Health Communication and Decision Making about Vaccine Clinical Trials during a Pandemic

"Although communication about vaccines and vaccine hesitancy were challenges long before COVID-19, the twin facts of a pandemic and an 'infodemic' of health information, misinformation, and disinformation have raised new challenges for vaccine-related communication and decision-making."

In the context of the COVID-19 pandemic, the need to quickly recruit a diverse group of participants into vaccine clinical trials while educating the public about vaccines and communicating about COVID-19 risk reduction behaviours has presented new challenges for researchers. Part of a special issue of the Journal of Health Communication (see Related Summaries, below), this paper highlights strategies to improve communication and decision-making for adults considering participation in COVID-19 vaccine clinical trials. It presents a general conceptual model for clinical trial participation that can be applied to various vaccine and other clinical trial contexts. It also introduces the ASK (Assume, Seek, Know) approach for enhancing equity, inclusion, and efficiency for vaccine clinical trial recruitment and future vaccine uptake.

The general conceptual model of clinical trial participation presented here is informed by the Theory of Planned Behaviour (TPB), the Elaboration Likelihood Model (ELM), and the Ottawa Decision Support Framework. It articulates health communication and decision-making considerations and their interactions, including, in brief:

• Patient characteristics - An important principle in health communication is to know your audience by understanding sociodemographic factors, languages spoken, health literacy, health beliefs, and health customs. For example, investigating the latter factor (e.g., degree to which family members are involved in decisions about health) may influence how researchers design clinical trial communications for their intended audience. In addition, the concepts of cultural sensitivity and cultural tailoring are considerations for developing vaccine clinical trial communications. Attending to these factors could help a researcher develop messages in a way that coheres with norms and thus gives a specific health behaviour or problem meaning that resonates.
• Clinical trial characteristics - Various aspects of a clinical trial can affect communication, deliberation, behavioural intentions, and outcomes. For example, who the sponsor is (e.g., pharmaceutical company or governmental agency) may affect protocol development, public messaging, and patient willingness to participate. Factors such as location of research sites in the community, travel time to research sites, number of study visits, and duration of the trial contribute to patients' perceived "hassle" associated with being in a trial. The existence of incentives for participation also play a role.
• Communication: Raising awareness and reaching your audience - Presented here is a framework developed by health communication experts that highlights five aspects of communication: source and channel, message, audience, and context. For example, when this paper was written, there were questions about context: when a COVID-19 vaccine would be available, how approved vaccines would be equitably distributed, and how to address medical trust among racial/ethnic minorities who may be leery about participating in COVID-19 vaccine clinical trials.
• Deliberation: Understanding and supporting decision making - On the TPB, attitudes, subjective norms, and perceived behavioural control precede an individual's intention to perform a behaviour or make a choice, such as whether or not to enroll in a vaccine clinical trial. With regard to how messages are received and perceived by potential vaccine clinical trial participants, the author draws on the concepts of central and peripheral route processing from the Elaboration Likelihood Model (ELM). For instance, with central route or "deeper level" cognitive processing, potential participants may be motivated to join a vaccine clinical trial for personal or social reasons (e.g., a parent died from COVID-19 in a nursing home). Other factors that influence one's intention to participate include knowledge about vaccine clinical trials generally and vaccines specifically, trial-specific values (e.g., what harms and benefits matter most), and motivation for participating.
• Behavioural intention - Factors discussed here include: readiness to make a decision, which is affected by knowledge, information-seeking ability, and clarity regarding one's opinions about research; the quality of the informed consent process; and certainty about the decision to participate.
• Outcomes - Patient-level outcomes in vaccine clinical trials may include whether or not patients decline participation or enroll in a study, retention of participants throughout the life of the study, and decision regret. Population-level outcomes may include improved medical innovation (e.g., a new vaccine or several new vaccines for COVID-19) and reduced morbidity and mortality.

To move from this conceptual model to practice, the author developed the ASK approach for enhancing clinical trial participation:

1. Assume "that all patients will want to know their options, will be open to considering clinical trials, and will enroll if eligible and explicitly asked. By starting with this assumption, researchers increase the likelihood that a greater number of patients will be aware of clinical trial opportunities, thus reducing disparities in communication and clinical trial offers..."
2. Seek the counsel of stakeholders "throughout the clinical trial process, [so that] challenges and opportunities can be identified and addressed when there is still time to make adjustments to the recruitment plan."
3. Know your numbers, including "the number of potentially eligible patients or 'pool of patients,' number of patients invited via different channels, response rates by different channels (e.g., patient portals vs. social media advertisements), number of interested but not eligible patients, number of declines by eligible patients, and number of enrolled patients."

The author provides an example of how the ASK approach can be applied in real-world settings, drawing on experiences within her own institution.

Table 1 in the paper features a curated list of vaccine, clinical trial, decision-making, and health literacy resources. "Future research should explore how best to communicate vaccine clinical trial opportunities while also addressing vaccine literacy in both clinical care and public health communication contexts."