Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

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.

Population Health Improvement Awards: Supporting Community and Academic Capacity to Partner in Research and Improve Population Health.

The Duke Clinical and Translational Science Institute Community Engaged Research Initiative began its Population Health Improvement Awards grant program in 2017. This program builds community-engaged research capacity by promoting the formation of community-academic research teams, educating researchers about equitable partnerships, and empowering community members and organizations to access academic research resources. With a focus on community-identified priorities, the program purposefully engages local communities in an enterprise that has traditionally labeled community members as "participants" rather than "partners." Key elements of the program include innovation, relationship building, and power sharing; education and research system navigation; iterative adaptation using the Plan-Do-Study-Act framework; and continual program improvements based on applicant feedback to ensure that the program becomes a national leader in funding local community-engaged research partnerships.

Participatory research to improve medication reconciliation for older adults in the community.

INTRODUCTION: Medication reconciliation, a technique that assists in aligning a care team's understanding of an individual's true medication regimen, is vital to optimize medication use and prevent medication errors. Historically, most medication reconciliation research has focused on institutional settings and transitional care, with comparatively little attention given to medication reconciliation in community settings. To optimize medication reconciliation for community-dwelling older adults, healthcare professionals and older adults must be engaged in co-designing processes that create sustainable approaches. METHODS: Academic researchers, older adults, and community- and health system-based healthcare professionals engaged in a participatory process to better understand medication reconciliation barriers and co-design solutions. The initiative consisted of two participatory research approaches: (1) Sparks Innovation Studios, which synthesized professional expertise and opinions, and (2) a Community Consultation Studio with older adults. Input from both groups informed a list of possible solutions and these were ranked based on evaluative criteria of feasibility, person-centeredness, equity, and sustainability. RESULTS: Sparks Innovation Studios identified a lack of ownership, fragmented healthcare systems, and time constraints as the leading barriers to medication reconciliation. The Community Consultation Studio revealed that older adults often feel dismissed in medical encounters and perceive poor communication with and among providers. The Community Consultation Studio and Sparks Innovation Studios resulted in four highly-ranked solutions to improve medication reconciliation: (1) support for older adults to improve health literacy and ownership; (2) ensuring medication indications are included on prescription labels; (3) trainings and incentives for front-line staff in clinic settings to become champions for medication reconciliation; and (4) electronic health record improvements that simplify active medication lists. CONCLUSION: Engaging community representatives with academic partners in the research process enhanced understanding of community priorities and provided a practical roadmap for innovations that have the potential to improve the well-being of community-dwelling older adults.

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.