Article
How CISCRP Made Tools for Informed Decision Making
By CISCRP Staff|Mar 20, 2023
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?
