Low health literacy is a significant barrier in healthcare. It’s strongly linked to poor health outcomes due to poor health management, medication mistakes, and more. Regarding patient recruitment and retention, patients with limited health literacy are less likely to be interested in participating in clinical research, and if they do enroll, they are less likely to complete trial participation.
Health literacy is often thought of as a binary — high and low. Those with high health literacy tend to be younger and more educated, and low health literacy is associated with people who are older, less educated, poorer, or non-native English speakers. However, limited health literacy is much more common than many healthcare professionals may realize. In a National Assessment of Adult Literacy, only 12% of Americans were considered to be proficient in health literacy.
For this reason, health literacy should be thought of as a spectrum. Someone might understand how to read a prescription label to take their medication correctly but may not be able to understand the risks and benefits of the treatment. Some may not understand how to read a prescription label, but they may be able to follow written directions from their physician on how to take the medicine. And even those with high literacy skills may struggle with health literacy, especially in times of stress or fear.
What is it that makes health literacy so difficult? Many think that incorporating health literacy practices means writing or speaking at a certain grade level, and while that is a part of it, it’s much more complex than just reading levels. The National Library of Medicine, along with the U.S. Department of Health and Human Services (HHS) Healthy People 2030 Initiative, breaks health literacy into four categories. This means that to have high health literacy, a person must be able to find, understand, and, most importantly, use health information they receive from the healthcare system (personal health literacy), find, understand, and appropriately appraise digital information to address their problem (digital health literacy) and have numeracy skills (quantitative literacy), as well as access to a healthcare organization that practices organizational health literacy.
What Can Investigators and Site Staff Do to Promote Organizational Health Literacy?
Despite America being at its most educated in history, the sheer task of mastering our complex and multifaceted healthcare system is a lot to ask of people. Not to mention, the educational setbacks from the COVID-19 pandemic and the constant battle of health misinformation and fear-mongering will likely set Americans back further for years to come. Therefore, the burden is on sponsors conducting clinical trials to support study teams in equitably promoting health literacy in potential participants. Here are some best practices to keep in mind during patient recruitment and trial participation.
- Meet Patients Where They Are in Their Journey: Patients’ understanding of their diagnoses, treatment options, and the healthcare system as a whole varies greatly. Many patients, especially those who are newly diagnosed, don’t know much about their condition. They also might be stressed and anxious and not in a good headspace to decide on the next steps. Conversely, some may have been living with difficult diagnoses for years and have spent hours researching their best options and the latest treatment developments. Understanding where the potential participant falls on that spectrum can help structure the conversion and provide guidance for toolkit development. If newly diagnosed, treatment-naive patients are required for the study, consider providing more educational materials about the disease and structuring the conversation around disease education, as well as education around clinical trials.
- Provide Clear Communication Throughout the Trial Lifecycle: With patient dropout rates as high as 40%, it’s crucial to find a way to keep patients engaged throughout the entire clinical trial. There are many reasons why participants drop out, but one major reason is they don’t understand the participation requirements or have found the requirements to be too difficult. Providing site staff with communications strategies and tools in addition to the ICF to educate and engage participants can improve retention. Mixed-media study toolkits that include a range of pre- and post-consent materials will help keep patients engaged throughout the entire clinical trial. Video content, for example, is often more memorable than written content, so including videos alongside written materials is a great way to connect emotionally with potential participants and reach a wider audience.
- Encourage Dialogue and Questions: Studies show that people are more likely to remember information when they are actively listening and participating in a conversation. Additionally, in clinical research, patients are much more receptive to investigators who are open, excited, and able to answer their questions. Investigators and site staff can encourage active listening by asking potential participants to repeat information in their own words and asking open-ended questions to help make sure they are listening and understanding. Investigators can also encourage potential participants to bring a loved one to visits to take notes or provide educational materials for them to take home and discuss.
- Consider the Impact of the Design: In written materials, health literacy is about more than the content. Before potential participants have even started reading, they digest the design. Design plays a huge role in people’s ability to read and understand as well. Is the typeface and sizes clean and clear? Is there enough white space? Is there enough color contrast for the text to be read clearly? Does the study population have any specific struggles with vision or cognition that need to be taken into account? Beyond basic readability, there is the study population and their journey to consider to create an emotional connection.For example, the Prevent-HD Trial evaluated an investigational drug to reduce the risk of blot clots and related complications as a result of COVID-19. At that time, the vaccine was not yet available, so the lack of medical prevention, coupled with rampant misinformation, was causing stress, worry, and confusion. We developed a study toolkit with this mind, focusing on clarity, a clean study identity, and providing people with a way to take action.
- Emphasize Patient Protections: One of the most common reasons that patients are not interested in clinical research, especially among those with lower health literacy, is the fear of being “experimented on.” More education about what clinical trials and Informed Consent are can help put potential participants more at ease. Helping patients understand the stringent review process for clinical trials, available safety data, and their rights and protections during participation can make them feel more confident in enrolling in a clinical trial.
Joining Together to Promote Health Literacy in Clinical Research
Up to 80% of clinical trials are terminated or delayed due to patient recruitment and retention issues. While there are many reasons this happens, one way we can combat this is by changing how we approach health literacy in patient recruitment. Putting a focus on organizational health literacy and investing in patient education can help bridge the gap.