Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

Development, implementation, and dissemination of operational innovations across the trial innovation network.

Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.

The RIC COVID-19 Recruitment & Retention Toolkit: A community-informed resource of recruitment tools and strategies for clinical trial investigators.

The Recruitment Innovation Center (RIC) has created a toolkit of novel strategies to engage potential participants in response to recruitment and retention challenges associated with COVID-19 studies. The toolkit contains pragmatic, generalizable resources to help research teams increase awareness of clinical trials and opportunities to participate; produce culturally sensitive and engaging recruitment materials; improve consent and return of results processes; and enhance recruitment of individuals from populations disproportionately impacted by COVID-19. This resource, the "RIC COVID-19 Recruitment and Retention Toolkit," is available free online. We describe the toolkit and the community feedback used to author and curate this resource.

Recruitment and Retention Strategies for the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study: From the Type 1 Diabetes in Acute Pancreatitis Consortium.

ABSTRACT: Recruitment and retention of patients with acute pancreatitis (AP) in clinical studies can be challenging. While some obstacles are similar to other clinical conditions, some are unique to AP. Identifying potential barriers early and developing targeted solutions can help optimize recruitment and retention in AP studies. Such pre-emptive and detailed planning can help prospective, longitudinal studies focus on exocrine and endocrine complications of AP in accurately measuring outcomes. This article highlights the challenges in recruitment and retention strategies in AP studies and reviews available resources to create opportunities to address them. We describe the multifaceted approach used by the Recruitment and Retention Committee of the Type 1 Diabetes in Acute Pancreatitis Consortium, which builds upon earlier experiences to develop a recruitment and retention plan for the DREAM (Diabetes RElated to Acute pancreatitis and its Mechanisms) study.

The Recruitment Innovation Center: Developing novel, person-centered strategies for clinical trial recruitment and retention.

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.

A High Level of Patient Activation Is Observed But Unrelated to Glycemic Control Among Adults With Type 2 Diabetes.

OBJECTIVE: To measure patient activation and its relationship to glycemic control among adults with type 2 diabetes who had not participated in a formal diabetes self-management education program as a baseline assessment for tailoring diabetes education in a primary care setting. RESEARCH DESIGN AND METHODS: Patient activation was assessed in a stratified, cross-sectional study of adults with controlled (n = 21) and uncontrolled (n = 27) type 2 diabetes, who were receiving primary care at a unique family practice center of Baylor Health Care System in Dallas, Tex. RESULTS: The mean patient activation was 66.0 (95% confidence interval [CI] 60.8-71.2) among patients with uncontrolled diabetes and 63.7 (55.9-71.5) among those with controlled diabetes (P = 0.607). A significant association was observed between the self-management behavior score and activation among patients whose glycemia was under control (ρ = 0.73, P = 0.01) as well as among patients with uncontrolled glycemia (ρ = 0.48, P < 0.001). CONCLUSIONS: Although activation is correlated with self-management and may be important in tailored patient-centered approaches to improving diabetes care outcomes, the highest stage of activation may be necessary to achieve glycemic control. These findings reinforce the importance of conducting prerequisite needs assessments so diabetes educators are able to tailor their educational interventions to individual patients' needs and readiness to take action.

Dissemination and implementation science activities across the Clinical Translational Science Award (CTSA) Consortium: Report from a survey of CTSA leaders.

INTRODUCTION: Dissemination and implementation (D&I) science is not a formal element of the Clinical Translational Science Award (CTSA) Program, and D&I science activities across the CTSA Consortium are largely unknown. METHODS: The CTSA Dissemination, Implementation, and Knowledge Translation Working Group surveyed CTSA leaders to explore D&I science-related activities, barriers, and needed supports, then conducted univariate and qualitative analyses of the data. RESULTS: Out of 67 CTSA leaders, 55.2% responded. CTSAs reported directly funding D&I programs (54.1%), training (51.4%), and projects (59.5%). Indirect support (e.g., promoted by CTSA without direct funding) for D&I activities was higher - programs (70.3%), training (64.9%), and projects (54.1%). Top barriers included funding (39.4%), limited D&I science faculty (30.3%), and lack of D&I science understanding (27.3%). Respondents (63.4%) noted the importance of D&I training and recommended coordination of D&I activities across CTSAs hubs (33.3%). CONCLUSION: These findings should guide CTSA leadership in efforts to raise awareness and advance the role of D&I science in improving population health.

Community Engagement Studios: A Structured Approach to Obtaining Meaningful Input From Stakeholders to Inform Research.

PROBLEM: Engaging communities in research increases its relevance and may speed the translation of discoveries into improved health outcomes. Many researchers lack training to effectively engage stakeholders, whereas academic institutions lack infrastructure to support community engagement. APPROACH: In 2009, the Meharry-Vanderbilt Community-Engaged Research Core began testing new approaches for community engagement, which led to the development of the Community Engagement Studio (CE Studio). This structured program facilitates project-specific input from community and patient stakeholders to enhance research design, implementation, and dissemination. Developers used a team approach to recruit and train stakeholders, prepare researchers to engage with stakeholders, and facilitate an in-person meeting with both. OUTCOMES: The research core has implemented 28 CE Studios that engaged 152 community stakeholders. Participating researchers, representing a broad range of faculty ranks and disciplines, reported that input from stakeholders was valuable and that the CE Studio helped determine project feasibility and enhanced research design and implementation. Stakeholders found the CE Studio to be an acceptable method of engagement and reported a better understanding of research in general. A tool kit was developed to replicate this model and to disseminate this approach. NEXT STEPS: The research core will collect data to better understand the impact of CE Studios on research proposal submissions, funding, research outcomes, patient and stakeholder engagement in projects, and dissemination of results. They will also collect data to determine whether CE Studios increase patient-centered approaches in research and whether stakeholders who participate have more trust and willingness to participate in research.

Clinical and translational research studios: a multidisciplinary internal support program.

The Vanderbilt Institute for Clinical and Translational Research implemented the "Studio" Program in 2007 to bring together experts to provide free, structured, project-specific feedback for medical researchers. Studios are a series of integrated, dynamic, and interactive roundtable discussions that bring relevant research experts from diverse academic disciplines together to focus on a specific research project at a specific stage. Vanderbilt's Clinical and Translational Science Award supports the program, which is designed to improve the quality and impact of biomedical research. In this article, the authors describe the program's design, and they provide an evaluation of its first four years.After an investigator completes a brief online Studio application, a Studio "manager" reviews the request, assembles a panel of three to six experts (research faculty from multiple disciplines), and circulates the pre-review materials electronically. Investigators can request one of seven Studio formats: hypothesis generation, study design, grant review, implementation, analysis and interpretation, manuscript review, or translation. A Studio moderator leads each Studio session, managing the time (90 minutes) and discussion to optimize the usefulness of the session for the investigator.Feedback from the 157 Studio sessions in the first four years has been overwhelmingly positive. Investigators have indicated that their Studios have improved the quality of their science (99%; 121/122 responses), and experts have reported that the Studios have been a valuable use of their time (98%; 398/406 responses).