Introduction
Clinical trials are often plagued by recruitment and retention challenges, with many closing early due to failure to meet projected enrollment goals [Reference Carlisle, Kimmelman, Ramsay and MacKinnon1,Reference Williams, Tse, DiPiazza and Zarin2]. Barriers to clinical trial enrollment and retention are numerous, well-documented, and multi-faceted [Reference Boden-Albala, Carman and Southwick3–5]. Furthermore, underrepresentation of minoritized racial and ethnic populations continues to be a pervasive problem in many clinical trials, with little progress made over the last several decades [5,Reference Turner, Steinberg, Weeks, Rodriguez and Cullen6].
A study’s recruitment materials offer a critical first impression with potential participants and are essential to communicating important details and establishing rapport. While previous work has demonstrated that culturally tailored recruitment materials may increase recruitment and enrollment rates among minoritized communities [Reference Cunningham-Erves, Kusnoor and Villalta-Gil7,Reference Vuong, Wright and Nolan8], many research teams lack the knowledge, training, and resources to develop professionally designed recruitment and retention materials that also enhance diversity and inclusion in research participation.
The Recruitment Innovation Center
The Recruitment Innovation Center (RIC) [Reference Bernard, Harris and Pulley9,Reference Wilkins, Edwards and Stroud10] Recruitment Materials resource line was developed to ensure study teams have resources to develop customized, authentic, engaging, culturally appropriate materials to maximize their impact. Broadly, the RIC works with Clinical and Translational Science Award (CTSA) hubs and their researchers to develop, test, and disseminate a range of innovations and resources to support studies’ recruitment and retention needs [Reference Cook, Kennedy and Boone11]. The Recruitment Materials resource line offers support for a variety of clinician- and participant-facing tools, including review and consultation on print materials, websites, and social media, as well as custom design, logos, templates, and development of mobile study applications. More recently, the RIC has developed and disseminated several publicly available community-informed tools for investigators and study teams to use when developing recruitment strategies for trials [Reference Kennedy, Dunagan and Boone12]. This paper describes the creation and contents of a new RIC Recruitment & Retention Materials Content + Design Toolkit, which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials.
Overview of Toolkit
The RIC Recruitment & Retention Materials Toolkit was created to inform research teams of the benefits of using community-informed recruitment and retention materials and to provide actionable tips and guidance for real-world implementation. While some toolkits exist for creating study materials, there is a gap in publicly available, community-informed tools and resources that offer no-cost, professionally designed templates. This new toolkit contains guidelines, templates, and resources based on design best practices and positions study participants and their communities as the priority audience. The toolkit emphasizes the importance of intentional focus on diversity and inclusion for study materials to reach and engage potential participants from communities historically excluded from and underrepresented in research.
Community-informed Content
A growing body of evidence demonstrates the importance of participant and community engagement in all phases of research to increase both the relevance and overall success of clinical trials [Reference Holzer, Ellis and Merritt13,Reference Andrasik, Broder and Wallace14], including the creation of recruitment and retention materials and messaging [Reference Bowers, Jacobson and Krupp15]. This toolkit incorporates in-depth feedback from two community stakeholder groups: (1) the RIC Community Advisory Board (CAB) [Reference Wilkins, Edwards and Stroud10] and (2) Community Engagement (CE) Studio Experts [Reference Joosten, Israel and Head16]. Table 1 provides a description of each group and how their guidance informed this toolkit.
Stakeholder engagement in the RIC Recruitment & Retention Materials Toolkit
CAB = community advisory board; CE = community engagement; RIC = recruitment innovation center.
Description of Toolkit
The toolkit is organized into four main sections as outlined and summarized below. In all sections, call-out boxes are woven throughout the toolkit and categorized according to the following themes: Notes, tips, and recommendations to help research teams create recruitment and retention materials, including guidance on content and design, engaging potential participants for feedback, and developing an appropriate budget; Community expert advice includes relevant advice and recommendations from CE Studio Experts; Spotlighted resources and links to external resources, including tools that address health literacy, readability, and diversity; and Purpose of recruitment/retention material offers a description and reasoning for different types of materials to help researchers select the best options for their study.
Introduction: The toolkit opens with an overview and important considerations when developing study materials. It explains how communities were engaged in its development, emphasizes knowing the needs and preferences of a study’s primary audience, and offers tips to evaluate the use and effectiveness of study materials.
Content & Design: This section provides guidelines, recommendations, and resources to inform content and key design elements of study materials. Key recommendations center around messaging and language, font, layout, and the use of color and images. Clear, concise, plain-language, personable, and consistent messaging is encouraged across all study materials. Content should be written at a sixth-grade reading level to reach individuals with varying levels of educational attainment, and should contain common, simplified medical terms, with limited use of acronyms. Key content to include in recruitment materials is described in detail and includes prominent “call-to-action,” language that encourages participants to talk to their health care provider and loved ones about study participation, study contact information, and a statement about the voluntariness of participation. Personalization of study retention materials is also encouraged to increase engagement and retention, such as including the participant’s name and a handwritten note. Across all materials, content and messaging should be culturally appropriate and tailored to specific audiences. Photos and images are another critical component to designing culturally appropriate, relevant materials, and should be carefully chosen to resonate with and reflect the diversity of potential recruitment populations. This is especially important for marginalized populations and those historically excluded from research. This toolkit offers tips on selecting images for study materials, such as choosing photographs that are relatable and approachable, and provides examples reflecting participant diversity across demographics such as race, ethnicity, age, gender, and relationships. Resources for free images are also included.
Recruitment material formatting recommendations are also offered, including how to create layouts that make the text easier to review and digest, such as organizing study brochure content in such a way that it tells the “story of the study” and includes details that are important to potential participants. It instructs research teams on best practices in “branding” by using consistent design elements across study materials, such as colors, fonts, and logos. Appropriate use of contrast, color, and whitespace is stressed to ensure study materials are accessible and easy to read.
Typeface plays a significant role in readability, as some fonts are easier to read than others. For instance, Arial font has very narrow lettering, and even when sized appropriately, is often challenging to read. In contrast, fonts like Helvetica and Open Sans have wider typefaces and are better suited for study materials. Styles that are simple, easy to read, and sized in 12-point font or larger will help to reach individuals with visual impairment and varying educational attainment. Once an appropriate typeface is selected, adjusting kerning (the space between individual letters) and leading (the space between lines of text) can also enhance readability.
Lastly, the toolkit provides guidance on using quick response (QR) codes on study materials to allow potential participants immediate access to additional study information. Digital recruitment materials accessible via QR code can be reviewed on a personal phone or tablet to ensure privacy.
Templates: This section includes a set of recruitment and retention material templates created in Canva, (https://www.canva.com/) a free online graphic design tool. The template catalog includes materials used with both research participants and clinicians for study awareness and referrals (Table 2). All templates include unique design elements, examples of watermarked images, and recommendations for content and language (Fig. 1). Templates are accessible via hyperlinks and allow unlimited access and customization by adopting study teams. Canva accounts are available at no cost through Canva.com and allow use and customization of templates with no software dependencies other than an internet browser.
Example recruitment materials templates – flyer, brochure, and study information sheet.
Recruitment and retention materials template offerings
Canva Tips & Tutorials: This section provides user-friendly video tutorials and detailed step-by-step instructions for using Canva to create recruitment and retention materials, study logos, and social media ads.
Dissemination
The RIC Recruitment & Retention Materials Toolkit was finalized in April 2022 and added to the Trial Innovation Network’s Toolbox [18], a forum for sharing resources from CTSAs and reputable community health partners. Anyone from the public can freely access this toolkit at trialinnovationnetwork.org. To date, the toolkit and templates have been viewed 345 and 621 times, respectively. Other dissemination activities include presentations and webinars to broadly share this resource across the CTSA consortium. While we have not yet engaged in formal evaluation and testing of this resource, preliminary feedback from research teams and CTSA liaisons [Reference Bernard, Harris and Pulley9,Reference Wilkins, Edwards and Stroud10] suggests this is a significant and useful resource. Future work includes updating the toolkit with new social media templates and additional community-informed feedback when garnered and deploying an evaluation survey to assess utilization and satisfaction among users.
Discussion
The new RIC Recruitment & Retention Materials Content + Design Toolkit serves as a community-informed resource for research teams to use to develop their own study recruitment and retention materials. Toolkit concepts and material assets were informed by key community stakeholders, a guiding principle of the RIC’s work [Reference Kennedy, Dunagan and Boone12], and integrated expertise and best practices in content development, health literacy [19], and graphic design. The templates provided offer research teams easy access to professionally designed, customizable recruitment and retention materials on a no-cost, user-friendly platform. While other clinical trial recruitment material toolkits are publicly available, many do not contain community-informed guidance, or they offer few examples and templates that incorporate professional design elements. To our knowledge, no such toolkit with the aforementioned offerings currently exists.
Intentional and thoughtful design of study materials, messaging, and branding has the potential to increase accessibility, awareness, and enrollment in clinical trials [Reference Vuong, Wright and Nolan8]. Utilizing cohesive design elements across study materials helps create a study “brand” that builds trust and recognition with potential participants [Reference Taylor, Mohain, Gibson, Solanki, Whelan and Fern20]. Previous research shows clinical trial recruitment materials are often written at a high reading level, portray few images of minoritized racial and ethnic groups, contain limited information about study eligibility criteria, and often omit clear “call-to-action" statements [Reference Friedman, Kim, Tanner, Bergeron, Foster and General21]. Yet, cultural and linguistic adaptations and tailoring of materials and study messaging also show increased recruitment rates and likelihood to participate in research [Reference Vuong, Wright and Nolan8,Reference Bowers, Jacobson and Krupp15]. Researchers are encouraged to use this toolkit resource to design clear, understandable, culturally appropriate materials that promote inclusion and diversity, especially when recruiting populations who have been marginalized or historically excluded from research. As common practice, researchers are encouraged to ask potential participants and community stakeholders for their feedback on study materials, to ensure they are authentically engaging and culturally appropriate. Study teams should also adapt and customize their recruitment materials toward specific populations, rather than using a single “one-size fits all” resource, to have the greatest impact. This could include creating multiple versions of materials that are culturally tailored to different groups and translated into additional languages.
Limitations
Although the toolkit includes templates that are community-informed, participant-centered, and promote diversity and inclusion, it does not include materials tailored to specific marginalized and historically excluded groups. There are many nuances in creating materials for such specific populations and disease conditions, and research teams are encouraged to adapt and customize the provided templates for their study’s unique participant demographics. Additionally, this tool is not meant to replace but rather enhance the important work of research teams to authentically engage and build positive relationships with potential participants and community stakeholders. This is especially true with underrepresented communities in health research, where study teams must use culturally and contextually appropriate engagement strategies to build relationships with, demonstrate their commitment to, and show respect for these communities and their stakeholders [Reference Yu, Kowalkowski, Roll and Lor22]. Lastly, while the toolkit recommends proactive budgeting for materials, it does not provide detailed guidance on specific budget considerations for creating and disseminating recruitment and retention materials. Study teams should seek guidance and leverage local resources at their institution for developing an appropriate recruitment materials budget.
Conclusion
Recruitment and retention materials are a critical component in the successful enrollment and retention of a diverse, representative study population. Research teams should utilize best practices in content development and design, as well as incorporate stakeholder input, to maximize and enhance their recruitment efforts and completion of their trial. This toolkit offers a centralized resource of aggregated best practices and no-cost, professionally designed, community-informed templates.
Acknowledgments
The authors would like to sincerely thank those who contributed to this toolkit including Julia Dunagan, Community Engagement Studio Experts, and the Recruitment Innovation Center’s Community Advisory Board (RIC CAB) members for their thoughtful feedback and guidance on this toolkit. A special thank you to the late Broderick Crawford and Steve Mikita for their leadership in the RIC CAB working group, and their passion and tireless commitment to making sure community and research participants have an equitable seat at the table with researchers. Their memory and legacy live on in the RIC CAB’s commitment to and engagement of the communities they live in and serve.
Funding statement
This project was supported by the National Institutes of Health (NIH)/National Center for Advancing Translational Sciences (NCATS) (Vanderbilt Institute for Clinical and Translational Research, awards number UL1 TR002243), (The Recruitment Innovation Center, grant number U24 TR001579). Its contents are solely the responsibility of the authors and do not necessarily represent official views of NCATS or NIH.
Competing interests
The authors have no conflicts of interest to declare.
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