Christopher Trudeau, J.D., Professor, Thomas M. Cooley Law School
Risk means something different to each of us: Lawyers think of risk as how to prevent the hospital from getting sued. Providers wonder, how do we communicate the info to patients so they can make good decisions?
What is risk communication? Helping people understand the nature and seriousness of a certain action so they can make an informed decision.
When someone is selling us something, they’re very clear and direct, but when they need to give us information, it can be very complicated.
Key components of risk communication:
- What we communicate
- How much patients want to know
- When we communicate it (ex. After you’ve prepped for a colonoscopy is not the time to ask for consent — The patient doesn’t care at this point.)
- How we communicate it.
Communicating risk is a process, not just documents to sign. We have to keep in mind both these factors:
- What is legally required for consent?
- How much info does the patient want?
Legal disclosure requirements differ for clinical procedures and research trials. There are a lot more legal requirements for research trials.
- The requirements for clinical procedures are state-based and grow out of the common law (lawsuits, etc.).
- The requirements for research studies were developed in response to bad acts by researchers and are federally controlled.
For procedural informed consent, we use the “reasonable physician-standard” and “reasonable-patient standard” as legal guidelines. But communicating risk goes way beyond the legal requirements.
Written communication does not substitute for in-person conversations that incorporate teach-back. So writing good consent forms isn’t enough. The process of informed consent has to be developed.
Design the consent process first, before you design the consent form. Example:
- Patient and provider discuss.
- Patient gets handout and consent form.
- Patient preps for the procedure.
- Patient goes to appointment.
- Patient and provider further discuss consent form, using teach-back (before anesthesia is given).
It’s important to create hierarchies of information: Prioritize the information so that it emphasizes the key risks to patients. Prioritize risk in the document by creating risk hierarchies.
- The most important info needs to go first, such as the fact that you need someone to drive you home after a colonoscopy.
- People decide for themselves how much attention to pay to a document.
- Documents are not novels; they are not meant to be read cover-to-cover. You may look at it when you get it, but when you consult it later, you’re only going to look for the information you’re after at that time. (You’re not going to read it through again.)
- People actively interpret AS THEY READ. They don’t wait till the end to get the big picture, so organization is KEY.
Structure all documents as if everyone has limited health literacy.
- Consider intended users (focus group? User testing afterwards?)
- Write down what your intended users would want to know.
- Rank the info from most important to least important.
- Then write down any other info you have to disclose by law.
How do you lobby the document owner for clearer documents? Get the owner to focus on the content, rather than the words. They will be more likely to buy in.
How to convey numbers?
Every medical decision requires some statistical literacy. Aim for communicating with a minimal need for statistical literacy. Minimal literacy focuses on the main concepts, such as absolute risks.
Tips on numbers:
- Focus on what you want the patient to do. The patient needs to get the gist. Include a call to action and relate the message to everyday life. Then you can reinforce with data or visuals that relate directly.
- Start with the most important info and group logically.
- Less is more, but underscore the gist.
- Round numbers are easier to understand and remember.
- Keep denominators consistent, eg. 1 in 10, 2 in 10.
- How you frame the question influences the patient’s decision.
- Talk about absolute risk rather than relative risk. (Relative risk: If you don’t take this medication, your risk of stroke will double. Absolute risk: Your risk of stroke will increase from 5% to 10%.)
- Use visual aids and cues. Icon arrays help people personalize/humanize numbers. You can create an icon array at: www.iconarray.com.
- Think about questions patients SHOULD ask: risk of death? Time frame? How big is the risk? Do the studies apply to me and my demographic? What are the benefits and harms of treatment?
Chris showed a rewritten consent form that has places for the provider to fill in the patient’s answers to teach-back questions. This forces the provider to use teach-back. This is also helpful as legal evidence of understanding. And if the patient has to initial statements, he or she is more likely to read them.