Health Literacy in Clinical Research Practice and Impact: Proceedings of a Workshop (2020) / Chapter Skim
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3 Embedding Health Literacy in Clinical Trials to Improve Recruitment and Retention
3 Embedding Health Literacy in Clinical Trials to Improve Recruitment and Retention
Pages 23-48
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From page 23... ...
She also mentioned that the panel would touch on informed consent documents and issues faced by Institutional Review Boards (IRBs) ; how to enroll minorities with variable health literacy into clinical trials; and the regulatory trend toward health literacy in clinical trials.
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ENROLLING MINORITIES WITH VARIABLE LITERACY IN CLINICAL TRIALS Ebony Boulware, Professor of Medicine, Chief of the Division of General Internal Medicine in the Department of Medicine, Vice Dean for Translational Science, and Associate Vice Chancellor for Translational Research in the School of Medicine, Duke University Boulware explained that she and her colleagues have focused on clinical trials that enrolled minorities with various literacy levels. She and her team had mainly worked on behavioral and educational interventions that were implemented in clinical settings, she said, as opposed to drug trials.
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The interventions included a community health worker, blood pressure cuffs, and other educational interventions to improve blood pressure self-management and control. The enrollment rate was 60 percent, and the retention rate was 83 percent (Boulware et al., 2020)
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. She added that there were several approaches to these studies that improved the enrollment and retention of diverse populations with various literacy levels, and that investigators should do the following: • Engage potential participant populations well before the study starts • Be willing to substantially change designs or materials from the original protocol to accommodate what the potential participant population thinks is more appropriate • Work with IRBs to clarify and tailor consent forms and communi cate with potential participants more clearly • Tailor recruitment letters, not just with plain language but with accessible and clear formatting, straightforward messaging, and cultural sensitivity • Continue to tailor materials throughout the study • Follow up via phone calls and home visits, in addition to the usual postcards or letters, to keep participants engaged and to help them understand the importance of their involvement Boulware added that she was excited by other examples of newer consent forms she had seen earlier in the day, as well the use of video and graphics to engage and educate potential participants.
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She noted that recruitment for clinical trials can involve a range of materials: flyers, letters, social media messaging, websites, and press releases (see Figure 3-1)
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28 FIGURE 3-1 Health literacy through the clinical trials process. SOURCE: Adapted from a presentation by Catina O'Leary at the workshop Health Literacy in Clinical Trials: Practice and Impact on April 11, 2019.
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Adding that the updated informed consent form was "not controversial," she emphasized that IRBs are accustomed to reviewing tables instead of text so developing consent forms like HLM's could make more patients and participants happy without impeding approval. "I would recommend having conversations [with other investigators]
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By using drawings in stead of images, the guide doesn't make any assumptions about who you are or what it means to be using it. Sample Trial Results Summary O'Leary's third and final example was a clinical trial summary.
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When you are first diagnosed with cancer or trying to make a clinical trial, she said, "that's exactly what you hear. Something like ‘blah, blah blah, informed consent, blah blah blah, and sign here.'" As a patient, when you receive lot of information, Staley said, you are often not given the proper context in which to evaluate it, take it in, or process it in a way that really makes sense for you in a critical moment.
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"Are we doing enough so that the patient can confidently go back to their family or care team to share updates or solicit input? " She highlighted something she had heard Collyar say earlier in the day: "The right information at the right time in the right context is really the key for truly engaging patients in clinical research." Staley summarized by emphasizing three components of best practices for technology improving patient experiences in clinical trials: • Design: Are you creating material with the patient perspective in mind?
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From page 33... ...
He noted that the language of the GDPR also recognizes that minors merit specific protection when it comes to data protection, and the GDPR requires that any communication addressed to children be written in plain language so they can easily understand. It is a broad regulation, Trudeau said, but it has "huge implications" for multinational clinical trials because it applies to any type of data collected from anyone while in the European Union.
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Having taken complete effect in January 2019, it is the "regulatory hammer that we can use to help encourage others and actually promote health literacy throughout not only the consent process but the entire clinical trial process as well," he added. The Common Rule revision requires that research consent materials be understandable, Trudeau continued, quoting from the Federal Register: [It]
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From page 35... ...
The recruiting relied on the altruistic nature of the trial, she added, and her team tried several print and video messages before they developed an informed consent process that potential participants could understand. Assaf and her colleagues also found success in identifying different recruitment strategies for different populations.
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Louis. We had some funding to create a fancy database with algorithms to enroll people from communities, to match them to open clinical trials and deliver them to the site of a trial [that]
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So I think that flexibility and collaboration with the folks you're trying to reach is really the gold standard." Trudeau explained that several years ago, he worked with a hospital association to develop a website focused on transparency. He had been "really excited" about a new gauge visual on the website that shared safety metrics at various hospitals, in which a high safety rating would read as a high percentage out of 100, resembling a speedometer.
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Those are all choices that reflect the philosophy and values connected with the community and the trial. Boulware added that at Duke, she is developing an information portal where study participants can log in at the beginning of the trial, and have constant communication with the investigative teams throughout the entire journey.
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From page 39... ...
"I do think that the Common Rule revision is supporting this shift toward facilitating understanding, using teach back, and a whole planned educational process, not just the ‘consent process,'" he said. Boulware echoed Trudeau, adding that she has often thought that investigators seem to race to get informed consent signatures, but wondered if the consent process should actually be broken up into separate pieces.
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"If there was a way for more industry collaboration around therapeutic areas or disease states where you're working for the collective good educating the community, not only about clinical trials, but health in general, we do a better service for everyone in general." "Reasonable Person" Consuelo H Wilkins from the Meharry–Vanderbilt Alliance cautioned the panelists and workshop audience to be careful using the term "reasonable person." She added: 5 The abstract "Exploring the Impact of Low Health Literacy on Participant Attrition in Clinical Research Studies" was authored by L
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From page 41... ...
She added she has wondered why trials do not use the same types of questions before participants are in the informed consent stage, to ensure that they are at a point where they understand what's needed in general to participate in clinical research. I don't think we do enough to assess the patient from that kind of perspective because there are financial implications to participating in clinical research.
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From page 42... ...
Patient Portals Collyar asked the panelists for their thoughts or experiences around the use of patient portals in trials or clinical settings. The burden is on the patient to ensure continuity of care by carrying their medical information between clinical research and primary care providers (PCPs)
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From page 43... ...
Boulware added that, as a general internist, she felt that PCPs were often left out of the clinical trials process with regard to their patients. She said that despite playing a key role in trial participants' care, PCPs frequently have little information about the actual trials.
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From page 44... ...
Smith from the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and Northwell Health added that trust between PCPs and patients is at the root of successful patient understanding and treatment, and developing that trust is an ongoing process. O'Leary said that printed materials are a necessary supplement to a structured conversation with patients and trial participants.
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Pettit Nassi from the University of Utah Huntsman Cancer Institute explained that part of her responsibility in her program is to do outreach to rural frontier populations, including American Indian and Alaska Native farmers, ranchers, polygamists, and Hutterites. She added that clinical trials are a component of the health education programs she runs, and they are included along a continuum of patient experiences.
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2020. Hypertension self-management in socially disadvantaged African Americans: The Achieving Blood Pressure Control Together (ACT)
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2015. The TALKS study to improve communication, logistical, and financial barriers to live donor kidney transplantation in African Americans: Protocol of a randomized clinical trial.
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