post-baccalaureate career plans or career attainment. Each of these outcomes have been collected from students who have completed the program as well as students currently enrolled. Data will be obtained via qualitative measures such as course surveys, Likert scale ratings, and evaluation of data-based outcomes. RESULTS/ANTICIPATED RESULTS: In this ongoing study, results will demonstrate there is a percentage of students who were directed into clinical research positions due to their exposure to the clinical research world during their undergraduate training. Transferable skills such as CITI training, knowledge of good clinical practice, and familiarity of current research topics are associated with a higher likelihood to pursue a career in clinical research. Students placed within an associated internship slot with the community partners has also led to an increase in career placement in clinical research. Other factors provided by the course such as establishment of an extensive network, exposure to career pathways related to clinical research, and an increase in cross-trainings that lead to increased advancement in the scientific domain. DISCUSSION/SIGNIFICANCE: To address clinical research workforce gaps by training students during their undergraduate education. Also, by addressing this gap, we can begin to strengthen the career trajectory and goals of students interested in a career in the life sciences. By targeting this workforce, it can lead to an increase in diversity and retention in the workforce.
124 The Formation of the ACTS Diversity, Equity, and Inclusion Committee to Increase Belonging
Authors: Balls-Berry Joyce E. , Rubio Doris , Aguilar-Gaxiola Sergio , Berryhill Davis LaTonya , McGee Rick , Miller Doriane , Meinzen-Derr Jareen , Messinger Shari , Pemu Pricilla , Pfund Christine
Published: April 2023

OBJECTIVES/GOALS: The Association of Clinical and Translational Science (ACTS) chartered a Diversity, Equity, and Inclusion (DEI) Committee to prioritize activities to support, develop and report on metrics for measuring progress toward DEI goals. This poster aims to describe the formative process toward prioritizing DEI in society’s efforts. METHODS/STUDY POPULATION: In 2021, the ACTS chartered the DEI Committee. Two ACTS Board of Directors members chair the committee, and members represent 10 academic institutions committed to prioritizing DEI. Members participated in a Human-Centered Design process to develop the committee’s mission, goals, and activities. The committee determined areas of opportunity for ACTS to increase DEI by identifying challenges to support DEI in clinical and translational science. The chairs facilitated a discussion using Mural to foster an interactive strategy to engage members in conversations that respected individual experiences, promoted a discussion of actions that ACTS as a society, and determining metrics for measuring DEI. RESULTS/ANTICIPATED RESULTS: We plan to present the committee’s efforts to create the ACTS mission statement and strategies to priority to DEI. We will describe current and future activities to engage historically underrepresented members and academic institutions in ACTS programs. Based on the committee’s work, ACTS has taken systematic approaches toward social justice and is beginning to determine new ways of engaging members. DISCUSSION/SIGNIFICANCE: Scientific societies that prioritize DEI increases equity and belonging across members. ACTS is at the forefront of advocacy, policy, and social justice effort. The DEI committee is positioned to aid ACTS in increasing DEI across the clinical and translational science spectrum.
126 A CTS team approach to reliable delivery of aerosols to lung cells at the air-liquid interface (ALI), through Dosimetric Aerosol in Vitro Inhalation Device (DAVID)
Authors: Shankar Sripriya Nannu , O’Connor Amber , Le Eric , Theodore Alex , Sabo-Attwood Tara , Lewis Gregory S. , Fernandez Arantzazu-Eiguren , Wu Chang-Yu
Published: April 2023

OBJECTIVES/GOALS: In vitro models that mimic the human respiratory system are needed to assess the toxicity of inhaled contaminants. Therefore, our goal is to establish a Dosimetric Aerosol in-Vitro Inhalation Device (DAVID) that delivers aerosols in different patterns to human lung cells cultured at an air-liquid interface (ALI). METHODS/STUDY POPULATION: The collection unit of DAVID was modified in this study to accommodate different deposition patterns (spots, annular ring, rectangle & circle). CuO aerosols of varying concentrations were generated using a 6-jet Collison nebulizer for varying time periods to achieve different doses. To quantify the doses that were delivered to cells, the samples were digested with nitric acid & analyzed by Inductively Coupled Plasma-Optical Emission Spectrometry. Following the exposure of A549 cells to CuO aerosols, cytotoxicity and mRNA expression (i.e., HMOX1 & IL-8) will be assessed via LDH and RT-qPCR to determine the effect of regional (mass deposited/area of the pattern) and global (mass deposited/area of the cell culture insert) doses in cells. RESULTS/ANTICIPATED RESULTS: The deposition areas covered by rectangular, spot, annular ring, and circular patterns are estimated to be 6, 17, 27 and 85% of the insert’s surface area, onto which cells are cultured. Results for the patterns tested (spots and annular ring) show that both the regional and global doses were greater for spots than annular ring. Also, the regional doses were higher than global doses. Irrespective of the patterns, the global doses were the same for nebulizer suspensions of 0.1-1 mg/mL. Statistical analysis by ANOVA revealed there was no significant difference in doses between replicate inserts used in the same trial. We anticipate that regional doses with aerosol deposition to a larger surface area of the cell culture insert will correspond with higher cytotoxicity and mRNA expression of HMOX1 and IL-8 in cells. DISCUSSION/SIGNIFICANCE: There are limited in vitro exposure systems that can efficiently deliver aerosols to lung cells, while also mimicking inhalation by humans. In addition to addressing this knowledge gap, we will show the role of regional & global doses in studying cellular response & the ability of DAVID to deliver aerosols in different deposition patterns.
127 A formative usability evaluation of a community pharmacist-facing health information exchange (HIE) interface
Authors: Hettinger Katelyn N. , Snyder Margie E. , Adeoye-Olatunde Omolola A. , Russ-Jara Alissa L.
Published: April 2023

OBJECTIVES/GOALS: To evaluate the usability of a HIE interface design among community pharmacists and technicians to identify opportunities for design improvements METHODS/STUDY POPULATION: Pharmacists and pharmacy technicians employed at Indiana community pharmacies participated in formative usability testing, via a Rapid Usability Evaluation (RUE), with an interactive, PDF prototype of the HIE interface. Participants were video-recorded to capture first impressions on the usability of the HIE prototype via the think aloud technique. Each participant had up to 1 hour to complete 4 clinical scenarios. Afterwards, participants completed the System Usability Scale (SUS; scale 0–100, with 100 being the best) to rate their satisfaction with the HIE prototype. RESULTS/ANTICIPATED RESULTS: Across 3 community pharmacies, 16 individuals participated in usability testing: 8 pharmacists and 8 technicians. The average SUS score for the HIE interface across participants from all sites was 70. Pharmacists on average scored the interface higher than technicians, 74 vs. 65, respectively. Initial findings from one pharmacy revealed that both pharmacists and technicians expressed a desire for improved efficiency (i.e. fewer clicks ) to access HIE data, alternative placement of HIE links within existing systems, and improved navigation to exit HIE links. DISCUSSION/SIGNIFICANCE: Initial results reveal opportunities to improve the HIE interface usability. Findings will inform design improvements to the interface and the creation of a toolkit to support the sustainable and scalable participation in HIE by community pharmacies.
130 Awareness and Implementation of Tobacco Control Practices in Rural Louisiana Federally Qualified Health Centers
Authors: Celestin Michael D. , Bryant Runet , Tseng Tung-Sung , Jones-Winn Krysten , Yu Qingzhao
Published: April 2023

OBJECTIVES/GOALS: Tobacco use remains a significant problem in rural America. Federally Qualified Health Centers (FQHCs) can help reduce the burden of tobacco use in rural areas. Still, we know little about center awareness and implementation of best practices for tobacco control. We assessed the knowledge and existence of tobacco control strategies in rural FQHCs. METHODS/STUDY POPULATION: We electronically surveyed health administrators and providers (n=33) in three rural Louisiana FQHCs between March and April 2021. The assessment measured awareness of the U.S. Public Health Service Clinical Practice Guideline for Treating Tobacco Use, center priority given to smoking cessation programming, the presence of best practices for tobacco control programming such as having a tobacco control champion and team, treatment and smoke-free campus policies, and referral to external cessation services. Descriptive statistics characterize survey respondents and responses. RESULTS/ANTICIPATED RESULTS: The majority of the respondents were female (88.5%), White (53.8%), between 35 and 54 years of age (69.2%), and non-smokers (65.4%). Among all respondents, 69.7% reported awareness of the U.S. Public Health Service Clinical Practice Guideline for Treating Tobacco Use. Less than half (48%) said their health center gave smoking cessation high priority relative to other health priorities. Only a third (36%) reported having a tobacco champion, and a quarter (25%) had a tobacco control team at their facility. Although all centers had a smoke-free campus policy, a quarter (27%) were unaware of the policy. Only a quarter (27%) reported having a written policy for smoking cessation treatment at their center, and a little more than half (56.7%) knew about cessation services to which they could refer tobacco users. DISCUSSION/SIGNIFICANCE: Centers had limited knowledge of the U.S. guideline for tobacco use treatment. Smoking cessation lacked priority, and tobacco control best practices implementation was low. FQHCs serving rural populations can implement guideline-recommend policies and clinical treatments, and future studies should test strategies to increase implementation.