A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for Informed Consent in Pediatric Critical Care Research*

Abstract

Objectives: The Heart And Lung Failure—Pediatric INsulin Titration study was experiencing poor subject enrollment due to low rates of informed consent. Heart And Lung Failure—Pediatric INsulin Titration investigators collaborated with the Perelman School of Medicine Standardized Patient Program to explore the novel use of telesimulation with standardized parents to train research staff to approach parents of critically ill children for informed consent. We describe the feasibility, learner acceptance, and financial costs of this novel intervention and performed a post hoc analysis to determine if this intervention improved study consent rates. Design: Observational, comparative effectiveness study. Setting: Heart And Lung Failure—Pediatric INsulin Titration study enrolling sites. Subjects: Research staff (at the remote site). Interventions: Individual 90-minute Skype telesimulation sessions with standardized parent and simulation facilitator (at the training site). Measurements and Main Results: Forty telesimulation sessions with 79 Heart And Lung Failure—Pediatric INsulin Titration research staff (participants) at 24 remote sites were conducted. Despite some technical delays, 40 out of 40 simulations (100%) were completed. Based on feedback surveys, 100% of respondents agreed (81% strongly agreed) that telesimulation sessions achieved intended learning objectives to prepare research staff to approach parents of eligible critically ill children to obtain informed consent. Additionally, 100% of respondents agreed (74% strongly agreed) that they would use lessons from the telesimulation when approaching parents to obtain informed consent for research. Telesimulation with standardized parents achieved lower financial costs (approximately $85 per session) compared with traditional in-person site visits for training research staff. There was no significant improvement in study consent rates with the intervention (pre: 46% vs post: 48%; p = 0.78). Conclusions: Remote telesimulation with standardized parents is feasible, acceptable, and associated with lower financial costs to prepare research staff to obtain informed consent from parents of critically ill children eligible for clinical research trials. Despite this novel approach, Heart And Lung Failure—Pediatric INsulin Titration study consent rates did not improve, suggesting that other factors influence parental consent and decision making in complex multicenter clinical research trials.

A practical guide for translating in-person simulation curriculum to telesimulation

“…The telesimulation curriculum presented in this article has been successfully applied to learners ( n = 2989) with minimal disruption and/or technical difficulties; however, it is important to highlight the fact that telesimulation in the format presented in this paper is time-consuming and more expensive than conducting in-person simulations. Other studies and reports on telesimulation have underlined its feasibility and proposed it as a low-cost alternative to provide training during the pandemic [ 13 ]; however, our experience suggests that telesimulation could become quite expensive with large student cohorts (more than 250 learners). The requirements to ensure active and engaged participation of the learners during telesimulation, such as small 6–8 student groups (compared to our typical 15–20 student groups during our in-person simulation), as well as the need for personal backup able to react quickly in case of technical or connection difficulties, all contribute to the necessity of securing appropriate resources.…”

“…Part of the in-person SPs simulation program for medical undergraduate students at the University of Montreal was modified and adapted to meet the logistic and learning requirements for a new telesimulation curriculum. Unlike most of the experiences documented in the literature, which describe the use of mannequin-based telesimulation to train technical skills at a distance, the competencies of the telesimulation program reported in this paper focused on communication skills for which the SP method was adopted [ 13 ]. The main objective of the telesimulation curriculum described here was to provide communication and clinical reasoning skills training for first, second, and third-year medical students during the COVID-19 pandemic.…”

“…Telesimulation is an emerging educational modality in which telecommunication and simulation resources are utilized together to build knowledge and provide skills training and/or assessment to learners at an off-site location [ 10 – 12 ]. It allows learners to have real-time interaction with instructors, standardized patients (SPs) [ 13 , 14 ], and/or mannequins, usually via videoconferencing tools. Telesimulation represents a unique opportunity to expand simulation training beyond the simulation centers and to overcome economic and geographical barriers, allowing not only local but also intercontinental experiences to happen, which otherwise would require more time, effort, and money or that would simply not be feasible [ 11 , 15 , 16 ].…”

Knowledge and Attitudes of Chinese Medical Researchers Toward Electronic Informed Consent in Clinical Research: A Cross-sectional Study

“…Some studies have shown that eIC provides location exibility by allowing researchers to obtain informed consent from prospective research participants in an online format, such as remote videoconferencing, rather than being limited to taking place onsite [46]. The remote eIC can improve the recruitment e ciency for some clinical investigations and reduce the costs of travel and time [25]. In a randomized trial of patients with emergent large vessel occlusion strokes, eIC streamlined the consenting process by reducing distance and time [47].…”

“…In terms of studies on subjects, for example, many scholars in the United States have conducted studies on one or more of these aspects of eIC, such as recruitment rate[18], information informativeness [19], understanding [20,21], satisfaction [22,23], and participation decision [24]. A survey of medical researchers found that pediatric critical care researchers had a positive attitude toward the usability of eIC [25]. However, a study has shown that some clinical trial researchers may not consider using eIC in the future [26].…”