A randomized clinical trial of TrialTALK, a communication tool to facilitate treatment-related shared decision making.

Abstract

45 Background: Cancer treatment decision making involves timely, high-risk, life altering shared decision-making conversations between patients, their families, and their oncologists. As such, these conversations are a prime target for a carefully designed, easy to interpret approach to facilitate preference-sensitive decision making. Patients need several important pieces of information delivered in a way that is easy to interpret. The TrialTALK approach has two core elements: a verbal approach and a pen and paper (P&P) diagram. The P&P diagram includes the diagnosis with prognostic implications, all available treatment options including best supportive care alone, estimates for efficacy, and anticipated impact on daily life. The verbal conversation corresponds to the diagram and includes a phrase to encourage deliberation, and empathic responses. Our trial is evaluating the effectiveness of TrialTALK to influence decision making, in particular clinical trial participation. Here, we report the results of the initial oncologist training. Methods: 28 oncologists volunteered to participate and were randomly assigned to control (Group A, n=13) or intervention (Group B, n=15). Oncologists in the intervention group each received two hours of training, including simulated conversations with feedback and optional 1:1 follow up for troubleshooting. At the conclusion of training, oncologists completed a video-recorded simulated encounter with an actor. Trainers reviewed P&P diagrams in real time and provided feedback. Results: We used a fidelity checklist to assess effectiveness of the training. We considered ≥ 14 points out of a possible 20 as an acceptable use of TrialTALK. The average score was 14.8 ± 2. Scores ranged 10-18. 12 of 15 intervention oncologists demonstrated adoption of the tool after 2 hours of training. Conclusions: Oncologist can effectively learn to use TrialTALK. The ongoing study will estimate preliminary efficacy of the TrialTALK intervention in regards to patient decision making and participation in clinical trials.