Interactive IC might provide education in entertaining way
Program can work in doctor's office
IRBs and investigators continually look for ways to improve the informed consent (IC) process. One novel idea is to create an interactive informed consent program that serves a dual purpose of providing education to patients and trial participants.
"Medical Animatics created a 3-D, animated and interactive software program for patient education and informed consent first for Lasik surgery and then for bariatric surgery," says Corinne C. Renguette, MA, TCM, a graduate assistant and doctoral student at Ball State University in Muncie, IN. Renguette and co-investigator Mary Theresa Seig, PhD, associate professor of applied linguistics at Ball State University, studied the interactive program's impact on learning among patients considering bariatric surgery.
"Patients log into the application and can do this at the doctor's office and then at their homes," Renguette says. "They learn about their potential surgeries, seeing what surgeons are going to do and what the pre- and post-operative possibilities are."
While viewing the electronic program, potential participants are asked questions designed to assess their interest in enrolling in the study, she says.
"There are informed consent questions to let the doctors know if they agree to the procedure or not," Renguette says.
Questions also assess potential participants' knowledge about the study, and if someone answers a comprehension question incorrectly then the program provides them with education about the concept they missed, she adds.
Renguette interviewed patients before and after they used the interactive program in the doctor's office.
"We compared the language they use before and after to see what the differences are," she explains. "We see what kind of learning is occurring."
For example, Renguette and Seig wanted answers to these questions:
• Are patients able to recall and recognize information?
• Are they able to achieve a level of critical thinking?
"We compared what the patients were saying and used linguistic analysis to determine their level of learning and understanding, Renguette says.
"We've been collecting data for quite some time, only handling one or two patients at a time," she adds. "We don't have the results yet because we're still in the analysis and data collection stage."
In writing informed consent and educational material for study participants, Renguette advocates keeping the language simple through editing.
"Many patients have an average of eighth or ninth grade education in literacy and comprehension levels," Renguette says. "We worked with staff members to edit the text and bring it to that level as much as possible."
For instance, they looked at the vocabulary and made sure that various medical terms were explained and that sentences weren't too complex, Renguette says.
The idea behind an interactive informed consent and education program is that it targets different learning styles.
"Some people prefer visual information, and some people prefer auditory information," Renguette explains. "Some want to read it, and some need to interact with the program."
That's why the software program asks participants different questions throughout, she adds.
"It doesn't personalize it to each person's specific learning style," Renguette says. "It targets all learning styles so regardless of their learning style they're able to see what they need in the program at some point."
For the visual learners, the animation and videos will engage their interest; for readers, there are captions under the pictures; for auditory learners, there is an actress who reads the material out loud, Renguette explains.
"They're watching, listening, reading, and answering," she adds. "It's really important to have alternative learning methods because not everyone can understand things written on paper."
Even if someone prefers a reading style, he won't understand 100% of it unless he's used to studying this way, Renguette says.
"If they are all college students, then they might be fine," she adds. "But the majority of people prefer a variety of modes for learning."
And people who must consider the ramifications of surgery and a clinical trial especially need various learning styles, including pictures to convey the information more clearly, she says.
The questions are visually presented, but participants have to use the mouse to interact and answer them, and they have to watch a repeat of the program's sections where they answered questions incorrectly.
"Physicians receive a printed report showing which questions they answered correctly and which ones they answered incorrectly and how many times it took them to get the answer right," Renguette says. "So if a person answered a question incorrectly three times, then chances are that person didn't understand what was happening in that section."
In these cases, the physician investigator can go over that section again with the patient, she adds.
The interactive IC and education software was created by a collaboration with software experts and physicians. Physicians gave the software designers the original training material booklet, and the software design team created a script for an actress to read, and they created captions, Renguette says.
"Then we edited the script, using literacy level tools, making it easier to understand," Renguette says. "Then Medical Animatics sent it back to the doctors who approved the final script before the program was created."
The process took many months, she says.
The team did consider ethical issues while creating the program.
"Originally, we worried that the animation might sway patients in one direction or another," Renguette says. "If they liked the animation, it might sway them to have surgery, or if they didn't like it they might not have surgery."
But based on study results so far, that does not appear to be a problem, she says.
"People liked the application, but some may have decided not to have the surgery by the time they saw the program," Renguette says. "It just helped them better understand what would be expected of them."
One of the reasons physicians were interested in the novel educational approach is because bariatric surgery requires a great deal from patients, she notes.
"They have to do so many things to have the surgery be a success, so by learning more about their surgery, their success rates could be improved," Renguette says.
"This program provides education and informed consent," she adds. "It's based on the idea that informed consent can only be a true informed consent if the patient is actually informed about everything he or she needs to know — so the education portion is very important."
IRBs and investigators continually look for ways to improve the informed consent (IC) process. One novel idea is to create an interactive informed consent program that serves a dual purpose of providing education to patients and trial participants.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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