In Focus: Addressing the Health Literacy Roadblock in Patient Recruitment
With universal adoption of health literacy best practices slow going over the years, advocates are redefining the term to encompass much more of what health-related communication requires beyond simply words.
If clinical trial enrollment is improving, it’s a secret well hidden. PubMed is chock full of studies that bemoan the little progress, if any, of trial sites reaching their desired accrual numbers. The HHS Office of the Inspector General, in its May report that looked at enrollment of underrepresented groups in NIH-funded trials, said, in general, that“the NIH monitors clinical trial enrollment but has had limited success spurring improvement.”1
In all fairness, Sisyphus had an easier task. Successful clinical trial enrollment might be a numbers game, but it’s a game involving people, and what attracts one person to sign a consent form might barely interest another. Older patients often stay away because they are sicker and, therefore, reluctant to travel to trial sites;2 younger patients with little means need child care and transportation. Some want technology, others think that “smartphone or tablet use during studies disrupt[ed] their daily routines.”3
To be sure, numerous, disparate studies are showing just how complicated it can be to get patients to sign on the dotted consent form line. “A wide range of strategies and tactics are needed to reduce barriers to participation and improve retention,” wrote Sine et al. of the 12,451 responses they received to an online global survey.4
Perhaps the widest need of all: The use of everyday plain language is not, at least judging by the literature, in wide use. Patients want the kind of communication that allows them to comprehend their disease, the trial process itself, what is expected of them, and what they can expect from the trial.
“It’s a deterrent [from participation] when you don’t know what you are reading,” said one oncology patient during a Center for Information and Study on Clinical Research Participation webinar.5
When the concept of health literacy was introduced years ago, the hope was that people would be better able to understand what they were hearing or reading about their situation, aided by simpler language. But health literacy best practices have not been universally adopted, so access to comprehensible materials has remained elusive.
To address this, health literacy advocates have essentially redefined the term. Initially, says Sylvia Baedorf Kassis, MPH, program director, multi-regional clinical trials, Center of Brigham and Women’s Hospital and Harvard (MRCT Center), the health literacy definition was focused on a person’s ability to access, understand, and use health information to make decisions. In the last few years, she says, the concept has expanded. There is still personal health literacy, but now there is organizational health literacy, which “makes it incumbent on the communicators to provide clear communication. The system needs intervention; there is an obvious reason people don’t understand it,” says Baedorf Kassis.
No longer just patient-directed, health literacy is now provider-directed, too. Further, says Baedorf Kassis, that once simple definition of health literacy now encompasses more of what clear, understandable health-related communication requires, taking into account not only words, but also numeric information, cultural humility, and understanding overarching social determinants of health.
Another factor that needs consideration, she says, is cognitive decline in the elderly, especially those whose childhood IQ scores were low to begin with.6 A patient’s emotional state also affects his or her ability to absorb the information being shared, adds Baedorf Kassis. Healthcare professionals in various roles have tried to address the problem, from creating plain language clinical trial templates, developing plain language glossaries that can be downloaded (The AMA’s includes words such as ableism, whiteness, and weathering), and even hiring patient advocacy employees who oversee writing of all patient-focused documents to ensure that they are health literacy accessible.7To support clear communication, for example, the MRCT Center has developed a downloadable Clinical Research Glossary. “Since April, the downloads are in the 1,000s. Folks are coming and using it,” says Baedorf Kassis.
Most potential clinical trial patients want more from their physicians. They want their physicians to give them the particulars of the trial—in a calm setting, not the emergency room—and once enrolled, they want trial staff who know how to communicate with them.8,9 How one patient with diabetes, for example, interprets their illness and its complications is not how another patient understands it.
This patient attachment to his physician is nothing new. A 2008 survey that asked cancer patients about knowledge of clinical trials, found that the more patients knew about the trial and its benefits to them, the more they felt their physicians’ support, and “when the physician invited the patient to participate (20% of the time), three of four patients” accepted.10 Other patient surveys have found that patients are increasingly more interested in leaning on their physicians to learn about trials.
Another huge boulder to roll up that hill: Journal articles advocating health literacy practice in the clinic go back decades—as do efforts by many federal agencies and professional organizations. But, according to various published reports, it doesn’t appear as if physicians, or medical schools in general, are adopting plain language ways.
“I don’t see them asking for help,” says Baerdorf Kassis. “This speaks to organizational and systemic issues that need to be addressed.”
One meta review in the journal Cureus on physicians’ attitudes regarding health literacy found most blamed “dysfunctions within the healthcare system, staff shortages, managing a large number of patients, limited time, work-related stress, cultural and socio-economic barriers, medical jargon, and language barriers.” A survey of community pharmacists in poorer sections of southwest Georgia, published in 2023 article in Journal of Pharmacy Practice, found they had no health literacy training, and most didn’t know that their lack of knowledge about health literacy kept them from screening their patients for their own health literacy levels.
Can we dismantle the hierarchy between patient and physician to allow for good communication? asks Baedorf Kassis. Researchers do not want to confuse patients, she believes. “I think it is hard to unlearn what you learned and to remember what it is like to have a beginner’s mindset. Medical professionals learn a scientific, technical language, so simplifying takes practice. But we need to meet patients where they are.”
She adds: “Doctors aren’t resisting on purpose. Medical professionals have learned medical and scientific language, so it takes practice.”
Christine Bahls is a Freelance Writer for Medical, Clinical Trials, and Pharma Information
References
1. Department of Health and Human Services. Office of Inspector General. Plans and Enrollment Often Fell Short for Underrepresented Groups in a Sample of NIH-Funded Clinical Trials. May 28, 2024. https://oig.hhs.gov/reports/all/2024/plans-and-enrollment-often-fell-short-for-underrepresented-groups-in-a-sample-of-nih-funded-clinical-trials/
2. Buttgereit, T.; Palmowski, A.; Forsat, N.; et al. Barriers and Potential Solutions in the Recruitment and Retention of Older Patients in Clinical Trials-Lessons learned from Six Large Multicenter Randomized Controlled trials. Age Ageing. 202. 50 (6), 1988-1996. doi: 110.1093/ageing/afab147
3. de Bruin, A. Latest CISCRP Patient Survey Reveals Diversity Gaps, Yields 5 Tips For Improvement. Clinical Leader. March 20, 2024. https://www.clinicalleader.com/doc/latest-ciscrp-patient-survey-reveals-diversity-gaps-yields-tips-for-improvement-0001
4. Sine, S.; de Bruin, A.; Getz, K. Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications. Ther Innov Regul Sci. 2021. 55 (5), 1059-1059. https://doi.org/10.1007/s43441-021-00306-8
5. Center for Information and Study on Clinical Research Participation. Tools of the Trade for Patient-Centric Clinical Development. YouTube. https://www.youtube.com/watch?v=YVAoZkBwP9M
6. Murray, C.; Johnson, W.; Wolf, M.S.; Deary; I.J. The Association Between Cognitive Ability Across the Lifespan and Health Literacy in Old Age: The Lothian Birth Cohort 1936. Intelligence. 2011. 39 (4), 178-187. https://www.sciencedirect.com/science/article/abs/pii/S0160289611000535
7. Empowering Patients on Clinical Trials Day and Beyond. Galapagos. May 20, 2024. https://www.glpg.com/stories/empowering-patients-on-clinical-trials-day-and-beyond/
8. Briel, M.; Speich, B.; von Elm, E.; Gloy, V. Comparison of Randomized Controlled Trials Discontinued or Revised for Poor Recruitment and Completed Trials with the Same Research Question: A Matched Qualitative Study. Trials. 2019. 20 (1), 800. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3957-4
9. Williams, C.P.; Senft Everson, N.; Shelburne, N.; Norton, W.E. Demographic and Health Behavior Factors Associated with Clinical Trial Invitation and Participation in the United States. JAMA Netw Open. 2021. 4 (9), e2127792. https://pubmed.ncbi.nlm.nih.gov/34586365/
10. Albrecht, T.L.; Eggly, S.S.; Gleason, M.E.; et al. Influence of Clinical Communication on Patients’ Decision-Making on Participation in Clinical trials. J Clin Oncol. 2008. 26 (16), 2666-26673.J1;26(16):2666-73. https://pubmed.ncbi.nlm.nih.gov/18509178/
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