Videos help subjects, families understand trials
Those who viewed video weren't more knowledgeable than those who didn't, but felt better prepared
Some institutions have created informational videos that help potential research subjects and their loved ones make a more informed decision about whether to enroll in a clinical trial.
But do these videos actually improve the informed consent process? A study published recently in the journal Cancer showed mixed results for one such informed consent video.
The video, "Entering a clinical trial: Is it right for you?" produced nearly 10 years ago by the Dana-Farber Cancer Institute in Boston, MA, has won awards that include the Health Improvement Institute's Award for Excellence in Human Research Protection and the International Health and Medical Media's "Freddie" Award.
In a study looking at 90 adults who were considering participation in cancer clinical trials, participants were randomized to either review an informed consent document with a clinician, or to have the same review and then take home a copy of the video to watch at their convenience, says Brianna Hoffner, RN, MSN, NP, who previously worked as a research coordinator at Dana-Farber.
Patients were lent a portable DVD player if needed or could watch the video in Dana-Farber's media library.
Both sets of patients were later tested regarding their knowledge about clinical trial participation using the Quality of Informed Consent tool.
No difference in understanding
Hoffner says an analysis of that data found no significant difference in understanding between those who viewed the video and those who didn't. She says this outcome may be explained by the fact that Dana-Farber patients tend to be better educated, meaning that even the control group may have entered the study with a higher degree of knowledge about clinical trials.
But she says some results did point to extra value that participants gained from the video. For example, 85 percent of those who viewed the video found it to be an important source of information about clinical trials. Eight-one percent said they felt better prepared to discuss the trial with their physicians.
They also reported better informed family members as a result of the video — 89 percent said it helped their families better understand clinical trials, while 79 percent said it helped families better accept the subject's decision about participation.
"A lot of times, only one family member would come to a clinical trial consult and then they'd go home and the rest of the family would ask, 'What did they say? What's going on?'" Hoffner says. "And this was something that they could watch together. That was a lot of the feedback."
IRB involved in video
The development team behind the Dana-Farber video consulted clinicians, ethicists and IRB members, and the chairman of the institution's IRB was among those who described human subjects protections on-camera in the video. (EDITOR'S NOTE: A story about the development of this video appeared in the April 2005 issue of IRB Advisor).
Hoffner says the important point that an informed consent video needs to make is the voluntary nature of clinical trials.
"The most important thing is that we were conveying this information in an unpressured manner," she says. "Everybody involved in this project wanted it to be conveyed to the patients that they do not have to participate in a clinical trial. They are given this option, but there are standard treatment options available as well. And that they understood that this was research — this was not standard treatment."
Dana-Farber continues to make the video available on its website for patients who are considering participation in a trial. There are also links to it from the websites of other research institutions.
Hoffner, who has since gone on to work as a nurse practitioner in the bone marrow transplant program at Memorial Sloan-Kettering Cancer Center in New York City, often refers her patients to the video if they are considering a trial.
"There's always an open protocol for patients to be consented for," she says. "And it's a hard decision to make, especially in the middle of a bone marrow transplant. I absolutely still see the need for (the video)."
Hoffner B, Bauer-Wu S, Hitchcock-Bryan S, et al. "Entering a clinical trial: Is it right for you?": A randomized study of the clinical trials video and its impact on the informed consent process. Cancer 2011 Aug. 25 epub.
To access the video, visit http://www.dana-farber.org/Health-Library/Entering-a-clinical-trial--Is-it-right-for-you-.aspx