Health Literacy in Clinical Research Practice and Impact: Proceedings of a Workshop (2020) / Chapter Skim
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4 Experiences Implementing Health Literacy Best Practices in Clinical Trials
4 Experiences Implementing Health Literacy Best Practices in Clinical Trials
Pages 49-68
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From page 49... ...
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.
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From page 50... ...
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
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From page 51... ...
"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.
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From page 52... ...
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.
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From page 53... ...
o Offer screening options and use decision aids to help patients identify the CRC test that they find most acceptable and feasible. o Use text or automated calls to remind patients to compete the test.
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From page 54... ...
found that a simplified consent form was associated with higher levels of objective and subjective understanding, she said, the BOX 4-1 Current Challenges Related to Informed Consent • Lack of bidirectional communication • Overwhelming participants with forms • Participants signing consent forms without completely understanding the information • Participant misunderstanding of the rationale and design of the study, particu larly randomization, leading to higher dropout rates SOURCE: Adapted from a presentation by Lauren McCormack at the workshop Health Lit eracy in Clinical Trials: Practice and Impact on April 11, 2019.
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From page 55... ...
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)
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From page 56... ...
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?
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From page 57... ...
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.
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From page 58... ...
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?
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From page 59... ...
"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.
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From page 60... ...
To evaluate provider knowledge, attitudes, self-efficacy, and behav ioral 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.
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From page 61... ...
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.
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. 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.
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From page 63... ...
Sheikh at the workshop Health Literacy in Clinical Trials: Practice and Impact on April 11, 2019. 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.
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From page 64... ...
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.
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From page 65... ...
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.
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From page 66... ...
2019. Follow-up approaches to a health literacy intervention to increase colorectal cancer screening in rural community clinics: A randomized controlled trial.
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2019. Repeat annual colorectal cancer screening in rural community clinics: A randomized clinical trial to evaluate outreach strategies to sustain screening.
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From page 68... ...
2015. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.
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