The NIH Center for Accelerated Innovations at Cleveland Clinic (NCAI-CC) was funded by the National Heart Lung and Blood Institute (NHLBI) to support academic investigators in technology development and commercialization. NCAI-CC was one of three multi-institutional Centers established in the fall of 2013. The goal of each Center was to catalyze the growth of an ecosystem of commercialization within their affiliated institutions and regions by managing a program of funding and guiding translational project development and by delivering commercialization education programs to participating investigators. NCAI-CC created and managed such a funding program, ultimately supporting 75 different projects across seven separate academic institutions and developed tailored educational content following the National Science Foundation I-Corps™ curriculum and delivered the program to 79 teams from 12 institutions. We determined early on that in establishment and implementation of projects, it is important to support the teams and principal investigators throughout the program. The support includes a change in principal investigator mindset from specific aims orientation to goals and deliverables on projects. Our skills development efforts emphasized commercialization and a deep understanding of customer needs for new technology adoption. Here, we review our experiences, outcomes, and insights, including the challenges identified in program implementation.

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.

Evidence-based psychotherapies (EBPs) are underused in health care settings. Aligning implementation of EBPs with the needs of health care leaders (i.e., operational stakeholders) can potentially accelerate their uptake into routine practice. Operational stakeholders (such as hospital leaders, clinical directors, and national program officers) can influence development and oversight of clinical programs as well as policy directives at local, regional, and national levels. Thus, engaging these stakeholders during the implementation and dissemination of EBPs is critical when targeting wider use in health care settings. This article describes how research–operations partnerships were leveraged to increase implementation of an empirically supported psychotherapy – brief Cognitive Behavioral Therapy (brief CBT) – in Veterans Health Administration (VA) primary care settings. The partnered implementation and dissemination efforts were informed by the empirically derived World Health Organization’s ExpandNet framework. A steering committee was formed and included several VA operational stakeholders who helped align the brief CBT program with the implementation needs of VA primary care settings. During the first 18 months of the project, partnerships facilitated rapid implementation of brief CBT at eight VA facilities, including training of 12 providers who saw 120 patients, in addition to expanded program elements to better support sustainability (e.g., train-the-trainer procedures).

OBJECTIVES/SPECIFIC AIMS: The goals in this project were two-fold:. Develop metrics that assessed community engagement support the center provides, and. Systematically document the fluid and time-intensive nature of providing community engaged research support, as well as key outcomes. METHODS/STUDY POPULATION: The CCH utilized REDCap software in combination with Excel, to create and implement a data collection system to monitor and report on the full spectrum of engagement activities offered by the center. Center staff collaborated in identifying relevant metrics, developing the data collection instruments, and beta-testing instruments with real examples. This facilitated the integration of contextual factors (defined as factors such as the history, size, and diversity of the community, the organizational mission, the structure and size of the CE team, the number of years a university has been supporting community-engaged research work, etc.). Taking a collaborative approach in developing the center’s evaluation plan offered the added benefit of facilitating staff/faculty buy-in, building staff capacity, and engaging the team in understanding concepts related to performance measurement versus management. RESULTS/ANTICIPATED RESULTS: Key benefits of these engagement tracking systems include: consolidating data into a central location, standardizing tracking processes and critical definitions, and supporting more automated reporting systems (e.g., dashboards) that facilitate quality improvement and highlight success stories. Data were compiled and reported via on-line dashboard (REDCap and Tableau) to help center leadership and staff analyze:. Quality improvement issues (How quickly are we responding to a request for support? Are we providing resources that meet the needs of community partners? Academics? Community-academic partnerships?);. Qualitative process analysis (In what research phase are we typically receiving requests for support (e.g. proposal development phase, implementation phase, etc.)? What types of projects are applying for seed grants? After the seed grant ends, are the community-academic partnerships continuing to partner on research activities?);. Outcomes (Are new partnerships stemming from our support? Are supported research projects leading to new policies, practices, programs?). DISCUSSION/SIGNIFICANCE OF IMPACT: There is a gap in the literature regarding meaningful, actionable, and feasible community engaged metrics that capture critical processes and outcomes. This project identified many more relevant metrics and demonstrates that it is worthwhile to take a collaborative, inclusive approach to identifying, tracking, and reporting on key process and outcome metrics in order to convey a more comprehensive picture of community engagement activities and to inform continuous improvement efforts. Community engagement centers across CTSIs offer a similar range of programs and services. At the same time, much of the community-engaged research literature describes metrics related to community-academic grant submissions, funds awarded, and peer-reviewed publications. Experts that work in the arena of providing community engagement support recognize that these metrics are sufficient in understanding the spectrum of engagement opportunities. Community engagement (CE) teams nationally can utilize these metrics in developing their evaluation infrastructure. At the national level, NCATS can utilize the metrics for CE common metrics related to these programs and services. Critical to this process:. Leveraging resources that will facilitate collecting generalizable data (national metrics) while allowing sites to continue collecting nuanced data (local programs and services). Gathering input from CE teams, stakeholders, and researchers to further refine these metrics and data collection methods. Utilizing REDCap, Tableau and other resources that can facilitate data collection and analysis efforts.

OBJECTIVES/GOALS: Project Extension for Community Health Outcomes (ECHO), a telehealth model, was launched at Penn State University in 2018 to connect specialists with community providers to provide education on best clinical practices. We aim to describe clinical topics covered and relevant provider level outcomes. METHODS/STUDY POPULATION: The heart of the ECHO model is a hub-and-spoke knowledge-sharing system. The ECHO model has four core principles: 1) use technology to leverage scarce resources; 2) share best practices to reduce disparities; 3) employ case-based learning to master complexity; 4) monitor outcomes to ensure benefit. Unlike telemedicine, where outside specialists assume the care of the patient, Project ECHO is a guided learning community aimed at practice improvement: providers receive mentoring and feedback on de-identified patient cases, strengthen their skillset, and retain responsibility for their patients. RESULTS/ANTICIPATED RESULTS: Clinical topics launched include Medication Assisted Treatment for Opioid Use Disorder, Ehlers Danlos Syndrome, Polyneuropathy, and Dementia. In addition, we launched a nutrition-focused ECHO with Boy Scout summer camp leaders in 26 states, reaching 107,347 scouts. Over the past year we have reached 118 clinicians in 62 clinics within 19 counties in Pennsylvania, providing a total of 268 CME hours. These providers have treated 2,294 patients and reported increased knowledge (94%), decreased sense of professional isolation (86%), and improvement in ability to provide patient care (92%) following completion of an ECHO series. DISCUSSION/SIGNIFICANCE OF IMPACT: Project ECHO is a powerful telehealth model providing mentorship and education to clinicians, encouraging them to treat more complex cases in their primary care clinics. As a result, patients receive higher quality care when they need it, and close to home, particularly important in rural areas.

We conducted a survey study of clinical research coordinators (CRCs) at the member institutions of the Pediatric Emergency Care Applied Research Network, to determine the demographic and linguistic characteristics of CRCs around the network, and any perceived impact of those characteristics on their duties. A total of 53/74 CRCs completed the survey. Most respondents identified as “female,” “white,” and “not Hispanic/Latino.” Most respondents felt that their race/ethnicity and their ability to speak a language other than English would positively impact recruitment. Four female respondents felt that their gender hindered their recruitment efforts and their sense of belonging within the research team.

We conducted a literature review to identify commonly used recruitment and retention strategies in research among adolescent and young adult (AYA) cancer survivors 15-39 years of age and examine the effectiveness of these strategies based on the reported recruitment and retention rates. We identified 18 publications published after 2010, including 14 articles describing recruitment strategies and four articles discussing retention strategies and addressing reasons for AYA cancer patients dropping out of the studies. In terms of recruitment, Internet and social networking strategies were used most frequently and resulted in higher participation rates of AYA cancer survivors compared to other conventional methods, such as hospital-based outreach, mailings, and phone calls. In terms of retention, investigators used monetary incentives in all four studies and regular emails in two studies. There was no association between the number of strategies employed and the overall recruitment (p = 0.09) and retention rates (p = 0.33). Future research and planned studies testing recruitment and retention strategies are needed to identify optimal, modern communication procedures to increase AYA participation and adherence. More education should be provided to AYAs to increase their knowledge of research studies and strengthen the connection between AYA cancer survivors and their health providers.

CTSI Career Development Award (KL2) programs provide junior faculty with protected time and multidisciplinary, mentored research training in clinical and translational science research. The KL2 Visiting Scholars Program was developed to promote collaborative cross-CTSA training, leverage academic strengths at host CTSAs, and support the career development of participating scholars through experiential training and the development of new partnerships. This manuscript provides a detailed programmatic description and reports outcomes from post-visit and outcomes surveys. Since 2016, 12 scholars have completed the program, with 6 scheduled to complete it in 2021. Post-visit surveys (n = 12) indicate all scholars reported the program valuable to career development, 11 reported benefit for research development, and 11 expansion of collaborative networks. Outcomes surveys (n = 11) revealed subsequent scholar interaction with host institution faculty for 10 scholars, 2 collaborative grant submissions (1 funded), 2 planned grant submissions, 1 published collaborative manuscript, and 3 planned manuscript/abstract submissions. The Visiting Scholars Program is a cost- and time-efficient program that leverages the academic strengths of CTSAs. The program enhanced KL2 scholar training by expanding their professional portfolio, promoting research development, and expanding collaborative networks. Resources to support the program are shared in this report to expedite the development of similar programs at regional and national levels.

OBJECTIVES/SPECIFIC AIMS: Although parent involvement is recognized as an integral autism intervention component, and two-thirds of children are currently raised in 2-parent families, the majority of ASD parent research to date has focused on mother-implemented interventions, and fathers have been largely overlooked. However, fathers use interaction styles and language models that are different from mothers and may benefit children with ASD in unique ways. Thus there is a critical need in the field to expand our understanding of the potential contributions of various caregivers to communication outcomes. This investigation aimed to address this void in the research literature and contribute to clinical practice by including fathers in parent-implemented intervention, and adapting parent-implemented autism intervention to fit paternal interaction and communication styles. Specifically, this pilot study investigated the effects of a father-mediated intervention on parent use of responsive verbal and play strategies. Distal effects on child communication and pre-post changes in parental stress levels were also investigated. METHODS/STUDY POPULATION: A single subject, multiple baselines across strategies experiment was conducted with one dyad (i.e., father, child with ASD). In-home father coaching sessions were delivered weekly, targeting 4 responsive strategies (i.e., follow-in comments, follow-in directives, symbolic object play, rough-tumble play). Single subject designs are particularly suitable for autism interventions, as they allow for experimental control with participants who are from heterogeneous populations (McReynolds and Kearn, 1983). Child participant was 3 years, 1 month at the start of intervention and had previously received a received community diagnosis of ASD by a psychologist. Throughout the duration of the study, the child participant attended part-day community-based day care and received 20 hours per week of Applied Behavioral Analysis intervention both in-home and community daycare, as well as occupational therapy and speech-language therapy for 1 hour per week. The participating father was a biological parent who resided with the child continuously since birth. In addition, the father had no other formal parent training in communication intervention before participating. RESULTS/ANTICIPATED RESULTS: The results of the father-implemented intervention program yielded positive results for both father and child participant. The father quickly achieved a high level of competency using 3 of the 4 targeted strategies (i.e., follow-in comments, follow-in directives, and rough-and-tumble/physical play). Follow-in comments were used more frequently than follow-in directives and rough-and-tumble play strategies were used more frequently than symbolic play. Child use of single words increased over baseline and beginning use of multiword utterances was documented. Pre-post changes in parental stress for participating father and his spouse were not significant, however patterns of change across Parental Stress Index subscales scores were noted. DISCUSSION/SIGNIFICANCE OF IMPACT: This pilot investigation provided information regarding the treatment efficacy of a clinically relevant instructional program designed to enhance fathers’ ability to use responsive strategies to increase communicative acts or children with ASD. The results of this investigation advance clinical practice in the ASD field by providing intervention data relating to the efficacy of father-implemented instructional programs on child communication goals.

OBJECTIVES/SPECIFIC AIMS: Epidemiologic data suggest that BV is sexually transmitted with male partners colonized or infected with the responsible organism(s). The objective of this study was to compare the genital microbiota of women with recurrent BV and their regular male sexual partner using 16S rRNA gene sequencing and quantitative PCR targeting BV-candidate bacteria (Gardnerella vaginalis, Atopobium vaginae, BVAB1-3, Sneathia, Leptotrichia, and Megasphaera type I). METHODS/STUDY POPULATION: Women with recurrent BV (≥3 prior episodes, including a current episode) and their regular male partner participating in a BV treatment trial and providing genital specimens (women: vaginal; men: urethral, coronal sulcus, urine) at enrollment were included. Male specimens for each participant were pooled. 250 bp 16S rRNA V4 region PCR amplicons were sequenced and analyzed using the QIIME pipeline. Taxonomy was assigned using the RDP Classifier against a modified Greengenes database with additional vaginal taxonomies added. An average relative abundance cutoff of 0.5% was used for analysis. qPCR was also performed for specific BV-candidate bacteria. Spearman correlation coefficients were used to investigate associations between all genital bacteria in addition to BV-candidate bacteria between partnerships. To determine positive associations between partnerships, the Wilcoxon signed-rank test was used. RESULTS/ANTICIPATED RESULTS: In total, 45 partnerships were included. Mean partnership age was 31.3 (SD=7.9), 91.1% partnerships were African-American. The majority of partnerships (70.0%) reported condomless sex during the past 3 months. Regarding 16S data, 37 genital bacteria had an average relative abundance of ≥0.5%. The average Spearman correlation across all 45 partnerships was 0.28 (SD=0.27) (median=0.27, minimum=−0.21, maximum=0.84). Overall, a positive association of all genital bacteria existed across the partnerships (p<0.0001). However, regarding specific BV-candidate bacteria, Spearman correlation tests for G. vaginalis, A. vaginae, Prevotella bivia, Megasphaera type I, BVAB1, and BVAB2 were nonsignificant. In contrast, Sneathia spp. were positively correlated between partnerships (r=0.37, p=0.01). With regards to qPCR results, RNA Cq analyses provided significant evidence for a linear association between male and females for only A. vaginae (r=0.52, p=0.006). DISCUSSION/SIGNIFICANCE OF IMPACT: In monogamous heterosexual couples in which the female has BV, the vaginal microbiota of women and the penile/urine microbiota of men were significantly correlated, particularly with regards to Sneathia spp. and A. vaginae, supporting the hypothesis that BV-associated bacteria are exchanged during sex.