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Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop (2020)

Chapter: 4 Experiences Implementing Health Literacy Best Practices in Clinical Trials

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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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4

Experiences Implementing Health Literacy Best Practices in Clinical Trials

The next panel of the workshop featured three speakers who presented their programs or research on implementing health literacy practices in clinical trials. Connie Arnold, professor of medicine, Louisiana State University (LSU) Health Sciences Center, described her takeaways from implementing two different health literacy interventions to promote cancer screenings. Lauren McCormack, vice president of the Public Health Research Division at RTI International, then spoke about her research on making clinical trials and informed consent more patient centered. Finally, Saira Z. Sheikh, assistant professor of medicine at the University of North Carolina (UNC) at Chapel Hill, director of the UNC Rheumatology Lupus Clinic, and director of the Clinical Trials Program at UNC’s Thurston Arthritis Research Center, addressed some common barriers to patient participation in clinical trials. Phyllis J. Pettit Nassi, associate director of Research and Science, Special Populations at the Huntsman Cancer Institute, moderated a discussion between the speakers and the audience.

LESSONS LEARNED FROM TWO HEALTH LITERACY INTERVENTIONS TO IMPROVE COLORECTAL CANCER SCREENINGS

Connie Arnold, Professor of Medicine, Louisiana State University Health Sciences Center

Arnold opened her presentation describing two clinical trials that she and Terry C. Davis had directed, during which they implemented health literacy interventions in cancer screenings in mostly rural areas.

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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The First Trial: 2007 to 2012

The first study was conducted between 2007 and 2012, observing eight federally qualified health centers’ (FQHCs’) colorectal cancer (CRC) screenings. Arnold noted that before she and Davis write grant proposals, they call the chief executive officers (CEOs) of the FQHCs they want to work with, set up a meeting, and go to meet them. Together, they walk through what works in the clinic for patients, and ask the staff how they envision any interventions progressing. “As Terry [Davis] always tells me, it’s all about the relationship,” she continued, “especially when you’re implementing interventions in a clinic you don’t actually work at.” Additionally, she said, clinic staff can advise investigators about what interventions might work really well or really poorly with patients.

Arnold also noted that FQHCs and community clinics and their staff are often unaccustomed to the cycle of grant proposals in clinical research. She continued:

If you don’t get funded the first time, you resubmit your proposal a year and a half, or maybe two years later. One of the keys is to keep the clinics involved in the process. We are very clear and very upfront with them about what we are submitting, and what we plan to resubmit, how long the proposals take to be reviewed, and we keep them updated on the status and the results of reviews. That’s really important, because otherwise, they forget who you are.

The FQHCs, she added, are government-supported clinics that provide health care services for up to 28 million people, regardless of their insurance status (HRSA, 2019). They are generally located in areas that are medically underserved, she said, so the target for the trial was five FQHCs in northern Louisiana, which is a predominantly rural area.

Arnold went on to explain that the first study was made of up 67 percent African American patients and 32 percent white patients, with 56 percent of them reading below an eighth-grade level (Arnold et al., 2016a,b; Davis et al., 2013, 2014a,b, 2015a,b). Additionally, the investigators had built focus groups into the study design to include patients and providers in developing and testing materials like brochures and surveys. One of the changes the investigators made to the materials involved developing a Likert scale but shaped vertically, because it improved comprehension for patients with lower health literacy. They also used something they called the “two-step” process, to encourage patients to identify the degree to which they agreed or disagreed with a statement on the scale. Arnold had found that patients with lower health literacy rarely answered that they “strongly” agreed or disagreed with any of the survey statements, so she had the research assistants (RAs) start the question with “do you agree

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

or disagree?” and then ask a follow-up question to define the answer. For example, if the patient said they agreed with the statement, the RA would ask them to clarify if they agreed or strongly agreed, which helped encourage more accurate responses.

The investigators also developed short videos with patients, she continued, using their interests and experiences to show a woman receiving a mammogram for a breast cancer screening and a man getting a fecal occult blood test (FOBT) for a CRC screening. She added that they used stock photos in the first brochures they developed, but in the subsequent study, they used actual patient photos. “We tried to incorporate all of the principles we know about health literacy,” she said, to find out what would resonate with the population. She added that, as great as they felt the videos were, patients did not really want to watch them. The three-arm study involved the following:

  1. An enhanced usual-care arm: patient given information, recommendation, no-cost mammogram or FOBT kit, and suggestion to talk with a primary care physician (PCP)
  2. A health-literate care arm: patient given information, recommendation, no-cost mammogram or FOBT with simple instructions, pamphlet, video, and suggestion to talk with a PCP
  3. A health-literate care-plus-nurse (plus) arm: patient given information, recommendation, nurse case manager, tailored education, either a mammogram scheduled by a nurse or an FOBT kit, and a follow-up call to remind and problem solve

The investigators also hired an RA for the clinics. To enroll three or four or five patients per week, Arnold said, they did not require a full-time RA, but the investigators worked with the FQHC CEOs to train someone to do informed consent, distribute materials, or run the questionnaire. Most of the time, the clinics chose a staff member who already had some extra time, Arnold said.

In 2007, Arnold added, the intervention really affected CRC screening knowledge, more than mammography and breast cancer knowledge (Arnold et al., 2009, 2017). The investigators were unsurprised that the results revealed that the patients in the health-literate care and the plus arms had a significant improvement in colon cancer screenings—the clinics had between 1 and 3 percent screening rates when the investigators began the study, she said. She noted that in years two and three, patients did not always return to the clinic to get their FOBT screening kit. The clinic mailed the kits to patients in every arm, but it was a challenge to have patients understand that they needed to return the kit every year, she explained.

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

Arnold noted that there were a handful of challenges she had identified when working with the FQHC partners:

  • Community clinics focus on service for patients, not research fidelity.
  • It can be difficult to find qualified RAs in rural areas.
  • Hiring RAs from clinic staff is a “catch-22”—while their relationships are helpful to the work overall, research is usually their secondary job and is put on the back burner if the clinic is understaffed.
  • There is high physician turnover in rural areas.
  • Follow-up calls are feasible, but phone lines are commonly disconnected then reconnected. The calls are often time consuming and it was not cost-effective to hire a nurse.
  • Patients lose FOBT kits or forget to complete them.
  • The wait time for diagnostic colonoscopy at LSU was up to 1 year during this study.

The Second Trial: 2012 Through 2018

For the second study, Arnold said, the investigators used what they learned in the first one: health literacy information was going to be standard in both arms, because they knew that it was more effective. “There wasn’t any reason to go back to using enhanced usual care,” she said. With colon cancer screenings, the issue was largely years two and three, in that patients did not continue to use the FOBT kits. “The point of our second study,” she continued, “was to look at automated and personal phone calls. Did it make a difference if it was a live person or would an automated phone call be just as effective?” The investigators worked again with clinic staff, this time in southern Louisiana. They also created a recorded phone call with a person who had a southern Louisiana accent, she noted.

The second study, which began in 2012, used the fecal immunochemical test (FIT) instead of the FOBT for CRC screenings, though both still required yearly tests, Arnold noted.1 At the time, she said, rural clinics were not referring patients for colonoscopies, because they were unlikely to be able to pay for them. The investigators simplified the FIT instructions and colorectal cancer screening materials and everyone enrolled in the trial was given health-literate materials by an RA in the clinic, Arnold explained. They had hired RAs in the same manner as in the first study, she added, and the RAs demonstrated the FIT, which could be confusing.

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1 For information about FIT, FOBT, and colonoscopy screenings, see www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/screening-tests-used.html (accessed September 20, 2019).

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

However, years two and three bore the same issues as the first study. If a patient did not return their FIT kit within 4 weeks of the first appointment, they received a follow-up call. Patients were randomized to receive either a personal call or an automated call. During years two and three, the FIT kits were mailed to patients, with a reminder letter preceding it. Arnold noted that the investigators were sure to brand the letters and packages with the name of the clinic as well as LSU to remind patients receiving them that they were part of the study, and to emphasize that the PCPs at the clinic felt it was important.

In years two and three, patients required more phone call reminders (Arnold et al., 2019; Davis et al., 2019). However, she noted, the automated call worked just as well as the personal call. Older patients preferred the personal call, she said, but overall, the calls were equally effective. Arnold shared a list of the lessons and challenges from the second study:

  • Regulatory paperwork was a barrier for community clinic RAs.
  • RAs need concrete research instructions and frequent “teach-back” of protocol.
  • Frequent face-to-face clinic visits build relationships and enhance fidelity.
  • Arranging for diagnostic colonoscopies for the uninsured was challenging.

She also described what approaches and considerations she thought were needed going forward and why:

  • Creative approaches are needed to promote long-term screening.
    • Offer screening options and use decision aids to help patients identify the CRC test that they find most acceptable and feasible.
    • Use text or automated calls to remind patients to compete the test.
  • The environment has changed.
    • When we began this grant, none of the clinics had electronic health records, and now they all have them.
    • Louisiana has now taken Medicaid expansion, so having a colonoscopy is a reality for patients in rural areas.
    • Because of Medicaid expansion, more gastroenterologists are having clinics in rural areas for 1 or 2 days per week. More rural hospitals are offering colonoscopies.

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

MAKING CLINICAL TRIALS AND INFORMED CONSENT MORE PATIENT-CENTERED

Lauren McCormack, Vice President, Public Health Research Division, RTI International

McCormack expressed her thanks to her colleagues at RTI, as well as to external collaborators, for their involvement in the work she was presenting at the workshop. She explained that she would be sharing some of the patient-centered strategies that RTI is implementing with UNC, Duke University, and Vanderbilt University. She continued, identifying several elements of what is currently not working with informed consent in trials (see Box 4-1) as well as several initiatives to improve patient experiences and the informed consent process.

Initiatives to Improve Patient Experiences

Several studies have examined the process of improving the consent experience, she added, as well as outcomes and measurements related to comprehension. For example, Beskow and colleagues (2017) and Grady and colleagues (2017) both found that a simplified version of a consent form was “just as good” as the standard consent form in practice, she said, though Beskow and colleagues did find that the simplified version was not superior for participants with lower health literacy. “One of the things I think we really need to be focusing on is looking at subgroup analyses and not just looking at everyone as a whole,” she continued. In another study, Kim and Kim (2015) found that a simplified consent form was associated with higher levels of objective and subjective understanding, she said, the

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

“objective being scoring questions as correct or incorrect, which is how we measured understanding in the study being presented.”

The use of interactive technology, she said, also has the potential to improve the process, but “it comes with its own set of complications and challenges and it often cannot replace the human connection. The question is, how do we still obtain that human interaction and connection but without the cost and time generally involved in one-on-one patient interactions?”

McCormack recommended paying attention to the Clinical Trials Transformation Initiative (CTTI), explaining that it is a public–private partnership of about 75 different organizations. CTTI, she said, has made recommendations recently about improving the informed consent process, as well as areas of patient engagement (CTTI, 2019a,b). She added that CTTI has general recommendations along with specific recommendations, such as how to tier the consent form (CTTI, 2019a).

Their tiering process suggests putting the federally required content up front, which would be HIPAA [Health Insurance Portability and Accountability Act] language followed by the IRB [Institutional Review Board]required content. Their example is in chapters, well organized using health literacy principles with an introduction or summary of the trial.

McCormack added that CTTI has also recommended training those who facilitate informed consent processes as well as the use of a discussion tool to help participants with understanding (CTTI, 2019a). She also noted that the U.S. Food and Drug Administration (FDA) has used its patient-focused drug development initiative to identify approaches to facilitating patient involvement and minimizing patient burden.2 The primary focus of the initiative is to better incorporate the patient’s voice in drug development and evaluation. One element of this initiative is conducting “tradeoff studies using discrete choice analyses or patient preference studies” to understand patient preference with respect to balancing benefits and risks. FDA has also published electronic informed consent (eIC) guidance, she noted (FDA, 2016).

Several different pharmaceutical industry and tech industry groups are now focused on the last issue of eIC, she noted, adding, “I would like to encourage all of us to coordinate and share lessons learned.”

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2 For more information about the FDA patient-focused drug development initiative, see https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development (accessed January 13, 2020).

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

A Randomized Controlled Trial to Assess the Efficacy of an Informed Consent Tool

The Importance of Decision Aids

“This brings me to the value of decision aids,” McCormack said, explaining that the Cochrane Collaboration has published several systematic reviews that emphasize “the importance of personalized decision making; providing tailored information to people that allows them to consider their preferences and values; and looking at outcomes such as knowledge and decisional conflict” (Stacey et al., 2017). McCormack noted that RTI carefully considers this research when developing decision aids.

Informed Consent Tool Trial

McCormack’s team conducted a randomized controlled trial to assess the efficacy of an informed consent tool, and specifically to address two questions:

  1. Does the tool improve the capacity of individuals to make an informed decision about consenting relative to standard practice?
  2. Is there variation in the tool’s utility by level of cognitive function?

The hypothesis, McCormack said, was that there may be a threshold at which a tool is more beneficial, and below which a tool may not make a significant difference. The trial participants were individuals with fragile X syndrome, ages 12 through 40. The study design based its measures on the MacArthur Competence Assessment Tool for Clinical Research (Appelbaum, 2008), she said, focusing on whether the participants

  1. understand the nature of the trial and its procedures,
  2. appreciate the impact of participating in the trial on their own care,
  3. use reasoning to decide whether they will participate, and
  4. express a choice about participating in the trial.

The trial itself was hypothetical, so participants never enrolled after the decision, McCormack added. She noted that they developed their informed consent tool using strategies like plain language and clear communication. “Interactive engagement was emphasized and we used multimedia communication,” she said. They also conducted a values clarification exercise, in which an avatar narrates to the trial participant and walks them through the informed consent process, all in a first-grade reading level. They developed several different avatars, she said, that can be selected based on the

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

needs of the study and its participants—they can vary by age, culture, ethnicity, gender, literacy level, and spoken language (American Sign Language is also available).

The informed consent modules included Institutional Review Board–required elements, McCormack explained, including the study purpose, what the study involves and how it works, risks and benefits, and the participants’ ability to withdraw from the study. She noted that these were standard, but some trials might have additional needs and modules. There were a few benefits to using the module, she added. Investigators could transform content to lower reading-grade levels and explain complex design elements or technology, but the tool also standardized the presentation of the information. Because there were participants in multiple study sites, having the information standardized helped protect the participants and the researchers, she said.

McCormack then explained that the participants received a score on a scale of zero to 100, to compare the informed consent tool with the comparison group. Taken as a whole, the full sample (n = 89) did not show any greater understanding after exposure to the consent tool. Once the sample was categorized by cognitive impairment, however, it became clear that there was improvement in understanding among the less cognitively impaired (higher IQ) participants. These individuals showed significant improvement in understanding, McCormack said. She noted that there was no improvement among those with higher cognitive impairment (lower IQ), but that was expected by the researchers.

McCormack added that her team has published several manuscripts about this study, including the protocol, the process of developing a decision-support tool, and its impact on decisional capacity. Several populations may benefit from decision aids, she said, particularly populations with cognitive impairments or intellectual disabilities; pediatric and adolescent populations; populations with sporadic or limited ties to the health care system; and populations with lower education or health literacy.

McCormack explained that RTI is working on infusing health literacy at the enrollment stage by

  • training research coordinators,
  • developing and distributing frequently asked questions and other take-home materials, and
  • bringing in a study advisory committee (which is partially made up of patients) to review and provide feedback on all patient-facing materials.

Citing a recent Health Affairs article, McCormack closed her talk by noting that the percentage of people who said their health care provid-

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

ers involve them in health care decisions as much as they would like has increased from 51.6 percent in 2007 to 56.8 percent—a slight but important uptick (Brach, 2019).

CRITICAL CONVERSATIONS IN CLINICAL TRIALS

Saira Z. Sheikh, Director, Clinical Trials Program, University of North Carolina Thurston Arthritis Research Center

Sheikh opened her talk by reiterating that there is a need to infuse health literacy practices into every step of the clinical trials process, and she wanted to start with the critical conversations that need to occur “well before” a patient decides to participate in a trial.

When, Where, and How?

Sheikh focuses on the “when, where, and how” of conversations about clinical trials between patients and providers, she said. As a rheumatologist and allergist immunologist, Sheikh has “a lot” of conversations with patients about clinical trials—not just because she cares about advancing science, she added, but because there is a critical need for newer and better therapies for her patients. Evidently, she said, this is a good thing, because “the majority of patients who participate in a clinical trial learn about it from their provider” (NIH, 2016). Regarding the backdrop against which such conversations occur, she added that health literacy demands are placed on patients “as soon as they set foot in the hospital or clinic.” Signs, directions, and paperwork can be overwhelming, and the clinics are often busy, with limited time slots for patients. These factors can be stressful and confusing for anyone, let alone for someone with lower health literacy, she added.

From the patients’ perspectives, this often feels like an overload of information:

It’s difficult to understand and process: often, patients are learning about a new diagnosis, there is disease prognosis, there is medication, there is dosage information, and there are costs. And then there are all these other factors—family, culture, beliefs, and it’s even more difficult for patients with limited English proficiency.

The questions she receives from colleagues and physicians across the country, she said, are “so in the middle of all of this, when, where, and how are we supposed to have conversations about clinical trials? Is this a good time? If not, when is a good time?” It does not surprise her, she said, and

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

she did not think it would surprise anyone else, that those conversations with patients about clinical trials frequently never even occur.

Sheikh quoted one patient, who described the term “clinical trial” as a foreign term because he had never heard of it before (Brown et al., 2013). In a 2001 survey, she continued, 85 percent of patients were unaware that participation in a clinical trial was an option at the time of diagnosis, and 75 percent of those patients said they would have been willing to enroll if they had known it was possible (NIH, 2016). Meanwhile, she added, we know that approximately 90 percent of clinical trials fail to meet their recruitment goals. “While it’s great that there are efforts focused on health-literate practices for participants in engagement and informed consent processes and in retention strategies, health literacy efforts should be prioritized well before the actual clinical trial begins and even well before recruitment,” she said.

We know that there a lot of barriers to patient participation in clinical trials, she said, on both the physician side and the patient side. On the physician side, “there is awareness and knowledge about clinical trials, implicit bias, and logistics around when to discuss it with the patient,” she said, whereas on the patient side, there’s “access, trust, opportunity, health literacy, culture, and beliefs.” Sheikh explained that her work focuses on addressing the lack of physician awareness and clinical trial health disparities. She added that while there are 100,000 clinical trials operating in the United States, African American participants make up only 5 percent of all participants, and Latinx participants only 1 percent (Coakley et al., 2012; NLM, 2019).

Sheikh added that her work addresses several questions:

  • Can we improve health care provider literacy about clinical trials?
  • Can we improve physician communication skills related to discussing clinical trials using patient-centered communication?
  • Can we equip clinical trial sites to recruit minority participants and participants with lower health literacy?

National and Institutional Programs

Sheikh described three programs she either leads or co-leads with multiple project partners. She explained that although the programs are specific to lupus, they are clinical trial–agnostic interventions. So, she said, they are not focused on one particular trial, but on the general idea of enrolling patients in or educating patients about clinical trials. They have all been developed with guidance from extensive patient input panels, she added, and are culturally and linguistically tailored.

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

Materials to Increase Minority Involvement in Clinical Trials

The first program, Sheikh said, focuses on the creation of materials to increase minority involvement in clinical trials, and it was developed by the American College of Rheumatology and funded by the Office of Minority Health. Materials to Increase Minority Involvement in Clinical Trials (MIMICT) is a multifaceted intervention model, she said, with three goals:

  1. To build on three intervention categories: educational materials,3 educational outreach with those materials, and patient-focused interventions
  2. To evaluate provider knowledge, attitudes, self-efficacy, and behavioral intention to refer minority patients to clinical trials
  3. To assess the feasibility of a clinical trial’s recruitment model

She added that there are educational modules for providers, in the form of interactive videos, transcripts, and slides; there are educational materials for patients; and there are tools and guides for investigators running clinical trial sites to help them conduct outreach with providers in their area and community. The center of this model is the patient and also patient-centered communication, she said. “The idea is that principal investigators and clinical trial staff would reach out to providers, in the community or at other surrounding academic medical centers, or to primary care providers or subspecialists, to let them know which clinical trials might be available to their patients and how to connect patients to those trials.” Only then, once adequately informed, she added, can patients consider their options and willingness to enroll in a trial.

The second part of MIMICT, she continued, is developing evidence-based and expert-informed practical guidance on how clinical trial sites can most effectively conduct outreach. PCPs are at the top of the list of providers, who are at the center of the outreach. Sheikh and her team are currently working on outreach to health care teams because they know that nurse practitioners, physician assistants, nurses, and everyone on health care teams are involved in the discussion about clinical trials with patients. They are also including subspecialists, so every practitioner who cares for lupus patients, including nephrologists and dermatologists in addition to rheumatologists, is aware of clinical trials and is knowledgeable about clinical trials in case patients want to speak with them about participating. Sheikh added that they are also expanding their outreach to patients, developing culturally and linguistically appropriate materials for Hispanics in

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3 Resources for providers can be found at https://thelupusinitiative.org/providers/resources (accessed September 27, 2019) and resources for patients and caregivers can be found at https://thelupusinitiative.org/patients-caregivers/resources (accessed September 27, 2019).

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

addition to African Americans. She noted that she is leading a longitudinal study in an underserved area in Durham, North Carolina, while a colleague is co-leading a sister study in an underserved area in Rochester, New York, to test the real-world effectiveness of the model.

Patient Advocates for Lupus Studies

The Patient Advocates for Lupus Studies (PALS) program is funded by Lupus Therapeutics and the Lupus Research Alliance through the lupus clinical investigators network. Other project partners are KDH Research and Communication, and Sheikh’s co-principal investigator for the project is at Emory University. The PALS program is an early educational intervention to introduce clinical trials to individuals before they have to decide if they want to participate. It is a peer-to-peer communication program, which has been particularly effective in engaging communities with the health care system, Sheikh said, but it has not been applied specifically to populations of patients with lupus in clinical trials.

In a survey of 300 lupus patients, when asked what would motivate them to participate in a clinical trial, more than 80 percent of respondents said that talking with other patients who have taken part in a clinical trial would have made them very likely to participate, Sheikh reported. Because of this, the PALS program was designed as a peer-support and educational intervention, and individuals living with lupus would be trained to serve as “trial agnostic resources” for patients. Principal investigators, evaluators, and patient advocate facilitators participated in a live training session, the materials of which were developed with input from patients living with lupus.

The PALS program has trained patient advocates who conduct semi-structured educational sessions, including introductions, clinical trials basics, decision making and risks and benefits, informed consent and patient protections, and patient-specific barriers and concerns. As part of the study, Sheikh said, they are looking to measure clinical trial knowledge, satisfaction with the program, intentions, and attitudes toward clinical trials. In terms of behavior, she said, the best predictor is the patient’s intention to perform that particular behavior.

Programs to Address Unmet Needs and Promote Representation of All Participants in Lupus Clinical Trials Using Mobile Technology for Engagement

Sheikh explained that the last program she wanted to talk about is referred to as Project PURPLE (Programs to Address Unmet Needs and

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

Promote Representation of All Participants in Lupus Clinical Trials Using Mobile Technology for Engagement), and its project partners include RTI International and Pattern Health. The program has four main areas of focus:

  1. Culturally tailored materials for all literacy levels and personalization
  2. Animations that explain complex study concepts
  3. Interactive decision-support activities
  4. Knowledge assessment surveys, based on teach-back principles

Sheikh explained that because 6 billion of the world’s 7 billion people have mobile phones they do not need to make a case for using mobile technology for any specific intervention (UN, 2013). In fact, she said, smart-phones are helping to bridge gaps among African Americans, Hispanics, and white Americans. African Americans and Hispanics are more likely to rely on a smartphone to review or research health information (Perrin and Turner, 2019; Vangeepuram et al., 2018). The program idea stemmed from conversations Sheikh has had with patients, as well as from all the times she can count that she did not have a chance to discuss trials with her patients. She elaborated that patients consistently rate their own doctors as their most trusted source of health information, but most physicians do not have sufficient time or resources to discuss clinical trials with patients (Hesse et al., 2010). “Project PURPLE allows patients to learn about clinical trials through interactive content using custom-built physician avatars modeled after patients’ real-life treating physicians,” she added. The tool will have an avatar for Sheikh herself, as well as for her colleague, Dr. Alfredo Rivadeneira, who is providing his voice for his avatar, which will have English and Spanish language options.

Creating a Health-Literate Clinical Trials Environment

Sheikh described some of the work done at UNC’s clinical trials program at the Thurston Arthritis Research Center, including their five major efforts to create health-literate clinical trials environments, and adopting universal precautions (see Box 4-2). She closed her talk by saying that health literacy in clinical trials is in a dynamic state influenced by how well we deliver information that matches patients’ abilities, needs, and preferences, and that informed decisions equal empowered patients.

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

DISCUSSION

Avatars and Technology

Pettit Nassi began the discussion by asking Sheikh about the development of a custom avatar based on a patient’s actual physician, and whether she worried if it would ever replace her. Sheikh answered that the idea came from the experience of wanting to have conversations with patients about clinical trials but not always having time. She added that it also enables many more opportunities to provide patient education regarding clinical trials. She continued,

What tools can we develop so that, while patients are waiting for their appointment and if their doctors are potentially running behind schedule,

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

patients could be using their time efficiently? In this climate where there are so many burdens and demands on all of us—patients, physicians, other health care providers—we really have to come up with ways that technology can facilitate the things we want to do but are not able to.

The avatar is not meant to replace her, she added, but to provide background knowledge and information and to continue the conversation she had started with her patients.

McCormack added that avatars delivering general information to patients will allow physicians to focus on conversations that are tailored to the patient, and they are also an easy signal to patients that the physician is supportive of the trial.

Spears said that she appreciated the idea that health literacy is not only understanding and appreciation, but also reasoning and the ability to make a choice about participating. She asked if McCormack had found that the method of communication could make a difference in whether a participant felt empowered to make a choice.

McCormack replied that the notion of reasoning through the decision to participate in a clinical trial is very important to her because of its effects on retention.

If someone doesn’t reason through that in advance, when they get to the fact that they have to have blood drawn, or go to the doctor’s office, or something else that affects their daily life, that’s where we may see them sign a consent form but quit the trial shortly after, because they haven’t thought through the implications.

I think the measurement of impact of the work we’re doing in health literacy is critical. I know that the field has developed a number of different measures over the years and I think we need to be doing the same thing here, assessing interventions to increase and improve informed consent.

Trudeau added that he liked the avatars and decisional tools, and wondered if the panelists had begun thinking about the scalability of the tools in sites that are not as well funded, and how they would like to see the tools evolve over time. McCormack replied that she and her team have been building a library of assets that will have generalizable content along with tailored elements to certain trials that might have unique avatars or might be a certain specific medication. With the library, she said, there will be a long-term path for efficiency and utility.

Sheikh reiterated that one of the strengths of the tools she and her team have been developing is that, although they may be disease specific, they are clinical trial agnostic. “So you could take it to clinical trials across disease

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

states,” she said. “Whenever you develop materials like this, it’s always more cost-effective because you can adapt it easily without a lot of work.”

Empowered Patients

Jennifer Dillaha from the Arkansas Department of Health asked the panelists to speak more about their experiences with patients and the measurability of “empowered patients.” She also asked what defined empowered patients in their experiences.

Arnold responded that empowered patients should first and foremost know that they can withdraw at any time from a trial, and that it is not going to affect the way their provider treats them. McCormack added that, because information is power, patients having access to information helps them make an informed decision, which is one aspect of empowerment.

As an investigator, Sheikh said, she thinks patients that are engaged and empowered are more likely to be retained in studies. Many of her patients are engaged throughout the whole process, she said, and remain as partners even after the clinical trial concludes. “I find that incredibly satisfying,” she added.

Nicole Holland from the Tufts University School of Dental Medicine asked if the panelists could elaborate on exactly how they culturally tailor materials for trials. Sheikh replied that when she was developing materials for MIMICT, the patient-input panel reinforced that the faces in the brochures and online guides need to reflect the people that look like them. “It’s been an important piece of material development, making sure they reflect the participants.” It is not only about the idea of “this person looks like me,” she added, but you will not know what cultural or family beliefs might inform someone’s decision about participating in a clinical trial unless you ask them. Because of this, it is very important to have ongoing patient input, especially patients from the communities of those participating in trials, she said.

Arnold agreed, saying that all of the photos in materials that they develop are of patients who want to be in the picture. She confirmed that people want to see someone who looks like them but also that they do not want to feel like their group is singled out as representing a disease. Everyone is different, she concluded, which is why it is so important to have focus groups and test your materials.

Collyar said that although it is not “one size fits all,” it is important to find out which methods are generalizable. She noted that literacy levels are “just the tip of the iceberg” and that it is important to confirm understanding through the use of tools such as teach-back. Sheikh responded that she agreed and believes that there is a lot of work being done that could be more synergistic and cost-effective because, although the details differ,

Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

in many ways the patient experience is similar. She added that convenings such as the workshop provide an opportunity to ask how all of these efforts can be brought together to make this a synergistic process for everybody involved.

McCormack added that perhaps this is an opportunity for members of the roundtable and others in the room to call on funders to accelerate and coordinate their efforts to share information and lessons learned across agencies and organizations. If funding agencies were to use their power to require patient-centered approaches and measuring patient understanding then that would make a big difference, she said. “The [revision to the] Common Rule is a great step forward, but [if] we’re not implementing it and funders are not requiring it then we’re not going to have progress in this area,” she concluded.

Arnold concluded by noting that funders have also shortened their timelines for studies, which allows less time for focus groups and stakeholder engagement. She said that results in some tension for researchers who are trying to develop communications tools and plans but also have to enroll patients quickly.

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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"4 Experiences Implementing Health Literacy Best Practices in Clinical Trials." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Because of the individualized nature of drug and therapeutic treatments, clinical trials require participants who represent the diversity of the patient base. If early trials do not have a broad patient base, it can be difficult to know who may or may not benefit from or respond to a treatment later. In addition to diversity in recruitment, informed consent during participation is also crucial. If participants do not fully understand what they are signing up for, they may become confused, mistrustful, or drop out of a trial altogether, confusing investigators and possibly affecting the generalizability of a study.

To explore the incorporation of health literacy practices into clinical trials, the Roundtable on Health Literacy convened a workshop titled Clinical Trials: Practice and Impact on April 11, 2019, in Washington, DC. The workshop presentations and discussion centered around issues related to the challenges or barriers for diverse populations' participation in clinical trials, best practices for clinical trial sites and researchers incorporating health literacy practices, and effective health literacy strategies for clear communication with participants. This publication summarizes the presentation and discussion of the workshop.

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