Enjoy this month's AccrualNet Guest Expert, Amy Yamokoski. Amy has a key role with the NCI-funded researcher, Dr. Eric Kodish, around improving physician communication of informed consent. Amy is here today to talk about this research. There is a link to the article at the end. Many thanks to Amy for her contribution!

Amy Yamokoski's Post:

Our previous study, which included direct observation methodologies and interviews, concluded that parents of children with newly diagnosed leukemia sometimes did not understand key aspects of clinical trials. The study culminated in the formation of a Parent Advisory Group on Informed Consent (PAGIC). This group would ultimately propose a sequenced model, the PAGIC model, to improve parental understanding and interactivity during informed consent conferences (ICCs) for randomized clinical trials (RCTs). The PAGIC model depends on teaching physicians that effective informed consent requires the delivery of three distinct components communicated during at least two separate meetings. The first meeting should include discussion around the patient’s diagnosis and the prognostic characteristics of their disease. Once parents/patients have demonstrated a good understanding of the diagnosis, physicians are to assess receptivity to further information and only then move on to a discussion focused on the best current treatment available. Once parents/patients demonstrate adequate understanding of current therapy, physicians can proceed to introduce the idea of an RCT—ideally in a second ICC meeting.

To test the effectiveness of the PAGIC model on physician communication and parental understanding of RCTs for acute leukemia, we recruited physicians at 2 major pediatric hospitals to participate in a training program. We conducted daylong seminars at both sites, focusing on didactic teaching based on the PAGIC model. We also provided physicians with data obtained from our prior work, emphasizing the poor understanding of randomization and choice of trial participation amongst parents of children with newly diagnosed leukemia. We stressed the importance of adherence to the sequenced approach to informed consent and the value of conducting at least two separate meetings, gauging parental understanding both cognitively and emotionally before moving onto the next component of the PAGIC model. During the seminars, we played audiotaped ICCs to highlight and demonstrate examples of effective versus problematic communication techniques. At the ends of the seminars, attendees were equipped with a laminated PAGIC model pocket card, a copy of the PowerPoint slides, and a copy of the article “The Day One Talk” by Jennifer W. Mack and Holcombe E. Grier [J Clin Oncol. 2004;22:563–566].

We reinforced the major points of these seminars through half-day booster sessions during the course of data collection. During booster sessions, we used audiotaped ICC examples collected from our previous study as practice cases. We presented three 40-minute cases during each booster session, prompting physicians to identify the positive or negative aspects of these taped ICCs. The attendees were then divided into groups of two and given the opportunity to role-play as physicians and parents with simulated cases. They were equipped with our Clinician ICC Checklist, a self evaluation tool for clinicians, during these role-play sessions to remind themselves of the important points discussed during the seminars.

We used our training modules to highlight some contributing factors and techniques to improve communication between physicians and parents. These include providing an emotionally supportive environment for parents and patients, simplifying information using pictures or diagrams, using appropriate metaphors, and limiting medical jargon to facilitate understanding. We also encouraged stimulation of reciprocal information exchange between the provider and the parents. We trained physicians to prompt for communication by inviting parents to ask questions and eliciting their understanding in an open-ended way. These physicians were also trained to clarify parental questions or comments.

When compared with physicians at control sites, those physicians who were trained at our seminars conducted longer ICCs, elicited parental questions and understanding in an open-ended way more frequently, were better at clarifying parents’ questions or comments, and showed improved adherence to all nine of the PAGIC criteria we examined. In fact, we noted a statistically significant difference between trained physicians’ cases and control cases in virtually every ICC criteria we coded, suggesting a powerful effect of this intervention on physician communication behavior.

Although our study was in the context of childhood cancer, such studies should also be considered in other clinical and research settings. Academic physicians who are involved in the current transformation of clinical research should be trained to conduct effective ICCs. The “see one, do one, teach one” approach is no longer adequate for informed consent. Find this article on AccrualNet here.

Amy Yamokoski, co-author and Program Coordinator

Cleveland Clinic

Department of Bioethics