Underrepresentation of health disparity populations in clinical trials has the potential to exacerbate and perpetuate health disparities. There are several notable barriers to clinical trials participation, however low research literacy may be a key barrier yet rarely addressed. Few tools exist for enhancing clinical trials research literacy and promoting clinical trials resources for consumers, and fewer yet have been specifically developed for minority and underrepresented populations. Developed in conjunction with 28 partner institutions associated with the NCI funded Cancer Disparities Research Network, we have developed a clinical trials research literacy tool intended to clearly and simply explain elements of research and trials that are understandable, usable and useful to will empower diverse consumers to make fully informed decisions when considering enrollment in clinical trials. We seek to leverage information technology and library partnerships to transform the research literacy materials into a web-based tool and evaluate implementation of the tool in libraries and hospital patient education centers. Due to their accessibility and roles as information gatekeepers, librarians and health providers that serve medically underserved underrepresented populations are promising partners for disseminating clinical trials information. Thus, we propose to employ a user-centered design process to transform our current card-based tool to a functional, and more easily accessible web-based tool for consumers and a supplemental training module for librarians and health providers. Iterative prototype development will involve focus groups, an environmental scan of available clinical trials resources to identify opportunities to enhance the tool with direct linkages to local clinical trials, and key informant interviews among librarians and healthcare providers to inform the development of a supplemental training module applicable across libraries and patient education centers. Following development of the tool, leveraging the consolidated framework for implementation research (CFIR), we will deploy the tool among 10 libraries and patient education centers to evaluate factors influencing implementation and clinical trials participation outcomes. Pre- post surveys among n=125 library and patient education center patrons using the tool will assess outcomes related to research literacy and intentions to engage in clinical trials. A survey among n=50 librarians, community organization leaders, community health workers and healthcare providers will identify factors influencing the implementation of the research literacy tool in libraries, community organizations and hospital patient education centers. Results will be used to develop a generalizable model for health system - public library partnerships to sustain and disseminate the tool to other settings.
The participation of diverse populations in clinical trials is crucial to advancing science, discoveries, health care delivery and overall human health. There are many studies focused on barriers to diverse clinical trials enrollment, however there is little focus on the conversations that need to occur prior to approaching a potential participant in clinical trials- including a focus on: building trust, dispelling research participation myths, improving research literacy. This proposal aims to build on our low-tech version of our research literacy communication tool tested in diverse populations and transform it to a web-based version to disseminate to diverse populations to use in conjunction with their local librarians, community organizations/community health workers, and health care providers.
