2021 Community Engagement Studio Virtual Training Summit: Increasing the Diversity of Stakeholders Engaged in Research.

BACKGROUND: There are few methods that focus on engaging racial and ethnic minorities in research. The Meharry-Vanderbilt Community Engaged Research Core partnered with the University of Utah, the University of Michigan, and community/patient partners to convene a virtual summit to share the Community Engagement Studio (CE Studio) model, a structured and widely-used approach that facilitates community engagement in research. OBJECTIVES: The CE Studio Virtual Training Summit (Summit) goal was to prepare multi-stakeholder (e.g., researchers, community members) research teams to engage more racial/ethnic minorities in CE studios. METHODS: Summit planning included (1) agenda development, including CE Studio training and a live CE Studio demonstration; (2) summit advertisement across several networks, including minority-serving institutions; and (3) development of pre-and post-Summit evaluations. RESULTS: Among 50 registrants (76.7% academicians) that completed evaluations, more than 65% planned to increase engagement of racial/ethnic minorities in research and implement CE Studios as a result of the Summit. Increased confidence in all CE training areas was reported, including in conducting an effective CE Studio planning meeting (32.1% pre-Summit/90.3% post-Summit) and identifying and preparing patient/community stakeholders for engagement as CE Studio experts (46.4% pre-Summit/93.6% post-Summit). CONCLUSIONS: Virtual CE Studio training that includes multi-stakeholder planning partners can be an effective method for introducing the CE Studio model and preparing multi-stakeholder research teams to engage racial and ethnic minorities in CE Studios. This is particularly salient given that effective community engaged research methods and best practices are not currently being distributed through research programs at a pace consistent with the demands.

The RIC Recruitment & Retention Materials Toolkit - a resource for developing community-informed study materials.

Clinical trials face many challenges with meeting projected enrollment and retention goals. A study's recruitment materials and messaging convey necessary key information and therefore serve as a critical first impression with potential participants. Yet study teams often lack the resources and skills needed to develop engaging, culturally tailored, and professional-looking recruitment materials. To address this gap, the Recruitment Innovation Center recently developed a Recruitment & Retention Materials Content and Design Toolkit, which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials. This paper seeks to describe the creation and contents of this new toolkit.

A community-informed recruitment plan template to increase recruitment of racial and ethnic groups historically excluded and underrepresented in clinical research.

INTRODUCTION: Engaging communities in research planning and implementation can enhance recruitment and retention (R&R) of racial and ethnic groups historically excluded and underrepresented in clinical research; however, most studies do not use community-informed approaches. This paper describes the formative research process used to design a Community-Informed Recruitment Plan Template for racial and ethnic groups historically excluded and underrepresented in clinical research. METHODS: Using an existing R&R template as a starting point, we iteratively developed and refined the community-informed template through a 3-phase process to achieve cultural-appropriateness. Phase 1 included a literature review, 34 community engagement (CE) studios to review recommendations, community advisory board (CAB) review, and survey data from minority recruitment experts. Phase 2 involved integration of content into existing R&R template. Phase 3 was a final review and revision using input of the CAB and researchers' panel. Survey data collected in Phase 1 were analyzed using descriptives (i.e., frequencies and percentages). Open-ended survey responses were analyzed using inductive, qualitative thematic analysis. RESULTS: The final 8-section template can help develop effective grant or proposal language where study R&R plans are requested. They include: 1) Recruitment Strategy; 2) A Stakeholder Communication Plan; 3) Evidence of Recruitment Feasibility; 4) Recruitment and Retention Team; 5) Recruitment and Retention Methods; 6) Recruitment and Retention Timeline; 7) Evaluation; and 8) Budget. CONCLUSIONS: Incorporating multiple perspectives into this formative research process enhances the cultural appropriateness of this community-informed R&R template to help research teams achieve R&R goals for individuals historically excluded and underrepresented in clinical research.

Tutorial: Using Community Engagement Studios to Enhance Pharmacogenetic Study Design for Maximizing Enrollment of Diverse Children and Pregnant People.

Most pharmacogenetic research is conducted in adult, non-pregnant populations of European ancestry. Study of more diverse and special populations is necessary to validate findings and improve health equity. However, there are significant barriers to recruitment of diverse populations for genetic studies, such as mistrust of researchers due to a history of unethical research and ongoing social inequities. Engaging communities and understanding community members' perspectives may help to overcome these barriers and improve research quality. Here, we highlight one method for engaging communities, the Community Engagement Studio (CES), a consultative session that allows researchers to obtain guidance and feedback based on community members' lived experiences. We also provide an example of its use in pharmacogenetic studies. In designing a survey study of knowledge and attitudes around pharmacogenetic testing among children with chronic conditions and pregnant individuals, we sought input from diverse community stakeholders through CESs at Vanderbilt University Medical Center. We participated in two CESs with community stakeholders representing study target populations. Our goals were to learn specific concerns about pharmacogenetic testing and preferred recruitment strategies for these communities. Concerns were expressed about how genetic information would be used beyond the immediate study. Participants emphasized the importance of clarity and transparency in communication to overcome participation hesitancy and mistrust of the study team. Recruitment strategy recommendations ranged from informal notices posted in healthcare settings to provider referrals. The CES enabled us to modify our recruitment methods and research materials to better communicate with populations currently under-represented in pharmacogenetics research.

Development and pilot implementation of guidelines for culturally tailored research recruitment materials for African Americans and Latinos.

BACKGROUND: Previous studies support cultural tailoring of recruitment materials as a strategy to promote the enrollment of minoritized groups in clinical trials. However, there is a lack of guidance for research teams to create culturally tailored materials, potentially contributing to low recruitment rates of minoritized groups. We describe the development and pilot testing of recruitment material guidelines used to culturally tailor clinical trial recruitment materials targeting African Americans and Latinos. METHODS: The guideline development team consisted of investigators, research staff, and community leaders and members experienced in the recruitment and community engagement of minoritized groups. The recruitment material guidelines were developed using the literature, focus groups with African Americans and Latinos, the teams' research experience, and guidance from a community advisory board. To assess the effectiveness of the guidelines, a pilot study was conducted comparing advertisement click-through rates and enrollment outcomes between two institutions differing in use of culturally tailored versus non-tailored Facebook banner ads for the "Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness" (ADAPTABLE) study. RESULTS: Five themes emerged from focus groups: (1) employ diversity and inclusion in recruitment efforts; (2) access multiple recruitment channels to increase reach and possible participation; (3) increase your "footwork"; (4) personalize outreach and recruitment to specific groups' beliefs and values; (5) align recruitment messaging with language preferences and motivations for study participation; and (6) specify incentives for participation. Guidelines were: 1) be inclusive; 2) use all forms of media; 3) take a personalized approach; 4) align recruitment messaging with motivations for study participation; 5) specify incentives; and 6) get out into the community. Additional guidelines were developed addressing specific considerations for images and language when targeting African American and Latino populations. Pilot study results demonstrated that clicks per impression ratio (0.47 clicks per impression vs. 0.03 clicks per impression) and the percentage of African American enrollment were significantly higher when using tailored compared to non-tailored ads (12.8% vs. 8.3%, respectively). CONCLUSION: The recruitment material guidelines offer practical recommendations to reach diverse populations for clinical trial participation more effectively. Our preliminary data supports use of these guidelines as a strategy to enhance recruitment of minoritized groups into clinical research studies.

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.

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.

Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research.

INTRODUCTION: Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups. METHODS: We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components. RESULTS: The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a "storytelling" intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process. CONCLUSIONS: The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.

Design and implementation of a massive open online course on enhancing the recruitment of minorities in clinical trials - Faster Together.

BACKGROUND: Racial and ethnic minorities are often underrepresented in clinical trials, threatening the generalizability of trial results. Several factors may contribute to underrepresentation of minorities in clinical trials, including lack of training for researchers and staff on the importance of diversity in clinical trials and effective strategies for recruiting and retaining minority populations. METHODS: Applying community engaged research principles, we developed a massive open online course (MOOC) to help research team members develop knowledge and skills to enhance the recruitment of minorities in clinical trials. A transdisciplinary working group, consisting of clinical researchers, community engagement specialists, minority clinical trial recruitment and retention educators and specialists, and knowledge management information scientists, was formed to develop an evidence-based curriculum. Feedback from the Recruitment Innovation Center Community Advisory Board was incorporated to help finalize the curriculum. The course was implemented in Coursera, an online learning platform offering MOOCs. A bootstrap paired sample t-test was used to compare pre- and post-assessments of knowledge, attitudes, and intentions as it relates to minority recruitment. RESULTS: The final course, entitled Faster Together, was divided into eight 1-h modules. Each module included video presentations, reading assignments, and quizzes. After 10 months, 382 individuals enrolled in the course, 105 participants completed the pre-test, and 14 participants completed the post-test. Participants' knowledge scores were higher with an increase in the mean number of correct answers from 15.4 (95% CI:12.1-18.7) on the pre-test to 18.7 (95% CI:17.42-20.2) on the post-test. All post-test respondents (n = 14) indicated that the course improved their professional knowledge, and 71.4% of respondents indicated that they were very likely to make changes to their recruitment practices. CONCLUSIONS: Faster Together, a massive open online course, is an acceptable, accessible approach to educating research teams on minority recruitment in clinical trials. Preliminary evidence indicates the course increased knowledge on how to recruit minorities into clinical trials and could promote change in their recruitment practices.

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent.

INTRODUCTION: The updated common rule, for human subjects research, requires that consents "begin with a 'concise and focused' presentation of the key information that will most likely help someone make a decision about whether to participate in a study" (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613-615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377-381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant's race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529-534.). METHODS: We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information. RESULTS: The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. CONCLUSIONS: Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.

Patient Stories Can Make a Difference in Patient-Centered Research Design.

Amid increasing interest in improving the patient-centeredness of research, new forms of engagement are emerging that enable researchers to get input from community members on research goals, methods, and implementation. This input often includes stories, which are useful for understanding lived experiences of illness and encounters with health care organizations, and for locating these experiences within larger meta-narratives of specific communities. We analyzed the stories in transcripts of 13 Community Engagement Studios and identified 4 major functions that the stories served in the sessions. Major functions included: (1) establishing mutual understanding, (2) adding expansion and depth, (3) characterizing abstract concepts, and (4) providing context for experience, with the latter being the most frequent. We assert that stories can serve to better communicate the complex contexts of patient experiences, helping to align research priorities and research design with community interests, leading to more patient-centered innovations in clinical practice.

Enhancing translational researchers' ability to collaborate with community stakeholders: Lessons from the Community Engagement Studio.

Community engagement is considered essential to effectively translate research into practice and is increasingly recognized as a key to successful clinical trial recruitment. Challenges to engaging community stakeholders in research persist and new methods are needed to facilitate meaningful stakeholder involvement. The Community Engagement Studio (CE Studio), a consultative model, has been used at every stage of the research process. Best practices drawn from the model could inform other methods of engagement. Using a mixed-methods approach that included evaluation surveys, impact surveys and interviews, we assessed the CE Studio program. We analyzed data from 75 CE Studios; 65 researchers and 591 community members completed surveys and 10 researchers completed interviews. Surveys indicate that 100% of researchers would request a CE Studio in the future, and 99.3% of community members would participate in a CE Studio again. We identified 6 practices to enhance community engagement in clinical and translational research: early input, researcher coaching, researcher humility, balancing power, neutral facilitator, and preparation of community stakeholders. These best practices may enhance the quality of existing community engagement approaches and improve the effectiveness of translational researchers' efforts to engage community stakeholders in their work.

Incorporating Patient and Caregiver Experiences Into Cardiovascular Clinical Trial Design.

Patient centeredness is a concept that is increasingly being viewed as essential for clinical research. A core principle involves a comprehensive assessment and integration of patient and caregiver perspectives into trial design. Importantly, this involves more than just soliciting feedback. Patients and caregivers are now considered vital members of the study team, even serving as coinvestigators who may help to conceive, plan, and develop the study; continue to direct the day-to-day conduct of the study; and fully participate in the dissemination of the study results. The Patient-Centered Outcomes Research Institute offers substantial funding to support this approach, but getting started, particularly at institutions that lack a robust community engagement infrastructure, can be daunting. In this Special Communication, successful methods that have been used by researchers to engage patients, caregivers, and the broader health care community in the research process are outlined, and examples of currently funded studies that have fully engaged key stakeholders are described. Although trials are designed to assess efficacy and effectiveness and inform future implementation and dissemination, this Special Communication emphasizes methods to ensure trial results are relevant to and understood by the individuals and groups that they are intended to impact. Critical next steps in this new research approach are also discussed. In doing so, this will inspire future cardiovascular research that evaluates not only traditional end points, such as mortality and readmission, but also emphasizes true patient-centered outcomes, including quality of life, knowledge and satisfaction, caregiver burden, time tradeoffs, and out-of-pocket costs.

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.

Community-Engaged Strategies to Promote Relevance of Research Capacity-Building Efforts Targeting Community Organizations.

OBJECTIVE: The study goal is to highlight strategies for promoting relevance of research capacity-building efforts targeting community organizations (CO)s. METHODS: Two community partners, representing two COs, were invited to participate in CO research development trainings, Community Research Forums (Forum)s. Their contributions were documented via Forum document review. Forum participants, representatives from other COs, completed post-Forum surveys to identify additional training needs and rate Forum impact relative to their training expectations. A content-based analysis and descriptive statistics were used to summarize needs assessment- and impact-related survey responses, respectively. RESULTS: Community partners were involved in eight Forum-related activities including marketing (planning), facilitation (implementation), and manuscript coauthorship (dissemination). Eighty-one individuals, representing 55 COs, attended the Forums. Needs assessment responses revealed a desire for additional assistance with existing Forum topics (e.g., defining research priorities) and a need for new ones (e.g., promoting organizational buy in for research). Ninety-one percent of participants agreed that the Forum demonstrated the value of research to COs and how to create a research agenda. CONCLUSIONS: Including community partners in all Forum phases ensured that CO perspectives were integrated throughout. Post-Forum needs and impact assessment results will help in tailoring, where needed, future training topics and strategies, respectively.