Clinical research communications are enhanced through in-person, verbal interactions.
Research has shown that providing both written and verbal information is more effective than written or verbal information alone (Al-Harthy et al, 2016).
Interactive techniques are particularly important and helpful in the clinical research environment, as they facilitate conversations that can lead potential and enrolled participants to greater clarity about research and their decision to participate. Thus, reviewing plain language materials and effectively using verbal teach-back to check for participant understanding are essential to determining understanding
Anyone presenting information can take on the role of a supportive teacher when sharing information so that potential and enrolled participants feel more comfortable asking questions or asking for clarification.
In this section are tips, as well as examples, of how to apply interactive health literacy techniques in the clinical research context.
Teach-back is an interactive, evidence-based best practice for sharing information and checking understanding. It involves participants demonstrating knowledge by “teaching it back” to the person that explained it.
The spirit of teach-back can be woven into all interactions between participants and clinical research stakeholders.
1. Share Information
Use simple terms to describe information in a way that meets the needs of you target audience
2. Confirm Understanding
Ask the participant to use their own words and repeat/teach back what they just learned
3. Rephrase or Clarify if necessary, and Reconfirm understanding
If the participant does not repeat back the key takeaways as they should have, try to convey the information differently and ask them to teach it back to you again.
4. Move on and repeat
Once the participant has demonstrated adequate understanding, move on to the next topic and continue the teach-back process as necessary
Teach-back is especially relevant:
- During the informed consent process
- When reviewing study procedures and instructions
- When scheduling and organizing study visits
- When discussing adverse events and reactions
- When determining next steps at the end of study participation.
Putting Teach-Back into Practice
The teach-back process can be repeated in every applicable participant interaction throughout the clinical trial life cycle. They key is to check understanding in a tactful way that does not make people feel like they are being given a “test.”
Use questions like:
- I want to be sure that I explained everything clearly. Can you please explain it back to me so I can be sure I did?
- When you go home and tell your family about what we discussed today, how will you explain it to them?
- Do you have any questions for me?
- Does this make sense to you?
- Do you understand the study?
- What two questions do you have?
- What can I review again for you?
- What study procedures need more explanation?
- What risks are concerning to you?
A Note About Yes/No Questions
Think carefully about whether yes/no questions are appropriate for your study population.
On one hand, questions that can be answered with a yes or no make it easy for a participant to mask their confusion so it can be helpful to opt for questions that require a more descriptive answer.
On the other hand, some populations may be non-speaking or have limited verbal ability, and thus might not be able to easily answer questions that require them to explain their responses.
In those types of cases, thoughtful presentation of a select number of yes/no questions may be more appropriate.
After signing this consent form, can you still decide not to answer questions asked by the person leading the focus group?
- Yes (correct answer)
- No (incorrect answer – Action: educate about their rights as a research participant)
Paraphrase testing is described at plainlanguage.gov. One-on-one paraphrase testing sessions work best for short documents, web pages, and survey questions.
Paraphrase testing will tell you what a reader thinks a piece of writing means and will help you know if they’re interpreting the message as you intended.
This can be particularly useful in the clinical research context.