Tips on using teach-back in the IC process
Site uses simulations in training
Research institutions that plan to use the teach-back method as part of their informed consent process should make certain there is adequate training for clinical trial professionals. One research site has found that simulations work best for this purpose.
The Dartmouth Hitchcock Medical Center in Lebanon, NH, developed an informed consent process that uses the teach-back method as a way for research professionals to make sure potential study participants fully understand what volunteering entails.
"A fundamental aspect of using the teach-back method is avoiding yes-or-no questions or asking the question, 'Do you understand?' because most of the time people will say 'yes' or nod their head," says Dianne Ferris, MS, CIP, human research analyst at Dartmouth College.
"The teach-back approach is recognition of the fact that human nature is such that if people are struggling to understand something or if they are struggling with literacy in general or health literacy, they may not admit they are struggling to understand you," Ferris says.
The Dartmouth Hitchcock Medical Center has a simulation center where research professionals can practice and learn teach-back methods.
"This is a patient safety training center that can handle any type of clinical situation and teach people how to react in those situations," explains Sandra Knowlton-Soho, MS, RN, practice manager of palliative care and critical care at Dartmouth Hitchcock Medical Center.
"We can have conversations, set up rooms such as clinic rooms, operating rooms, and exam rooms," Knowlton-Soho says. "Also, the simulation center provides us with a standardized patient, which is someone from the community who enjoys acting and comes into the center to pretend to be a patient."
In testing the teach-back method as part of the Dartmouth IRB's Valid Optimizing Informed Consent Education Program (VOICE), the trainers could videotape research professionals as they performed a mock informed consent process with one of the actors.
When members of the VOICE team initially discussed using the teach-back method in the context of VOICE, they decided it would be a great technique, Ferris says.
"It's a relatively straightforward and simple technique," Ferris says. "It takes a little time getting used to it, and training would help people learn how to implement it and use it well."
The first step was to pilot-test the teach-back method and see if it made a difference in how researchers handled the informed consent process.
"Our project was not just creating the education but seeing if VOICE made any difference," Knowlton-Soho says. "So we had people doing an informed consent discussion before they had training, and then we gave them a two-hour training session and immediately had them do another session in the simulation center."
After two months, the trainees returned to do another informed consent session, and the videotaped sessions were compared, she adds.
"We could see the difference in how people asked more questions that were not just 'yes' or 'no' questions, and they started having more conversations with [mock subjects]," she says.
For example, the study coordinator who is trained in the teach-back approach would first discuss with the potential participant what they'd have to do at their first study visit, Knowlton-Soho says.
The coordinator might say: "This is your first appointment, and it involves coming into the medical center within three hours of having a migraine headache. Once you're here, you have to sit for four hours and answer some questions from us every hour," she explains. "We also need for you to identify someone who will bring you home after the appointment."
Then at breaks in the conversation with the subject, the coordinator might say, "Let me hear from you when you go home and talk to your husband tonight about what you will tell him about the first visit," she adds.
If the potential participant says, "I don't know, something about coming in early, but what was it?" then the coordinator can repeat the instructions and continue to ask questions that will make certain the person recalls the important information.
Ferris and Knowlton-Soho offer these additional suggestions for questions to ask as part of the teach-back method for informed consent:
- Purpose of the study: "If you were going home tonight to talk to your husband or wife about being approached to be in this study, what would you say about what the study is all about? Or if your sister called you later, what would you explain to her?"
- Study's risks: "Tell me what are some of the side effects we talked about? And explain to me what you might do if you are concerned about something that's happening;" or "If you were given study drug X, what are some symptoms that you would be looking for? What are some side effects that you would want to keep an eye out for and report to your doctor?"
- Voluntary participation:"Tell me what would happen if you decide volunteering for this study is not working for you? What are your options and what would you do? Do you feel you need to be in this study? Explain to me what you would do if you wanted to change your mind about this study at any point."
- What is required of participants: "How many times would you have to come to the clinic if you were to take part in this study? How often would you have to come to the clinic? What are some of the major tasks you will have to do if you participate in this study?"