Introduction
Participant or community engagement in research, including participatory action research (PAR), are not new concepts in clinical trials but remain rare in practice [Reference Harrison, Auerbach and Anderson1–4]. The struggles of healthcare workers (HCWs) early in the pandemic have been well published [Reference Murthy5–Reference Fronteira, Mathews and Dos Santos7], yet HCWs were also involved in participatory research aimed at tackling COVID-19. Finding treatments and a protective vaccine for COVID-19 was at the forefront of public health efforts, creating an urgent need to quickly coordinate clinical research efforts on local, national, and international levels early in the pandemic. This urgency extended to frontline HCWs who struggled with the diagnosis and management of COVID-19-infected patients. HCWs also had to grapple with the critical lack of personal protective equipment (PPE) and fear for their own safety and that of loved ones. Although the needs and concerns of HCWs evolved over the course of the pandemic, there was often little opportunity for HCW groups to voice lived experiences at the moment.
Thus, while efforts were underway to find treatments and vaccines for public health, HCWs were also enlisted as research participants to learn about their experiences and struggles during an active crisis. A national registry, the Healthcare Worker Exposure Response and Outcomes (HERO) Registry, opened to HCWs across many roles, focused on the experiences of HCWs, shed light on their experiences during the pandemic, and enlisted participation in COVID-19-related clinical research. The HERO Principal Investigators, who launched the HERO Registry, also formed a subcommittee to increase participant input through Good Participatory Practice (GPP) guidelines [4,8]. This subcommittee of HCW Registry members, representing various HCW roles across the U.S., informed the continuing structure, research, and design of the HERO Registry Program. As trial participants and community stakeholders of the HERO Registry, HCW subcommittee members voiced the needs and experiences of HCWs nationally based on individual diverse backgrounds during the pandemic. The HCW subcommittee and HERO Registry team embraced the principles of mutual respect, trust, transparency, and accountability while maintaining community stakeholder autonomy over the course of the subcommittee work. The purpose of this paper is to describe how the HCW subcommittee was formed, how community participation impacted the HERO Registry and Research Program, lessons learned, and implications for future research.
How the HCW subcommittee was formed
HERO Registry
In March 2020, the Duke Clinical Research Institute (DCRI) received funding from the Patient-Centered Outcomes Research Network (PCORnet), a subsidiary of the Patient-Centered Outcomes Research Institute (PCORI), to create a novel online registry of HCWs. The goal of the HERO Registry was to bring together HCWs from across the country and centralize outreach and data collection regarding the experiences of HCWs during the pandemic. HERO defined HCWs as anyone who worked in a setting where people received healthcare, including nurses, therapists, physicians, laboratory workers, food service workers, environmental service workers, interpreters, emergency responders, transporters, and others.
By collecting data from frontline HCWs in real time, the HERO Registry created an opportunity to rapidly generate data on issues relating to the protection of HCWs’ health and well-being, including topics such as stress, burnout, moral injury, anger, COVID-19 testing, PPE usage, and racial and ethnic disparities [Reference Forrest, Xu and Thomas9,Reference Friedland, Hernandez and Anstrom10]. In addition, HERO Registry participants were invited to join COVID-related clinical research. This research included HERO-HCQ, a randomized controlled clinical trial testing hydroxychloroquine (HCQ) as a pre-exposure prophylaxis against COVID-19 infection [Reference Naggie, Milstone and Castro11], and HERO-TOGETHER, a 2-year observational study of registry participants’ experiences after receiving a COVID-19 vaccine [12]. The HERO Registry was launched on April 10, 2020. The HERO-HCQ trial began recruitment shortly thereafter, on April 22, 2020 (Figure 1). Findings from the HERO Registry are available from Forrest et al. [Reference Forrest, Xu and Thomas9] and Friedland et al. [Reference Friedland, Hernandez and Anstrom10]. PCORnet provided access to 8 clinical research networks across the U.S. as hubs for sharing awareness and recruiting to both the HERO Registry and the HERO-HCQ trial.
Timeline of the first weeks of the creation of the HERO Registry, HERO-HCQ trial, and HCW subcommittee. HCW = healthcare worker; HERO = Healthcare Worker Exposure Response and Outcomes; IRB = institutional review board; PCORI = Patient-Centered Outcomes Research Institute; PCORnet = Patient-Centered Outcomes Research Network; RTC = Research Transformation Committee, PCORI.
Participant-engaged research
The HERO Registry launched within a month of the national lockdown in the U.S., and the HCW subcommittee was formed in May 2020. See Forrest et al. [Reference Forrest, Xu and Thomas9] for details on the launch of the registry. Patient- or community-engaged research is a requirement for PCORI funding, and there are many ways to adopt these principles or strategies [Reference Wong, Song and Jiao2,Reference Forsythe, Ellis and Edmundson13], such as community-based participatory research (CBPR) [Reference Scher, Scott-Barrett, Hickman and Chrisinger14,Reference Winterbauer, Bekemeier, VanRaemdonck and Hoover15], PAR [Reference Cornish, Breton and Moreno-Tabarez3], or GPP [4,8]. CBPR and PAR, which would have required various HCW engagements from the initial planning and design, were not feasible at the time due to the urgency to launch the program and capture the experiences of the frontline HCWs. Thus, in line with GPP, creating an HCW subcommittee was necessary as there were no existing relationships among the HERO research team to provide HCW knowledge and experience across various roles that could inform the research regarding inclusive outreach, accessible design, and understanding value for participants.
Good Participatory Practice
The idea of GPP was formally proposed in 2007 by the Joint United Nations Programme on HIV/AIDS (UNAIDS) to address ethical and equality issues arising from HIV prevention trials [4]. GPP guidelines were published to instruct those involved in the design and implementation of biomedical human immunodeficiency virus (HIV) prevention trials on how to effectively engage community stakeholders and collaborate with them during all trial phases. Collaboration between researchers and the individuals or groups with a stake in the trial outcome was found to increase innovation, improve study participation and equity, and ultimately enhance and broaden the applicability of study results. GPP is now an integral part of HIV prevention research [Reference Baron, Essien and Pato16,Reference Newman and Rubincam17]. Community partner engagement and GPP have been implemented in many other research contexts as well, ranging from Ebola vaccine trials [Reference Dada, McKay, Mateus and Lees18] to tuberculosis drug trials [19] to an after-school social intervention aimed at reducing school dropout among adolescent girls in South Africa [Reference Kutywayo, Yah, Naidoo, Malotana, Dyani and Mullick20]. Partner engagement reflecting community or individual lived experiences is also viewed as crucial for addressing new, emerging pathogens for which limited medical interventions are available and for which misinformation and/or social taboos may be rampant. In 2016, the World Health Organization published GPP guidelines for trials involving such pathogens [8] and later adapted a toolbox for COVID-19 [21]. These principles have been particularly important when applied to research on COVID-19 and have provided a path to foster trust between research teams and study participants during the global pandemic [Reference Wilson, Wright, Taylor and Higgs22–Reference Barnes, Hall Dykgraaf and O’Brien25].
Initiation of the HCW subcommittee
At the center of the engagement initiatives for the HERO Registry, the HERO HCW subcommittee was created to advise the HERO research team by providing insights and perspectives based on their lived experiences as representatives of the healthcare workforce during the COVID-19 pandemic. HCWs make up 14% of all U.S. workers; they differ in terms of their roles, cultural identities, workplace settings, and communities of residence [Reference Laughlin, Anderson, Martinez and Gayfield26]. The HERO Registry was open to all U.S. HCWs. Therefore, to reflect the diversity among the HCWs in the registry, an effort was made to choose HCW subcommittee members of diverse racial backgrounds, ages, genders, HCW roles, geographic locations, facility types, and experiences.
HERO research leadership mainly comprised of researchers and academics, identified a need for representation from HCWs. A call for advisors to serve on the HCW subcommittee was issued through PCORnet to the eight clinical research networks in March 2020 with the goal of forming the subcommittee and starting work with the HERO Registry as quickly as possible given the rapidly emerging pandemic. Potential candidates either applied directly for membership or were nominated by another contact in their network. Tasked by the HERO executive committee to form the HCW subcommittee, a team composed of engagement specialists trained in bidirectional engagement, inclusive partnerships, and co-learning principles reviewed applications and conducted phone interviews with individual applicants as part of the selection process. The phone interviews also enabled applicants to understand the role and expectations of subcommittee members. One applicant from each of the eight PCORnet clinical research networks was recommended by the engagement team to serve on the subcommittee. The HERO leadership reviewed these recommendations and contacted the selected members via email to formally invite them to participate in the HCW subcommittee. The process for nomination and selection is outlined in Figure 2.
Process of nomination and selection for the members of the HCW subcommittee. CAPriCORN = Chicago Area Patient-Centered Outcomes Research Network; CRN = clinical research network; HCW = healthcare worker; HERO = Healthcare Worker Exposure Response and Outcomes; PaTH = Path Towards a Learning Health System; REACHnet = Research Action for Health Network, Science, Technology and Research partnership.
The HCW subcommittee was composed of non-licensed (n = 3) and licensed (n = 5) HCWs: an environmental service worker, a paramedic, a medical technician, a respiratory therapist, nurses, a clinician, and a hospital administrator in pediatric and adult care health settings. The racial and ethnicity distribution included three members who identify as non-Hispanic Asian, three members identifying as non-Hispanic Black/African American, and two members identifying as non-Hispanic White. Members were from the Northeast, Southeast, and Midwest regions of the US. Two subcommittee members, a respiratory therapist and a medical laboratory scientist, were elected as co-chairs. The co-chairs also became members of the HERO executive committees, to create conduits for bidirectional communication with HERO leadership. Their liaison role aimed to ensure the adoption of priorities defined by the HCW subcommittee.
A charter was created to outline the activities, purpose, and responsibilities of HCW subcommittee membership. Contracts between the members and the DCRI were formalized, and each HCW subcommittee member received an honorarium for their time. Committee membership was renewed on an annual basis.
HCW responsibilities
The HCW subcommittee was primarily responsible for providing recommendations to the HERO leadership on how to best engage with and understand the priorities of the members of the HERO Registry. Specific input provided by the HCW subcommittee included the following:
• Helping prioritize research topics
• Identifying privacy concerns
• Recommending approaches to ensure the enrollment and retention of HERO Registry members with the registry itself and with COVID-related clinical trials
• Advising on ensuring diverse outreach and enrollment into the registry
• Creating connections and insights to organizations and association partnerships
• Messaging and delivering recruitment & retention material and study communications
• Proposing methods of disseminating research findings to multi-stakeholder audiences
The HCW subcommittee met virtually on a monthly basis starting in May 2020 and lasting through August 2022. The typical meeting included check-ins from subcommittee members about their experiences on the front line, HERO Program updates, and bidirectional dialog regarding the priorities of the HCW subcommittee and the current initiatives of the HERO Registry Program and research team. The HCW subcommittee members provided up-to-date insights on the impact of COVID-19 as an evolving healthcare crisis given that all of the members were HCWs. Study leadership attended meetings with the HCW subcommittee to discuss the latest developments in the COVID-19 scientific landscape and pandemic trends affecting HCWs.
The GPP principles of mutual respect, trust, transparency, and accountability were intentional from the beginning of the HCW subcommittee and the HERO Registry and research team. As an example of mutual respect and transparency, subcommittee members were also placed in governance roles as key members of all HERO committees, including the HERO executive, registry, publication, and ancillary studies committees. Two of the HCW subcommittee members were a part of HERO executive committee in an effort to integrate subcommittee into overall project design. (Supplementary material, HERO Org Chart Figure.) Over the course of the HCW subcommittee engagement, HCW voices and experiences were embedded within the operational structure to guide and influence the HERO Registry’s design, development, and future direction. From the initiation, the HERO research team recognized the importance of maintaining HCW community stakeholder autonomy. The subcommittee did not speak for HCWs as a whole but was able to voice individual concerns and experiences at every meeting, sharing thoughts on research proposals, approaches, or outreach with the intent to broaden applicability, equity, and inclusion across roles or demographics. Initiatives of the HCW subcommittee included:
• Engaging HCW and HCW groups with authenticity to inform and enhance inclusive study recruitment and retention strategies
• Establishing a shared governance model, in which HCWs partnered with clinician-scientists in the research process
• Establishing diverse membership in committee and group work to ensure voices were heard from multiple perspectives
• Developing multifaceted approaches that combined engagement tools including systems for returning value to HERO Registry participants
• Implementing study strategies and metrics for enhanced HCW engagement and adoption of HCW advisor-directed priorities
HCW subcommittee experience
At the end of year 1, a survey was conducted with all HCW Subcommittee members to understand members’ experiences and assess the effectiveness of the engagement. Additionally, near the end of the HCW subcommittee engagement, six semi-structured interviews were conducted via phone and Zoom with available subcommittee members from February 4, 2022, through March 1, 2022. The HCW subcommittee member interviews were conducted and analyzed by a non-partisan team from the coordinating center. All members disclosed they were HERO Registry participants during the HCW subcommittee interviews. Table 1 highlights a reflective summary of the HCW subcommittee member experience.
Healthcare worker (HCW) subcommittee interview findings
Notes: Subcommittee members did not necessarily respond to each question, nor were questions asked in the same order. While points above may be attributed to certain subcommittee members, the list captures their collective sentiment.
The impact of the HCW subcommittee
The HCW subcommittee impacted a wide range of initiatives throughout the HERO Registry Program from recruitment to generation of the HERO TOGETHER research. Documentation from all HCW Subcommittee meetings, activities, and impact were captured in the HERO Engagement Plan which was a living document throughout the project. Table 2 highlights the areas of impact and the outcomes. These efforts led to connections beyond the usual reach of the HERO research team and had an influence on future research programs.
Examples of healthcare worker (HCW) subcommittee engagement with the HERO Registry Program and Research
Notes: The HCW subcommittee represented the community stakeholder group of the HERO Registry Program and trial participants of the research according to the Good Participatory Practice Guidelines [21]. The table provides descriptions of how the HCW subcommittee met the needs of the HERO Registry and research program. The results column includes outcomes or impacts as a result of the HCW subcommittee engagement that improved the efforts of the HERO Registry Program and Research.
EMS = emergency medical services; HCQ = hydroxychloroquine; HCW = healthcare worker; HERO = Healthcare Worker Exposure Response and Outcomes.
Influence on recruitment, retention, and educational outreach
The HCW subcommittee’s insights informed messaging and the delivery of recruitment and retention communications for the HERO Registry and the two associated clinical trials. Subcommittee feedback prompted changes in recruitment materials and social media kits to increase clarity in the registry and trials and to increase diverse representation of HCWs in promotional materials. Additionally, the public-facing website was reconstructed to improve user experience and increase the visual representation of people of color and diverse HCW roles. Several subcommittee members created recruitment videos to encourage membership in the HERO Registry. Finally, messaging around the mRNA COVID-19 vaccines was created to support vaccination efforts with input from the subcommittee members. See Table 2 for additional details.
Engaging national HCW organizations, unions, and associations
A communication plan was developed to directly engage HCW stakeholder organizations in the HERO Registry. The engagement team, research leadership, and HCW subcommittee members leveraged their contacts and previously formed trusted relationships and reached out to 47 healthcare organizations to engage members in the HERO Registry.
An example of such outreach included the SEIU Local 2015 Los Angeles, California Facebook Live Event with Dr Naggie, a HERO Investigator and infectious disease specialist, as a guest panelist. Dr Naggie discussed the HERO Registry as well as the HERO-recruited vaccine trial, HERO Together; the video has since been viewed over 1,600 times. An example organization that was engaged by HERO outreach efforts is The American College of Physicians, Inc., which promoted the HERO Registry to its two boards and included information on HERO in its weekly news email.
Influence on research initiatives
Feedback from the subcommittee members also identified priority topics for HCWs at different times during the pandemic. In addition, the members stressed the importance of focusing on research outcomes most meaningful to HCWs at the time and ongoing approaches to ensure robust engagement and value for participating in HERO. Specific forms of engagement by the HCW subcommittee that translated to direct changes in the HERO Registry or the HERO-HCQ/HERO-Together trials’ inclusive outreach, accessible design, or efforts to create mutual value are described in Table 2.
Exemplar of subcommittee member contribution
In February 2021, an outreach campaign featuring a subcommittee member who worked in environmental services was launched in response to feedback from the HCW subcommittee that many individuals who did not perform direct patient care did not identify themselves as “healthcare workers.” The HCW subcommittee member co-developed all material content, including a photo and the following quote: “We just want to keep people safe, and while doing our job to clean and disinfect surfaces to reduce the spread of the virus, we face the risk of COVID-19 ourselves and put our families at risk. By joining the HERO Registry, we can share our experiences on the front lines and participate in research that can make a difference in this crisis.” This campaign utilized a blog, social media posts, and a flyer to highlight key members of the healthcare team whose roles are often overlooked, and these materials were shared broadly through social media and PCORnet Clinical Research Networks.
Reflections on lessons learned
With approximately 22 million HCWs in the U.S., creating a truly representative group to give voice to the common experience of HCWs during the COVID-19 pandemic was difficult. The HERO subcommittee was formed rapidly at the beginning of the COVID-19 pandemic, with nominations made only through the eight clinical research networks. This meant that the western U.S. was not represented geographically within the subcommittee. In addition, the members had defined roles in healthcare and may not have had an accurate picture of the experiences of other HCWs nationally. The work would have been better informed by a larger group of HCWs that included more geographic diversity, more types of HCW roles, and broader diversity in ethnic/cultural identity. In retrospect, the subcommittee should have been expanded to include such representative members over time if such members were not initially available. Such changes or additions should be made if another national community of HCWs is established for future research endeavors.
Additionally, although a survey of subcommittee members halfway through their two-year membership showed that members had positive feedback about their participation, members also commented on their desire to accomplish more with the registry. Six out of eight members completed the survey responses. Results showed that members felt that they had enough information about the topic areas to participate effectively in the subcommittee; that the engagement team had a clear understanding of members’ expertise, strengths, and roles; that open communication was fostered; that information was presented in understandable ways; and that co-learning occurred. Yet, both the year 1 survey and year 2 interviews of the HCW subcommittee members shed light on several concerns. First, they indicated that there were no specific tasks for members to complete, aside from sharing insights during or in between meetings. In addition, outside of the two clinical trials, there was a lack of clear goals for questions the research was aimed to address. Finally, the members felt that they had more of a consultative rather than collaborative role with the HERO executive committee and the HERO Registry as a whole. Collaboration may have been better fostered with a clearer picture of the tasks and goals of the HERO Registry project where subcommittee members could lend their expertise and perspectives to specific research objectives. Future research, including a community partner group such as the HCW subcommittee, should include periodic reassessment of membership experience to strengthen GPP principles and the research representation of the participants and its community.
Implications for future research
An engagement strategy that centers equity through inclusive committee structure and pathways of influence can generate a balanced perspective and directly influence various aspects of a program [Reference Aguilar-Gaxiola, Ahmed and Anise27,Reference Cunningham-Erves, Mayo-Gamble and Campbell28]. Lessons learned from the HCW subcommittee’s work on HERO include the following:
Adopt GPP guidelines [21] with the population being researched partnering with clinician-scientists to develop and implement the research process, especially in the setting of an emergent disease or during a global health emergency.
Establish diverse membership in committees to ensure that voices are heard from multiple perspectives [Reference Walsh, Stead, Sawyer, O’Shea, Watson and Anderson29,Reference Flores, Mendoza and DeBaun30].
Employ agile strategies to include representative voices; initial engagement plans must include frequent assessments and adaptability to ensure that the engagement strategy is effective and that the communities experiencing the greatest impact are partners in the research. Examples include seeking partnerships with organizations that serve racially/ethnically diverse groups, such as the National Association of Hispanic Nurses; or creating ways to collect diverse perspectives, such as shorter-term focus groups or listening sessions.
Co-create opportunities for growth, mutual value, and enhanced involvement based on partners’ interests or expertise. Examples include being members of executive committees, coauthoring manuscripts or posters, leading virtual or in-person events, or being ambassadors for programs at a local or national level.
Implement strategies to enhance HCW engagement and track the adoption of HCW partner-directed priorities.
Conclusion
GPP has enhanced clinical research in many areas and is especially important in trials dealing with new/emergent diseases. The formation of the HCW subcommittee helped guide the design and conduct of the HERO Registry, a novel online registry of HCWs developed early in the COVID-19 pandemic. The subcommittee members’ diverse roles in healthcare and lived experiences helped to generate a balanced perspective for the HERO Registry Program and directly influenced aspects of its research efforts.
Prioritizing participant partner engagement with the research team enhances research recruitment and retention efforts as well as overall research quality. The HERO Registry’s HCW subcommittee provides an example of how lived experience partners can be integrated successfully into a research program and can provide valuable insights to shape and support participant-focused research.
Supplementary material
The supplementary material for this article can be found at https://doi.org/10.1017/cts.2024.668.
Acknowledgments
We would like to thank all of the HCWs who served on the frontline of the COVID-19 pandemic. We are particularly grateful to those who chose to participate in the HERO Registry and the HERO-HCQ and HERO-TOGETHER trials. The authors thank Diana Steele Jones of the DCRI and Pamela Walter of Thomas Jefferson University for providing editorial support. The authors are entirely responsible for the scientific content of the paper. The paper adheres to the journal’s authorship policy.
Author contributions
All authors co-developed the outline and key messaging for this manuscript. All authors reviewed the manuscript. JK wrote first draft. MC-L, JK, and RL wrote main manuscript text. RL prepared Table 1; MC-L prepared Table 2; LC prepared Figure 1; RL prepared Figure 2. RL/MC-L prepared supplemental figure.
Funding statement
The PCORI, Contract Number COVID-19-2020-001, funded this project.
Competing interests
The authors declare that they have no competing interests.
Ethical approval and consent to participate
Study procedures for the HERO Registry were reviewed by the Duke University School of Medicine Institutional Review Board and approved by the Western Institutional Review Board (Pro00105284). (Pro00105274).
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