11 - Peer-evaluation and Role-Playing as a Novel Approach to Informed Consent Training in Emergency Research Trials

Background:  Learning how to approach families of critically ill patients about informed consent for trials in emergency settings is challenging. The ICECAP trial enrolls comatose survivors of cardiac arrest at sites across the US. To improve the skills and confidence of research coordinators, we developed training using role-play and peer-to-peer feedback.

Program

Description:  At two in-person investigators’ meetings in 2020 and 2022, participating research coordinators were grouped into pairs and provided with 1) a copy of the consent form, 2) a video recording device with instructions, 3) a description of the activity, and 4) a peer evaluation checklist. Pairs of participants were allotted ten minutes each to role-play a consent discussion with one participant as the researcher and one as the patient’s family member. The role-plays were video recorded. Each “family member” role was assigned a unique trait (e.g. confused, tangential, worried, etc.) to act out. These were chosen among common potential barriers arising in consent discussions. After both role play sessions, participants first reviewed their own video, then exchanged the video device with another participant to review and provide each other peer feedback. Participants were provided the opportunity to repeat the role-play to address specific feedback they received.

Program

Assessment:  Challenges with consenting family members into ICECAP are a consistent topic of discussion between the ICECAP clinical coordinating center and the on-site research staff. This peer-to-peer exercise provided us with the opportunity to address concerns previously discussed and provide training. Approximately 40 research staff participated in this exercise in both 2020 and 2022. During the 2022 exercise, 16 staff completed an evaluation and 62% of responders found the exercise helpful and 38% found it “somewhat helpful”. No participants reported the exercise was unhelpful. Of responders, 50% of people had already had experience consenting patients’ family members into ICECAP. Participants provided narrative feedback that they learned the importance of emphasizing certain areas of the consent form such as outcomes, randomization, and duration of cooling; that they learned new “tips” from their peers on wording during the consent process; and tips on how to word questions to assess understanding of the family members. Additionally, participants learned how to respond to distinct challenges through use of the character roles, such as keeping family members focused.

Limitations: Participation in the training and informal feedback was robust, but the written evaluation survey was optional and the response rate was relatively low. Participants providing written responses suggested the activity could be improved by a more detailed script, more written instructions, and a smaller room with less background noise. It is also unclear if this single opportunity to role play is enough practice to help, especially for low-enrolling sites or coordinators with limited prior experience.

Discussion:  How family members are approached for informed consent for participation in clinical trials may be important to recruitment, retention, and the ethical conduct of research, but effective training in this skill is often scarce. The use of role-playing practice, video recording, and peer-to-peer evaluation may improve the confidence of coordinators approaching family members for emergency research involving medical emergencies. Peer-evaluation leverages the experience of fellow coordinators, and provides a safe space in which to get feedback. Offering this training at investigator meetings can efficiently use training time and resources in a novel training opportunity that can improve the enrollment experience.