In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers. Each HLT serves as an expert intermediary, connecting CTSA Hub investigators with TIN support, and connecting TIN research teams with potential multicenter trial site investigators. The cross-consortium Liaison Team network was developed during the first TIN funding cycle, and it is now a mature national network at the cutting edge of team science in clinical and translational research. The CTSA-based HLT structures and the external network structure have been developed in collaborative and iterative ways, with methods for shared learning and continuous process improvement. In this paper, we review the structure, function, and development of the Liaison Team network, discuss lessons learned during the first TIN funding cycle, and outline a path toward further network maturity.

Background: Oncology patients are at high risk for bloodstream infection (BSI) due to immunosuppression and frequent use of central venous catheters. Surveillance in this population is largely relegated to inpatient settings and limited data are available describing community burden. We evaluated rates of BSI, clinic or emergency department (ED) visits, and hospitalizations in a large cohort of oncology outpatients with peripherally inserted central catheters (PICCs). Methods: In this prospective, observational study, we followed a convenience sample of adults (age>18) with PICCs at a large academic outpatient oncology clinic for 35 months between July 2015 and November 2018. We assessed demographics, malignancy type, PICC insertion and removal dates, history of prior PICC, and line duration. Outcomes included BSI events (defined as >1 positive blood cultures or >2 positive blood cultures if coagulase-negative Staphylococcus), ED visits (without hospitalization), and unplanned hospitalizations (excluding scheduled chemotherapy hospitalizations). We used χ2 analyses to compare the frequency of categorical outcomes, and we used unpaired t tests to assess differences in means of continuous variable in hematologic versus solid-tumor malignancy patients. We used generalized linear mixed-effects models to assess differences in BSI (clustered by patient) separately for gram-positive and gram-negative BSI outcomes. Results: Among 478 patients with 658 unique PICC lines and 64,190 line days, 271 patients (413 lines) had hematologic malignancy and 207 patients (232 lines) had solid-tumor malignancy. Cohort characteristics and outcomes stratified by malignancy type are shown in Table 1. Compared to those with hematologic malignancy, solid-tumor patients were older, had 47% fewer clinic visits, and had 32% lower frequency of prior PICC lines. Overall, there were 75 BSI events (12%; 1.2 per 1,000 catheter days). We detected no significant difference in BSI rates when comparing solid-tumor versus hematologic malignancies (P = 0.20); BSIs with gram-positive pathogen were 69% higher in patients with solid tumors. Gram-negative BSIs were 41% higher in patients with hematologic malignancy. Solid-tumor malignancy was associated with 4.5-fold higher odds of developing BSI with gram-positive pathogen (OR, 4.48; 95% CI, 1.60–12.60; P = .005) compared to those with hematologic malignancy, after adjusting for age, sex, history of prior PICC, and line duration. Differences in gram-negative BSI were not significant on multivariate analysis. Conclusions: The burden of all-cause BSIs in cancer clinic adults with PICC lines was 12% or 1.2 per 1,000 catheter days, as high as nationally reported inpatient BSI rates. Higher risk of gram-positive BSIs in solid-tumor patients suggests the need for targeted infection prevention activities in this population, such as improvements in central-line monitoring, outpatient care, and maintenance of lines and/or dressings, as well as chlorhexidine bathing to reduce skin bioburden.

Disclosures: None

One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.

Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational Sciences of the National Institutes of Health to develop innovative strategies and technologies to enhance participant engagement in all stages of multicenter clinical trials. In collaboration with investigator teams and liaisons at Clinical and Translational Science Award institutions, the RIC is charged with the mission to design, field-test, and refine novel resources in the context of individual clinical trials. These innovations are disseminated via newsletters, publications, a virtual toolbox on the TIN website, and RIC-hosted collaboration webinars. The RIC has designed, implemented, and promised customized recruitment support for 173 studies across many diverse disease areas. This support has incorporated site feasibility assessments, community input sessions, recruitment materials recommendations, social media campaigns, and an array of study-specific suggestions. The RIC’s goal is to evaluate the efficacy of these resources and provide access to all investigating teams, so that more trials can be completed on time, within budget, with diverse participation, and with enough accrual to power statistical analyses and make substantive contributions to the advancement of healthcare.

In recent years, mass-casualty incidents (MCIs) have become more frequent and deadly, while emergency department (ED) crowding has grown steadily worse and widespread. The ability of hospitals to implement an effective mass-casualty surge plan, immediately and expertly, has therefore never been more important. Yet, mass-casualty exercises tend to be highly choreographed, pre-scheduled events that provide limited insight into hospitals’ true capacity to respond to a no-notice event under real-world conditions. To address this gap, the US Department of Health and Human Services (Washington, DC USA), Office of the Assistant Secretary for Preparedness and Response (ASPR), sponsored development of a set of tools meant to allow any hospital to run a real-time, no-notice exercise, focusing on the first hour and 15 minutes of a hospital’s response to a sudden MCI, with the goals of minimizing burden, maximizing realism, and providing meaningful, outcome-oriented metrics to facilitate self-assessment. The resulting exercise, which was iteratively developed, piloted at nine hospitals nationwide, and completed in 2015, is now freely available for anyone to use or adapt. This report demonstrates the feasibility of implementing a no-notice exercise in the hospital setting and describes insights gained during the development process that might be helpful to future exercise developers. It also introduces the use of ED “immediate bed availability (IBA)” as an objective, dynamic measure of an ED’s physical capacity for new arrivals.

WaxmanDA, ChanEW, PillemerF, SmithTWJ, AbirM, NelsonC. Assessing and Improving Hospital Mass-Casualty Preparedness: A No-Notice Exercise. Prehosp Disaster Med. 2017;32(6):662–666.

The lack of frequent real-world opportunities to study preparedness for large-scale public health emergencies has hindered the development of an evidence base to support best practices, performance measures, standards, and other tools needed to assess and improve the nation’s multibillion dollar investment in public health preparedness. In this article, we argue that initial funding priorities for public health systems research on preparedness should focus on using engineering-style methods to identify core preparedness processes, developing novel data sources and measures based on smaller-scale proxy events, and developing performance improvement approaches to support the translation of research into practice within the wide variety of public health systems found in the nation. (Disaster Med Public Health Preparedness. 2008;2:247–250)