Abstract: The Development and Evaluation of a Communication Skills Training Program for Clinical Research Coordinators

◆ Susan E. Morgan, University of Miami
◆ Tyler R. Harrison, University of Miami
◆ Kallia O. Wright, University of Miami
◆ Xiaofeng Jia, University of Miami
◆ Ekaterina Malova, University of Rochester
◆ Rutendo Chimbaru, University of Miami
◆ Hanna Birenbaum, University of Miami

In this paper, we first review the growing literature on clinical trial communication, focusing particularly on the communication factors that drive disparities in the participation of Black and Hispanic patients in clinical trials and research studies. One of the most influential and controllable factors is the way that medical providers and staff talk about clinical trials to prospective participants. While there are few communication training programs that have been developed to improve communication skills that can be expected to positively impact clinical trial accrual, there are indications that such programs can be successful (Eggly, et al., 2021; Hamel, et al., 2022). After reviewing the formative research that serves as the foundation of our intervention, which includes studies of both clinical research coordinators and Black and Hispanic patients that have previously been asked to join clinical trials (Morgan, et al., 2023a, 2023b; Wright, et al., 2023), we will describe the development of a communication skills training program. This brief 4.5-hour program consisted of didactic presentations, skills demonstrations, role plays, skills practice, and open discussion/debriefing. In this paper, we also describe the innovative methodologies used to evaluate the efficacy of the program. First, participants (N = 15) interacted with a Black Caribbean standardized patient who played the role of a middle-aged woman with hypertension. Participants, all of whom were clinical research coordinators with at least 3 months of experience recruiting patients, were asked to spend 10-15 minutes presenting the SPRINT trial, which is a relatively simple study that seeks to discover the most effective treatment protocol for controlling hypertension. This interaction was video recorded and transcribed for analysis, using NVivo 12. One week after the training program, participants again interacted with the same standardized patient to present the SPRINT study again. The ability to apply verbal and nonverbal communication skills covered in the training program were assessed by coding both the verbal transcript and the video recording. In addition, other measures of effectiveness were analyzed, including a self-assessment grounded in both the elaboration likelihood model (Petty & Cacioppo, 1986) and the communication competence framework (Spitzberg, 2015). The standardized patient also provided a 20-item assessment of clinical research coordinators’ performances at both Time 1 and Time 2. Finally, we asked a naïve coder (an undergraduate student with an interest in health communication) to provide a global assessment of the CRC’s communication with the standardized patient at both Time 1 and Time 2. Approximately two weeks after the intervention and assessment procedures, all participants received both the Time 1 and Time 2 recordings of their interactions with the standardized patient. Within 6 weeks of the Time 2 assessment of communication skills, a member of the study team met with each participant to go over the recordings and to discuss the changes in exhibited skills evidenced from Time 1 to Time 2. While practice effects are a methodological confound to the assessment of this communication skills training program, financial constraints prevented us from incorporating a control group until external funding can be secured.