How CISCRP Made Tools for Informed Decision Making

Guiding Informed Decisions

It’s an all too familiar story – a patient receives a new diagnosis of a rare disorder. But now, they are told that there is a clinical trial option available. However, their lack of knowledge about clinical trials concerns them. In another case, a pediatric patient receives a new diagnosis and is offered an opportunity to participate in a clinical trial. Similarly in this case, the parents or caregivers of this child are not familiar with clinical trials. An important decision needs to be made in both scenarios.

Unlike the scenarios described above, most Americans have never faced a personal decision about whether to participate in a clinical trial. Of those who are invited, less than half choose to participate. There can be many reasons for this; the choice to participate or not is deeply personal. It means thinking about things like finances, family, current and past social injustices, and values, among other things.

Well before the need arises to access trial treatments, people should learn about the clinical research process, how to partner with researchers generally, and what it means to participate in trials. Even after learning about trials by reading brochures, and watching videos for adults or children, the process of making a decision may remain unclear. Making this kind of “informed decision” — one that looks at a complex decision from all angles — is hard under the best circumstances. When the choice involves personal health, or the health of a loved one, it can feel overwhelming. So, the team at CISCRP has developed brochures to address questions about clinical research and help guide the decisions of potential clinical trial participants. More examples of stories and articles can be found here, here, here, here, and here.

Developing the Brochures

CISCRP’s Health Literacy Team thought a lot about what goes into the decision to take part in a clinical trial — and what tools can help make the decision process easier — when we developed 2 new educational brochures on the topic.

The first brochure, titled “Should I Participate in a Clinical Trial?”, is for people weighing the pros and cons of taking part in a clinical trial. It includes questions that people may want to consider asking themselves, a healthcare professional, and trusted family and friends before making a decision. The brochure also serves as a resource for healthcare providers, community and faith leaders, family members, and anyone else helping potential trial participants navigate this process.

The second brochure, titled “Should My Child Participate in a Clinical Trial?”, is designed to help parents and caregivers of children who have been asked to join a pediatric clinical trial. As we wrote in a recent blog post, children have different healthcare needs and rights than adults, including different rights to make medical decisions. Parents and caregivers are tasked with making big decisions (like ones about trial participation) on their child’s behalf. Sometimes, a child might agree to join a clinical trial, but a parent or caregiver is still undecided. This means having to consider multiple perspectives at once.

The Importance of Empowering Patients as Health Literacy Professionals

As health literacy professionals, our goal with both projects was to improve the ability of individuals to find, understand, and use information and services to make health-related decisions. We emphasize this point because all materials we create, including these brochures, are planned with care to be non-promotional and unbiased. The brochures share user-friendly information to help participants, potential participants, and the public make the decisions that are best for them, and that benefit everyone and help improve the research process.

In these brochures, we aimed to address the unanswered questions people may have: What does it mean to be in a clinical trial? What does it mean to “weigh risks and benefits”? And how can I make sense of all the information coming my way?

Providing cognitive tools and points to consider helps guide the decision-making process, making it a more empowering and less overwhelming process. Additionally, we worked with patients, advocates, and subject matter experts (SMEs), who reviewed and provided input on both brochures. This helped us ensure the appropriate information and tools were included.

Conclusion

Our hope with these educational brochures is to not only empower patients or caregivers to make informed decisions, but also encourage providers and study teams to start open conversations with potential participants to help make decisions. And, we welcome conversations about other tools and information that could help patients during the clinical research process. How else can we empower patients and the public to make more informed decisions and partner with the research community to improve clinical trials?

References:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784556

https://hints.cancer.gov/docs/Briefs/HINTS_Brief_48.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3565180/

https://www.sciencedirect.com/science/article/abs/pii/S0738399198000603

https://www.pharmacytimes.com/view/final-analysis-of-monarch-2-trial-results-confirms-overall-survival-endpoint

DEI Series — Educating Clinical Research Practitioners Through Video

Recently, CISCRP partnered with WCG to create a video for researchers and study staff that emphasizes the importance of diversity in clinical trials. In addition to educating the public, raising awareness among research professionals about the importance of Diversity, Equity, and Inclusivity (DEI) is critical to increasing cultural competence and understanding of participants’ needs.

You may have read our post about how videos are becoming a key tool of health literacy, and how clinical research could benefit from more videos communicating information in an accessible way. In this post, we dive into our creative process for producing a video with that objective in mind.

We were delighted to collaborate with WCG on this video. WCG partnered with CISCRP to produce this video because of our expertise in educating the public and clinical research professionals about the importance of diversity in clinical research. Like CISCRP, WCG is committed to helping ensure that the public gets the most effective and safe treatment possible. 

Because of that urgent need, WCG were very excited to work with CISCRP on addressing this topic. We know this engaging video collaboration will help energize researchers, and especially site staff, to bring more diversity into their trials.

To see the video, click here.

Research and Creative Planning

As with any complex project, whether you’re writing a novel or baking a cake, it’s important to plan every step in advance. However, for this project, assessing our audience’s needs, perceptions, and general level of cultural competency would determine how we structured the tasks ahead – so we started there.

The purpose of this video was simple: to encourage clinical research professionals to take tangible actions to ensure their trials had diverse populations. Given our experience developing educational materials on diversity in clinical research by collaborating with patients, their communities, and the public to understand their concerns and needs, we knew the key messages researchers needed to see and hear. Delivering that message in a way that will have an impact was the challenge.

Clinical research professionals may already know about the importance of diversity in clinical research and may even know about the available tools and practices to improve their trial’s diversity. So, how could we convince them to make more of an effort to invest in and implement these tools and practices?

We certainly didn’t want to bore them with information they already knew. Instead, we decided to focus on an impactful narrative to give them that extra push and reinvigorated perspective. And we had to do it in under 3 minutes.

Script

We decided on an animated video that portrayed a realistic scenario: patients from a diverse background whose prescribed treatments were not as effective or tolerable as demonstrated in the less diverse study populations during clinical trials. The storyline focuses on one patient to begin with, then shifts to a larger patient population who all realize that the clinical trials for the treatment they needed did not include patients from their respective communities.

As each patient asks their doctor some tough questions, treatments disappear from the shelves of the pharmacy shown in the animation:

“Could my race affect how this drug works?”

“Was the drug tested on women like me?”

“Could my weight be why this drug didn’t work?”

Then in the final scene of this part of the video, the problem is summed up by a disappointed patient:

“I think I understand. They didn’t test this for people like us.”

After the scenario, the narrator addresses this problem directly to the audience. It was important that the messages were not received as a critique of researchers—as we say in the video, there’s already so much good work they’re doing. Rather, we wanted to bring this subject to the top of their minds and say that by taking steps to ensure diversity in their trials, we can avoid situations like the one they just watched.

The script went through several drafts which included reviews from CISCRP’s team, our WCG collaborators, and subject matter experts on DEI in clinical research.  Each round of feedback included more voices and perspectives from folks in the clinical research world. As a result, each draft became more engaging, appropriate, and relatable to our intended audience.

For example, the original plan was to follow one patient. In the final script, we decided to combine the stories of five diverse participants. Then we realized that our characters’ names were not diverse. At first, they were named common names, which likely wouldn’t represent the diverse groups that are underrepresented in clinical research. We also ensured we represented the doctor, a “Dr. Smith,” from a white man to a black woman.

Key Learnings

In early drafts of the video animations, while the characters had different skin tones, they didn’t have other aspects that represented diversity. Something important we all have to keep in mind is that diversity comes in many different forms—from some of the more obvious things, like race, ethnicity, sex, and gender, to more specific details like health conditions, weight, and even lifestyle. So, we made a few subtle tweaks to represent diverse bodies, appearances, and cultural appearances.

Also, in choosing the voice-over actor, we settled on someone who represented a diverse population to add credibility to the messaging.

Some of the considerations went beyond diversity. We wanted our video to feel real, because the scenario we crafted is something that unfortunately happens too often. Given the prevalence of this issue, we also wanted the video to demonstrate sensitivity towards the difficult situations participants often face.

For example, in early drafts of the video, the doctor was smiling throughout, even as she learned that her patients were suffering. Not only is this not realistic, it appeared insensitive and even offensive. Still, we had to find the balance between making character emotion powerful while making sure they didn’t act like children’s cartoon characters.

Finally, once we were done tweaking the thematic elements of the video, we polished the presentation to a fine, professional gloss. Over the course of three drafts, spread out over weeks of review, we gave feedback on the timing of edits, the tone and speed of the voice actors through specific sections, and the subtle connotations of the animated characters’ movements. All of this was to ensure that this video was produced to the highest standards.

Never call it a day

As we’ve mentioned in other posts, the health literacy process does not stop here. We want to learn how effective this video is, and what we can do to improve our communication and education in future projects. Whether we’re making content for a professional audience or for the general public, the insights we gain on any given project accumulate and inform the production of future projects.

Written by Scott Finger, Senior Editor – Health Literacy, CISCRP

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Volunteer opportunities with CISCRP, visit our Volunteer page

No “Kidding”: Using Health Literacy to Communicate Clearly About Pediatric Trials

Written by: Holly Arthur

In a recent post, CISCRP’s Health Literacy team discussed why it’s important to make information about clinical trials clear for everyone. We consider a lot of things when creating materials — like brochures or videos — depending on the audience. For example, we’ve been developing brochures for people from different racial and ethnic groups about the importance of diversity and representation in clinical trials. With these projects, we’ve looked at how language, culture, personal values, and history shape people’s decisions about participation. A main goal of these projects is to connect with people who don’t always have access to information about clinical trials that is both relatable and easy to understand.

But what if your “audience” includes almost a quarter of the population of the United States, yet doesn’t include anyone legally allowed to make all their own medical decisions? Recently, the Health Literacy Team has been expanding a key part of CISCRP’s mission — “education before participation” — to a new generation. We have been working on projects to help kids, families, and their healthcare providers navigate decisions about clinical trial participation together. We’re excited to tell you about some of these projects today, and to share a few of the challenges — and accomplishments (!) — we’ve encountered so far.

 

Not just short adults

It may seem funny to think of children as an underrepresented group, but among clinical trial participants, they are. Just like there isn’t enough gender, racial, or ethnic diversity among trial participants, the number of registered pediatric clinical trials doesn’t reflect the number of children who depend on trials for new, safer treatments.

As the saying goes, kids aren’t just small adults. Children’s bodies may respond differently to treatments than adults’, even if it’s the same treatment for the same condition. And too often, treatments prescribed to children have only been tested in adults. Pediatric trials help us make sure that treatments children receive are safe and effective for them.

 Of course, the differences between kids and adults aren’t just physical! As they get older, people go through changes in how they think, learn, and relate to others. Even an infant and a toddler only a year apart, for example, have different abilities, interests, and needs. So do a 10- and a 16-year-old. Creating materials for pediatric participants means thinking about all kinds of age-related differences that have a big impact on health literacy.

Children also don’t have the right to sign legal documents, in most cases. This includes documents agreeing to participate in clinical trials, also called “informed consent forms.”  A parent or guardian must give permission, called “consent,” for their child to participate. Children old enough to understand what being in a trial involves are asked to give their “assent,” or agreement. This is not a substitute for a parent or guardian’s consent, but a child can refuse to give assent after learning about a trial, so it’s important to share information in a way that is age-appropriate.

What is the Health Literacy Team Doing?

 

Pediatric Video Project

Earlier this year, we launched our 4-part Pediatric Education Video Series, created specifically for children and their caregivers. The live-action videos were developed with help from various community members — most importantly, kids — to provide an age-appropriate overview of clinical trials. As health literacy experts, explaining ideas like “informed consent” or “placebo” so the average person can understand them is our bread and butter. Still, explaining these things to kids at all different ages and stages really forced us to up our game! The actors in the videos do a great job of making new information feel safe and not (too) scary for viewers. Check out the videos on our website  or YouTube page.

 

Updated Brochure for Parents and Guardians

We are wrapping up a complete rewrite and redesign of our brochure on pediatric trial participation, “Should My Child Participate in a Clinical Trial?” This is one of many brochures on clinical trial participation you’ll find in CISCRP’s online education center. Like all our educational materials, the creation process was guided by insights from the CISCRP community. We listened to parents, guardians, professionals, and other experts to understand what matters most to them. What do real parents of past pediatric clinical trial participants, or potential clinical trial participants, think is most important for others to know? What information do professionals who work with pediatric participants and their families wish those families had more access to?

We heard your feedback that caring for a child with a medical condition is stressful for the whole family. Parents need empathy and support when making difficult decisions about their child’s health. We also heard your feedback that it’s important to discuss clinical trial participation with children, even though it can be a tricky subject. We used these insights to shape the content of the new brochure. Our health literacy experts worked closely with our in-house Medical Writing team to make sure this important subject hit all the right notes. The new brochure will be available soon on CISCRP’s website and for purchase in our online store. (Want more information? Contact Lucas Goren at lgoren@ciscrp.org.)

 

Pediatric Plain Language Summary

One of CISCRP’s signature programs is our communicating Trial Results Summaries service. All participants have the right to receive results of the study they helped make possible, written in language that makes sense to them. However, information written for and by researchers is not always clear or friendly for non-scientists. This is why CISCRP works with study sponsors to create hundreds of plain language summaries of trial results every year.

But what about pediatric trials? As it turns out, creating kid-friendly, age-appropriate plain language summaries of pediatric trial results isn’t the norm. This is partly due to lack of regulation, or unclear regulations, about sharing pediatric trial results. Because this is new territory compared to creating adult trial summaries, experts (like CISCRP) are still developing and testing best practices.

We can’t wait to share details from our first-ever pediatric plain language clinical trial results summary. It’s not ready to “go live” just yet, but we can tell you a little about what it includes. For starters, we focused on using a narrative, or story, to talk about the process of being in a pediatric clinical trial from start to finish. The summary tells the story of a character who participated in a pediatric trial as she learns about the results and reflects on being a participant. We hope this “picture-book” style helps make complicated information approachable and engaging for kids, and we’re excited to get some feedback from real-life pediatric trial participants down the road.

 

Consent and Assent Forms

Informed consent forms (ICFs) and assent forms can be hard to understand. But it’s very important that potential participants, and parents of participants, understand what these forms say. Knowing what a trial involves, and what the risks and benefits are, is critical for making an informed decision. 

CISCRP recently worked with a sponsor company, parents, advocates, and other experts to create clear, engaging informed consent and assent forms that support health literacy. These will be shared with potential participants in a pediatric study starting soon. This project came with some challenges and some creative solutions. For example, we decided the materials should feature an animal character. But consent and assent forms need to be balanced, not biased, about possible risks and benefits of joining a study. How do you make sure a cartoon animal looks thoughtful, but not scared? Or proud, but not boastful? How do you write about risk honestly and in a way children will understand, without causing unnecessary fear because risk is a hard thing to explain, even to adults?

The balance between information and neutrality is tricky, so we had a lot to think about! But in the end, we are thrilled with how the project came out. We hope to work on more projects like this — and other new projects for pediatric participants — soon.

Want to help us create, test, and improve new materials like these? We depend on your feedback. Learn more about volunteering and how you can sign up today.

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Videos in Health Literacy

Written by: Scott Finger

Everyone learns differently. Though as time and technology move forward, more people are getting their information through interactive formats like video. With the rapid integration of patient engagement in clinical research, the formats the research community uses are also shifting. While printed documents remain a regulatory imperative, videos are more patient-centric and engaging, especially for younger audiences. Also, with the pandemic pushing more trial conduct towards remote models, more trial participants are interacting with clinical researchers through a computer or mobile device. The need for video-based educational tools, especially about trial participation and eConsent, is more important now than ever.

According to CISCRP’s 2021 Perceptions and Insights Study, 13% of survey respondents would be interested in getting results of their clinical trial through video, which is nearly double the number of respondents who expressed this from 2019 (7%). Also from the 2021 study, 74% of respondents said that they would be willing to participate in a trial that was completely remote, which includes video conferencing from home.

In addition to the content itself, a key aspect of health literacy is actually reaching your audience. To do so, you need to consider how to best get out your message in a way that works for as much of the audience as possible. Usually, that means communicating your content in a few different formats for different learning preferences.

Through our research, we’ve identified a need for more videos when it comes to clinical research education, especially accessible videos that explain clinical research in a simple way. So, CISCRP has dedicated time and resources and partnered with sponsors and health professionals to create such videos. You can find a complete library of our videos on our website or on our YouTube page, but here are some examples:

Based on our experiences and expertise in health literacy in clinical research, we have developed a list of best practices for video creation. We would like to share some tips to help researchers, advocates, and anyone else looking to develop videos for patients, trial participants, or the public.

 

Planning your video

You’ll first need to consider: What do you want to say? You may have a clear message and an idea of how that should be communicated, but creating a video fit for clinical research education won’t be as simple as clicking the big red “record” button and adding a filter.

Always keep in mind that the video isn’t about you—it’s about the audience. So, every video creator must consider the best way to reach their target audience. Some factors include:

  • Style—should your video be flashy and attention-grabbing, or should it focus on laying out information as cleanly as possible?
  • Format—is your video going to be animated, performed by live actors, or both? Or, is your video going to feature real patients or trial participants?
  • Tone—will your video have elements of humor, or will it stick to the facts? Will any animations be more cartoon-like or abstract, or will they imitate real life?
  • Time—how long should your video be? Should it be a few seconds, a few minutes, or broken out into multiple parts?
  • Culture—are you appropriately representing the individuals from the communities you want to reach? Are you acknowledging the experiences and hardships of the individuals from those communities?
  • Language—is your audience made up of experienced clinical research professionals, or people who may have never heard of a clinical trial before? Your audience will determine what lingo you should or shouldn’t use.

 

Audience engagement

As we mentioned, a big part of health literacy is reaching your audience. So, what does your audience want to hear? How do they want to hear it? We cannot stress enough the importance of opening a two-way dialogue with the intended viewers.

For example, when we made the 4-part pediatric series, we spoke directly with some children who may be involved in clinical trials, and their parents. From this research, we learned that the children would prefer TikTok-style videos that featured live actors in addition to supporting animations and quick transitions, and videos that were no longer than 2 or 3 minutes each. More importantly, we learned what the children wanted to learn: the benefits and risks of participation, information about placebos, the fact that they could stop participating at any time, and more.

We also had our materials reviewed by an external review panel consisting of patient advocates, healthcare professionals, and members of the public. All of the reviewers helped us shape the video and ensure our content was appropriate, understandable, and engaging. It’s important to continually get feedback throughout the video’s development.

 

Developing your video

Once you’ve completed the necessary research, we recommend starting with an outline. What’s your key message? What points will support that key message? How can you arrange those points to have a naturally flowing narrative that will engage the audience? For a documentary-type video about real patients and trial participants, an outline can help determine what kind of questions you want to ask and how you want the video to flow.

Depending on the format—animated or “live-action”—you’ll need to consider the best way to actually create the video. Do you have the resources to recruit the talent and create the video, or will you need to use a third-party vendor? In either case, all members involved should be aware of the key message, purpose, and audience. You’ll also want to make sure your video cast—whether animations or live actors—is diverse and representative of the population.

One other thing to consider is making sure that your video is an appropriate communication tool. This may include getting IRB approval for both the script and the final video, especially if you plan on using the video during recruitment or consent.

 

Health Literacy is a living process

You may have noticed a common theme here: There are so many factors to consider in each stage of the video development process! This concept applies to all aspects of health literacy. While you may figure out the best approach for one video, for example, that exact process may not work for the next. And even if you create a nearly identical video a few years down the road, the times and culture change, so you’ll likely have to start from the beginning. Specifically, content creators should always take care to research what ever-changing pressure points are at top of mind for each community and how to best address those concerns.

Once you’ve completed a video, the work doesn’t stop. Get feedback—what worked? What didn’t work? How can you improve for the next one? As challenging and demanding as this cyclical process may be, health literacy is such an important aspect of clinical research or any health-based communication, and we should all do our part to make sure our messages are properly reaching the intended audience!

CISCRP is also developing a manuscript discussing the process and findings of our 4-part video series; stay tuned for the publication!

Health Literacy: Making content clear, engaging, and appropriate for patients and the public

Health literacy has always been an important part of CISCRP’s work. From general educational content about clinical research to sharing information and results for specific trials, we take pride in making content that is easy-to-understand, non-biased, non-promotional, culturally sensitive, and relevant for the communities we connect with.

In late 2021, CISCRP formed our Health Literacy team to further this part of our mission. We are excited to share some insights on what our team has been up to!

In this blog, you will learn how we are expanding our library of educational content and applying principles of health communication to new and engaging types of content. Most importantly, you will also hear about how we are working more closely with individuals from the communities we hope to inform and empower.

What is health literacy?

Many people know that health literacy, on a personal level, is the degree to which individuals can find, understand, and use information and services to make health-related decisions. A common example is following instructions for using medicine. A more complex example is understanding how clinical trials work, how they might impact your life if you participate, deciding whether to participate based on that information, then actually finding and determining whether to enroll in any particular trial.

Many people might not know that there is an equal and crucially important other half to health literacy – the organizational level. This is the degree to which organizations equitably enable personal health literacy.

At CISCRP, our focus and dedication to health literacy supports both individuals and organizations, including our own. We aim to achieve a high standard for health literacy to help patients, study participants, and members of the public.

What is the Health Literacy team doing?

Our team of editors, project managers, graphic designers, and community engagement specialists have been busy! Our favorite projects have focused on the topics of diversity, equity and inclusivity, Pediatric Research, and raising awareness on the key role of health literacy among researchers involved in medicinal product development.

Our newly redeveloped educational brochure about clinical research for Black and African American communities was created by working together with members of these communities, as well as subject matter experts who have experience working with them. This included receiving feedback from 500 members of Black and African American communities through an anonymous survey.

We also redeveloped our Common Myths About Clinical Trials educational brochure. The brochure, which is for all audiences, provides a fair and balanced view to addresses some challenging issues and misconceptions about clinical research.

One pharmaceutical company showed a big commitment to health literacy by asking us to deliver a series of health literacy trainings for their staff. We also developed other awareness content including a crossword puzzle and an infographic about simple ways to apply health literacy in everyday life.

 

Community Engagement and Insights

To ensure the materials we create meet the health literacy needs of the people we hope to inform and empower, we ensure members of the target audience are involved in the development process. Most often, this means our content is reviewed by a “Review Panel” of volunteers that includes patients, health professionals, patient advocates, and members of the public.

For some projects, we hold “Feedback Forums,” which are like focus groups, user-test through interviews, or even survey 500 or more members of the target audience. This helps us make sure we really understand what the community wants to know and what they think about new materials we create. We also make sure some materials, such as brochures and videos, are reviewed by an Institutional Review Board.

Stay tuned for more blog posts about the work we do to learn how you can apply health literacy best practices in your daily life and work!

For a sneak peek, check out our 4-part Pediatric Education video series which combines live actors and animation to help kids learn about clinical research!

Written by: Behtash Bahador, Scott Finger, and Holly Arthur