Listening, interactive media transform informed consent
Approach particularly helpful in complex trials
A new approach to informed consent currently being developed at St. Jude Children's Research Hospital could greatly improve the way in which patients and their families learn about complicated protocols, says the physician who is leading the development team.
The approach, which engages pediatric patients and their parents using an interactive media presentation on a handheld device, has great potential for use both inside and outside clinical research, says Ray Barfield, MD, PhD, a bone marrow transplant specialist at St. Jude in Memphis, TN.
Barfield says a team from St. Jude and the University of Memphis that includes health communications scholars, graphic artists and computer technicians has spent the last two years working on the project. They've used information gathered from physicians, other health care workers, patients, and families to try to overcome the vast learning challenge that awaits pediatric cancer patients and their families who are considering participating in a cancer trial.
"The most useful thing we've done is to begin with our foundational assumption, which is, we need to listen to the nurses, the physicians, the parents and patients to actually come up with interesting approaches to delivering information that's useful to them," Barfield says.
"I think just listening to people is a wonderful, generalizable lesson from this."
Frustration: The mother of invention
Barfield says his interest in this subject was borne out of frustration with trying to explain complicated protocols to patients and their families. He says his consent forms regularly run to 25 pages of single-spaced text.
"We struggle here with the process of informed consent, because the more complex the research protocols become, the more difficult it becomes to meet the goal of true informed consent," he says. "In an effort to include everything for the sake of completeness, there are times that we actually reach a point of diminishing returns, when the volume of information begins to become an obstacle to seeing what's most important about the research protocol."
Barfield describes the experience of trying to explain a protocol to a patient's family and seeing them having difficulty digesting the information.
"I would get 30 or 45 minutes into a discussion and feel that I was sort of losing people," he says. "It's like being a professor at the front of the class and you start to see all your students' eyes glaze over and you know the final exam is coming down the pike and you know they need to know it."
As he began to look at how he might approach informed consent from another perspective, he learned about a group from the University of Memphis' Center for the Study of Rhetoric and Applied Communications that wanted to find a way to work with St. Jude on health communications issues.
They enlisted the help of graphic artists from the university's Center for Multimedia Studies to find ways to overcome the information gap for patients and families.
An important step, Barfield says, was to set up the focus groups of physicians, health care workers, parents, and older St. Jude patients, ages 12-17.
Their input helped Barfield's team realize a few key points:
• Different people learn new information differently.
"This is a process of learning — the 'informed' part requires understanding, learning new terms, learning new ideas," he says. "Because the people who write the informed consent documents tend to be people who've been in school a lot, a text-based document is a natural approach to delivering information for us. But other people respond to visual things, to graphic information, to verbal communication."
So the team explored the feasibility of developing a multimodal approach to delivering the informed consent information, so that everyone could review it in the way they understood best.
• Patients and families want to know what information is most important.
Barfield says one of the biggest complaints about the standard consent documents was that there was no prioritization of information.
"Everything is sort of presented the same," he says. "One consistent theme, especially from the parents and from the non-physician health care givers, is that it would be enormously helpful to stratify the information."
So the team worked to develop a hierarchy of information using a standard consent document as a model.
At the top level, would be the most important information about the protocol: "Absolutely crucial required information — if you don't get this, you don't understand the protocol," Barfield says.
Then, he says, there would be a second telling of the information in a more detailed way. Barfield describes it as a "recommended" section, for parents who want more depth.
Finally, for those who want to dig into the protocol even further, there would be access to PDF files of published articles about the subject that would be available through the St. Jude library.
"One of the nice things about this is it allows us to choose articles that are accessible, that are factually correct," he says. "That acts as a kind of antidote to the fire-hydrant approach to information that most people experience through the Internet."
Finding a successful model
When the team began to consider how they would relay this information to families, they looked at a successful model in another field: museums.
"We wanted an analogous situation, where you have an enormous amount of information, that is completely unfamiliar," he says. "We came up with the analogous situation of a museum, where you have room after room of unfamiliar information."
As they explored the idea further, they found a software company in Canada that specializes in working with museums. They teamed up with company to develop software that could run on a small handheld device — looking something like a personal digital assistant (PDA) — currently in use with museum exhibits.
For the first prototype, the team used one of Barfield's own protocols, breaking down the information and organizing it for use on the handheld device. In addition to text, the software employs graphic animations to help explain complicated processes.
"You can say, 'This is an antibody study, it's used to target neuroblastoma and it helps to focus the immune systems so that T-cells and natural killer cells can blah, blah, blah,' and nobody understands what you're talking about," he says. "With this animation, it's just beautiful, because you know what an antibody is and what it's intended to do."
As the team worked on this project, it became clear that this approach to informed consent was too resource intensive to use on every protocol, even at a large institution like St. Jude, which has an extensive protocol department. But Barfield does see the approach as having real value in a number of situations:
— Large, long-term studies involving many patients. Barfield says one example at St. Jude would be a large protocol for patients with acute lymphoblastic leukemia (ALL). "ALL is the most common pediatric malignancy and there's an enormous amount of institutional support for this protocol – it's the largest protocol we run," he says. "And it's the kind of protocol that you might be able to develop a module for that would have a five-year usefulness."
— Large national studies such as those conducted by the Children's Oncology Group (COG), where the consent program could be set up nationally and distributed, along with devices, to participating hospitals.
"If you have a children's hospital that's primarily taking care of kids rather than doing research, but they participate in COG studies, then they might benefit from having a COG protocol in this sort of format," Barfield says. "They could use the format, but they wouldn't have to develop it themselves because they're using a protocol from a national working group."
— Explanation of key concepts in research that cross protocols, such as the purpose of a Phase 1 trial or the idea of informed consent.
— Quality of life studies, in which the assent of the participating child is extremely important since he or she will be the one reporting the various measures of pain, depression or other factors.
— Informed consent for non-research procedures such as installing a central line. Because these procedures tend not to change much over time, the modules could be used for years, Barfield says.
Barfield says that as the team has continued to work on the project, they've found ways to more amend the software to make changes without heavy investments of time and resources.
"And the software is very, very flexible, so it's not attached to any one device," he says. "You could fit it onto any kind of hardware, including just a computer mainframe."
Barfield says usability testing for the device is being conducted this summer, to enable the team to revise it to make it even more usable and flexible for future research projects.