Improve communication using these techniques
Improve communication using these techniques
Role playing and actor/patient are used
Clinical trial sites could improve staff's informed consent communication skills through the use of role playing and using trained actors or others skilled in this type of exercise to portray potential research participants, an expert suggests.
While the clinical trial industry focuses intently on the informed consent document, less attention is paid to the process of consent and determining a potential participant's comprehension of the consent information, says Susan Dorr Goold, MD, MHSA, MA, director of the bioethics program and an associate professor of internal medicine and health management and policy at the University of Michigan in Ann Arbor, MI.
"There is an understanding that this is an issue," Goold says. "But the regulations and the industry's focus are on what you have to cover in informed consent and much less on how to do it."
So the University of Michigan's curriculum focuses on skills rather than knowledge among research staff and trainees, with the goal of improving the informed consent process, Goold says.
This is done through a mini-lecture, distribution of communication strategies, and role playing exercises that involve a trained actor who portrays a potential participant. The trainee has to obtain informed consent from the actor in a role playing exercise, she says.
"They have to discuss research with the simulated participant, and this improves their skills and the process of consent," Goold adds.
The University of Michigan has established a reputation as a leader in using simulated patient instructors to teach communication skills for both medical training and clinical trial research training.
"We've used simulated patient instructors (SPIs) for medical training for many years," Goold says. "We have a parallel clinical consent process we adopted first, and then we adapted it to the research context."
Actors are hired and trained to portray potential research subjects and to evaluate researchers and research staff, Goold says.
The evaluation includes videotaping the role playing process and an assessment of consistency in how informed consent is obtained, as well as a 30-item checklist of other indicators of success in learning the most effective communication skills, she says.
Some of these checklist questions include the following:
- Did the person obtaining informed consent assess the patient's comprehension of the research protocol?
- Did the person obtaining informed consent treat the patient with respect?
- Did the person obtaining informed consent pick up on nonverbal cues?
The informed consent students also do a self-assessment which is compared with the SPI's assessment during a debriefing process, Goold says.
Role-playing with a facilitator and practice protocol is conducted separately from the SPI sessions.
"We give them their parts to play, saying, 'This is the research project that you're discussing,'" Goold says. "For role-playing we have a lot more flexibility to target different groups, so if we have a group of pediatric researchers, we'll focus on role-play that works with family members."
If the group being trained involves social science research, then the role-playing will involve social-science research.
"So the role-playing exercise is a small group exercise that we lead and they practice obtaining informed consent on each other, and they give feedback to each other," Goold says. "The role-playing comes before the SPI, so they have practice before meeting with the SPI."
"Most learners had favorable reports of their experience with both role-playing and the simulated patient instructor," Goold says.
SPIs, which are also called simulated potential participant instructors, portray the common participant, but there are a few added twists in the role-playing sessions, Goold notes.
"There will be children, people who don't speak English, or someone who is only in the research for the money or who really believes the research will benefit his or her health," Goold says.
One goal of role-playing is for the person being trained to develop skills in determining a potential participant's true motives for becoming involved in research.
For example, the person being trained needs to be aware of cues that the person may be participating due entirely to an incentive, rather than for altruistic or other purposes.
"The goal overall is that the learners will first uncover that the potential patient is involved solely for the money," Goold says. "They would realize that the potential participant doesn't realize how much risk is involved and how many interventions will happen to him or her."
In the case of therapeutic misconception, the role-playing student needs to uncover the fact that the role-playing potential participant is doing the study with a belief his or her health will improve and a cure will be found, Goold adds.
"We want them to uncover these motives, but you can only uncover that if you can communicate skillfully with the participant," she adds.
The three different scenarios include the socio-behavioral research scenario, an intervention study that is a drug trial for heart disease, and a basic science protocol that involves collection of a sample, Goold says.
"That is also because we have a huge variety of learners who take this training program," Goold says. "We have some in epidemiology, some in behavioral, and some in clinical research."
The consent communication curriculum includes 2.5 hours in lecture and role-playing and 1.5 hour one-on-one sessions with the SPIs, Goold says.
"We don't have a way to evaluate the impact of the SPI, but we use the SPI to assess the outcomes of other portions of the curriculum, Goold says.
"What we've found so far, and this is preliminary, is that people's confidence in their abilities to communicate about research participation are improved," Goold says. "And, also, their attitudes about communications strategies are improved."
The trainees' knowledge of informed consent had not improved significantly, but that was probably because their knowledge was high to begin with, Goold says.
"We focus on skills, not knowledge," Goold says. "People also have more of a commitment to using these techniques and more competence in their ability to do so."
Clinical trial sites could improve staff's informed consent communication skills through the use of role playing and using trained actors or others skilled in this type of exercise to portray potential research participants, an expert suggests.Subscribe Now for Access
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