Clinical Translational Science Institute Research Articles

Program Evaluation Standards for Utility Facilitate Stakeholder Internalization of Evaluative Thinking in the West Virginia Clinical Translational Science Institute.

The program evaluation standards (PES) can be considered established criteria for high-quality evaluations. We emphasize PES Utility standards and evaluation capacity building as we strive for meaningful application of our work in the real world. We focused our methodology on understanding how stakeholders discussed utility and how their perceptions related to our evaluation work aligned with the Utility domain of the program evaluation standards. The West Virginia Clinical Translational Science Institute (WVCTSI), a statewide multi-institutional entity for which we have conducted tracking and evaluation since 2012. Sustained collaborative engagement of evaluation stakeholders with the goal of increasing their utilization of evaluation products and evaluative thinking. Case study. We interviewed five key stakeholders. We used themes developed from coding of interview data to inform document analyses. We used interview and document analyses to develop additional themes and illustrative examples, as well as to develop and describe a five-level evaluation uptake scale. We describe shifts in initiation, use, and internalization of evaluative thinking by non-evaluation personnel. These shifts prompted our development and application of an evaluation uptake scale to capture increased evaluation capacity among stakeholders over time. We discuss how focus on the PES Utility standards and evaluation capacity building facilitated these shifts, and their implications for maximizing utility of evaluation activity in large, complex programmatic evaluations.

Effect of the population health inpatient Medicare Advantage pharmacist intervention on hospital readmissions: A quasi-experimental controlled study

BACKGROUND: The population health inpatient Medicare Advantage pharmacist (PHIMAP) intervention is a pharmacist-led, transitions-of-care intervention that aims to reduce hospital readmissions among Medicare Advantage beneficiaries. PHIMAP includes inpatient pharmacist participation in interdisciplinary rounds, admission and discharge medication reconciliation, pharmacy staff delivery of discharge medications to the bedside, personalized discharge medication lists and counseling, and communication with outpatient pharmacists through an electronic health record. OBJECTIVE: To evaluate the effect of the PHIMAP intervention on unplanned 30-day same-hospital readmissions among Medicare Advantage patients. METHODS: Those included were patients admitted to a large urban academic medical center between May 2018 and March 2020 who had a Medicare Advantage plan and were aged at least 18 years. A 2-group, quasi-experimental design was utilized. Control patients received the usual care, which included a best possible medication history and a postdischarge phone call. A multivariable logistic regression model was estimated to predict unplanned 30-day same-hospital readmissions. This study was a Hypothesis Evaluating Treatment Effectiveness study. RESULTS: In total, 884 patients were included. The majority were White (59.0%), non-Hispanic (87.7%), English speaking (90.5%), and older adults (median age, 75 years; interquartile range, 70-83 years). We detected no statistically significant association between the PHIMAP intervention and unplanned 30-day same-hospital readmissions (odds ratio [OR] = 0.91, 95% CI = 0.56-1.52). After adjusting for patient demographics and clinical covariates, significant predictors of 30-day readmissions included the number of emergency department/inpatient visits within 180 days prior to index admission (OR = 1.40, 95% CI = 1.11-1.77); discharge to a post-acute care facility, such as an inpatient rehabilitation facility, long-term acute care facility, or skilled nursing facility (OR = 1.69, 95% CI = 1.06-2.66); hospital length of stay in days (OR = 1.04, 95% CI=1.01-1.07); and the Agency for Healthcare Research and Quality Elixhauser Comorbidity Index score (OR = 1.01, 95% CI = 1.01-1.02). CONCLUSIONS: Significant predictors of readmissions among Medicare Advantage beneficiaries were consistent with greater illness severity, including a recent history of prior hospital utilization, a discharge to post-acute care facility (vs home), a longer length of hospital stay, and a higher comorbidity burden. Although we detected no statistically significant association between PHIMAP and unplanned 30-day same-hospital readmissions, differences in study group assignment based on the day of hospital discharge (weekend vs weekday) was a noted limitation of this study. Future studies of inpatient pharmacist-led interventions should plan to minimize the risk of selection bias due to differences in the time of patient discharge. DISCLOSURES: This study was supported in part by the National Institute on Aging under award number R01AG058911 (to Pevnick) and the UCLA Clinical Translational Science Institute (UL1 TR001881). The sponsor had no role in the design and conduct of the study, nor the writing of this report.

A discussion among deans on advancing community engaged research.

The benefits of community-engaged research (CEnR) have been documented in the literature. However, the adoption of community engaged (CE) and participatory approaches among health researchers remains limited. The Boston University (BU) Clinical Translational Science Institute's community engagement program initiated a discussion among five BU Deans to explore their approaches to support the practice of CEnR among faculty in their schools. The discussion was recorded and the transcript analyzed to identify and explore themes that emerged. Most strategies discussed by the Deans were not focused on changing institutional systems to advance CEnR. Instead, the analyses showed that institutional CE efforts highlighted by the Deans were focused on "responsibility centered on one person" or "research mentors." Approaches to developing a culture of CEnR that centers responsibility for promoting it on a few people in a university may place significant burden on leadership and researchers and is not an effective way to promote culture change. Systems change is needed to support CEnR, improve accountability, and realize successful partnerships between academic institutions and communities. The dialogue among Deans focused on the topic of CEnR provided an effective method to catalyze discussion and over time may help to strengthen a culture of CEnR research.

0290 Associations between sleep duration and sedentary behavior in healthy, young adults

Abstract Introduction Chronic diseases are more prevalent among populations with greater daily sedentary time and among populations with insufficient sleep duration. Yet, little is known about the potential links between insufficient sleep and sedentary behavior. Early findings from recent studies show variable and bidirectional associations between sleep duration and sedentary behavior, based on the population studied. The purpose of this investigation was to measure associations between: (1) sleep duration and sedentary time the next day; and (2) sedentary time and sleep duration the same study day/night, during a sleep extension intervention. Methods Data collection are ongoing. To date, three participants (2 female; aged 24.7±4.04yr; BMI 21.73±2.38kg/m2) with self-reported habitual insufficient sleep (<6.5h per night) completed the study protocol in its entirety. Sedentary behavior (<1.5 METs, in seated or lying posture) and sleep duration were measured via activPALTM and wrist-actigraphy, respectively, at baseline for days 1-13. After baseline, participants completed a sleep extension intervention for study days 15-41, with sedentary behavior and sleep duration measured during study days 28-41. Only study days with full 24h activPAL™ wear time were included in statistical analyses. Associations between sedentary behavior and nightly sleep duration were analyzed by linear mixed-model regression. We focused this preliminary analysis of 3 participants on R2. Results Sleep duration was significantly increased (p<0.05) during sleep extension (7.6±1.5h) versus baseline (7.0±1.4h). Sedentary behavior was not significantly different (p=0.869) during sleep extension (8.4±1.6h) versus baseline (8.3±2.0h). The association between sleep duration to sedentary time the following day had p=0.683, R2=0.51, and =2.5±6.2h. The association between daily sedentary time to sleep duration the same study day/night had p=0.72, R2=0.12, and =2.3±6.2h. Conclusion Preliminary findings from 3 participants in this ongoing study suggest that sleep extension is not associated with changes in sedentary behavior. Support (If Any) NIH-UL1TR002535, NIH-K01HL145099, Colorado Clinical Translational Science Institute Pilot (CO-J-20-119), University of Utah Seed Grant-10060570

50565 CTSA collaboration to support K-12 school re-opening in the COVID-19 pandemic

ABSTRACT IMPACT: The mobilization of a CTSA-sponsored team with multi-disciplinary translational science expertise enabled the university to provide a range of T1-T4 expertise to a large, complex school district that resulted in permanent learning and data science infrastructure. OBJECTIVES/GOALS: The Clinical Translational Science Institute (CTSI) formed a multidisciplinary science team to provide expertise in support of the re-opening of in-person learning in the second-largest U.S. school district during the COVID-19 pandemic. METHODS/STUDY POPULATION: The assembled interdisciplinary science team provided expertise in epidemiology, machine learning, causal inference and agent-based modeling, data and improvement science, biostatistics, clinical and laboratory medicine, health education, community engagement, and experience in outbreak investigation and management. The team included TL1 pre and postdoctoral fellows and mobilized scientists from multiple professional schools and T1-T4 stages of translational research. RESULTS/ANTICIPATED RESULTS: Tangible outcomes achieved using this team approach included the development of practical metrics for use in the school community, a learning process, the integration of preventive design elements into a testing and tracing program, and targeted and data-driven health education. The team, for example, generated new data displays for community engagement and collaborated with the school district in their use to visualize, learn from, and act on variation across a 700 square mile region. DISCUSSION/SIGNIFICANCE OF FINDINGS: Novel translational methods can be used to establish a learning environment and data science infrastructure that complements efforts of public health agencies to aid schools in the COVID-19 pandemic. These new capabilities apply to COVID-19 testing and vaccines and can be mobilized for future population health challenges faced by school districts.

Abstract OT-22-01: Opportunities and lessons learned in using electronic health record patient portal (MyChart) for recruitment to the population-based WISDOM study

Abstract Background: WISDOM is a preference-tolerant, pragmatic study comparing annual mammogram screening to personalized, risk-based breast screening in healthy women with a target accrual of 100,000. This sizable recruitment goal requires creative and broad-based strategies that are not typical for traditional clinical research. One of the recruitment methods is use of an electronic health record patient portal (Epic’s MyChart) to invite patients to participate in research. We tested various MyChart implementation strategies across WISDOM recruitment sites and report response rates, barriers and lessons learned. The study is registered on ClinicalTrials.gov, NCT02620852. Methods: Women aged 40-74 years with no history of breast cancer, DCIS, or double mastectomy can join the WISDOM Study online at wisdomstudy.org. Participants either elect to be randomized or self-select one of the study arms, the control (annual mammogram screening) arm or the treatment (personalized, risk-based breast screening) arm. All study steps can be completed electronically, with no requirement to travel to a study site. University of California, Los Angeles (UCLA) was the first WISDOM site to gain approval to use MyChart as a recruitment tool as part of the Clinical Translational Science Institute pilot in Spring 2018. The pilot was designed to demonstrate feasibility, patient response, and recruitment metrics. Following UCLA’s pilot, additional WISDOM sites received approval to use MyChart; however, implementation differed across sites based on local medical center leadership decisions. MyChart Implementation: As of July 2020, use of MyChart is ongoing at five of WISDOM’s six initial recruitment sites (UCLA, Sanford Health, UCSF, UCSD, UCI). Three sites (UCLA, Stanford, and UCSF) implemented MyChart broadly, and two sites (UCI and UCSD) are phasing in MyChart recruitment. UCLA and Sanford Health implemented MyChart recruitment through a centralized approach targeting all eligible patients and sending a MyChart invitation with a link to the study’s enrollment website. UCSF was approved to send WISDOM information on the MyChart portal, but the patients must opt in to learn more by outreach from a research coordinator. UCSD and UCI approaches are more limited requiring departmental or primary care provider approval for communications to be sent to patients. Results: MyChart enabled direct communication to a large number of potential study participants at UCLA and Sanford Health (UCLA 107,829, Sanford Health 86,684) during a 12-month period. The experiences of both sites were similar in that 50% of individuals read the MyChart message, 2.5-5% registered for additional information, and 1.5-2.5% consented to participate. UCSF’s implementation approach was similar with 8005 individuals invited, 6.6% indicating interest to participate, and 2.4% consenting. Although the number of consented participants represented a small portion of the total women consented to join the study to date, the recruitment rates from using MyChart were 2.5-10X higher compared to sites that did not use it or were in pilot phase. Participating sites saw 30%-50% increased recruitment rates during periods when MyChart messages were in use. Implementations at the departmental (UCSD) and primary care provider level (UCI) demonstrated similar trends (3.8% and 3% consented respectively), albeit with smaller samples. Conclusions: Use of electronic health record patient portal (MyChart) recruitment for the WISDOM Study increased enrollment rate by site and is a cost-effective approach to recruiting for large scale trials with broad eligibility criteria like the WISDOM Study. Citation Format: Antonio Petruse, Alyssa Rocha, Liliana Johansen, Neil Wenger, Mandy Che, Steele Fors, Hannah L Park, Janet Wernisch, Irene Acerbi, Allison S Fiscalini, Jasmin Hassam, Andrea LaCroix, Barbara Parker, Lisa Madlensky, Laura Van't Veer, Celia Kaplan, Hoda Anton-Culver, Andrea Kaster, Skye Stewart, Samrrah Rouf, Alexander Borowsky, Ian Hurley, Robert Hiatt, Vivian Lee, Diane Heditsian, Susie Brain, Olufunmilayo Olopade, Deepa Sheth, Laura Esserman, Wisdom Study and Athena Breast Health Network Investigators and Advocate Partners, Arash Naeim. Opportunities and lessons learned in using electronic health record patient portal (MyChart) for recruitment to the population-based WISDOM study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-22-01.

Discoidin domain receptor 1 activation links extracellular matrix to podocyte lipotoxicity in Alport syndrome.

BackgroundDiscoidin domain receptor 1 (DDR1) is a receptor tyrosine kinase that is activated by collagens that is involved in the pathogenesis of fibrotic disorders. Interestingly, de novo production of the collagen type I (Col I) has been observed in Col4a3 knockout mice, a mouse model of Alport Syndrome (AS mice). Deletion of the DDR1 in AS mice was shown to improve survival and renal function. However, the mechanisms driving DDR1-dependent fibrosis remain largely unknown.MethodsPodocyte pDDR1 levels, Collagen and cluster of differentiation 36 (CD36) expression was analyzed by Real-time PCR and Western blot. Lipid droplet accumulation and content was determined using Bodipy staining and enzymatic analysis. CD36 and DDR1 interaction was determined by co-immunoprecipitation. Creatinine, BUN, albuminuria, lipid content, and histological and morphological assessment of kidneys harvested from AS mice treated with Ezetimibe and/or Ramipril or vehicle was performed.FindingsWe demonstrate that Col I-mediated DDR1 activation induces CD36-mediated podocyte lipotoxic injury. We show that Ezetimibe interferes with the CD36/DDR1 interaction in vitro and prevents lipotoxicity in AS mice thus preserving renal function similarly to ramipril.InterpretationOur study suggests that Col I/DDR1-mediated lipotoxicity contributes to renal failure in AS and that targeting this pathway may represent a new therapeutic strategy for patients with AS and with chronic kidney diseases (CKD) associated with Col4 mutations.FundingThis study is supported by the NIH grants R01DK117599, R01DK104753, R01CA227493, U54DK083912, UM1DK100846, U01DK116101, UL1TR000460 (Miami Clinical Translational Science Institute, National Center for Advancing Translational Sciences and the National Institute on Minority Health and Health Disparities), F32DK115109, Hoffmann-La Roche and Alport Syndrome Foundation.

Using a process improvement approach to identifying barriers to research in a CTSA hub environment.

For the past 4 years, as part of the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) grant award number UL1TR001436, the Clinical Translational Science Institute of Southeast Wisconsin (CTSI) has used process engineering approaches to identify and understand barriers that local researchers and other stakeholders face when engaging in clinical and translational science. We describe these approaches and present preliminary results. We identified barriers from published and unpublished work at other CTSA hubs, supplemented by surveys and semi-structured interviews of CTSI faculty. We then used a multifaceted approach to organize, visualize, and analyze the barriers. We have identified 27 barriers to date. We ranked their priority for CTSI to address based on the barrier's impact, the feasibility of intervention, and whether addressing the barrier aligned with CTSI's institutional role. This approach provides a systematic framework to scope and address the "barriers to research problem" at CTSI institutions.

Tailored Messages About Research Participation: Using an Interactive Information Aid to Improve Study Recruitment.

After a diagnosis of cancer (or other serious disease), patients may be asked to consider joining a clinical trial. Because most people are unfamiliar with the scientific concepts that are necessary to the provision of meaningful informed consent, patient education is necessary. Increasing knowledge alone is not sufficient; understanding how clinical trial participation aligns with personal circumstances and knowledge is central to the decision-making process. In this study, 302 cancer patients and survivors evaluated an interactive information aid (IA) designed to inform their decision to join a research study or clinical trial by providing tailored information to patients' responses to questions pertaining to seven key barriers or facilitators of clinical trial participation. The development of the IA was done with input from the authors' Clinical Translational Science Institute; linked components of the IA were vetted by members and leaders of the institution's NCI-designated comprehensive cancer center. Results of the study indicated that the information aid was successful in significantly reducing fears and increasing knowledge, attitudes, perceived behavioral control, and behavioral intentions about research participation relative to a control condition. Thus, an interactive information aid that provides information that is responsive to patients' values, knowledge, and personal circumstances can help patients to be better prepared to consider a decision about research participation.

4209 Early Electrographic Seizure Detection by Neuro ICU Nurses via Bedside Real-Time Quantitative EEG

OBJECTIVES/GOALS: 1.Determine test characteristics of Neuro ICU nurse interpretation of real-time bedside qEEG for seizure detection2.Determine difference in time to detection of seizures between qEEG interpretation and raw cEEG reads3.Determine how seizure characteristics affect accuracy of qEEG readsMETHODS/STUDY POPULATION: Subjects: Nurses caring for patients admitted to the Neuro ICU at Duke University Hospital who are initiated on cEEG.Nurses evaluate qEEG display at the bedside on an hourly basis after undergoing a standardized qEEG training session. The standard practice of independent review of cEEG and treatment by the Neuro ICU team remains unchanged.Post-hoc review of cEEG data by two blinded, board-certified neurophysiologists will be performed for each patient. The raw cEEG data will be scored for the number of seizures present per hour, background, seizure duration, and seizure spatial extent.The time from first seizure occurrence to clinical recognition will be recorded.RESULTS/ANTICIPATED RESULTS: Thus far, 91 patients with 583 1-hour blocks of nurse interpretations have been studied, with 6 patients experiencing seizures while on study. Enrollment will be completed on 1/17/20Preliminary data show a sensitivity of 95.8% (79.9%, 99.9%), specificity of 95.2 (93.1%, 96.8%), positive predictive value of 46.0% (36.9%, 55.4%), negative predictive value of 99.8% (98.7%, 99.9%), positive likelihood ratio of 19.8 (13.6, 28.9), negative likelihood ratio (0.04 (0.01, 0.3). All confidence intervals are 95%. False alarm rate is 0.05/hour.Further analyses are pending completion of enrollment in January 2020.DISCUSSION/SIGNIFICANCE OF IMPACT: Nurse interpretation of real-time bedside qEEG for seizure detection is feasible in the Duke Neuro ICU. QEEG functions well as a screening tool with good specificity and low false alarm rate. Use of qEEG by nurses could lead to shorter time to seizure detection, which may improve patient outcomes. CONFLICT OF INTEREST DESCRIPTION: Safa Kaleem, BS: Research reported in this publication was supported by a Pfizer Foundation grant and the Duke Clinical Translational Science Institute (CTSI). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Pfizer Foundation or the Duke CTSI. Jennifer H. Kang, MD: None to declare. Alok Sahgal, MD: None to declare. Christa B. Swisher, MD: Received speaker’s honorarium from EISAI and UCB.

Peer Mentor Development Program: Lessons Learned in Mentoring Racial/Ethnic Minority Faculty.

Mentorship is crucial for academic success. And yet, there are few mentoring programs that address the needs of underrepresented, racially/ethnically diverse junior faculty conducting health-related research in the United States. To expand mentoring capacity for these racially/ethnically diverse faculty, we developed a Peer Mentor Development Program (PMDP) to prepare near-peers, who have similar characteristics and personal experiences, to provide support to participants in an NIH-PRIDE funded Institute. The PMDP program is designed based on the 8-year experience of the Mentor Development Program of the NYU-Health and Hospitals Clinical Translational Science Institute. Annually, up to six alumni are selected into the PMDP, participate in the 12-hour program over 4 days, are paired with 1 to 3 scholar participants to mentor and join monthly PMDP conference calls during the ensuing year. We describe the program, participant experience and lessons learned from our first 18 peer mentors in three PMDP cohorts. Additionally, all 18 peer mentors completed a post-evaluation survey to assess the program. Overall, peers agreed that participating in the PMDP enhanced most of the specific skills targeted. Participants rated 53%-86% of skills as "more than before" participating in PMDP, demonstrating the appreciation and impact of the program. The PMDP may be a model for higher education and academic medicine programs committed to mentoring and retaining racially/ethnically diverse faculty and ultimately contributing to reducing entrenched health disparities between majority and minority populations.

Clinical Translational Science Institute (CTSI) Brain HQ Modules vs. Active Controls for Elderly Survivors of ICU

Clinical Translational Science Institute (CTSI) Brain HQ Modules vs. Active Controls for Elderly Survivors of ICU

Measuring team science: Associations between a clinical-translational science institute and investigator ego networks.

The National Institutes of Health's Clinical and Translational Science Awards (CTSA) institutes have been created, in part, to have a positive impact on collaboration and team science. This study is the first to examine the associations between a CTSA hub, the Michigan Institute for Clinical and Health Research (MICHR), and investigators' ego networks. We ran cross-sectional and panel models of the associations between consulting with MICHR and the ego network measure of two-step reach (TSR) - that is, colleagues of colleagues reachable in two steps - from a network of 2161 investigators who had co-submitted a grant proposal to an external sponsor in 2006. Our analyses covered the period 2004-2012, although some model specifications covered the shorter time period 2006-2010. Consulting with MICHR had positive associations with the size of and changes in an investigator's TSR across and over time, even controlling for research productivity and organizational affiliation. For example, over the period 2006-2010 an investigator who consulted with MICHR reached 44 more individuals than a non-consulting investigator. This study expands our understanding of the indirect impacts that clinical and translational science institutes have on investigators' scientific networks. This network-based approach might be useful in quantifying the impact of team science initiatives at the university level.

Maximizing NVivo Utilities to Analyze Open-Ended Responses

Open-ended responses are widely used to explore and understand participants’ experiences and perspectives in a variety of fields. As one of the most powerful computer-assisted qualitative data analysis software, NVivo allows researchers to analyze open-ended responses to survey and/or interview questions, as well as other text data like reflective writing, image, and videos. The purpose of this paper is to describe and demonstrate how the NVivo word frequency, text search, and matrix coding features can be used to analyze qualitative data from a longitudinal evaluation project. The authors show how the matrix coding feature maximizes NVivo utilities in an analysis of open-ended responses and highlights differences across and within participants’ groups. The authors explain this approach by presenting a step by step overview: data cleaning and case coding; data import; word frequency analysis; text coding and reference extracting; and matrix coding and inductive analysis. Using this approach, the Clinical Translational Science Institute (CTSI) evaluation team acquired deeper insight into the participants’ experiences and perspectives about CTSI programs and received insights that may lead to improvement. From a methodological perspective, this approach capitalizes on NVivo’s features to mine qualitative data. The methodology described in this paper is applicable to other educational or program evaluations. Also, it is appropriate for analyzing large samples or longitudinal qualitative data in marketing and management.

3342 Developing a population health learning system

OBJECTIVES/SPECIFIC AIMS: Population health research seeks to identify and address variation in needs, care experiences, and outcomes for a defined geography or subgroup. Solutions often require collective actions of complex interdependent health and social service systems in communities. System sciences focused on implementation and dissemination are vital for developing interventions that work at the intended scale in these “real world” environments; yet these approaches are often underutilized. METHODS/STUDY POPULATION: The UCLA Clinical Translational Science Institute (CTSI) co-developed a Population Health Program with the local health department to advance the practice and use of these system science methods. The vision is integrated training, methodological innovation, and real-world application in the region. One specific aim of the program is preparing investigators to apply suitable translational methods to solve population health problems in both health systems and in public health. Investigators from different parts of the university partnered with health services and public health leadership to develop and team-teach new curriculum in system sciences that integrates their disciplines (epidemiology, education, psychology, health policy and management). RESULTS/ANTICIPATED RESULTS: New curriculum in population and implementation/improvement sciences offers junior investigators effective modules and training opportunities that can support their career awards. The program is also increasing the receptivity and readiness of population health delivery systems to apply system science methods to pressing problems. Program metrics include total participants, research yielded by the collaboration, and skills and system science mindset acquisition among trainees, investigators, and health personnel. DISCUSSION/SIGNIFICANCE OF IMPACT: CTSAs can partner with health and public health agencies to develop shared infrastructure, developing capacity in the university and in the partnered local agencies so that investigators and the agencies that are responsible for population health can work together to apply suitable translational methods to solve population health problems in both health systems and in public health.

3545 “Sofia Learns about Research”: an interactive storybook to educate children and their families on clinical research with a welcoming and inclusive approach.

3545 “Sofia Learns about Research”: an interactive storybook to educate children and their families on clinical research with a welcoming and inclusive approach.

Assessing Participant Group Affiliation and Attitudes Towards CTSI Services

Analyzing open-ended survey text responses holds the capacity to yield greater insight about participants’ perceptions of clinical translational science institute (CTSI) initiatives. Few translational research studies have explored their effectiveness. The aim of this mixed methods analysis was to assess participant perspectives of the impact and effectiveness of our CTSI program and services. We selected two open-ended survey question items (how CTSI benefitted research, and the most important impact of the research facilitated by the CTSI) from a larger set and compared responses by participant affiliations (clinical/non-clinical; lab/non-lab). We used a three-step analysis. First, nodes were generated using NVivo word frequency function. Next, with the aid of Python, we used sentiment analysis to classify each node (as positive, negative, or neutral) to indicate participant ratings toward their experiences with the CTSI and computed the average differences between groups. Third, we selected nodes that met pre-established criteria and report the qualitative distinctions. We recommend using precisely worded open-ended questions in future annual surveys or administering a survey using only opened-ended questions every six months.

Assessing mentor academy program effectiveness using mixed methods

ABSTRACTThe purpose of our study was to assess how an academic health center (AHC) mentor academy program affected mentor competence and optimized the mentor–mentee relationship. Mixed methods were used to assess the effectiveness of an AHC mentor program at a clinical translational science institute (CTSI). Twenty biomedical research faculty mentors took a validated survey and submitted reflective writings to discover if they corroborated or refuted statistically significant survey results. There was a significant improvement in participants’ confidence of mentor skills, integral mentoring quality, and the extent to which they fulfill mentees’ expectations. Males provided constructive feedback and helped mentees develop goal strategies more often compared to females. Reflective writings supported these findings yet refuted two survey findings. The use of a mixed methods approach offers novel insight into how mentoring programs benefit translational research mentoring capacity building and raises questions about the sole use of surveys as evidence of program effectiveness.

Paediatric acute respiratory distress syndrome incidence and epidemiology (PARDIE): an international, observational study

Paediatric acute respiratory distress syndrome (PARDS) is associated with high mortality in children, but until recently no paediatric-specific diagnostic criteria existed. The Pediatric Acute Lung Injury Consensus Conference (PALICC) definition was developed to overcome limitations of the Berlin definition, which was designed and validated for adults. We aimed to determine the incidence and outcomes of children who meet the PALICC definition of PARDS. In this international, prospective, cross-sectional, observational study, 145 paediatric intensive care units (PICUs) from 27 countries were recruited, and over a continuous 5 day period across 10 weeks all patients were screened for enrolment. Patients were included if they had a new diagnosis of PARDS that met PALICC criteria during the study week. Exclusion criteria included meeting PARDS criteria more than 24 h before screening, cyanotic heart disease, active perinatal lung disease, and preparation or recovery from a cardiac intervention. Data were collected on the PICU characteristics, patient demographics, and elements of PARDS (ie, PARDS risk factors, hypoxaemia severity metrics, type of ventilation), comorbidities, chest imaging, arterial blood gas measurements, and pulse oximetry. The primary outcome was PICU mortality. Secondary outcomes included 90 day mortality, duration of invasive mechanical and non-invasive ventilation, and cause of death. Between May 9, 2016, and June 16, 2017, during the 10 study weeks, 23 280 patients were admitted to participating PICUs, of whom 744 (3·2%) were identified as having PARDS. 95% (708 of 744) of patients had complete data for analysis, with 17% (121 of 708; 95% CI 14-20) mortality, whereas only 32% (230 of 708) of patients met Berlin criteria with 27% (61 of 230) mortality. Based on hypoxaemia severity at PARDS diagnosis, mortality was similar among those who were non-invasively ventilated and with mild or moderate PARDS (10-15%), but higher for those with severe PARDS (33% [54 of 165; 95% CI 26-41]). 50% (80 of 160) of non-invasively ventilated patients with PARDS were subsequently intubated, with 25% (20 of 80; 95% CI 16-36) mortality. By use of PALICC PARDS definition, severity of PARDS at 6 h after initial diagnosis (area under the curve [AUC] 0·69, 95% CI 0·62-0·76) discriminates PICU mortality better than severity at PARDS diagnosis (AUC 0·64, 0·58-0·71), and outperforms Berlin severity groups at 6 h (0·64, 0·58-0·70; p=0·01). The PALICC definition identified more children as having PARDS than the Berlin definition, and PALICC PARDS severity groupings improved the stratification of mortality risk, particularly when applied 6 h after PARDS diagnosis. The PALICC PARDS framework should be considered for use in future epidemiological and therapeutic research among children with PARDS. University of Southern California Clinical Translational Science Institute, Sainte Justine Children's Hospital, University of Montreal, Canada, Réseau en Santé Respiratoire du Fonds de Recherche Quebec-Santé, and Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care Medicine.

2231 Research partnership, community commitment, and the people-to-people for Puerto Rico (#p2p4PUR) Movement: Researchers and citizens in solidarity

OBJECTIVES/SPECIFIC AIMS: Island communities face greater environmental risks creating challenges in their populations. A community and participatory qualitative research method aiming to understand community perspectives regarding the ecology and environmental risks of the island of Culebra was performed to develop a community-centered Information and Communications Technology (ICT) intervention (an app). The island of Culebra, a municipality from the archipelago of Puerto Rico is located 17 miles from the eastern coast of Puerto Rico’s main island. This ICT—termed mZAP (Zonas, Acción & Protección)—is part of a Translational Biomedical doctoral degree dissertation housed at the University of Rochester’s Clinical Translational Science Institute (CTSI) Informatics Core funded by an NIH Clinical Translational Science Award (CTSA). In September 2017, the island of Culebra faced 2 major category hurricanes 2 weeks apart. Hurricane Irma and Hurricane Maria devastated homes, schools, health clinics, and local businesses, disrupting an already-fragile ecological balance on the island. METHODS/STUDY POPULATION: These 2 storms catastrophically affected the archipelago of Puerto Rico. Culebra’s geographically isolated location, along with the inefficient response from authorities, exacerbated the stressors caused by these natural disasters, increasing the gap of social determinants of health, including the lack of potable water. Leveraging a community engagement partnership established before the hurricanes by the mZAP participatory research, which naturally halted once the hurricanes hit a new humanitarian objective formed to deliver aid. Along with another NIH funded RCMI Translational Research Network, or RTRN institution (University of Puerto Rico, Medical Science Campus) students and faculty, The Puerto Rico Testsite for Exploring Contamination Threats Program (PROTECT) an NIEHS Funded Grant, and the National Guard, a “people to people” approach was established to ascertain needs and an opportunity to meet those needs. A people-to-people approach brings humanitarian needs, identified directly by the community to the people who need it most; without intermediaries and bureaucratic delays that typically occur during catastrophes. RESULTS/ANTICIPATED RESULTS: The consumption of potable water in plastic bottles and subsequent accumulation of plastic material has proven to be collateral damage of a vulnerable water distribution system creating another environmental hazard on the island of Culebra. Therefore, this humanitarian partnership, worked to delivered community and family sized water filters, providing a safe environmental alternative to drinkable water for the island. The success of this approach, People to People for Puerto Rico (#p2p4PUR), demonstrated the power of genuine community engagement—arising from a previous clinical research partnership—and true established commitment with members of the community. DISCUSSION/SIGNIFICANCE OF IMPACT: Research partnerships can (and should, when needed) lead to humanitarian partnerships that extend beyond research objectives. Research may subsequently be adapted based on new realities associated with natural disasters and the altered nature of existing partnerships, allowing for a rapid response to communities need. Further, #p2p4PUR was not only able to channel a partnership humanitarian response but also created an opportunity to reflect on how the commitment between members of society and academia (researchers) can create beneficial bilateral relationships, always putting the community needs first. The resulting shared experience elevates community interest and engagement with researchers, and helps researchers see communities as true partners, rather than—simply—research subjects.