VA develops patient handbook for research
Early studies indicate it’s effective
Staff within the Veterans Affairs (VA) research arm have produced a handbook for veterans considering involvement in clinical trials.
The booklet, which still is being tested for eventual use in a clinical trial, has shown success in an early study of its usefulness among pharmacy students who read it. A second study, testing an elderly patient population, still is under review for publication.
Dennis Raisch, RPH, PhD, associate center director for scientific affairs at the VA Cooperative Studies Program’s Clinical Research Pharmacy Coordinating Center in Albuquerque, NM, says he hopes to continue with a third study as part of an actual clinical trial.
The VA Cooperative Studies Program (CSP) is a research organization within the Veterans Health Administration’s Office of Research and Development. The CSP works on large-scale multicenter clinical trials, primarily within the VA system. Raisch’s center is the pharmacy coordinating center, which makes sure drugs being tested are distributed to various sites.
"For a number of years, we’ve been concerned that patients in the VA and in all sorts of clinical trials may not fully understand the informed consent that they’re signing or have a very good background and understanding of the consent process," he says. "And that’s really where the initiation of the idea for this project came."
Raisch says that the higher profile clinical trials have in the public mind these days doesn’t necessarily translate into more willingness to participate.
"It makes the public’s awareness of clinical trials heightened, but it also makes their fears of clinical trials heightened," he says.
One key issue he wanted to address was patients’ understand that signing up for a trial doesn’t obligate one to finish it.
"Patients need to understand that before they’re even considering a trial," Raisch says. "Your right is to make choices as you go along. I think that’s a fear that people have — If I get in this trial, they won’t let me out. The doctor will treat me differently if I get out of the trial.’"
He says the idea was to provide a booklet with basic information about clinical trials presented in an easy-to-understand format. The first draft was written by then-pharmacy student Agatha C. Graham, PharmD, now clinical assistant professor of pharmacy practice at the University of Wyoming School of Pharmacy in Casper.
Graham says she looked to the National Cancer Institute’s clinical trials booklet and other similar published materials to come up with the general organization of the VA handbook. After discussions with staff, the format was changed to a question-and-answer style with questions such as: What is a clinical trial? What should you know before participating in a clinical trial?
"It actually is a fairly generic booklet," she says. "It does talk a little bit about the CSP program, so it’s specific to the cooperative studies program."
Raisch says the booklet was written from the perspective of the type of patients who would be in the VA system.
"From the perspective of Why would you as a veteran want to participate in this type of thing?’" he says. "But with a few changes, it could be used in other types of facilities."
Students tested better
The booklet was tested among pharmacy students at the University of New Mexico, which collaborates with the CSP in training students in pharmacy.
In the controlled study, students in the experimental group were given 15-20 minutes to read the handbook, then given a questionnaire that included 25 true/false questions testing participants’ knowledge of clinical trials. Also included in the questionnaire were questions regarding attitudes about clinical trials and motivation toward participation in a hypothetical clinical trial.
Students in the control group were given the questionnaire, but not the handbook.
The experimental group’s knowledge scores were higher (89% vs. 83% for the control group), as were their positive attitudes. There was no difference between the groups in their motivation to participate in the hypothetical clinical trial.
Raisch says it’s noteworthy that even among pharmacy students, who are more sophisticated about the research process, the handbook increased understanding of clinical trials.1
He explains the decision to start with a student group, rather than immediately attempting to test the booklet in a real clinical trial.
"What if our booklet had actually affected people’s perceptions in a negative way?" Raisch says. "Of course we assumed it would have a more positive impact on people’s thoughts about trials. But if it had had a negative impact, it could have affected the enrollment in the main study."
While he couldn’t release details yet from the study of more elderly patients who read the booklet — a group that included patients who were at the VA for other reasons — he said they found it easy to use.
"They stuck with it, they read the whole booklet — it took them maybe 20 minutes," he says. "We’re pretty pleased with their response."
Raisch says ease of use is key to creating a successful handbook for clinical trial participants. The most recent form of the booklet includes color photos, graphics to explain some concepts and boldfaced type of key terms, with a glossary at the back for reinforcement.
"The most challenging part of it was getting it down to that seventh-grade reading level," he says. "It seemed like most of that was the short sentences. It’s the long sentences that bring you up into a higher-grade reading level."
Graham suggests that institutions attempting a similar project should seek feedback from as many different perspectives as possible, including people currently participating in clinical trials.
"Just ask [the patients] what kind of things they have questions about that they’d like to see in written format," she says. "Definitely get a group of people working on it so you can get feedback."
Reference
- Graham AC, Raisch DW, Fye CL, et al. Assessment of the impact of a patient clinical trials handbook among pharmacy students. Clin Ther 2005; 27(2):238-245.
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