By Paul Nicolaus

April 25, 2017 | “What we’ve got here is a failure to communicate.”

It’s one of the most famous film lines of all time, uttered in 1967’s “Cool Hand Luke” starring Paul Newman, but it also seems to translate particularly well to the current U.S. healthcare landscape. Only 12% of American adults have a “proficient” level of health literacy while over one-third have trouble with basic health related tasks like reading the directions on a prescription drug label, according to a 2003 National Assessment of Adult Literacy (NAAL) conducted by the U.S. Department of Education.

As society moves further and faster into the digital world, new advances in health information technology (HIT) are resulting in an explosion of tools such as patient portals, mobile apps, and wearable technologies that provide the potential to help resolve this communication breakdown by providing clear, compelling information in easily digestible forms. But as a recent study in the Journal of Medical Internet Research has shown, there’s also a chance that these new technologies could be creating added obstacles.

New Digital Divide?

Lead author Michael Mackert of the University of Texas at Austin says the study, in some ways, goes back roughly a decade to previous research focused on the ways in which lower health literacy parents used the Internet to raise their kids. One of the interesting elements that kept popping up within his focus group at that time was the indication that the parents did not trust the government for health information. Over time, they learned to avoid websites ending in .gov or .edu because the information presented on these sites was too complex.

Around this time, there was plenty of talk about the so-called “digital divide” as disparities grew between those benefitting from the Internet and those who were missing out. With broadband becoming cheaper and smartphones becoming more widespread, the common assumption is that this gap has been closing over time thanks to increased access. But Mackert and his colleagues suspected the divide might still exist.

This time around they were less focused on access and more tuned into the design and content levels of patient-facing healthcare IT apps and products, and their research revealed that lower health literacy populations were less likely to see these technologies as easy to use and useful.

“What that means to me is that we’re doing a bad job of both explaining the value of some of these new technologies to lower health literate audiences and populations, but also making them look like they’re easy to use,” Mackert explained.

If a person’s first impression is that something doesn’t look easy to use, you’ve lost them before they even think about whether they want to use it. “In some ways, it’s kind of a training problem on the developer side,” Mackert said. Developers could be taught to think about this audience and the elements that could improve comprehension, such as relevant images. “The hope is that as people get better at using these kinds of tools and as the tools themselves get better, it can lead to better clinical encounters with providers and can lead to better outcomes.”

Removing HIT barriers could help level the playing field and ensure that a whole new digital divide does not grow between the more health-literate users who benefit from technology and the less health-literate who avoid digital tools or struggle to use them to their full potential.

Clinical Research Implications

These issues extend beyond just clinical care to include clinical research as well, noted Wendy Tate, director of data analytics at Nimblify—a clinical trials technology company. From recruiting patients to helping them understand the consent process, literacy plays a huge role. Without effective communication, patient misunderstandings can lead to medication mistakes, lower compliance rates, failure to follow instructions, and poor outcomes for a study.

In her current role, Tate collaborates with institutions to develop and validate meaningful and quality metrics regarding various aspects of clinical trial operations. Before joining Nimblify, she worked at the University of Arizona in clinical trials administration at the school’s cancer center and for the Human Subjects Protection Program, the administrative and regulatory support program to the Institutional Review Boards (IRBs).

It was during this time that she had the opportunity to read human research being conducted in every college on campus, and she noticed varying concepts of how researchers thought they needed to speak to the populations they were working with. One of the most interesting dynamics she learned from working with the IRB members and listening to them perform ethical reviews is that so much of the impacted population had no idea about the science behind the research.

“It’s a literacy problem from a scientific perspective, and it really is amplified when it comes to health literacy,” she said. “The average American doesn’t necessarily even understand the prescription bottles that they’re reading or understand the concepts that are being put forth by their insurance company on what’s covered and what’s not covered, and that’s really a shame because it impacts how your life is going to play out and the quality of life that you have.”

Medicine is based on clinical research. It’s the way our society is set up, Tate said. Any medication obtained over the counter or by prescription has to be approved by the Food and Drug Administration (FDA), and the FDA approval process relies on clinical research and trials.

That research needs to be understandable to the people participating in it because they are the ones who are helping guide everyone else’s future. They are not just science guinea pigs but actual participants in a process that is important for their own health and future, as well as science at large.

“When the government put out their health literacy they mentioned that the average reading capacity of an American is about the 6th to 8th grade level, and so really if you want to talk to the average American in health terms you need to do it in a way that a middle schooler can understand,” she said. “And when you take a look at scientific literature, you don’t see that. It’s very often written at a college or college graduate level.”

Trials and Technology

Testing a drug can be thought of as a science project. Most grade school or middle school students learn about the scientific method, which involves asking a question, formulating a hypothesis, setting up procedures, performing the experiment, collecting data, analyzing the results, and drawing a conclusion. This method applies to the way clinical research is conducted, and it is something that needs to be related back to the community in ways that can be easily digested.

Technology can help with that comprehension, whether it’s the use of dictionaries, simple language terms, pictures, or other online resources. At the moment, however, the failure to communicate is putting the brakes on research. “Up to 90% of clinical trials don’t recruit the number of subjects that they want to within the time period that they were hoping,” Tate said, “and so you have an extension of these recruitment periods that sometimes lasts years.”

Time is money, of course, and the longer trials go on, the longer before needed data are obtained (or if a drug is not approved, other research is delayed). One of the first steps of a clinical trial should be developing a quality health literacy program geared toward those who are needed for a study to move forward. Using multiple platforms and simple language designed to reach prospective subjects can potentially lead to greater levels of understanding and trust.

The consent process is another opportunity to improve health literacy for patients. Rather than asking individuals to simply read a document that explains a trial, interactive methods such as apps or video content can be used to enhance comprehension. It is becoming increasingly popular to integrate elements like test questions within a consent form used on a tablet or computer, for example. If a question is not answered correctly, additional information can then be provided.

Tapping into technology is also allowing research participants to absorb information in an environment where they are most comfortable. Receiving information at home, for example, allows patients to share information with friends and family to gather other thoughts and opinions.

Similarly, methods of gathering data used for medical research are evolving to include the added comforts of home. Rather than driving to a doctor’s office to have test measurements taken, participants can weigh themselves or take their blood pressure and enter the information on their own thanks to products like Apple’s ResearchKit. And wearables put out by companies like Fitbit and Jawbone are being used to capture daily activities and measure figures like heart rate and calorie intake.

Keeping Target Population Top of Mind

“Even though everybody’s excited about this mobile technology and this ability to tap into these different resources, they are not universally accessible,” she cautioned. It is essential to keep the target population in mind at all times. Research examining those who may be in a lower socioeconomic group needs to consider that the population may not have the same sort of access to smartphones as the general population, for example.

Also, technology isn’t for everybody and shouldn’t necessarily be used just because it is available. “While technology is a really great tool that everyone wants to use because it is kind of the cool thing of the day,” Tate said, “you have to make sure that it is actually right for your study population as well as for the science that you are conducting.” Beyond socioeconomic status, age and maturity level are other factors that should be considered. While older adults are certainly capable of learning to use a new technology, for instance, this may not be an appropriate fit for a population experiencing dementia.

“I think what it comes down to is that technology can really help us with a problem that we’ve been having ever since clinical research came into being,” Tate noted, being able to communicate with a population in a way that they understand what’s going on. Though it varies by population, there’s a huge level of distrust with science and researchers, and a lot of that comes down to the fact that health literacy is not where it needs to be. You can blame the education system, but it is never too late to learn, she said.

“Scientists really have a responsibility to the public to educate them and the people that they’re working with on the research that they’re doing,” said Tate, “and I think that technology can really help us in a huge way to bridge the gap between complex scientific terms and language that people speak.”

Paul Nicolaus is a freelance writer specializing in health and medicine. Learn more at www.nicolauswriting.com.